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Jul31
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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
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Jul31
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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...
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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...
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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...
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Jul30
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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,...
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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),...
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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...
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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...
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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...
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Jul29
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Jul28
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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,...
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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...
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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...
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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...
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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...
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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...
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Jul27
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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)...
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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) –...
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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...
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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...
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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...
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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...
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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...
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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...
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Jul26
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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...
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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...
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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...
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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...
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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...
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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,...
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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...
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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...
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Jul25
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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...
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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...
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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...
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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...
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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...
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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...
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Jul24
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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...
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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...
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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...
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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...
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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...
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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...
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Jul23
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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...
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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...
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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....
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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...
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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...
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Jul22
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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...
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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...
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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...
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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...
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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...
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Jul21
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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...
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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...
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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...
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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...
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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...
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Jul20
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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...
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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...
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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)...
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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...
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