PharmaGazette: July 2006 Archives

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Jul31	FDA Approves Barrier Therapeutics' Xolegel™ For Treatment of Seborrheic Dermatitis Gloria Gamat July 31, 2006 Know More: Drug Regulations & Approval The USFDA has approved Xolegel™ (ketoconazole, USP) Gel, 2% for the topical treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older. Seborrheic dermatitis is a chronic inflammatory skin condition, whose cause is still unknown, but is associated with yeast infections, and other genetic and hormonal factors. Individuals with disorders of the central nervous system also appear to be prone to more extensive cases of seborrheic dermatitis. "There are approximately 8.5 million people in the U.S. that suffer with seborrheic dermatitis and having this new convenient treatment option available to manage the symptoms associated with the disease should be of significant benefit for both physicians and patients," stated Al Altomari, Barrier's Chief Operating Officer. Xolegel, previously referred to as Sebazole, is a topical formulation of 2.0% ketoconazole, an antifungal agent, in waterless gel. It will be launched during the fourth quarter of 2006, making it the third product to be launched in the US by Barrier Therapeutics (BTRX) this year. Source: Barrier Therapeutics Posted at 4:20 AM \| Permalink \| Comments
Jul31	Schering-Plough Corp.’s SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the Substitution Treatment of Opioid Dependence, Received Positive Opinion from the EU Advisory Panel Gloria Gamat July 31, 2006 Schering-Plough Corporation (NYSE: SGP)’s SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the substitution treatment of opioid dependence, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), thereby recommending... Continue Reading Posted at 3:14 AM \| Permalink \| Comments
	Roche’s Cancer Drug Tarceva (erlotinib), Received Negative Opinion from the EU Advisory Panel Gloria Gamat July 31, 2006 Roche’s cancer medicine Tarceva (erlotinib), has received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) for use in combination with gemcitabine chemotherapy for the first line treatment of advanced pancreatic cancer. In spite of... Continue Reading Posted at 2:05 AM \| Permalink \| Comments
	USFDA Approved sNDA for Novartis Pharma Corp.’s Antiviral Agent Famvir® Gloria Gamat July 31, 2006 Novartis Pharmaceuticals Corporation's sNDA for Famvir® (famciclovir) tablets has been approved by the USFDA as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH). "Famvir is the first and only antiviral approved to treat recurrent genital herpes in... Continue Reading Posted at 12:51 AM \| Permalink \| Comments
Jul30	NDA of UCB, Inc.’s Xyzal®, Submitted to the USFDA Gloria Gamat July 30, 2006 Xyzal® (levocetirizine dihydrochloride) is UCB, Inc. (Public, EBR: UCB)’s new prescription antihistamine for treatment of allergy symptoms, by which the company has recently submitted USFDA New Drug Application (NDA) of. Xyzal®, while already available in many countries around the world,... Continue Reading Posted at 9:43 PM \| Permalink \| Comments
	Dainippon Sumitomo Pharma Partners With Bristol-Myers K.K. On Anti-Hypertension And Hepatocellular Cancer Drugs Gloria Gamat July 30, 2006 Japanese firm Dainippon Sumitomo Pharma (DSP) and Bristol-Myers K.K. (BMKK) will collaborate to co-develop and market irbesartan, an anti-hypertension drug and SM-11355 (miriplatin hydrate), a drug for hepatocellular cancer. Irbesartan, one of the top selling an angiotensin receptor blockers (ARB),... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Gentope Corp.’s MyVax® Personalized Immunotherapy Phase 3 Trial, Recommended to Proceed by DSMB Gloria Gamat July 30, 2006 Genitope Corporation (Nasdaq: GTOP)’s independent Data Safety Monitoring Board (DSMB) has recommended after a review, that the company’s pivotal Phase 3 clinical trial of MyVax® for treatment of follicular non-Hodgkin's Lymphoma (fNHL) should go ahead as planned. The trial which... Continue Reading Posted at 9:16 PM \| Permalink \| Comments
	BioProgress Registers HypoSalix Artificial Saliva Spray For Treatment of Xerostomia Gloria Gamat July 30, 2006 BioProgress plc (BPRG) has registered HypoSalix, an artificial saliva spray, as a medical device in the EU. HypoSalix cotains a polymer that acts as artificial saliva and may be used for the treatment of xerostomia, or dry mouth, a condition... Continue Reading Posted at 1:45 AM \| Permalink \| Comments
	Serono Earmarks $10 Billion in Acquisitions Gloria Gamat July 30, 2006 Swiss biopharmaceutical firm Serono (SRA) is planning to expand through acquisitions, and could spend upt to $10 billion to improve bring more drugs into its pipeline and reduce its dependence on its top-seller, Rebif, a drug against multiple sclerosis. "We... Continue Reading Posted at 12:43 AM \| Permalink \| Comments
Jul29	Annan Urges Pharmaceutical Companies to Review Prices of AIDS Drugs Gloria Gamat July 29, 2006 Urged by U.N. Secretary-General Kofi Annan, nine pharmaceutical companies will review the prices of antiretroviral drugs to make the more affordable and accessible, and appropriate for use in low- and middle income countries. Annan met with the following executives and... Continue Reading Posted at 2:36 PM \| Permalink \| Comments
	Merck's Gardasil Gets Positive Recommendation From EU Advisory Panel Gloria Gamat July 29, 2006 GARDASIL®, the first vaccine against cervical cancer, vaginal and vulvar pre-cancers, and warts, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe. The CHMP recommends that GARDASIL, developed by Merck (MRK), be... Continue Reading Posted at 1:22 PM \| Permalink \| Comments
	USFDA Special Protocol Assessment (SPA) Enables Genta Incorporated to Proceed Trial of Genasense® Plus Chemotherapy in Chronic Lymphocytic Leukemia Gloria Gamat July 29, 2006 Genta Incorporated (Nasdaq: GNTA)’s proposal for a confirmatory trial of Genasense® (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia (CLL) has completed USFDA Special Protocol Assessment (SPA). This means that the USFDA has agreed with the proposed trial design... Continue Reading Posted at 6:15 AM \| Permalink \| Comments
	Somaxon Pharmaceuticals, Inc.’s Oral Nalmefene Passed Pilot Phase 2 Study in Smoking Cessation Gloria Gamat July 29, 2006 Oral nalmefene hydrochloride, an opiate antagonist under development by Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), demonstrated positive results in a pilot Phase 2 clinical trial for smoking cessation. Smokers dosed with nalmefene 40mg demonstrated numerically higher abstinence rates at all timepoints... Continue Reading Posted at 4:05 AM \| Permalink \| Comments
	AstraZeneca’s NEXIUM®: Better than Lansoprazole in Healing Maintenance of Erosive Esophagitis Gloria Gamat July 29, 2006 NEXIUM® (esomeprazole magnesium) demonstrated better efficacy than lansoprazole (Prevacid®) in preventing a recurrence in patients with healed erosive esophagitis (EE) and is equally effective in reducing its associated symptoms. These findings support the results of previous head-to-head trials demonstrating the... Continue Reading Posted at 2:45 AM \| Permalink \| Comments
	Altor BioScience Corp. Received Phase II SBIR Grant for Manufacture of Anti-Cancer Antibody from Transgenic Lettuce Gloria Gamat July 29, 2006 Altor BioScience Corporation has received a Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to support further development of its proprietary processes for making therapeutic antibodies in transgenic lettuce. Lettuce, a self-pollinating, ecologically friendly... Continue Reading Posted at 1:10 AM \| Permalink \| Comments
	Genentech, Inc. & Inotek Pharma Corp. Agreed on a Global Strategic Alliance for the Discovery, Development and Commercialization of PARP Cancer Inhibitors Gloria Gamat July 29, 2006 Genentech, Inc. (NYSE: DNA) and Inotek Pharmaceuticals Corporation have entered into an exclusive global collaboration to discover, develop, manufacture and commercialize inhibitors of poly (ADP-ribose) polymerase (PARP) for the potential treatment of cancer. PARP, a nuclear enzyme within cells, directs... Continue Reading Posted at 12:23 AM \| Permalink \| Comments
Jul28	FDA Approves Enzon Pharmaceutical's sBLA for Oncaspar Against Acute Lymphoblastic Leukemia Gloria Gamat July 28, 2006 The US FDA has approved of Enzon Pharmaceuticals, Inc.'s (ENZN) supplemental Biologics License Application (sBLA) for Oncaspar (pegaspargase), a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). Oncaspar, a PEG enhanced version of L-asparaginase,... Continue Reading Posted at 6:50 AM \| Permalink \| Comments
	Avalon Collaborates with ChemDiv To Develop Small-Molecule Drugs Against Cancer Gloria Gamat July 28, 2006 Avalon Pharmaceuticals (AVRX) is collaborating with ChemDiv to discover, develop and commercialize small-molecule drugs for cancer. Under the terms of the deal, Avalon will use its AvalonRx® platform, and access ChemDiv's Discovery outSource™ services platform, as well. Avalon also gains... Continue Reading Posted at 4:46 AM \| Permalink \| Comments
	Shanghai Genomics Collaborates with Centocor on Drug Discovery Project Gloria Gamat July 28, 2006 China-based Shanghai Genomics, Inc enters a one-an-a-half year collaboration with US biopharmaceutical company Centocor, Inc. to develop drugs focusing on inflammation and oncology. Shanghai Genomics will use its expertise in protein purification and cell-based interaction assays to explore receptor protein... Continue Reading Posted at 3:42 AM \| Permalink \| Comments
	Schering-Plough Corp.’s Once-Daily Broad Spectrum Antibiotic: AVELOX®, Equally Effective as Multi-dose Combination Therapy for Intra-abdominal Infections Gloria Gamat July 28, 2006 According to the results of a study involving 681 patients published in the current issue of the Annals of Surgery, monotherapy with Schering-Plough Corporation (NYSE: SGP)’s once-daily, broad-spectrum antibiotic AVELOX® (moxifloxacin HCl) was as effective and well tolerated as a... Continue Reading Posted at 2:29 AM \| Permalink \| Comments
	Genzyme Received USFDA Approval for Additional Manufacturing at its Ireland Plant Gloria Gamat July 28, 2006 The USFDA has approved Genzyme Corporation (Nasdaq: GENZ)’s fill/finishing, packaging and labeling of Thymoglobulin® (anti-thymocyte globulin, rabbit) at its state-of-the-art Waterford, Ireland facility. This approval allows Genzyme to commence the manufacturing and distribution of Thymoglobulin, Genzyme Corp.’s product for the... Continue Reading Posted at 1:24 AM \| Permalink \| Comments
	TorreyPines Therapeutics, Inc.’s NGX267, A Selective M1 Agonist for the Treatment of Alzheimer's Disease (AD), Passed Phase 1 Study Gloria Gamat July 28, 2006 TorreyPines Therapeutics, Inc. has recently completed the second Phase 1 study of its NGX267 in clinical development for the treatment of Alzheimer's disease. NGX267 is a selective cholinergic muscarinic (or M1) receptor agonist that previously demonstrated potential in providing both... Continue Reading Posted at 12:19 AM \| Permalink \| Comments
Jul27	Debiopharm Group’s Sanvar® Applied for First European Marketing in France Gloria Gamat July 27, 2006 The Debiopharm Group (Debiopharm) has filed a French Marketing Authorization Application (MAA) for Sanvar® in the treatment of esophageal variceal bleeding (EVB). Following this application, Debiopharm intends to further apply for wider European approval through the Mutual Recognition Procedure (MRP)... Continue Reading Posted at 9:05 PM \| Permalink \| Comments
	L'Oreal USA’s New Sunscreen Formula Containing Mexoryl™ SX, USFDA Approved Gloria Gamat July 27, 2006 The U.S. subsidiary of the global beauty company L'Oreal SA (Public, EPA:OR), L'Oreal USA, has been granted USFDA approval for its new sunscreen formula containing Mexoryl™ SX (a unique organic filter that is highly protective against short UVA waves) –... Continue Reading Posted at 8:41 PM \| Permalink \| Comments
	Cobalis Begins Twin Phase III Clinical Trials for PreHistin Against Ragweed Allergies Gloria Gamat July 27, 2006 Cobalis Corp. (CLSC) has started enrolling patients for its twin Phase III clinical trials to assess the efficacy and safety of its anti-allergy drug, PreHistin™, as a pre-seasonal treatment of ragweed allergies. Approximately 1,600 to 2,000 patients in total will... Continue Reading Posted at 6:33 AM \| Permalink \| Comments
	7th Annual Drug Discovery and Technology Leaders Summit Gloria Gamat July 27, 2006 What: 7th Annual Drug Discovery and Technology Leaders Summit When: November 13-15, 2006 Where: JW Marriott, Grande Lakes, Orlando, USA This exclusive event expects over a hundred senior-level R&D and information management decision-makers from leading pharmaceutical and biotechnology companies, including... Continue Reading Posted at 4:30 AM \| Permalink \| Comments
	Novartis/Sandoz Enters Agreement with Momenta Pharmceuticals to Develop Generic Biotech Drugs Gloria Gamat July 27, 2006 Sandoz, the generics arm of Novartis (NYSE:NVS), has entered into an agreement with Momenta Pharmaceuticals (NASDAQ: MNTA) to develop generic versions of four existing recombinant biotechnology and complex drugs. As part of the deal, Sandoz is making an $75 million equity... Continue Reading Posted at 2:25 AM \| Permalink \| Comments
	Novartis’ Immunosuppressant Neoral® Demonstrated Equal Efficacy with Tacrolimus in Kidney Transplant Patients Gloria Gamat July 27, 2006 In a large-scale head- to-head study, Neoral® (cyclosporine) and tacrolimus demonstrated equal efficacy in the prevention of organ rejection in kidney transplant patients. However, those treated with Neoral had a significantly lower incidence of new-onset diabetes. These study results, suggesting... Continue Reading Posted at 1:14 AM \| Permalink \| Comments
	Mylan Technologies Inc. Received US Patent Covering EMSAM® Transdermal Product Gloria Gamat July 27, 2006 Mylan Laboratories Inc. (NYSE: MYL)’s subsidiary, Mylan Technologies Inc. (MTI), has been recently issued with U.S. Patent No. 7,070,808, a patent containing one or more claims covering the EMSAM® transdermal product that is indicated for the treatment of major depressive... Continue Reading Posted at 12:51 AM \| Permalink \| Comments
	Pharmaxis Ltd. Filed Marketing Application for Aridol in Switzerland Gloria Gamat July 27, 2006 Pharmaxis Ltd. (Nasdaq: PXSL) has recently lodged the registration documents for marketing approval of its asthma management product (Aridol) with the Swiss regulatory agency for therapeutic products, Swissmedic. Trimedal AG, a specialist respiratory and allergy pharmaceutical company based in Zurich... Continue Reading Posted at 12:04 AM \| Permalink \| Comments
Jul26	Shire plc’s ELAPRASE™, USFDA Approved for Treatment of Hunter Syndrome Gloria Gamat July 26, 2006 The USFDA has granted approval to Shire plc (NASDAQ: SHPGY)’s ELAPRASE™, a human enzyme replacement therapy for the treatment of Hunter syndrome. Hunter Syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare, life-threatening genetic condition that results from... Continue Reading Posted at 8:30 PM \| Permalink \| Comments
	USPTO Issued Patent for Method to Manufacture Immtech Pharma Inc.’s Drug Candidate Compounds Gloria Gamat July 26, 2006 The United States Patent and Trademark Office (USPTO) has recently issued to Immtech Pharmaceuticals, Inc. (Amex: IMM) a patent related to the manufacturing of Immtech's drug candidate compounds. The patent, entitled "Process for the synthesis of bis-aryl diamidoxime compounds," claims... Continue Reading Posted at 7:59 AM \| Permalink \| Comments
	Shire plc Submitted NDA for SPD465, Treatment of Adult ADHD Gloria Gamat July 26, 2006 Shire plc (NASDAQ: SHPGY) has submitted a new drug application (NDA) to the USFDA for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population. SPD465, though containing the same active ingredient as ADDERALL... Continue Reading Posted at 6:46 AM \| Permalink \| Comments
	Lilly and Alcon Signed Marketing Collaboration for Arxxant™, A Potential First Oral Medication for Diabetic Retinopathy Gloria Gamat July 26, 2006 Eli Lilly and Company (NYSE: LLY) and Alcon, Inc. (NYSE: ACL) have recently signed a long-term agreement to co-promote ruboxistaurin mesylate (proposed brand name, Arxxant™, pronounced ark-ZONT) in the United States and Puerto Rico. The above co-promotion agreement is subject... Continue Reading Posted at 5:43 AM \| Permalink \| Comments
	Carrington and Brookwood Pharmaceuticals Joined Forces to Expand The Development of GelSite® Drug Delivery Technology Gloria Gamat July 26, 2006 DelSite Biotechnologies, Inc. (a subsidiary of Carrington Laboratories, Inc. (Nasdaq:CARN)) has entered into a joint development initiative with Brookwood Pharmaceuticals, Inc. in order to carry out an expanded evaluation of GelSite® (a DelSite patented drug-delivery technology) as a matrix for... Continue Reading Posted at 2:56 AM \| Permalink \| Comments
	Foamix's Valerate 0.12% foam Demonstrated High Efficacy in Psoriasis Treatment and 85% Better Usability over Cream in Phase I/II Study Gloria Gamat July 26, 2006 Foamix Ltd. recently announced the results of its Phase I/II study of Betamethasone Valerate 0.12% foam, for the treatment of psoriasis which demonstrated efficacy and safety. The foam was also found better than other creams with respect to skin absorption,... Continue Reading Posted at 1:34 AM \| Permalink \| Comments
	Oscient Pharmaceuticals To Acquire US Rights to Cardiovascular Drug ANTARA For $78 Million Gloria Gamat July 26, 2006 Oscient Pharmaceuticals (OSCI) has acquired US commercialization rights to cardiovascular drug Antara 130 mg (fenofibrate) capsules from Reliant Pharmaceuticals. Oscient will pay Reliant an upfront fee of $78 million for the agreement. "Acquiring ANTARA, a product that achieved approximately $35 million... Continue Reading Posted at 12:32 AM \| Permalink \| Comments
	TissueGene, Inc. Commences Phase I Clinical Trial of its Tissue Regenerator, TG-C Gloria Gamat July 26, 2006 TissueGene, Inc.’s Investigational New Drug (IND) application and for the initiation of its Phase I clinical trial evaluating a single dose of TG-C for the treatment of degenerative joint diseases, has been accepted by the USFDA. The said clinical trial... Continue Reading Posted at 12:22 AM \| Permalink \| Comments
Jul25	Human Genome Sciences, Inc. Commenced Randomized Phase 2 Clinical Trial of HGS-ETR1 in Combination With Bortezomib in Multiple Myeloma Patients Gloria Gamat July 25, 2006 Human Genome Sciences, Inc. (Nasdaq: HGSI) recently initiated dosing of patients in a randomized Phase 2 clinical trial of HGS-ETR1 (mapatumumab) in combination with bortezomib (VELCADE®) in advanced multiple myeloma. Bortezomib is a proteosome inhibitor indicated for use in multiple... Continue Reading Posted at 10:01 PM \| Permalink \| Comments
	Serono Initiates Large Scale European Clinical Study of Psoriasis Drug, Raptiva® Gloria Gamat July 25, 2006 Serono (SRA) announced that it has begun with the first large-scale pharmaco-epidemiological study in psoriasis in Europe to study the long-term safety of Raptiva®, a psoriasis drug. There were more than 7,000 adult patients with moderate-to-severe plaque psoriasis recruited for the... Continue Reading Posted at 10:28 AM \| Permalink \| Comments
	Multiple Sclerosis Drug Tysabri®, Re-released in US Pharmacies Gloria Gamat July 25, 2006 After 17 months of being on hold, Tysabri®, a drug for multiple sclerosis, is now available in US pharmacies. According to this article, Tysabri was taken off the market in early 2005 following two deaths resulting from brain inflammation in... Continue Reading Posted at 8:23 AM \| Permalink \| Comments
	The U.S. Government Purchased GlaxoSmithKline’s Relenza® for State Stockpiles Gloria Gamat July 25, 2006 GlaxoSmithKline (NYSE:GSK) has entered into an agreement with the U.S. Government to provide states with the anti-viral Relenza® (zanamivir for inhalation) in preparation for a potential influenza pandemic. The Department of Health and Human Services (HHS) has guaranteed the initial... Continue Reading Posted at 4:54 AM \| Permalink \| Comments
	Spanish Research Provided More Evidence that Red Grape Juice Has Heart Health Benefits Gloria Gamat July 25, 2006 According to a Spanish research, red grape juice improved the cholesterol levels and inflammatory markers associated with heart disease in both healthy subjects and those that are at a higher risk of cardiovascular complications, the hemodialysis patients. While pervious research... Continue Reading Posted at 2:37 AM \| Permalink \| Comments
	YM BioSciences’ Anti-EGFr Drug, Nimotuzumab, Approved in India for Head and Neck Cancer Treatment Gloria Gamat July 25, 2006 YM BioSciences Inc. (AMEX: YMI) reported that 's Drug Controller General has granted marketing approval to nimotuzumab (an anti-EGFr monoclonal antibody) for the treatment of head & neck cancer. Biocon Biopharmaceuticals Ltd., a joint venture between Biocon (NSE:BIOCON) and CIMAB... Continue Reading Posted at 12:23 AM \| Permalink \| Comments
Jul24	Product Recall: Single Lot of Berlex Inc.’s Ultravist® Injection 370 mgI/mL, 125 mL in the United States Gloria Gamat July 24, 2006 Berlex, Inc. initiated the nationwide recall of a single lot (No. 41500A) of its intravenous X-ray contrast agent, Ultravist® Injection 370 mgI/mL, 125 mL (iopromide injection) NDC 50419-246-12, EXP 01/2007 because of the presence of particulate matter in conjunction with... Continue Reading Posted at 7:11 AM \| Permalink \| Comments
	PhosLo® (calcium acetate) Demonstrated Superior Serum Phosphorus Control Over Sevelamer Gloria Gamat July 24, 2006 Nabi Pharmaceuticals (Nasdaq: NABI) recently announced the results of a study that further demonstrated that PhosLo® (calcium acetate) provides superior control of serum phosphorus (a key determinant of morbidity and mortality among end-stage renal disease (ESRD) patients) when compared to... Continue Reading Posted at 6:04 AM \| Permalink \| Comments
	Warning on Dangers of Excess Acetaminophen, Issued by the American Liver Foundation Gloria Gamat July 24, 2006 The American Liver Foundation (ALF) recently issued a warning based on a recent study on the effects of high doses of the popular pain reliever acetaminophen on one’s liver. The recent study (published in the Journal of the American Medical... Continue Reading Posted at 3:58 AM \| Permalink \| Comments
	VivaGel ™’s Clinical Development IND for Prevention of Genital Herpes Cleared by USFDA Gloria Gamat July 24, 2006 Starpharma Holdings Limited (SPL)’s Investigational New Drug application (IND) for the clinical development of SPL7013 gel (VivaGel™) for prevention of genital herpes has been cleared by the USFDA. The company can now proceed with the first microbicide clinical development program... Continue Reading Posted at 2:46 AM \| Permalink \| Comments
	Ovation Pharmaceuticals Launches NeoProfen For the Treatment of Patent Ductus Arteriosus Gloria Gamat July 24, 2006 Ovation Pharmaceuticals has launched a novel drug to treat a potentially life-threatening congenital heart defect in premature infants, called Patent Ductus Arteriosus (PDA). PDA a condition in which a blood vessel (ductus arteriosus) in the heart fails to close after... Continue Reading Posted at 2:39 AM \| Permalink \| Comments
	FDA Approves of Pearly Pigments To Color Medicines Gloria Gamat July 24, 2006 Eight years after the petition was filed, the USFDA has approved the use of special mica-based pigments on pills, tablets and liquids, giving medicines a unique pearly sheen similar to those seen on cosmetics. The pigments, made by coating the... Continue Reading Posted at 1:29 AM \| Permalink \| Comments
Jul23	FDA Warns Consumers Against Bismacine/Chromacine Gloria Gamat July 23, 2006 Following the report of a death and several other injuries, the FDA is warning consumers and health care professionals not to use "Bismacine", also known as "Chromacine". Bismacine is an injectable product supposedly against Lyme disease, and is prescribed or... Continue Reading Posted at 11:53 PM \| Permalink \| Comments
	Long-Term Ibuprofen Treatment After Brain Injury Worsens Cognitive Abilities Gloria Gamat July 23, 2006 Ibuprofen is a common pain reliever prescribed to patients following head injuries to alleviate chronic pain. In a preliminary animal-model study, however, researchers from the University of Pennsylvania School of Medicine found out the long-term ibuprofen therapy after traumatic brain... Continue Reading Posted at 11:45 PM \| Permalink \| Comments
	FDA Approves AstraZeneca's Symbicort® For Asthma Maintenance Therapy Gloria Gamat July 23, 2006 The USFDA has approved AstraZeneca (AZN)'s SYMBICORT® (budesonide/formoterol) for the maintenance treatment of asthma in patients age 12 and older. SYMBICORT is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one inhaler.... Continue Reading Posted at 11:09 PM \| Permalink \| Comments
	FDA Warning: Migraine Drugs and Antidepressants are a Dangerous Combination Gloria Gamat July 23, 2006 On Wednesday, July 19, the USFDA warned patients and consumers that the use of some migraine drugs, called triptans, with certain antidepressants can cause a fatal condition in which patients experience hallucinations, overactive reflexes and rapid heart beat. Such antidepressants... Continue Reading Posted at 2:02 AM \| Permalink \| Comments
	Data on CONCERTA® (methylphenidate HCl) Extended-release Tablets Formulation, Presented by McNeil Pediatrics Gloria Gamat July 23, 2006 As part of an information exchange on "Progress in Creating New Drug Formulations that Discourage Tampering and Abuse”, The U.S. Department of Health and Human Services' Substance Abuse and Mental Health Services Administration (SAMHSA) has invited McNeil Pediatrics (a division... Continue Reading Posted at 12:57 AM \| Permalink \| Comments
Jul22	Antileukotrienes and Inhaled Corticosteroids Combo, Effectively Treats Asthma Gloria Gamat July 22, 2006 A new study entitled "Bronchial responsiveness to leukotriene D4 is resistant to inhaled fluticasone propionate", provides support that the combined therapy of inhaled corticosteroids and antileukotriene drugs treat asthma. Study results showed that although the fluticasone propionate therapy vs. placebo... Continue Reading Posted at 4:47 AM \| Permalink \| Comments
	Tranzyme Pharma Receives Notice of Allowance from USPTO on Patent Protecting Macrocyclic Template Chemistry Platform Gloria Gamat July 22, 2006 The U.S. Patent and Trademark Office (USPTO) has granted a Notice of Allowance to Tranzyme Pharma for its patent application entitled "Combinatorial Synthesis of Libraries of Macrocyclic Compounds." The patent protects key aspects of the Company's core drug-design platform, Macrocyclic... Continue Reading Posted at 3:39 AM \| Permalink \| Comments
	Gilead Sciences Buys Corus Pharma for $365 Million Gloria Gamat July 22, 2006 Gilead Sciences, Inc.(GILD) has agreed to buy out Corus Pharma, a privately-held, venture capital backed company specializing on therapeutics for respiratory and infectious diseases, for $365 million. Concurrently, Gilead and Novartis Vaccine and Diagnostics, Inc. have entered into an agreement... Continue Reading Posted at 2:30 AM \| Permalink \| Comments
	Clinical Trials Review Suggests that Calcium Supplementation Could Reduce Pre-eclampsia in Pregnancy Gloria Gamat July 22, 2006 According to a new review of clinical trials, increased intake of calcium supplements can reduce the risk of hypertension and pre-eclampsia during pregnancy. This finding may lead to a review and probably revision of current recommendations like that of the... Continue Reading Posted at 1:19 AM \| Permalink \| Comments
	Ranbaxy Laboratories Ltd. Acquires GSK’s Mundogen Generic Business in Spain Gloria Gamat July 22, 2006 India’s largest pharmaceutical company and one of the top ten generic pharmaceutical companies in the world, Ranbaxy Laboratories Limited (Ranbaxy), recently announced that the company has acquired Mundogen generic business of GlaxoSmithKline (GSK) in Spain, throught its Spanish subsidiary, Laboratorios Ranbaxy... Continue Reading Posted at 12:12 AM \| Permalink \| Comments
Jul21	MRI Revealed Donepezil Slows Brain Shrinkage Leading to Alzheimer’s Disease Gloria Gamat July 21, 2006 According to a new Mayo Clinic study, the drug donepezil (as shown by MRI) measurably slows the rate of brain shrinkage in some patients with mild cognitive impairment, a condition prior to Alzheimer’s disease. The MRI study is an adjunct... Continue Reading Posted at 4:29 AM \| Permalink \| Comments
	Diabetes Drug is Potential Cure of Alzheimer’s Disease Gloria Gamat July 21, 2006 Alzheimer’s disease (AD) brings impaired thinking and memory, affecting up to 4.5 million older Americans. Treatment of high blood sugar probably has a connection to memory loss that could one day benefit these millions of AD sufferers. In fact it... Continue Reading Posted at 3:17 AM \| Permalink \| Comments
	Ashton Pharmaceuticals Ltd., Inyx Inc.’s U.K. Subsidiary: Selected to Produce Generic Drugs for EU Markets Gloria Gamat July 21, 2006 Inyx, Inc.’s wholly owned U.K. subsidiary (Ashton Pharmaceuticals Ltd.) has been selected by a leading Indian specialty pharmaceutical company to manufacture a range of generic drugs for the United Kingdom and other European countries. Initially, Ashton will provide process transfer... Continue Reading Posted at 2:11 AM \| Permalink \| Comments
	Exelon® Patch: First Transdermal Therapy for Alzheimer's Disease Gloria Gamat July 21, 2006 Data from a 1,195-patient trial demonstrate that Exelon® Patch (rivastigmine transdermal patch) may be a potential treatment approach for the management of Alzheimer's Disease. The results of the study, which were presented at the ongoing International Conference on Alzheimer's Disease... Continue Reading Posted at 1:47 AM \| Permalink \| Comments
	Ranbaxy to Sell Generic Psychotherapeutic Drug Risperidone in Canada Gloria Gamat July 21, 2006 Ranbaxy Pharmaceuticals Canada Inc., a subsidiary of India-based Ranbaxy Laboratories Limited (RLL) will tie up with Janssen-Ortho Inc. for the licensing and supply of a generic version of Risperidone compressed tablets in Canada. Sold under the label Ran™ Risperidone, the... Continue Reading Posted at 12:42 AM \| Permalink \| Comments
Jul20	Anti-Herpes Drug Valtrex Reduces C-sections Rates in Infected Women Gloria Gamat July 20, 2006 Current medical protocol offers Cesarian sections to pregnant women with active genital herpes lesions at the time of delivery. To study antivirap suppression of herpes during late stage pregnancy, a randomized clinical trial was conducted, where women were given valacyclovir... Continue Reading Posted at 4:38 AM \| Permalink \| Comments
	European Patent Office Will Soon Grant Patent Decision to Celator Pharma’s CombiPlex™ Technology for Developing Fixed-ratio Combination Chemotherapies Gloria Gamat July 20, 2006 Celator Pharmaceuticals, Inc. has received confirmation that the Examining Division of the European Patent Office intends to grant a European patent covering the company's proprietary CombiPlex™ technology. "This decision represents a major milestone for Celator, offering us broad protection for multiple... Continue Reading Posted at 3:33 AM \| Permalink \| Comments
	FDA Warning: "Dietary Supplements" Promoted for Sexual Enhancement Contain Dangerous Ingredients Gloria Gamat July 20, 2006 Last week the USFDA has issued a warning to consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON: products that are being promoted and sold on websites as "dietary supplements" for treating erectile dysfunction (ED)... Continue Reading Posted at 2:24 AM \| Permalink \| Comments
	Pycnogenol Found More Effective than Conventional Drug in the Treatment of Chronic Venous Insufficiency (CVI) Gloria Gamat July 20, 2006 Pycnogenol, the French pine bark extract has demonstrated more effectivity in a new study against conventional drug in reducing the symptoms of chronic venous insufficiency (CVI). CVI is caused by leg veins' inability to pump blood back to the heart... Continue Reading Posted at 1:19 AM \| Permalink \| Comments
	Archemix Corp. Engaged in Strategic Alliance with Elan Corp. to Discover and Develop Aptamer Therapeutics Gloria Gamat July 20, 2006 Archemix Corporation has entered into a multi-year, multi-product alliance with Elan Corporation plc that will focus on the discovery, development, and commercialization of first-in-class aptamer therapeutics to treat autoimmune disease. The alliance of the two companies will seek to develop... Continue Reading Posted at 12:02 AM \| Permalink \| Comments
Jul19	Alexion Pharmaceuticals, Inc. Purchased Rhode Island Biopharmaceutical Manufacturing Site For Production of Soliris™ Gloria Gamat July 19, 2006 Alexion Pharmaceuticals, Inc. has purchased the former Dow manufacturing facility in Smithfield, Rhode Island which the company will use primarily in the production of Soliris™ (eculizumab). Soliris™ is the company's lead product candidate for Paroxysmal Nocturnal Hemoglobinuria (PNH), an acquired... Continue Reading Posted at 4:55 AM \| Permalink \| Comments
	Mylan Lab Inc.’s Amlodipine Besylate and Benazepril Hydrochloride Capsules, Granted USFDA Tentative Approval Gloria Gamat July 19, 2006 Mylan Laboratories, Inc. has been granted tentative approval by the USFDA for its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate and Benazepril Hydrochloride Capsules, 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg and 10 mg... Continue Reading Posted at 3:50 AM \| Permalink \| Comments
	Zelapar, Now Available for Parkinson's Disease Patients in the US Gloria Gamat July 19, 2006 Valeant Pharmaceuticals International announced that Zelapar (selegiline HCl) Orally Disintegrating Tablets will be available in US pharmacies nationwide starting on July 19, 2006. The new drug formulation is the first treatment for Parkinson's disease which uses a novel oral delivery... Continue Reading Posted at 2:46 AM \| Permalink \| Comments
	Nastech Pharma Co.’s Calcitonin-Salmon Nasal Spray: Not Approvable This Time, Says USFDA Gloria Gamat July 19, 2006 A USFDA written notification dated July 10, 2006 was received by Nastech Pharmaceutical Company Inc. stating that Nastech's abbreviated new drug application (ANDA) for intranasal calcitonin-salmon spray is not approvable at this time. Nastech's formulation of calcitonin-salmon nasal spray was... Continue Reading Posted at 1:34 AM \| Permalink \| Comments
	Nabi Biopharmaceuticals’ Nabi-HB™ Intravenous Received Positive Opinion from USFDA Blood Products Advisory Committee (BPAC) Gloria Gamat July 19, 2006 The Blood Products Advisory Committee (BPAC) of the USFDA gave a positive opinion of Nabi Biopharmaceuticals’ Biologic License Application (BLA) for Nabi-HB™ Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] in last week’s meeting. Nabi-HB™ Intravenous’ BLA has been submitted by... Continue Reading Posted at 12:30 AM \| Permalink \| Comments
Jul18	Vectomega®, A Revolutionary Omega-3 Phospholipid Complex (DHA/EPA) Showed Positive Health Benefits in Preliminary Human Clinical Trial Gloria Gamat July 18, 2006 Vectomega® is a revolutionary Omega-3 phospholipid complex with DHA/EPA which EuroPharma has obtained North American distribution rights of. This product is molecularly different from other omega-3’s currently on the market because this is 50 times more absorbable across cellular membranes... Continue Reading Posted at 4:22 AM \| Permalink \| Comments
	Nationwide Voluntary Recall of a Single Manufacturing Lot (Lot 558470A) of Azathioprine Tablets in the U.S. and Puerto Rico Initiated by Roxane Lab, Inc. Gloria Gamat July 18, 2006 Last week (13th July), Roxane Laboratories, Inc. started the nationwide recall of a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009). Azathioprine tablets are indicated to help prevent rejection in kidney transplant patients,... Continue Reading Posted at 3:12 AM \| Permalink \| Comments
	Generic Drugs are Significantly Cheaper in the U.S. than in Canada Gloria Gamat July 18, 2006 Millions of Americans have been turning to Canada for lower cost of prescription drugs. Canada regulates its prescription drug prices, often beating U.S. prices on branded drugs by 30% or more. However, a survey conducted by the Federal Drug Administration... Continue Reading Posted at 2:06 AM \| Permalink \| Comments
	FDA Grants Fast Track Designation to Intravenuous Methylnaltrexone Gloria Gamat July 18, 2006 The USFDAhas granted Fast Track designation to an intravenuous form of methylnaltrexone for the treatment of post-operative ileus, a gastrointestinal condition that delays recovery and prolongs hospitalization. Methylnaltrexone is an investigational drug for the treatment of the peripheral side effects of... Continue Reading Posted at 1:01 AM \| Permalink \| Comments
	FDA Approves New Lidocaine/Tetracaine Anesthetic Patch For Dermatological Procedures Gloria Gamat July 18, 2006 The USFDA has approved a new topical local anesthetic patch, S-Caine™ Peel (Lidocaine and Tetracaine) 7%/7% Cream for use as a topical anesthetic patch in dermatological procedures such as dermal filler injections, pulsed dye laser therapy, facial laser resurfacing, and... Continue Reading Posted at 12:38 AM \| Permalink \| Comments
Jul17	Schering AG-Avid Radiopharma Collaboration Will Develop Novel Diagnostic Imaging Agents for Alzheimer's Disease Gloria Gamat July 17, 2006 To develop novel diagnostic imaging agents for Alzheimer's disease, Schering AG, collaborates with Avid Radiopharmaceuticals Inc. The management of Alzheimer’s disease patients and the development of new therapies remain significantly impeded by the lack of current clinical methods for definitive... Continue Reading Posted at 11:32 PM \| Permalink \| Comments
	Roche Collaborates With Actelion To Develop Selective S1P1 Receptor Agonist For AutoImmune Disorders Gloria Gamat July 17, 2006 Swiss biopharmaceutical firm Actelion entered into an agreement with Roche to develop and market S1P1, a drug candidate against autoimmune diseases such as multiple sclerosis, rheumatoid arthritis and Crohn's disease. S1P1 is a receptor agonist under Phase I development. Under... Continue Reading Posted at 10:18 PM \| Permalink \| Comments
	MD&DI’s 50 'Companies to Watch' Includes Baxa Corporation Gloria Gamat July 17, 2006 In its review of the medical device industry, the '50 Companies to Watch' by Medical Device and Diagnostic Industry included the Colorado-based manufacturer of medical devices for health-system pharmacies, Baxa Corporation. The MD&DI magazine chose companies with formidable track records... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
	CuraGen and TopoTarget Commenced Phase I/II Trial of PXD101 for Hepatocellular Cancer (Liver Cancer) Gloria Gamat July 17, 2006 CuraGen Corporation and TopoTarget A/S commenced the patient dosing of PXD101 (a small molecule histone deacetylase (HDAC) inhibitor) in a Phase I/II clinical trial evaluating the safety and potential efficacy of the product for the treatment of inoperable hepatocellular cancer.... Continue Reading Posted at 8:50 PM \| Permalink \| Comments
	FDA Approves Eli Lilly's Gemzar® For Ovarian Cancer Treatment Gloria Gamat July 17, 2006 The USFDA has approved Eli Lilly and Company's drug against recurrent ovarian cancer, Gemzar®, to be used in combination with carboplatin, a widely-used anti-cancer agent. Clinical data showed that the combination of Gemzar and carboplatin increased progression-free survival and response... Continue Reading Posted at 8:09 PM \| Permalink \| Comments
Jul15	LAB International Inc.’s Fentanyl TAIFUN® Passed Phase IIA Clinical Trial Gloria Gamat July 15, 2006 LAB International, Inc. is an integrated drug development company with subsidiaries focused on developing therapies for the inhalation market and on providing contract research services. The company recently announced the positive results for the first phase II trial of Fentanyl... Continue Reading Posted at 2:51 AM \| Permalink \| Comments
	Sanofi-Aventis’ AMBIEN CR™ (zolpidem tartrate extended- release) Tablets C(IV), Effective and Safe to Use for up to 24 Weeks in Insomnia Patients Gloria Gamat July 15, 2006 Study of Sanofi-Aventis’ AMBIEN CR™ showed that the product is well-tolerated and effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia when taken as needed for up to seven nights per... Continue Reading Posted at 1:45 AM \| Permalink \| Comments
	Rolling NDA of GPC Biotech’s Satraplatin (Lead Oncology Drug Candidate), In Progress Gloria Gamat July 15, 2006 GPC Biotech AG submitted the non-clinical section of the rolling submission of a USFDA New Drug Application (NDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). The CMC (chemistry, manufacturing... Continue Reading Posted at 12:39 AM \| Permalink \| Comments
Jul14	Alfacell Corp. Collaboration Will Produce Novel Fusion Protein Against non-Hodgkin’s Lymphoma (NHL) Gloria Gamat July 14, 2006 Alfacell Corporation went into a new collaboration with the West German Cancer Center at the University of Duisburg-Essen for the development, characterization and large-scale production of a novel fusion protein for non-Hodgkin's lymphoma (NHL), consisting of ONCONASE® (ranpirnase) and a... Continue Reading Posted at 4:34 AM \| Permalink \| Comments
	Procter & Gamble Pharmaceuticals and ARYx Therapeutics, Agreed to Develop an Investigational Treatment for Gastrointestinal Disorders Gloria Gamat July 14, 2006 A division of The Procter & Gamble Company, Procter & Gamble Pharmaceuticals, Inc. has entered into a strategic alliance with ARYx Therapeutics to develop and commercialize ARYx's novel drug (ATI-7505) for the treatment of gastrointestinal disorders (like gastroesophageal reflux disease... Continue Reading Posted at 3:29 AM \| Permalink \| Comments
	Portola Pharma, Inc. Commenced Phase II Clinical Trial of Factor Xa Inhibitor Gloria Gamat July 14, 2006 Portola Pharmaceuticals, Inc. commenced the Phase II clinical trial of its oral Factor Xa inhibitor for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing knee replacement surgery. "This candidate selectively inhibits Factor Xa, a... Continue Reading Posted at 2:19 AM \| Permalink \| Comments
	GlaxoSmithKline’s Avandamet® (Rosiglitazone Maleate and Metformin HCl), USFDA Approved as Initial Therapy in Type 2 Diabetes Treatment Gloria Gamat July 14, 2006 GlaxoSmithKline’s Avandamet® (rosiglitazone maleate and metformin HCl) has been granted USFDA approval for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet® was previously approved as a second-line therapy in patients who were... Continue Reading Posted at 1:13 AM \| Permalink \| Comments
	ZymoGenetics Begins Phase 1 Trial of IL-21 and Rituxan® Combo in Patients with Non-Hodgkin's Lymphoma Gloria Gamat July 14, 2006 ZymoGenetics, Inc. has commenced the Phase 1 clinical trial of Interleukin 21 (IL-21) in combination with the monoclonal antibody Rituxan® in patients with advanced non- Hodgkin's lymphoma. "Patients need better treatments to fight cancer," said Bruce L. A. Carter, Ph.D.,... Continue Reading Posted at 12:11 AM \| Permalink \| Comments
Jul13	CSC's DVC Commenced Phase 2 Clinical Trial of rF1V, a Plague Vaccine Candidate Gloria Gamat July 13, 2006 DynPort Vaccine Company LLC (DVC), a Computer Sciences Corporation (CSC) company has entered into a Phase 2 clinical trial for its recombinant plague vaccine candidate, rF1V. "An effective, licensed plague vaccine is a crucial component of U.S. biodefense initiatives," said... Continue Reading Posted at 10:48 PM \| Permalink \| Comments
	Caraco Pharma’s Glizipide Tablets (Generic Glucotrol®) Received USFDA Final Approval Gloria Gamat July 13, 2006 Caraco Pharmaceutical Laboratories, Ltd. has been granted USFDA final approval of its Abbreviated New Drug Application (ANDA) for Glipizide tablets. Glipizide tablets are the generic equivalent of Pfizer's Glucotrol®, an anti-diabetic drug indicated as an adjunct to diet for... Continue Reading Posted at 10:33 PM \| Permalink \| Comments
	CoGenesys, Inc Raises $55 Million, Initiates Human Trials On Cardeva For Chronic Heart Failure Gloria Gamat July 13, 2006 CoGenesys Inc., a new spin-off biotech company from Human Genome Sciences, Inc, will begin human testing of Cardeva, a drug against chronic heart failure, a condition that is predicted to afflict more than 10 million patients by year 2020. Cardeva... Continue Reading Posted at 9:21 PM \| Permalink \| Comments
	I was interviewed at B5media's Genetics and Health Gloria Gamat July 13, 2006 My fellow science blogger and Science and Health Channel Editor at B5media, Hsien-Hsien Lei, is running an interview series at Genetics and Health. This week, I am the featured interviewee. Read the interview for my views on genetics and science blogging.... Continue Reading Posted at 8:24 PM \| Permalink \| Comments
	Antigenics to Supply GlaxoSmithKline With QS-21 Stimulon® Adjuvant Until 2014 Gloria Gamat July 13, 2006 GlaxoSmithKline broadens the deal with Antigenics, Inc., a NY-based biopharmaceutical company supplying GSK a vaccine component for about 20 of its products. Under the new deal, GSK will continue to purchase the adjuvant QS-21 Stimulon® from Antigenics until 2014, Antigenics... Continue Reading Posted at 8:16 PM \| Permalink \| Comments
Jul12	Beta-agonist Inhalers Increase Risk of Respiratory Deaths in COPD Patients Gloria Gamat July 12, 2006 In a new Cornell and Stanford Universities statistical analysis comparing two common inhalers in chronic obstructive pulmonary disease (COPD) patients found that common bronchodilators known as anticholinergics (generically named tiotropium and ipratropium) reduced severe respiratory events by 33 percent and... Continue Reading Posted at 9:41 PM \| Permalink \| Comments
Jul11	Cardinal Health To Manufacture Tamiflu for Roche Gloria Gamat July 11, 2006 To help meet current and future demands for Tamiflu®, Cardinal Health will be manufacturing and packaging the influenza drug for Roche. Under the terms of the manufacturing agreement, Cardinal Health will manufacture 75 mg hard gelatin capsules of Tamiflu(R) on... Continue Reading Posted at 8:04 AM \| Permalink \| Comments
	Barr Files All Regulatory Filings of its Proposed PLIVA Acquisition Gloria Gamat July 11, 2006 Specializing in the development, production and distribution of generic pharmaceutical products, including biologicals, cytostatics, and other value-added generics (as well as active pharmaceutical ingredients), PLIVA d.d. (established in 1921) is a leading global generic pharmaceutical company based in Central and... Continue Reading Posted at 6:59 AM \| Permalink \| Comments
	CV Therapeutics’ MERLIN TIMI-36 Study, Granted DSMB Go Signal to Proceed as Planned Gloria Gamat July 11, 2006 CV Therapeutics, Inc.’s MERLIN TIMI-36 study of Ranexa® (ranolazine extended-release tablets), has been given the go signal by the Data Safety Monitoring Board (DSMB) (the study’s overseer) to go ahead as planned. MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less... Continue Reading Posted at 2:53 AM \| Permalink \| Comments
	ISTA Pharmaceuticals Filed USFDA NDA for T-Pred™ (a Tobramycin and Prednisolone Acetate combination product) Gloria Gamat July 11, 2006 ISTA Pharmaceuticals, Inc. filed a New Drug Application (NDA) to the USFDA for its investigational ophthalmic product, T-Pred™, containing tobramycin and prednisolone acetate in a fixed combination. T-Pred™ when approved will be a treatment for inflammatory ocular conditions for which... Continue Reading Posted at 12:44 AM \| Permalink \| Comments
Jul10	Measles Mumps Rubella (MMR) and Mercury-based Immunizations’ Link to Autism, Cleared by MUHC study Gloria Gamat July 10, 2006 Measles Mumps Rubella (MMR) vaccines and thimerosal–containing vaccines (which are approximately 50 percent ethylmercury) have been suggested as possible causes of pervasive developmental disorders (PDD) like autism and Asperger Syndrome. However, in a new study from MUHC that assessed the... Continue Reading Posted at 3:14 AM \| Permalink \| Comments
	King Pharmaceuticals and Wyeth, Into an Amended and Restated Co-Promotion Agreement for ALTACE® (ramipril) Gloria Gamat July 10, 2006 Wyeth Pharmaceuticals (a Wyeth division) has entered into an Amended and Restated Co-Promotion Agreement regarding King's product ALTACE® (ramipril). ALTACE® is angiotensin converting enzyme (ACE) inhibitor which King Pharmaceuticals will assume full responsibility for the selling and marketing of, starting... Continue Reading Posted at 3:10 AM \| Permalink \| Comments
	Abbott and Dharmacon Collaborate in Development of New siRNA-Based Therapeutics Gloria Gamat July 10, 2006 Abbott and Dharmacon, Inc. (a unit of Fisher Biosciences) have entered into a collaboration to develop new therapeutic agents based on a gene silencing technology of RNA interference (RNAi): a research venture that could extend drug discovery efforts for the... Continue Reading Posted at 1:06 AM \| Permalink \| Comments
	Favrille’ FavId® Passed Phase II Clinical Trial in Indolent Non-Hodgkin's Lymphoma Patients Gloria Gamat July 10, 2006 Favrille, Inc. recently announced the positive results of its initial Phase 2 clinical trial evaluating FavId® as a single therapeutic agent in previously treated and relapsed patients with indolent B-cell non-Hodgkin's lymphoma (NHL). The trial result demonstrating that FavId® as... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Jul 8	Avicena Group Inc. Commenced Phase II Clinical Trial of ALS-08 Combination Therapies in ALS (or Lou Gehrig’s Disease) Gloria Gamat July 8, 2006 Avicena Group, Inc. has commenced its Phase II clinical trial of two combination therapies incorporating ALS-08 (one of its proprietary drug candidates) for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's Disease). The efficacy, safety and tolerability of... Continue Reading Posted at 7:55 PM \| Permalink \| Comments
	USFDA Approves 3-in-1 AIDS Pill From Aurobindo Pharma Gloria Gamat July 8, 2006 The USFDA has approved the first 3-in-1 antiretroviral pill for use by the White House Emergency Plan for AIDS Relief, an American-sponsored program against AIDS in the developing world. The new pill, made by Aurobindo Pharma of Hyderabad, India, combines... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
	Tumor-shrinking Compounds, Discovered at University of Minnesota Gloria Gamat July 8, 2006 “Small molecules” drug belonging to a class or pharmaceutical agents called anti-angiogenics are novel anti-cancer drugs developed by the University of Minnesota to treat solid tumors. These new compounds are refined form of drugs that effectively reduce blood flow to... Continue Reading Posted at 2:12 AM \| Permalink \| Comments
	Cell Genesys’ GVAX® Immunotherapy Passed Phase 1/2 Clinical Trial for Prostate Cancer in Early Stage Patients before Receiving Hormone Therapy Gloria Gamat July 8, 2006 Encouraging results from an initial clinical trial of GVAX® immunotherapy for prostate cancer in patients with early-stage disease have been announced by Cell Genesys, Inc. The results showed that 16 of 21 (76%) patients showed a statistically significant decrease in... Continue Reading Posted at 1:08 AM \| Permalink \| Comments
	Tri-REX Vaccination Protocol for Breast Cancer, Commenced by Epeius Biotech Gloria Gamat July 8, 2006 Epeius Biotechnologies has commenced the vaccine-assisted Phase I/II clinical trial for metastatic breast cancer that is refractory to conventional chemotherapy. The novel protocol introduces Reximmune-C™, the second in a series of targeted biologic therapies designed to seek out, accumulate in,... Continue Reading Posted at 12:03 AM \| Permalink \| Comments
Jul 7	Antibiotic Rapamycin May Protect The Heart Gloria Gamat July 7, 2006 Rapamycin is an antibiotic used to boost organ survival in transplant patients which was found by Virginia Commonwealth University researchers to potentially protect the heart against tissue damage following acute heart attack. The researchers headed by Rakesh C. Kukreja, Ph.D.,... Continue Reading Posted at 7:57 AM \| Permalink \| Comments
	FDA Requires New Warning Label for Antibiotic Product, Ketek Gloria Gamat July 7, 2006 Ketek is an antibiotic made by Sanofi-Aventis that was approved in 2004 for the treatment of respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Ketek is the first FDA-approved antibiotic of the ketolide class but has been associated with rare... Continue Reading Posted at 6:52 AM \| Permalink \| Comments
	Bz-423, U-M Drug that Dials Down Energy within Cells Gloria Gamat July 7, 2006 University of Michigan researchers headed by Gary Glick have on a drug called benzodiazepine-423 (Bz-423) that is effective in treating animal models of human autoimmune disorders and other diseases by dialing down the activity of a key enzyme involved in... Continue Reading Posted at 5:44 AM \| Permalink \| Comments
	Alliance Pharma Acquires UK Rights to Three Pfizer Drugs Gloria Gamat July 7, 2006 Alliance Pharma plc expands its dermatology portfolio by acquiring UK rights to three Pfizer products: Atarax, an oral antihistamine Deltacortril, an oral steroid, and Terracortril, a topical combination steroid For each of the three brands, Alliance will transfer the manufacturing,... Continue Reading Posted at 4:42 AM \| Permalink \| Comments
	Fish Omega-3s, Still Beneficial Down to the Bone Gloria Gamat July 7, 2006 The following are a few of the potential benefits of omega-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil whose summary is reported in the June 2006 Fats of Life e-newsletter for consumers and PUFA Newsletter for health professionals:... Continue Reading Posted at 3:31 AM \| Permalink \| Comments
Jul 6	Aradigm and Novo Nordisk Restructures Partnership, Novo Nordisk Buys Inhaled Insulin Patents for $27.5M Gloria Gamat July 6, 2006 Aradigm Corporation gets an cash infusion of $27.5 million from partner Novo Nordisk in exchange for a number of patents that are especially important for inhaled insulin. This agreement is expected to strengthen Novo Nordisk's inhaled insulin program, currently on... Continue Reading Posted at 4:31 AM \| Permalink \| Comments
	Abbott and AstraZeneca To Co-Develop Fibrate-Statin Combi-Pill For Cholesterol Management Gloria Gamat July 6, 2006 Abbott Laboratories and AstraZeneca will co-develop and market an anti-cholesterol drug that combines the functions of Astrazeneca's CRESTOR drug with that of Abbott's TriCor and ABT-335 drugs. The resulting combi-pill will target all three major blood lipids: LDL-C "bad" cholesterol,... Continue Reading Posted at 3:29 AM \| Permalink \| Comments
	Sanofi-Aventis Acquires Rights to Taiho's S-1 Oral Anticancer Agent for $360M Gloria Gamat July 6, 2006 Sanofi-Aventis has bought development and marketing rights to Taiho Pharmaceutical Co. Ltd.'s proprietary oral, pyrimidine fluoride derived oral anticancer agent, S-1. Sanofi-Aventis is paying Taiho $360 million for the rights to develop and commercialize the drug, which is already on... Continue Reading Posted at 2:27 AM \| Permalink \| Comments
	Abiogen Pharma Initiates Phase III Clinical Trials For Anxiety Drug, ABIO 05/01 Gloria Gamat July 6, 2006 Phase II clinical trial for Abiogen Pharma's new anti-anxiety drug, ABIO 08/01, has been initiated. ABIO 08/01 is a non-addictive drug candidate for the treatment of clinical anxiety states such as panic disorder or General Anxiety Disorder (GAD). Abiogen Pharma... Continue Reading Posted at 1:25 AM \| Permalink \| Comments
	Seizure Drug Gabapentin is as Effective as Estrogen in Easing Menopausal Symptoms Gloria Gamat July 6, 2006 As reported by researchers from the University of Rochester Medical Center in the July issue of Obstetrics and Gynecology journal, the seizure drug gabapentin is as effective as estrogen, which used to be the gold standard treatment for menopause symptoms.... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Jul 5	Antipsychotic Drug Clozapine, Linked to Increased Rate of Metabolic Syndrome Gloria Gamat July 5, 2006 According to a novel study from the University of Rochester Medical Center, clozapine (the most effective antipsychotic drug) when taken by patients have significantly increased their metabolic syndrome rate. Metabolic syndrome is a group of conditions (including high blood pressure,... Continue Reading Posted at 9:14 PM \| Permalink \| Comments
	BioPartners “Biosimilar” Hepatitis C Drug, Disapproved in Europe Gloria Gamat July 5, 2006 Swiss firm BioPartners failed to seek the approval of the European Agency for the Evaluation of Medicinal Products (EMEA) for Alpheon, a “biosimilar” version of Roche's Roferon-A, an injectable interferon used for the treatment of hepatitis C. Alpheon is BioPartners’... Continue Reading Posted at 8:07 PM \| Permalink \| Comments
	Nicotine Water (NICLite), Declared Not a Supplement by the USFDA Gloria Gamat July 5, 2006 Nicotine water, NICLite has been declared not a dietary supplement by the USFDA, in violation of the Federal Food, Drug and Cosmetic Act. NICLite is marketed by the California-based company Nichonica as a dietary supplement. This product was first sold... Continue Reading Posted at 7:00 PM \| Permalink \| Comments
	German Biopharmaceutical Firm TeGenero Files for Insolvency Gloria Gamat July 5, 2006 Germany-based biopharmaceutical firm TeGenero AG has filed for insolvency at the local court in Würzburg, Germany. According to the released statement, the company has no longer been able to attract the necessary investments following the failure of TGN 1412, a... Continue Reading Posted at 1:51 AM \| Permalink \| Comments
	Par Pharma’s Tranylcypromine Sulfate Tablets (Generic Parnate®) Received USFDA Final Approval Gloria Gamat July 5, 2006 Par Pharmaceutical Companies, Inc.’s wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the USFDA for its Abbreviated New Drug Application for tranylcypromine sulfate tablets, 10 mg. Tranylcypromine Sulfate Tablets, 10 mg is the generic version of GlaxoSmithKline's Parnate®... Continue Reading Posted at 12:05 AM \| Permalink \| Comments
Jul 4	Treatment of Multiple Myeloma with Celgene Corp.’s REVLIMID® in Combination with Dexamethasone, Approved by the USFDA Gloria Gamat July 4, 2006 Celgene Corporation’s REVLIMID® has been previously approved by the USFDA for use in the treatment of patients with transfusion-dependent anemia due to Low-or- Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Last... Continue Reading Posted at 4:55 AM \| Permalink \| Comments
	Genentech, Inc.’s Treatment for (Wet) Age-Related Macular Degeneration (AMD), LUCENTIS™ (ranibizumab injection): USFDA Approved Gloria Gamat July 4, 2006 Genentech, Inc.’s LUCENTIS™ (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD) has recently been approved by the USFDA. The approval came after a Priority Review period of six months. Following the approval, Genetech started the shipment... Continue Reading Posted at 3:44 AM \| Permalink \| Comments
	Additional U.S. Patent for its Lead Immunosuppressive Drug (ISA247) Issued to Isotechnika, Inc. Gloria Gamat July 4, 2006 Isotechnika Inc. has been issued U.S. Patent No. 7,060,672 for its lead immunosuppressive drug, ISA247. The patent entitled "Novel Cyclosporin Analog Formulations" is the first patent to be issued in this patent family in the United States with patent claims... Continue Reading Posted at 2:36 AM \| Permalink \| Comments
	Dendreon Corp.’s PROVENGE® (sipuleucel-T), Passed Phase III Study in Men with Advanced Androgen-independent Prostate Cancer Gloria Gamat July 4, 2006 Dendreon Corporation announced the positive results of its pivotal Phase 3 study (D9901) of PROVENGE® (sipuleucel-T) in men with advanced androgen-independent prostate cancer. These results demonstrating the significant survival benefit and favorable safety profile of PROVENGE® are published in the... Continue Reading Posted at 1:29 AM \| Permalink \| Comments
	According to AIDS HF: Pfizer Ad Pushes Viagra as 'Confidence-Builder' for All Men More than Being a Treatment to a Medical Condition, Erectile Dysfunction (ED) Gloria Gamat July 4, 2006 AIDS Healthcare Foundation (AHF), the nation's largest AIDS group and a direct provider of HIV/AIDS medical care to tens of thousands of AIDS patients in the US, Africa, Central America and Asia, blasted Pfizer, Inc. last week for contributing to the... Continue Reading Posted at 12:19 AM \| Permalink \| Comments
Jul 3	Bristol-Myers Squibb’s Sprycel (dasatinib), New Oral Treatment for Chronic Myeloid Leukemia (CML), Given USFDA Accelerated Approval Gloria Gamat July 3, 2006 Chronic myeloid leukemia (CML) is a rare cancer characterized by the uncontrolled growth of white blood cells. For the (new oral) treatment of this condition that affects about 4,600 people in the United Sates, Bristol-Myers Squibb’s Sprycel (dasatinib) has been... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
	Cephalon Inc.’s FENTORA(TM) (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer; Granted USFDA Approvable Letter Gloria Gamat July 3, 2006 Cephalon, Inc., last week received an approvable letter from the USFDA for FENTORA™ (fentanyl buccal tablet) [C-II] for which the company sought in August 2005 to market for the treatment of breakthrough pain opiod-tolerant patients with cancer via a submitted... Continue Reading Posted at 8:06 PM \| Permalink \| Comments
	SCHWARZ PHARMA Applies for Neupro in Advanced Parkinson's Disease in EU Gloria Gamat July 3, 2006 German firm SCHWARZ PHARMA has submitted a variation application for Neupro® (active ingredient: Rotigotine) to the European Medicines Agency (EMEA). Neupro is a transdermal patch for the treatment of advanced stage Parkinson's disease. The drug has been approved as a... Continue Reading Posted at 7:02 PM \| Permalink \| Comments
	Nicotine Reward Machinery in the Brain, Revealed Gloria Gamat July 3, 2006 Jean-Pierre Changeux of CNRS, Collège de France, and Institut Pasteur and Philippe Faure of Institut Pasteur and CNRS and colleagues revealed the key details of how nicotine stimulates neurons that are an integral part of the reward circuitry. The researchers... Continue Reading Posted at 1:54 AM \| Permalink \| Comments
	Cytokine Interleukin-7 (IL-7): Potential Weight Loss Element Gloria Gamat July 3, 2006 In a study in mice by researchers from the Centre National de la Recherche Scientifique (CNRS) at the Pasteur Institute and the University of Lille in France have found the possibility that we might be able to turn our immune... Continue Reading Posted at 12:46 AM \| Permalink \| Comments

« June 2006 | Main | August 2006 »

Jul31	FDA Approves Barrier Therapeutics' Xolegel™ For Treatment of Seborrheic Dermatitis Gloria Gamat July 31, 2006 Know More: Drug Regulations & Approval The USFDA has approved Xolegel™ (ketoconazole, USP) Gel, 2% for the topical treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older. Seborrheic dermatitis is a chronic inflammatory skin condition, whose cause is still unknown, but is associated with yeast infections, and other genetic and hormonal factors. Individuals with disorders of the central nervous system also appear to be prone to more extensive cases of seborrheic dermatitis. "There are approximately 8.5 million people in the U.S. that suffer with seborrheic dermatitis and having this new convenient treatment option available to manage the symptoms associated with the disease should be of significant benefit for both physicians and patients," stated Al Altomari, Barrier's Chief Operating Officer. Xolegel, previously referred to as Sebazole, is a topical formulation of 2.0% ketoconazole, an antifungal agent, in waterless gel. It will be launched during the fourth quarter of 2006, making it the third product to be launched in the US by Barrier Therapeutics (BTRX) this year. Source: Barrier Therapeutics Posted at 4:20 AM \| Permalink \| Comments
Jul31	Schering-Plough Corp.’s SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the Substitution Treatment of Opioid Dependence, Received Positive Opinion from the EU Advisory Panel Gloria Gamat July 31, 2006 Schering-Plough Corporation (NYSE: SGP)’s SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the substitution treatment of opioid dependence, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), thereby recommending... Continue Reading Posted at 3:14 AM \| Permalink \| Comments
	Roche’s Cancer Drug Tarceva (erlotinib), Received Negative Opinion from the EU Advisory Panel Gloria Gamat July 31, 2006 Roche’s cancer medicine Tarceva (erlotinib), has received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) for use in combination with gemcitabine chemotherapy for the first line treatment of advanced pancreatic cancer. In spite of... Continue Reading Posted at 2:05 AM \| Permalink \| Comments
	USFDA Approved sNDA for Novartis Pharma Corp.’s Antiviral Agent Famvir® Gloria Gamat July 31, 2006 Novartis Pharmaceuticals Corporation's sNDA for Famvir® (famciclovir) tablets has been approved by the USFDA as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH). "Famvir is the first and only antiviral approved to treat recurrent genital herpes in... Continue Reading Posted at 12:51 AM \| Permalink \| Comments
Jul30	NDA of UCB, Inc.’s Xyzal®, Submitted to the USFDA Gloria Gamat July 30, 2006 Xyzal® (levocetirizine dihydrochloride) is UCB, Inc. (Public, EBR: UCB)’s new prescription antihistamine for treatment of allergy symptoms, by which the company has recently submitted USFDA New Drug Application (NDA) of. Xyzal®, while already available in many countries around the world,... Continue Reading Posted at 9:43 PM \| Permalink \| Comments
	Dainippon Sumitomo Pharma Partners With Bristol-Myers K.K. On Anti-Hypertension And Hepatocellular Cancer Drugs Gloria Gamat July 30, 2006 Japanese firm Dainippon Sumitomo Pharma (DSP) and Bristol-Myers K.K. (BMKK) will collaborate to co-develop and market irbesartan, an anti-hypertension drug and SM-11355 (miriplatin hydrate), a drug for hepatocellular cancer. Irbesartan, one of the top selling an angiotensin receptor blockers (ARB),... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Gentope Corp.’s MyVax® Personalized Immunotherapy Phase 3 Trial, Recommended to Proceed by DSMB Gloria Gamat July 30, 2006 Genitope Corporation (Nasdaq: GTOP)’s independent Data Safety Monitoring Board (DSMB) has recommended after a review, that the company’s pivotal Phase 3 clinical trial of MyVax® for treatment of follicular non-Hodgkin's Lymphoma (fNHL) should go ahead as planned. The trial which... Continue Reading Posted at 9:16 PM \| Permalink \| Comments
	BioProgress Registers HypoSalix Artificial Saliva Spray For Treatment of Xerostomia Gloria Gamat July 30, 2006 BioProgress plc (BPRG) has registered HypoSalix, an artificial saliva spray, as a medical device in the EU. HypoSalix cotains a polymer that acts as artificial saliva and may be used for the treatment of xerostomia, or dry mouth, a condition... Continue Reading Posted at 1:45 AM \| Permalink \| Comments
	Serono Earmarks $10 Billion in Acquisitions Gloria Gamat July 30, 2006 Swiss biopharmaceutical firm Serono (SRA) is planning to expand through acquisitions, and could spend upt to $10 billion to improve bring more drugs into its pipeline and reduce its dependence on its top-seller, Rebif, a drug against multiple sclerosis. "We... Continue Reading Posted at 12:43 AM \| Permalink \| Comments
Jul29	Annan Urges Pharmaceutical Companies to Review Prices of AIDS Drugs Gloria Gamat July 29, 2006 Urged by U.N. Secretary-General Kofi Annan, nine pharmaceutical companies will review the prices of antiretroviral drugs to make the more affordable and accessible, and appropriate for use in low- and middle income countries. Annan met with the following executives and... Continue Reading Posted at 2:36 PM \| Permalink \| Comments
	Merck's Gardasil Gets Positive Recommendation From EU Advisory Panel Gloria Gamat July 29, 2006 GARDASIL®, the first vaccine against cervical cancer, vaginal and vulvar pre-cancers, and warts, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe. The CHMP recommends that GARDASIL, developed by Merck (MRK), be... Continue Reading Posted at 1:22 PM \| Permalink \| Comments
	USFDA Special Protocol Assessment (SPA) Enables Genta Incorporated to Proceed Trial of Genasense® Plus Chemotherapy in Chronic Lymphocytic Leukemia Gloria Gamat July 29, 2006 Genta Incorporated (Nasdaq: GNTA)’s proposal for a confirmatory trial of Genasense® (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia (CLL) has completed USFDA Special Protocol Assessment (SPA). This means that the USFDA has agreed with the proposed trial design... Continue Reading Posted at 6:15 AM \| Permalink \| Comments
	Somaxon Pharmaceuticals, Inc.’s Oral Nalmefene Passed Pilot Phase 2 Study in Smoking Cessation Gloria Gamat July 29, 2006 Oral nalmefene hydrochloride, an opiate antagonist under development by Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), demonstrated positive results in a pilot Phase 2 clinical trial for smoking cessation. Smokers dosed with nalmefene 40mg demonstrated numerically higher abstinence rates at all timepoints... Continue Reading Posted at 4:05 AM \| Permalink \| Comments
	AstraZeneca’s NEXIUM®: Better than Lansoprazole in Healing Maintenance of Erosive Esophagitis Gloria Gamat July 29, 2006 NEXIUM® (esomeprazole magnesium) demonstrated better efficacy than lansoprazole (Prevacid®) in preventing a recurrence in patients with healed erosive esophagitis (EE) and is equally effective in reducing its associated symptoms. These findings support the results of previous head-to-head trials demonstrating the... Continue Reading Posted at 2:45 AM \| Permalink \| Comments
	Altor BioScience Corp. Received Phase II SBIR Grant for Manufacture of Anti-Cancer Antibody from Transgenic Lettuce Gloria Gamat July 29, 2006 Altor BioScience Corporation has received a Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to support further development of its proprietary processes for making therapeutic antibodies in transgenic lettuce. Lettuce, a self-pollinating, ecologically friendly... Continue Reading Posted at 1:10 AM \| Permalink \| Comments
	Genentech, Inc. & Inotek Pharma Corp. Agreed on a Global Strategic Alliance for the Discovery, Development and Commercialization of PARP Cancer Inhibitors Gloria Gamat July 29, 2006 Genentech, Inc. (NYSE: DNA) and Inotek Pharmaceuticals Corporation have entered into an exclusive global collaboration to discover, develop, manufacture and commercialize inhibitors of poly (ADP-ribose) polymerase (PARP) for the potential treatment of cancer. PARP, a nuclear enzyme within cells, directs... Continue Reading Posted at 12:23 AM \| Permalink \| Comments
Jul28	FDA Approves Enzon Pharmaceutical's sBLA for Oncaspar Against Acute Lymphoblastic Leukemia Gloria Gamat July 28, 2006 The US FDA has approved of Enzon Pharmaceuticals, Inc.'s (ENZN) supplemental Biologics License Application (sBLA) for Oncaspar (pegaspargase), a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). Oncaspar, a PEG enhanced version of L-asparaginase,... Continue Reading Posted at 6:50 AM \| Permalink \| Comments
	Avalon Collaborates with ChemDiv To Develop Small-Molecule Drugs Against Cancer Gloria Gamat July 28, 2006 Avalon Pharmaceuticals (AVRX) is collaborating with ChemDiv to discover, develop and commercialize small-molecule drugs for cancer. Under the terms of the deal, Avalon will use its AvalonRx® platform, and access ChemDiv's Discovery outSource™ services platform, as well. Avalon also gains... Continue Reading Posted at 4:46 AM \| Permalink \| Comments
	Shanghai Genomics Collaborates with Centocor on Drug Discovery Project Gloria Gamat July 28, 2006 China-based Shanghai Genomics, Inc enters a one-an-a-half year collaboration with US biopharmaceutical company Centocor, Inc. to develop drugs focusing on inflammation and oncology. Shanghai Genomics will use its expertise in protein purification and cell-based interaction assays to explore receptor protein... Continue Reading Posted at 3:42 AM \| Permalink \| Comments
	Schering-Plough Corp.’s Once-Daily Broad Spectrum Antibiotic: AVELOX®, Equally Effective as Multi-dose Combination Therapy for Intra-abdominal Infections Gloria Gamat July 28, 2006 According to the results of a study involving 681 patients published in the current issue of the Annals of Surgery, monotherapy with Schering-Plough Corporation (NYSE: SGP)’s once-daily, broad-spectrum antibiotic AVELOX® (moxifloxacin HCl) was as effective and well tolerated as a... Continue Reading Posted at 2:29 AM \| Permalink \| Comments
	Genzyme Received USFDA Approval for Additional Manufacturing at its Ireland Plant Gloria Gamat July 28, 2006 The USFDA has approved Genzyme Corporation (Nasdaq: GENZ)’s fill/finishing, packaging and labeling of Thymoglobulin® (anti-thymocyte globulin, rabbit) at its state-of-the-art Waterford, Ireland facility. This approval allows Genzyme to commence the manufacturing and distribution of Thymoglobulin, Genzyme Corp.’s product for the... Continue Reading Posted at 1:24 AM \| Permalink \| Comments
	TorreyPines Therapeutics, Inc.’s NGX267, A Selective M1 Agonist for the Treatment of Alzheimer's Disease (AD), Passed Phase 1 Study Gloria Gamat July 28, 2006 TorreyPines Therapeutics, Inc. has recently completed the second Phase 1 study of its NGX267 in clinical development for the treatment of Alzheimer's disease. NGX267 is a selective cholinergic muscarinic (or M1) receptor agonist that previously demonstrated potential in providing both... Continue Reading Posted at 12:19 AM \| Permalink \| Comments
Jul27	Debiopharm Group’s Sanvar® Applied for First European Marketing in France Gloria Gamat July 27, 2006 The Debiopharm Group (Debiopharm) has filed a French Marketing Authorization Application (MAA) for Sanvar® in the treatment of esophageal variceal bleeding (EVB). Following this application, Debiopharm intends to further apply for wider European approval through the Mutual Recognition Procedure (MRP)... Continue Reading Posted at 9:05 PM \| Permalink \| Comments
	L'Oreal USA’s New Sunscreen Formula Containing Mexoryl™ SX, USFDA Approved Gloria Gamat July 27, 2006 The U.S. subsidiary of the global beauty company L'Oreal SA (Public, EPA:OR), L'Oreal USA, has been granted USFDA approval for its new sunscreen formula containing Mexoryl™ SX (a unique organic filter that is highly protective against short UVA waves) –... Continue Reading Posted at 8:41 PM \| Permalink \| Comments
	Cobalis Begins Twin Phase III Clinical Trials for PreHistin Against Ragweed Allergies Gloria Gamat July 27, 2006 Cobalis Corp. (CLSC) has started enrolling patients for its twin Phase III clinical trials to assess the efficacy and safety of its anti-allergy drug, PreHistin™, as a pre-seasonal treatment of ragweed allergies. Approximately 1,600 to 2,000 patients in total will... Continue Reading Posted at 6:33 AM \| Permalink \| Comments
	7th Annual Drug Discovery and Technology Leaders Summit Gloria Gamat July 27, 2006 What: 7th Annual Drug Discovery and Technology Leaders Summit When: November 13-15, 2006 Where: JW Marriott, Grande Lakes, Orlando, USA This exclusive event expects over a hundred senior-level R&D and information management decision-makers from leading pharmaceutical and biotechnology companies, including... Continue Reading Posted at 4:30 AM \| Permalink \| Comments
	Novartis/Sandoz Enters Agreement with Momenta Pharmceuticals to Develop Generic Biotech Drugs Gloria Gamat July 27, 2006 Sandoz, the generics arm of Novartis (NYSE:NVS), has entered into an agreement with Momenta Pharmaceuticals (NASDAQ: MNTA) to develop generic versions of four existing recombinant biotechnology and complex drugs. As part of the deal, Sandoz is making an $75 million equity... Continue Reading Posted at 2:25 AM \| Permalink \| Comments
	Novartis’ Immunosuppressant Neoral® Demonstrated Equal Efficacy with Tacrolimus in Kidney Transplant Patients Gloria Gamat July 27, 2006 In a large-scale head- to-head study, Neoral® (cyclosporine) and tacrolimus demonstrated equal efficacy in the prevention of organ rejection in kidney transplant patients. However, those treated with Neoral had a significantly lower incidence of new-onset diabetes. These study results, suggesting... Continue Reading Posted at 1:14 AM \| Permalink \| Comments
	Mylan Technologies Inc. Received US Patent Covering EMSAM® Transdermal Product Gloria Gamat July 27, 2006 Mylan Laboratories Inc. (NYSE: MYL)’s subsidiary, Mylan Technologies Inc. (MTI), has been recently issued with U.S. Patent No. 7,070,808, a patent containing one or more claims covering the EMSAM® transdermal product that is indicated for the treatment of major depressive... Continue Reading Posted at 12:51 AM \| Permalink \| Comments
	Pharmaxis Ltd. Filed Marketing Application for Aridol in Switzerland Gloria Gamat July 27, 2006 Pharmaxis Ltd. (Nasdaq: PXSL) has recently lodged the registration documents for marketing approval of its asthma management product (Aridol) with the Swiss regulatory agency for therapeutic products, Swissmedic. Trimedal AG, a specialist respiratory and allergy pharmaceutical company based in Zurich... Continue Reading Posted at 12:04 AM \| Permalink \| Comments
Jul26	Shire plc’s ELAPRASE™, USFDA Approved for Treatment of Hunter Syndrome Gloria Gamat July 26, 2006 The USFDA has granted approval to Shire plc (NASDAQ: SHPGY)’s ELAPRASE™, a human enzyme replacement therapy for the treatment of Hunter syndrome. Hunter Syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare, life-threatening genetic condition that results from... Continue Reading Posted at 8:30 PM \| Permalink \| Comments
	USPTO Issued Patent for Method to Manufacture Immtech Pharma Inc.’s Drug Candidate Compounds Gloria Gamat July 26, 2006 The United States Patent and Trademark Office (USPTO) has recently issued to Immtech Pharmaceuticals, Inc. (Amex: IMM) a patent related to the manufacturing of Immtech's drug candidate compounds. The patent, entitled "Process for the synthesis of bis-aryl diamidoxime compounds," claims... Continue Reading Posted at 7:59 AM \| Permalink \| Comments
	Shire plc Submitted NDA for SPD465, Treatment of Adult ADHD Gloria Gamat July 26, 2006 Shire plc (NASDAQ: SHPGY) has submitted a new drug application (NDA) to the USFDA for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population. SPD465, though containing the same active ingredient as ADDERALL... Continue Reading Posted at 6:46 AM \| Permalink \| Comments
	Lilly and Alcon Signed Marketing Collaboration for Arxxant™, A Potential First Oral Medication for Diabetic Retinopathy Gloria Gamat July 26, 2006 Eli Lilly and Company (NYSE: LLY) and Alcon, Inc. (NYSE: ACL) have recently signed a long-term agreement to co-promote ruboxistaurin mesylate (proposed brand name, Arxxant™, pronounced ark-ZONT) in the United States and Puerto Rico. The above co-promotion agreement is subject... Continue Reading Posted at 5:43 AM \| Permalink \| Comments
	Carrington and Brookwood Pharmaceuticals Joined Forces to Expand The Development of GelSite® Drug Delivery Technology Gloria Gamat July 26, 2006 DelSite Biotechnologies, Inc. (a subsidiary of Carrington Laboratories, Inc. (Nasdaq:CARN)) has entered into a joint development initiative with Brookwood Pharmaceuticals, Inc. in order to carry out an expanded evaluation of GelSite® (a DelSite patented drug-delivery technology) as a matrix for... Continue Reading Posted at 2:56 AM \| Permalink \| Comments
	Foamix's Valerate 0.12% foam Demonstrated High Efficacy in Psoriasis Treatment and 85% Better Usability over Cream in Phase I/II Study Gloria Gamat July 26, 2006 Foamix Ltd. recently announced the results of its Phase I/II study of Betamethasone Valerate 0.12% foam, for the treatment of psoriasis which demonstrated efficacy and safety. The foam was also found better than other creams with respect to skin absorption,... Continue Reading Posted at 1:34 AM \| Permalink \| Comments
	Oscient Pharmaceuticals To Acquire US Rights to Cardiovascular Drug ANTARA For $78 Million Gloria Gamat July 26, 2006 Oscient Pharmaceuticals (OSCI) has acquired US commercialization rights to cardiovascular drug Antara 130 mg (fenofibrate) capsules from Reliant Pharmaceuticals. Oscient will pay Reliant an upfront fee of $78 million for the agreement. "Acquiring ANTARA, a product that achieved approximately $35 million... Continue Reading Posted at 12:32 AM \| Permalink \| Comments
	TissueGene, Inc. Commences Phase I Clinical Trial of its Tissue Regenerator, TG-C Gloria Gamat July 26, 2006 TissueGene, Inc.’s Investigational New Drug (IND) application and for the initiation of its Phase I clinical trial evaluating a single dose of TG-C for the treatment of degenerative joint diseases, has been accepted by the USFDA. The said clinical trial... Continue Reading Posted at 12:22 AM \| Permalink \| Comments
Jul25	Human Genome Sciences, Inc. Commenced Randomized Phase 2 Clinical Trial of HGS-ETR1 in Combination With Bortezomib in Multiple Myeloma Patients Gloria Gamat July 25, 2006 Human Genome Sciences, Inc. (Nasdaq: HGSI) recently initiated dosing of patients in a randomized Phase 2 clinical trial of HGS-ETR1 (mapatumumab) in combination with bortezomib (VELCADE®) in advanced multiple myeloma. Bortezomib is a proteosome inhibitor indicated for use in multiple... Continue Reading Posted at 10:01 PM \| Permalink \| Comments
	Serono Initiates Large Scale European Clinical Study of Psoriasis Drug, Raptiva® Gloria Gamat July 25, 2006 Serono (SRA) announced that it has begun with the first large-scale pharmaco-epidemiological study in psoriasis in Europe to study the long-term safety of Raptiva®, a psoriasis drug. There were more than 7,000 adult patients with moderate-to-severe plaque psoriasis recruited for the... Continue Reading Posted at 10:28 AM \| Permalink \| Comments
	Multiple Sclerosis Drug Tysabri®, Re-released in US Pharmacies Gloria Gamat July 25, 2006 After 17 months of being on hold, Tysabri®, a drug for multiple sclerosis, is now available in US pharmacies. According to this article, Tysabri was taken off the market in early 2005 following two deaths resulting from brain inflammation in... Continue Reading Posted at 8:23 AM \| Permalink \| Comments
	The U.S. Government Purchased GlaxoSmithKline’s Relenza® for State Stockpiles Gloria Gamat July 25, 2006 GlaxoSmithKline (NYSE:GSK) has entered into an agreement with the U.S. Government to provide states with the anti-viral Relenza® (zanamivir for inhalation) in preparation for a potential influenza pandemic. The Department of Health and Human Services (HHS) has guaranteed the initial... Continue Reading Posted at 4:54 AM \| Permalink \| Comments
	Spanish Research Provided More Evidence that Red Grape Juice Has Heart Health Benefits Gloria Gamat July 25, 2006 According to a Spanish research, red grape juice improved the cholesterol levels and inflammatory markers associated with heart disease in both healthy subjects and those that are at a higher risk of cardiovascular complications, the hemodialysis patients. While pervious research... Continue Reading Posted at 2:37 AM \| Permalink \| Comments
	YM BioSciences’ Anti-EGFr Drug, Nimotuzumab, Approved in India for Head and Neck Cancer Treatment Gloria Gamat July 25, 2006 YM BioSciences Inc. (AMEX: YMI) reported that 's Drug Controller General has granted marketing approval to nimotuzumab (an anti-EGFr monoclonal antibody) for the treatment of head & neck cancer. Biocon Biopharmaceuticals Ltd., a joint venture between Biocon (NSE:BIOCON) and CIMAB... Continue Reading Posted at 12:23 AM \| Permalink \| Comments
Jul24	Product Recall: Single Lot of Berlex Inc.’s Ultravist® Injection 370 mgI/mL, 125 mL in the United States Gloria Gamat July 24, 2006 Berlex, Inc. initiated the nationwide recall of a single lot (No. 41500A) of its intravenous X-ray contrast agent, Ultravist® Injection 370 mgI/mL, 125 mL (iopromide injection) NDC 50419-246-12, EXP 01/2007 because of the presence of particulate matter in conjunction with... Continue Reading Posted at 7:11 AM \| Permalink \| Comments
	PhosLo® (calcium acetate) Demonstrated Superior Serum Phosphorus Control Over Sevelamer Gloria Gamat July 24, 2006 Nabi Pharmaceuticals (Nasdaq: NABI) recently announced the results of a study that further demonstrated that PhosLo® (calcium acetate) provides superior control of serum phosphorus (a key determinant of morbidity and mortality among end-stage renal disease (ESRD) patients) when compared to... Continue Reading Posted at 6:04 AM \| Permalink \| Comments
	Warning on Dangers of Excess Acetaminophen, Issued by the American Liver Foundation Gloria Gamat July 24, 2006 The American Liver Foundation (ALF) recently issued a warning based on a recent study on the effects of high doses of the popular pain reliever acetaminophen on one’s liver. The recent study (published in the Journal of the American Medical... Continue Reading Posted at 3:58 AM \| Permalink \| Comments
	VivaGel ™’s Clinical Development IND for Prevention of Genital Herpes Cleared by USFDA Gloria Gamat July 24, 2006 Starpharma Holdings Limited (SPL)’s Investigational New Drug application (IND) for the clinical development of SPL7013 gel (VivaGel™) for prevention of genital herpes has been cleared by the USFDA. The company can now proceed with the first microbicide clinical development program... Continue Reading Posted at 2:46 AM \| Permalink \| Comments
	Ovation Pharmaceuticals Launches NeoProfen For the Treatment of Patent Ductus Arteriosus Gloria Gamat July 24, 2006 Ovation Pharmaceuticals has launched a novel drug to treat a potentially life-threatening congenital heart defect in premature infants, called Patent Ductus Arteriosus (PDA). PDA a condition in which a blood vessel (ductus arteriosus) in the heart fails to close after... Continue Reading Posted at 2:39 AM \| Permalink \| Comments
	FDA Approves of Pearly Pigments To Color Medicines Gloria Gamat July 24, 2006 Eight years after the petition was filed, the USFDA has approved the use of special mica-based pigments on pills, tablets and liquids, giving medicines a unique pearly sheen similar to those seen on cosmetics. The pigments, made by coating the... Continue Reading Posted at 1:29 AM \| Permalink \| Comments
Jul23	FDA Warns Consumers Against Bismacine/Chromacine Gloria Gamat July 23, 2006 Following the report of a death and several other injuries, the FDA is warning consumers and health care professionals not to use "Bismacine", also known as "Chromacine". Bismacine is an injectable product supposedly against Lyme disease, and is prescribed or... Continue Reading Posted at 11:53 PM \| Permalink \| Comments
	Long-Term Ibuprofen Treatment After Brain Injury Worsens Cognitive Abilities Gloria Gamat July 23, 2006 Ibuprofen is a common pain reliever prescribed to patients following head injuries to alleviate chronic pain. In a preliminary animal-model study, however, researchers from the University of Pennsylvania School of Medicine found out the long-term ibuprofen therapy after traumatic brain... Continue Reading Posted at 11:45 PM \| Permalink \| Comments
	FDA Approves AstraZeneca's Symbicort® For Asthma Maintenance Therapy Gloria Gamat July 23, 2006 The USFDA has approved AstraZeneca (AZN)'s SYMBICORT® (budesonide/formoterol) for the maintenance treatment of asthma in patients age 12 and older. SYMBICORT is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one inhaler.... Continue Reading Posted at 11:09 PM \| Permalink \| Comments
	FDA Warning: Migraine Drugs and Antidepressants are a Dangerous Combination Gloria Gamat July 23, 2006 On Wednesday, July 19, the USFDA warned patients and consumers that the use of some migraine drugs, called triptans, with certain antidepressants can cause a fatal condition in which patients experience hallucinations, overactive reflexes and rapid heart beat. Such antidepressants... Continue Reading Posted at 2:02 AM \| Permalink \| Comments
	Data on CONCERTA® (methylphenidate HCl) Extended-release Tablets Formulation, Presented by McNeil Pediatrics Gloria Gamat July 23, 2006 As part of an information exchange on "Progress in Creating New Drug Formulations that Discourage Tampering and Abuse”, The U.S. Department of Health and Human Services' Substance Abuse and Mental Health Services Administration (SAMHSA) has invited McNeil Pediatrics (a division... Continue Reading Posted at 12:57 AM \| Permalink \| Comments
Jul22	Antileukotrienes and Inhaled Corticosteroids Combo, Effectively Treats Asthma Gloria Gamat July 22, 2006 A new study entitled "Bronchial responsiveness to leukotriene D4 is resistant to inhaled fluticasone propionate", provides support that the combined therapy of inhaled corticosteroids and antileukotriene drugs treat asthma. Study results showed that although the fluticasone propionate therapy vs. placebo... Continue Reading Posted at 4:47 AM \| Permalink \| Comments
	Tranzyme Pharma Receives Notice of Allowance from USPTO on Patent Protecting Macrocyclic Template Chemistry Platform Gloria Gamat July 22, 2006 The U.S. Patent and Trademark Office (USPTO) has granted a Notice of Allowance to Tranzyme Pharma for its patent application entitled "Combinatorial Synthesis of Libraries of Macrocyclic Compounds." The patent protects key aspects of the Company's core drug-design platform, Macrocyclic... Continue Reading Posted at 3:39 AM \| Permalink \| Comments
	Gilead Sciences Buys Corus Pharma for $365 Million Gloria Gamat July 22, 2006 Gilead Sciences, Inc.(GILD) has agreed to buy out Corus Pharma, a privately-held, venture capital backed company specializing on therapeutics for respiratory and infectious diseases, for $365 million. Concurrently, Gilead and Novartis Vaccine and Diagnostics, Inc. have entered into an agreement... Continue Reading Posted at 2:30 AM \| Permalink \| Comments
	Clinical Trials Review Suggests that Calcium Supplementation Could Reduce Pre-eclampsia in Pregnancy Gloria Gamat July 22, 2006 According to a new review of clinical trials, increased intake of calcium supplements can reduce the risk of hypertension and pre-eclampsia during pregnancy. This finding may lead to a review and probably revision of current recommendations like that of the... Continue Reading Posted at 1:19 AM \| Permalink \| Comments
	Ranbaxy Laboratories Ltd. Acquires GSK’s Mundogen Generic Business in Spain Gloria Gamat July 22, 2006 India’s largest pharmaceutical company and one of the top ten generic pharmaceutical companies in the world, Ranbaxy Laboratories Limited (Ranbaxy), recently announced that the company has acquired Mundogen generic business of GlaxoSmithKline (GSK) in Spain, throught its Spanish subsidiary, Laboratorios Ranbaxy... Continue Reading Posted at 12:12 AM \| Permalink \| Comments
Jul21	MRI Revealed Donepezil Slows Brain Shrinkage Leading to Alzheimer’s Disease Gloria Gamat July 21, 2006 According to a new Mayo Clinic study, the drug donepezil (as shown by MRI) measurably slows the rate of brain shrinkage in some patients with mild cognitive impairment, a condition prior to Alzheimer’s disease. The MRI study is an adjunct... Continue Reading Posted at 4:29 AM \| Permalink \| Comments
	Diabetes Drug is Potential Cure of Alzheimer’s Disease Gloria Gamat July 21, 2006 Alzheimer’s disease (AD) brings impaired thinking and memory, affecting up to 4.5 million older Americans. Treatment of high blood sugar probably has a connection to memory loss that could one day benefit these millions of AD sufferers. In fact it... Continue Reading Posted at 3:17 AM \| Permalink \| Comments
	Ashton Pharmaceuticals Ltd., Inyx Inc.’s U.K. Subsidiary: Selected to Produce Generic Drugs for EU Markets Gloria Gamat July 21, 2006 Inyx, Inc.’s wholly owned U.K. subsidiary (Ashton Pharmaceuticals Ltd.) has been selected by a leading Indian specialty pharmaceutical company to manufacture a range of generic drugs for the United Kingdom and other European countries. Initially, Ashton will provide process transfer... Continue Reading Posted at 2:11 AM \| Permalink \| Comments
	Exelon® Patch: First Transdermal Therapy for Alzheimer's Disease Gloria Gamat July 21, 2006 Data from a 1,195-patient trial demonstrate that Exelon® Patch (rivastigmine transdermal patch) may be a potential treatment approach for the management of Alzheimer's Disease. The results of the study, which were presented at the ongoing International Conference on Alzheimer's Disease... Continue Reading Posted at 1:47 AM \| Permalink \| Comments
	Ranbaxy to Sell Generic Psychotherapeutic Drug Risperidone in Canada Gloria Gamat July 21, 2006 Ranbaxy Pharmaceuticals Canada Inc., a subsidiary of India-based Ranbaxy Laboratories Limited (RLL) will tie up with Janssen-Ortho Inc. for the licensing and supply of a generic version of Risperidone compressed tablets in Canada. Sold under the label Ran™ Risperidone, the... Continue Reading Posted at 12:42 AM \| Permalink \| Comments
Jul20	Anti-Herpes Drug Valtrex Reduces C-sections Rates in Infected Women Gloria Gamat July 20, 2006 Current medical protocol offers Cesarian sections to pregnant women with active genital herpes lesions at the time of delivery. To study antivirap suppression of herpes during late stage pregnancy, a randomized clinical trial was conducted, where women were given valacyclovir... Continue Reading Posted at 4:38 AM \| Permalink \| Comments
	European Patent Office Will Soon Grant Patent Decision to Celator Pharma’s CombiPlex™ Technology for Developing Fixed-ratio Combination Chemotherapies Gloria Gamat July 20, 2006 Celator Pharmaceuticals, Inc. has received confirmation that the Examining Division of the European Patent Office intends to grant a European patent covering the company's proprietary CombiPlex™ technology. "This decision represents a major milestone for Celator, offering us broad protection for multiple... Continue Reading Posted at 3:33 AM \| Permalink \| Comments
	FDA Warning: "Dietary Supplements" Promoted for Sexual Enhancement Contain Dangerous Ingredients Gloria Gamat July 20, 2006 Last week the USFDA has issued a warning to consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON: products that are being promoted and sold on websites as "dietary supplements" for treating erectile dysfunction (ED)... Continue Reading Posted at 2:24 AM \| Permalink \| Comments
	Pycnogenol Found More Effective than Conventional Drug in the Treatment of Chronic Venous Insufficiency (CVI) Gloria Gamat July 20, 2006 Pycnogenol, the French pine bark extract has demonstrated more effectivity in a new study against conventional drug in reducing the symptoms of chronic venous insufficiency (CVI). CVI is caused by leg veins' inability to pump blood back to the heart... Continue Reading Posted at 1:19 AM \| Permalink \| Comments
	Archemix Corp. Engaged in Strategic Alliance with Elan Corp. to Discover and Develop Aptamer Therapeutics Gloria Gamat July 20, 2006 Archemix Corporation has entered into a multi-year, multi-product alliance with Elan Corporation plc that will focus on the discovery, development, and commercialization of first-in-class aptamer therapeutics to treat autoimmune disease. The alliance of the two companies will seek to develop... Continue Reading Posted at 12:02 AM \| Permalink \| Comments
Jul19	Alexion Pharmaceuticals, Inc. Purchased Rhode Island Biopharmaceutical Manufacturing Site For Production of Soliris™ Gloria Gamat July 19, 2006 Alexion Pharmaceuticals, Inc. has purchased the former Dow manufacturing facility in Smithfield, Rhode Island which the company will use primarily in the production of Soliris™ (eculizumab). Soliris™ is the company's lead product candidate for Paroxysmal Nocturnal Hemoglobinuria (PNH), an acquired... Continue Reading Posted at 4:55 AM \| Permalink \| Comments
	Mylan Lab Inc.’s Amlodipine Besylate and Benazepril Hydrochloride Capsules, Granted USFDA Tentative Approval Gloria Gamat July 19, 2006 Mylan Laboratories, Inc. has been granted tentative approval by the USFDA for its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate and Benazepril Hydrochloride Capsules, 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg and 10 mg... Continue Reading Posted at 3:50 AM \| Permalink \| Comments
	Zelapar, Now Available for Parkinson's Disease Patients in the US Gloria Gamat July 19, 2006 Valeant Pharmaceuticals International announced that Zelapar (selegiline HCl) Orally Disintegrating Tablets will be available in US pharmacies nationwide starting on July 19, 2006. The new drug formulation is the first treatment for Parkinson's disease which uses a novel oral delivery... Continue Reading Posted at 2:46 AM \| Permalink \| Comments
	Nastech Pharma Co.’s Calcitonin-Salmon Nasal Spray: Not Approvable This Time, Says USFDA Gloria Gamat July 19, 2006 A USFDA written notification dated July 10, 2006 was received by Nastech Pharmaceutical Company Inc. stating that Nastech's abbreviated new drug application (ANDA) for intranasal calcitonin-salmon spray is not approvable at this time. Nastech's formulation of calcitonin-salmon nasal spray was... Continue Reading Posted at 1:34 AM \| Permalink \| Comments
	Nabi Biopharmaceuticals’ Nabi-HB™ Intravenous Received Positive Opinion from USFDA Blood Products Advisory Committee (BPAC) Gloria Gamat July 19, 2006 The Blood Products Advisory Committee (BPAC) of the USFDA gave a positive opinion of Nabi Biopharmaceuticals’ Biologic License Application (BLA) for Nabi-HB™ Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] in last week’s meeting. Nabi-HB™ Intravenous’ BLA has been submitted by... Continue Reading Posted at 12:30 AM \| Permalink \| Comments
Jul18	Vectomega®, A Revolutionary Omega-3 Phospholipid Complex (DHA/EPA) Showed Positive Health Benefits in Preliminary Human Clinical Trial Gloria Gamat July 18, 2006 Vectomega® is a revolutionary Omega-3 phospholipid complex with DHA/EPA which EuroPharma has obtained North American distribution rights of. This product is molecularly different from other omega-3’s currently on the market because this is 50 times more absorbable across cellular membranes... Continue Reading Posted at 4:22 AM \| Permalink \| Comments
	Nationwide Voluntary Recall of a Single Manufacturing Lot (Lot 558470A) of Azathioprine Tablets in the U.S. and Puerto Rico Initiated by Roxane Lab, Inc. Gloria Gamat July 18, 2006 Last week (13th July), Roxane Laboratories, Inc. started the nationwide recall of a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009). Azathioprine tablets are indicated to help prevent rejection in kidney transplant patients,... Continue Reading Posted at 3:12 AM \| Permalink \| Comments
	Generic Drugs are Significantly Cheaper in the U.S. than in Canada Gloria Gamat July 18, 2006 Millions of Americans have been turning to Canada for lower cost of prescription drugs. Canada regulates its prescription drug prices, often beating U.S. prices on branded drugs by 30% or more. However, a survey conducted by the Federal Drug Administration... Continue Reading Posted at 2:06 AM \| Permalink \| Comments
	FDA Grants Fast Track Designation to Intravenuous Methylnaltrexone Gloria Gamat July 18, 2006 The USFDAhas granted Fast Track designation to an intravenuous form of methylnaltrexone for the treatment of post-operative ileus, a gastrointestinal condition that delays recovery and prolongs hospitalization. Methylnaltrexone is an investigational drug for the treatment of the peripheral side effects of... Continue Reading Posted at 1:01 AM \| Permalink \| Comments
	FDA Approves New Lidocaine/Tetracaine Anesthetic Patch For Dermatological Procedures Gloria Gamat July 18, 2006 The USFDA has approved a new topical local anesthetic patch, S-Caine™ Peel (Lidocaine and Tetracaine) 7%/7% Cream for use as a topical anesthetic patch in dermatological procedures such as dermal filler injections, pulsed dye laser therapy, facial laser resurfacing, and... Continue Reading Posted at 12:38 AM \| Permalink \| Comments
Jul17	Schering AG-Avid Radiopharma Collaboration Will Develop Novel Diagnostic Imaging Agents for Alzheimer's Disease Gloria Gamat July 17, 2006 To develop novel diagnostic imaging agents for Alzheimer's disease, Schering AG, collaborates with Avid Radiopharmaceuticals Inc. The management of Alzheimer’s disease patients and the development of new therapies remain significantly impeded by the lack of current clinical methods for definitive... Continue Reading Posted at 11:32 PM \| Permalink \| Comments
	Roche Collaborates With Actelion To Develop Selective S1P1 Receptor Agonist For AutoImmune Disorders Gloria Gamat July 17, 2006 Swiss biopharmaceutical firm Actelion entered into an agreement with Roche to develop and market S1P1, a drug candidate against autoimmune diseases such as multiple sclerosis, rheumatoid arthritis and Crohn's disease. S1P1 is a receptor agonist under Phase I development. Under... Continue Reading Posted at 10:18 PM \| Permalink \| Comments
	MD&DI’s 50 'Companies to Watch' Includes Baxa Corporation Gloria Gamat July 17, 2006 In its review of the medical device industry, the '50 Companies to Watch' by Medical Device and Diagnostic Industry included the Colorado-based manufacturer of medical devices for health-system pharmacies, Baxa Corporation. The MD&DI magazine chose companies with formidable track records... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
	CuraGen and TopoTarget Commenced Phase I/II Trial of PXD101 for Hepatocellular Cancer (Liver Cancer) Gloria Gamat July 17, 2006 CuraGen Corporation and TopoTarget A/S commenced the patient dosing of PXD101 (a small molecule histone deacetylase (HDAC) inhibitor) in a Phase I/II clinical trial evaluating the safety and potential efficacy of the product for the treatment of inoperable hepatocellular cancer.... Continue Reading Posted at 8:50 PM \| Permalink \| Comments
	FDA Approves Eli Lilly's Gemzar® For Ovarian Cancer Treatment Gloria Gamat July 17, 2006 The USFDA has approved Eli Lilly and Company's drug against recurrent ovarian cancer, Gemzar®, to be used in combination with carboplatin, a widely-used anti-cancer agent. Clinical data showed that the combination of Gemzar and carboplatin increased progression-free survival and response... Continue Reading Posted at 8:09 PM \| Permalink \| Comments
Jul15	LAB International Inc.’s Fentanyl TAIFUN® Passed Phase IIA Clinical Trial Gloria Gamat July 15, 2006 LAB International, Inc. is an integrated drug development company with subsidiaries focused on developing therapies for the inhalation market and on providing contract research services. The company recently announced the positive results for the first phase II trial of Fentanyl... Continue Reading Posted at 2:51 AM \| Permalink \| Comments
	Sanofi-Aventis’ AMBIEN CR™ (zolpidem tartrate extended- release) Tablets C(IV), Effective and Safe to Use for up to 24 Weeks in Insomnia Patients Gloria Gamat July 15, 2006 Study of Sanofi-Aventis’ AMBIEN CR™ showed that the product is well-tolerated and effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia when taken as needed for up to seven nights per... Continue Reading Posted at 1:45 AM \| Permalink \| Comments
	Rolling NDA of GPC Biotech’s Satraplatin (Lead Oncology Drug Candidate), In Progress Gloria Gamat July 15, 2006 GPC Biotech AG submitted the non-clinical section of the rolling submission of a USFDA New Drug Application (NDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). The CMC (chemistry, manufacturing... Continue Reading Posted at 12:39 AM \| Permalink \| Comments
Jul14	Alfacell Corp. Collaboration Will Produce Novel Fusion Protein Against non-Hodgkin’s Lymphoma (NHL) Gloria Gamat July 14, 2006 Alfacell Corporation went into a new collaboration with the West German Cancer Center at the University of Duisburg-Essen for the development, characterization and large-scale production of a novel fusion protein for non-Hodgkin's lymphoma (NHL), consisting of ONCONASE® (ranpirnase) and a... Continue Reading Posted at 4:34 AM \| Permalink \| Comments
	Procter & Gamble Pharmaceuticals and ARYx Therapeutics, Agreed to Develop an Investigational Treatment for Gastrointestinal Disorders Gloria Gamat July 14, 2006 A division of The Procter & Gamble Company, Procter & Gamble Pharmaceuticals, Inc. has entered into a strategic alliance with ARYx Therapeutics to develop and commercialize ARYx's novel drug (ATI-7505) for the treatment of gastrointestinal disorders (like gastroesophageal reflux disease... Continue Reading Posted at 3:29 AM \| Permalink \| Comments
	Portola Pharma, Inc. Commenced Phase II Clinical Trial of Factor Xa Inhibitor Gloria Gamat July 14, 2006 Portola Pharmaceuticals, Inc. commenced the Phase II clinical trial of its oral Factor Xa inhibitor for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing knee replacement surgery. "This candidate selectively inhibits Factor Xa, a... Continue Reading Posted at 2:19 AM \| Permalink \| Comments
	GlaxoSmithKline’s Avandamet® (Rosiglitazone Maleate and Metformin HCl), USFDA Approved as Initial Therapy in Type 2 Diabetes Treatment Gloria Gamat July 14, 2006 GlaxoSmithKline’s Avandamet® (rosiglitazone maleate and metformin HCl) has been granted USFDA approval for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet® was previously approved as a second-line therapy in patients who were... Continue Reading Posted at 1:13 AM \| Permalink \| Comments
	ZymoGenetics Begins Phase 1 Trial of IL-21 and Rituxan® Combo in Patients with Non-Hodgkin's Lymphoma Gloria Gamat July 14, 2006 ZymoGenetics, Inc. has commenced the Phase 1 clinical trial of Interleukin 21 (IL-21) in combination with the monoclonal antibody Rituxan® in patients with advanced non- Hodgkin's lymphoma. "Patients need better treatments to fight cancer," said Bruce L. A. Carter, Ph.D.,... Continue Reading Posted at 12:11 AM \| Permalink \| Comments
Jul13	CSC's DVC Commenced Phase 2 Clinical Trial of rF1V, a Plague Vaccine Candidate Gloria Gamat July 13, 2006 DynPort Vaccine Company LLC (DVC), a Computer Sciences Corporation (CSC) company has entered into a Phase 2 clinical trial for its recombinant plague vaccine candidate, rF1V. "An effective, licensed plague vaccine is a crucial component of U.S. biodefense initiatives," said... Continue Reading Posted at 10:48 PM \| Permalink \| Comments
	Caraco Pharma’s Glizipide Tablets (Generic Glucotrol®) Received USFDA Final Approval Gloria Gamat July 13, 2006 Caraco Pharmaceutical Laboratories, Ltd. has been granted USFDA final approval of its Abbreviated New Drug Application (ANDA) for Glipizide tablets. Glipizide tablets are the generic equivalent of Pfizer's Glucotrol®, an anti-diabetic drug indicated as an adjunct to diet for... Continue Reading Posted at 10:33 PM \| Permalink \| Comments
	CoGenesys, Inc Raises $55 Million, Initiates Human Trials On Cardeva For Chronic Heart Failure Gloria Gamat July 13, 2006 CoGenesys Inc., a new spin-off biotech company from Human Genome Sciences, Inc, will begin human testing of Cardeva, a drug against chronic heart failure, a condition that is predicted to afflict more than 10 million patients by year 2020. Cardeva... Continue Reading Posted at 9:21 PM \| Permalink \| Comments
	I was interviewed at B5media's Genetics and Health Gloria Gamat July 13, 2006 My fellow science blogger and Science and Health Channel Editor at B5media, Hsien-Hsien Lei, is running an interview series at Genetics and Health. This week, I am the featured interviewee. Read the interview for my views on genetics and science blogging.... Continue Reading Posted at 8:24 PM \| Permalink \| Comments
	Antigenics to Supply GlaxoSmithKline With QS-21 Stimulon® Adjuvant Until 2014 Gloria Gamat July 13, 2006 GlaxoSmithKline broadens the deal with Antigenics, Inc., a NY-based biopharmaceutical company supplying GSK a vaccine component for about 20 of its products. Under the new deal, GSK will continue to purchase the adjuvant QS-21 Stimulon® from Antigenics until 2014, Antigenics... Continue Reading Posted at 8:16 PM \| Permalink \| Comments
Jul12	Beta-agonist Inhalers Increase Risk of Respiratory Deaths in COPD Patients Gloria Gamat July 12, 2006 In a new Cornell and Stanford Universities statistical analysis comparing two common inhalers in chronic obstructive pulmonary disease (COPD) patients found that common bronchodilators known as anticholinergics (generically named tiotropium and ipratropium) reduced severe respiratory events by 33 percent and... Continue Reading Posted at 9:41 PM \| Permalink \| Comments
Jul11	Cardinal Health To Manufacture Tamiflu for Roche Gloria Gamat July 11, 2006 To help meet current and future demands for Tamiflu®, Cardinal Health will be manufacturing and packaging the influenza drug for Roche. Under the terms of the manufacturing agreement, Cardinal Health will manufacture 75 mg hard gelatin capsules of Tamiflu(R) on... Continue Reading Posted at 8:04 AM \| Permalink \| Comments
	Barr Files All Regulatory Filings of its Proposed PLIVA Acquisition Gloria Gamat July 11, 2006 Specializing in the development, production and distribution of generic pharmaceutical products, including biologicals, cytostatics, and other value-added generics (as well as active pharmaceutical ingredients), PLIVA d.d. (established in 1921) is a leading global generic pharmaceutical company based in Central and... Continue Reading Posted at 6:59 AM \| Permalink \| Comments
	CV Therapeutics’ MERLIN TIMI-36 Study, Granted DSMB Go Signal to Proceed as Planned Gloria Gamat July 11, 2006 CV Therapeutics, Inc.’s MERLIN TIMI-36 study of Ranexa® (ranolazine extended-release tablets), has been given the go signal by the Data Safety Monitoring Board (DSMB) (the study’s overseer) to go ahead as planned. MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less... Continue Reading Posted at 2:53 AM \| Permalink \| Comments
	ISTA Pharmaceuticals Filed USFDA NDA for T-Pred™ (a Tobramycin and Prednisolone Acetate combination product) Gloria Gamat July 11, 2006 ISTA Pharmaceuticals, Inc. filed a New Drug Application (NDA) to the USFDA for its investigational ophthalmic product, T-Pred™, containing tobramycin and prednisolone acetate in a fixed combination. T-Pred™ when approved will be a treatment for inflammatory ocular conditions for which... Continue Reading Posted at 12:44 AM \| Permalink \| Comments
Jul10	Measles Mumps Rubella (MMR) and Mercury-based Immunizations’ Link to Autism, Cleared by MUHC study Gloria Gamat July 10, 2006 Measles Mumps Rubella (MMR) vaccines and thimerosal–containing vaccines (which are approximately 50 percent ethylmercury) have been suggested as possible causes of pervasive developmental disorders (PDD) like autism and Asperger Syndrome. However, in a new study from MUHC that assessed the... Continue Reading Posted at 3:14 AM \| Permalink \| Comments
	King Pharmaceuticals and Wyeth, Into an Amended and Restated Co-Promotion Agreement for ALTACE® (ramipril) Gloria Gamat July 10, 2006 Wyeth Pharmaceuticals (a Wyeth division) has entered into an Amended and Restated Co-Promotion Agreement regarding King's product ALTACE® (ramipril). ALTACE® is angiotensin converting enzyme (ACE) inhibitor which King Pharmaceuticals will assume full responsibility for the selling and marketing of, starting... Continue Reading Posted at 3:10 AM \| Permalink \| Comments
	Abbott and Dharmacon Collaborate in Development of New siRNA-Based Therapeutics Gloria Gamat July 10, 2006 Abbott and Dharmacon, Inc. (a unit of Fisher Biosciences) have entered into a collaboration to develop new therapeutic agents based on a gene silencing technology of RNA interference (RNAi): a research venture that could extend drug discovery efforts for the... Continue Reading Posted at 1:06 AM \| Permalink \| Comments
	Favrille’ FavId® Passed Phase II Clinical Trial in Indolent Non-Hodgkin's Lymphoma Patients Gloria Gamat July 10, 2006 Favrille, Inc. recently announced the positive results of its initial Phase 2 clinical trial evaluating FavId® as a single therapeutic agent in previously treated and relapsed patients with indolent B-cell non-Hodgkin's lymphoma (NHL). The trial result demonstrating that FavId® as... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Jul 8	Avicena Group Inc. Commenced Phase II Clinical Trial of ALS-08 Combination Therapies in ALS (or Lou Gehrig’s Disease) Gloria Gamat July 8, 2006 Avicena Group, Inc. has commenced its Phase II clinical trial of two combination therapies incorporating ALS-08 (one of its proprietary drug candidates) for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's Disease). The efficacy, safety and tolerability of... Continue Reading Posted at 7:55 PM \| Permalink \| Comments
	USFDA Approves 3-in-1 AIDS Pill From Aurobindo Pharma Gloria Gamat July 8, 2006 The USFDA has approved the first 3-in-1 antiretroviral pill for use by the White House Emergency Plan for AIDS Relief, an American-sponsored program against AIDS in the developing world. The new pill, made by Aurobindo Pharma of Hyderabad, India, combines... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
	Tumor-shrinking Compounds, Discovered at University of Minnesota Gloria Gamat July 8, 2006 “Small molecules” drug belonging to a class or pharmaceutical agents called anti-angiogenics are novel anti-cancer drugs developed by the University of Minnesota to treat solid tumors. These new compounds are refined form of drugs that effectively reduce blood flow to... Continue Reading Posted at 2:12 AM \| Permalink \| Comments
	Cell Genesys’ GVAX® Immunotherapy Passed Phase 1/2 Clinical Trial for Prostate Cancer in Early Stage Patients before Receiving Hormone Therapy Gloria Gamat July 8, 2006 Encouraging results from an initial clinical trial of GVAX® immunotherapy for prostate cancer in patients with early-stage disease have been announced by Cell Genesys, Inc. The results showed that 16 of 21 (76%) patients showed a statistically significant decrease in... Continue Reading Posted at 1:08 AM \| Permalink \| Comments
	Tri-REX Vaccination Protocol for Breast Cancer, Commenced by Epeius Biotech Gloria Gamat July 8, 2006 Epeius Biotechnologies has commenced the vaccine-assisted Phase I/II clinical trial for metastatic breast cancer that is refractory to conventional chemotherapy. The novel protocol introduces Reximmune-C™, the second in a series of targeted biologic therapies designed to seek out, accumulate in,... Continue Reading Posted at 12:03 AM \| Permalink \| Comments
Jul 7	Antibiotic Rapamycin May Protect The Heart Gloria Gamat July 7, 2006 Rapamycin is an antibiotic used to boost organ survival in transplant patients which was found by Virginia Commonwealth University researchers to potentially protect the heart against tissue damage following acute heart attack. The researchers headed by Rakesh C. Kukreja, Ph.D.,... Continue Reading Posted at 7:57 AM \| Permalink \| Comments
	FDA Requires New Warning Label for Antibiotic Product, Ketek Gloria Gamat July 7, 2006 Ketek is an antibiotic made by Sanofi-Aventis that was approved in 2004 for the treatment of respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Ketek is the first FDA-approved antibiotic of the ketolide class but has been associated with rare... Continue Reading Posted at 6:52 AM \| Permalink \| Comments
	Bz-423, U-M Drug that Dials Down Energy within Cells Gloria Gamat July 7, 2006 University of Michigan researchers headed by Gary Glick have on a drug called benzodiazepine-423 (Bz-423) that is effective in treating animal models of human autoimmune disorders and other diseases by dialing down the activity of a key enzyme involved in... Continue Reading Posted at 5:44 AM \| Permalink \| Comments
	Alliance Pharma Acquires UK Rights to Three Pfizer Drugs Gloria Gamat July 7, 2006 Alliance Pharma plc expands its dermatology portfolio by acquiring UK rights to three Pfizer products: Atarax, an oral antihistamine Deltacortril, an oral steroid, and Terracortril, a topical combination steroid For each of the three brands, Alliance will transfer the manufacturing,... Continue Reading Posted at 4:42 AM \| Permalink \| Comments
	Fish Omega-3s, Still Beneficial Down to the Bone Gloria Gamat July 7, 2006 The following are a few of the potential benefits of omega-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil whose summary is reported in the June 2006 Fats of Life e-newsletter for consumers and PUFA Newsletter for health professionals:... Continue Reading Posted at 3:31 AM \| Permalink \| Comments
Jul 6	Aradigm and Novo Nordisk Restructures Partnership, Novo Nordisk Buys Inhaled Insulin Patents for $27.5M Gloria Gamat July 6, 2006 Aradigm Corporation gets an cash infusion of $27.5 million from partner Novo Nordisk in exchange for a number of patents that are especially important for inhaled insulin. This agreement is expected to strengthen Novo Nordisk's inhaled insulin program, currently on... Continue Reading Posted at 4:31 AM \| Permalink \| Comments
	Abbott and AstraZeneca To Co-Develop Fibrate-Statin Combi-Pill For Cholesterol Management Gloria Gamat July 6, 2006 Abbott Laboratories and AstraZeneca will co-develop and market an anti-cholesterol drug that combines the functions of Astrazeneca's CRESTOR drug with that of Abbott's TriCor and ABT-335 drugs. The resulting combi-pill will target all three major blood lipids: LDL-C "bad" cholesterol,... Continue Reading Posted at 3:29 AM \| Permalink \| Comments
	Sanofi-Aventis Acquires Rights to Taiho's S-1 Oral Anticancer Agent for $360M Gloria Gamat July 6, 2006 Sanofi-Aventis has bought development and marketing rights to Taiho Pharmaceutical Co. Ltd.'s proprietary oral, pyrimidine fluoride derived oral anticancer agent, S-1. Sanofi-Aventis is paying Taiho $360 million for the rights to develop and commercialize the drug, which is already on... Continue Reading Posted at 2:27 AM \| Permalink \| Comments
	Abiogen Pharma Initiates Phase III Clinical Trials For Anxiety Drug, ABIO 05/01 Gloria Gamat July 6, 2006 Phase II clinical trial for Abiogen Pharma's new anti-anxiety drug, ABIO 08/01, has been initiated. ABIO 08/01 is a non-addictive drug candidate for the treatment of clinical anxiety states such as panic disorder or General Anxiety Disorder (GAD). Abiogen Pharma... Continue Reading Posted at 1:25 AM \| Permalink \| Comments
	Seizure Drug Gabapentin is as Effective as Estrogen in Easing Menopausal Symptoms Gloria Gamat July 6, 2006 As reported by researchers from the University of Rochester Medical Center in the July issue of Obstetrics and Gynecology journal, the seizure drug gabapentin is as effective as estrogen, which used to be the gold standard treatment for menopause symptoms.... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Jul 5	Antipsychotic Drug Clozapine, Linked to Increased Rate of Metabolic Syndrome Gloria Gamat July 5, 2006 According to a novel study from the University of Rochester Medical Center, clozapine (the most effective antipsychotic drug) when taken by patients have significantly increased their metabolic syndrome rate. Metabolic syndrome is a group of conditions (including high blood pressure,... Continue Reading Posted at 9:14 PM \| Permalink \| Comments
	BioPartners “Biosimilar” Hepatitis C Drug, Disapproved in Europe Gloria Gamat July 5, 2006 Swiss firm BioPartners failed to seek the approval of the European Agency for the Evaluation of Medicinal Products (EMEA) for Alpheon, a “biosimilar” version of Roche's Roferon-A, an injectable interferon used for the treatment of hepatitis C. Alpheon is BioPartners’... Continue Reading Posted at 8:07 PM \| Permalink \| Comments
	Nicotine Water (NICLite), Declared Not a Supplement by the USFDA Gloria Gamat July 5, 2006 Nicotine water, NICLite has been declared not a dietary supplement by the USFDA, in violation of the Federal Food, Drug and Cosmetic Act. NICLite is marketed by the California-based company Nichonica as a dietary supplement. This product was first sold... Continue Reading Posted at 7:00 PM \| Permalink \| Comments
	German Biopharmaceutical Firm TeGenero Files for Insolvency Gloria Gamat July 5, 2006 Germany-based biopharmaceutical firm TeGenero AG has filed for insolvency at the local court in Würzburg, Germany. According to the released statement, the company has no longer been able to attract the necessary investments following the failure of TGN 1412, a... Continue Reading Posted at 1:51 AM \| Permalink \| Comments
	Par Pharma’s Tranylcypromine Sulfate Tablets (Generic Parnate®) Received USFDA Final Approval Gloria Gamat July 5, 2006 Par Pharmaceutical Companies, Inc.’s wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the USFDA for its Abbreviated New Drug Application for tranylcypromine sulfate tablets, 10 mg. Tranylcypromine Sulfate Tablets, 10 mg is the generic version of GlaxoSmithKline's Parnate®... Continue Reading Posted at 12:05 AM \| Permalink \| Comments
Jul 4	Treatment of Multiple Myeloma with Celgene Corp.’s REVLIMID® in Combination with Dexamethasone, Approved by the USFDA Gloria Gamat July 4, 2006 Celgene Corporation’s REVLIMID® has been previously approved by the USFDA for use in the treatment of patients with transfusion-dependent anemia due to Low-or- Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Last... Continue Reading Posted at 4:55 AM \| Permalink \| Comments
	Genentech, Inc.’s Treatment for (Wet) Age-Related Macular Degeneration (AMD), LUCENTIS™ (ranibizumab injection): USFDA Approved Gloria Gamat July 4, 2006 Genentech, Inc.’s LUCENTIS™ (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD) has recently been approved by the USFDA. The approval came after a Priority Review period of six months. Following the approval, Genetech started the shipment... Continue Reading Posted at 3:44 AM \| Permalink \| Comments
	Additional U.S. Patent for its Lead Immunosuppressive Drug (ISA247) Issued to Isotechnika, Inc. Gloria Gamat July 4, 2006 Isotechnika Inc. has been issued U.S. Patent No. 7,060,672 for its lead immunosuppressive drug, ISA247. The patent entitled "Novel Cyclosporin Analog Formulations" is the first patent to be issued in this patent family in the United States with patent claims... Continue Reading Posted at 2:36 AM \| Permalink \| Comments
	Dendreon Corp.’s PROVENGE® (sipuleucel-T), Passed Phase III Study in Men with Advanced Androgen-independent Prostate Cancer Gloria Gamat July 4, 2006 Dendreon Corporation announced the positive results of its pivotal Phase 3 study (D9901) of PROVENGE® (sipuleucel-T) in men with advanced androgen-independent prostate cancer. These results demonstrating the significant survival benefit and favorable safety profile of PROVENGE® are published in the... Continue Reading Posted at 1:29 AM \| Permalink \| Comments
	According to AIDS HF: Pfizer Ad Pushes Viagra as 'Confidence-Builder' for All Men More than Being a Treatment to a Medical Condition, Erectile Dysfunction (ED) Gloria Gamat July 4, 2006 AIDS Healthcare Foundation (AHF), the nation's largest AIDS group and a direct provider of HIV/AIDS medical care to tens of thousands of AIDS patients in the US, Africa, Central America and Asia, blasted Pfizer, Inc. last week for contributing to the... Continue Reading Posted at 12:19 AM \| Permalink \| Comments
Jul 3	Bristol-Myers Squibb’s Sprycel (dasatinib), New Oral Treatment for Chronic Myeloid Leukemia (CML), Given USFDA Accelerated Approval Gloria Gamat July 3, 2006 Chronic myeloid leukemia (CML) is a rare cancer characterized by the uncontrolled growth of white blood cells. For the (new oral) treatment of this condition that affects about 4,600 people in the United Sates, Bristol-Myers Squibb’s Sprycel (dasatinib) has been... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
	Cephalon Inc.’s FENTORA(TM) (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer; Granted USFDA Approvable Letter Gloria Gamat July 3, 2006 Cephalon, Inc., last week received an approvable letter from the USFDA for FENTORA™ (fentanyl buccal tablet) [C-II] for which the company sought in August 2005 to market for the treatment of breakthrough pain opiod-tolerant patients with cancer via a submitted... Continue Reading Posted at 8:06 PM \| Permalink \| Comments
	SCHWARZ PHARMA Applies for Neupro in Advanced Parkinson's Disease in EU Gloria Gamat July 3, 2006 German firm SCHWARZ PHARMA has submitted a variation application for Neupro® (active ingredient: Rotigotine) to the European Medicines Agency (EMEA). Neupro is a transdermal patch for the treatment of advanced stage Parkinson's disease. The drug has been approved as a... Continue Reading Posted at 7:02 PM \| Permalink \| Comments
	Nicotine Reward Machinery in the Brain, Revealed Gloria Gamat July 3, 2006 Jean-Pierre Changeux of CNRS, Collège de France, and Institut Pasteur and Philippe Faure of Institut Pasteur and CNRS and colleagues revealed the key details of how nicotine stimulates neurons that are an integral part of the reward circuitry. The researchers... Continue Reading Posted at 1:54 AM \| Permalink \| Comments
	Cytokine Interleukin-7 (IL-7): Potential Weight Loss Element Gloria Gamat July 3, 2006 In a study in mice by researchers from the Centre National de la Recherche Scientifique (CNRS) at the Pasteur Institute and the University of Lille in France have found the possibility that we might be able to turn our immune... Continue Reading Posted at 12:46 AM \| Permalink \| Comments

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