PharmaGazette: October 2006 Archives

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Oct31	Shire plc’s ADHD Patch, DAYTRANA™ (methylphenidate transdermal system): Provided Individualized Symptom Management Gloria Gamat October 31, 2006 Know More: Patents and Clinical Trials Shire plc’s Attention Deficit Hyperactivity Disorder (ADHD) patch, DAYTRANA™ (methylphenidate transdermal system), significantly reduced the symptoms of ADHD in children aged 6 to 12 years, even when the ADHD patch is taken off earlier than the recommended nine hours. Being able to remove the patch earlier than the recommended nine-hour wear time enables physicians to manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping. Such were the phase IIIb clinical trial results recently reported by Shire Plc (LON: SHP, Nasdaq: SHPGY) at the 53rd Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in San Diego, California. Timothy E. Wilens, M.D., Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School, explained: "The patch's delivery system offers physicians individualized control of their patients' ADHD symptoms, adding an important dimension to the treatment of ADHD, since a child's schedule often varies between school day and weekend. Because it is a patch, if a child sleeps late on the weekend and the patch is applied later than on a school day, it can still be removed at the usual time. That way, the child receives the benefit of their long-acting ADHD medication for a shorter duration of effect, as well as managing the potential for late-day side effects. The physician, in consultation with the parent, can determine the appropriate patch wear time, up to the recommended nine hours." DAYTRANA™ is the first and only patch medication approved by the USFDA for the treatment of the symptoms of pediatric ADHD and is available in four dosage strengths -- 10 mg, 15 mg, 20 mg and 30 mg -- all designed for once-daily use. Find more details from the press release. Posted at 2:18 AM \| Permalink \| Comments
Oct31	Pharmasset Commenced Phase 1 Study of R7128 for Hepatitis C Virus Gloria Gamat October 31, 2006 This is the last day of the Liver Meeting® 2006 or the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) and so the drug pipeline on the Hepatitis viruses is in focus. Here goes... Continue Reading Posted at 12:52 AM \| Permalink \| Comments
Oct30	Dendreon’s PROVENGE® Demonstrated Prostate Cancer Survival in Phase 3 Studies Gloria Gamat October 30, 2006 Recently announced by Dendreon Corporation (Nasdaq: DNDN) are data from an exploratory analysis of Phase 3 Studies (D9901 and D9902A) which demonstrated significant correlation between cumulative CD54 upregulation and survival for patients treated with Dendreon's investigational active cellular immunotherapy PROVENGE®... Continue Reading Posted at 11:42 PM \| Permalink \| Comments
	Telbivudine (TYZEKA™) Data from Idenix’s GLOBE Study, Presented at AASLD Annual Meeting Gloria Gamat October 30, 2006 New data from three clinical studies of telbivudine for the treatment of chronic hepatitis B (CHB) was presented by Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) at the still ongoing 57th Annual Meeting of the American Association for the Study of Liver... Continue Reading Posted at 10:21 PM \| Permalink \| Comments
	Schering –Plough’s INTRON® and REBETOL® Retreatment Study Results, Presented at AASLD Annual Meeting Gloria Gamat October 30, 2006 Clinical data from Schering-Plough (NYSE: SGP)’s EPIC3 (a large ongoing clincinal study) recently revealed that retreatment with combination therapy of PEG-INTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) can result in sustained virologic response(1) (SVR) in patients with chronic hepatitis C... Continue Reading Posted at 9:23 PM \| Permalink \| Comments
Oct29	NicOx’s Naproxcinod Sucessfully Passed Osteoarthritis Phase 3 Trial Gloria Gamat October 29, 2006 NicOx S.A. (EPA: COX) recently announced the successful top-line results from a phase 3 trial of naproxcinod (HCT 3012) in patients with osteoarthritis of the knee (the 301 study).Naproxcinod is the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class,... Continue Reading Posted at 10:30 PM \| Permalink \| Comments
	Strattera®, Effective in Treating ADHD Symptoms in Children and Adolescents with ADHD and Reading Disorders, New Study Says Gloria Gamat October 29, 2006 As reported recently at a meeting of child and adolescent psychiatrists, new clinical data demonstrated that Strattera® (atomoxetine HCl) improved ADHD symptoms in children and adolescents who had both ADHD and a reading disorder, like dyslexia. The said study measured... Continue Reading Posted at 9:07 PM \| Permalink \| Comments
	European Patent Office Supports Validity of Pfizer's Lipitor® Patent Gloria Gamat October 29, 2006 As if Ranbaxy (BOM: 500359) needed more salt to add to its Lipitor patent wound...Once more another patent office, this time the European Patent Office (EPO) has issued an upholding opinion to Pfizer’s calcium salt patent covering Lipitor®, in its... Continue Reading Posted at 7:48 PM \| Permalink \| Comments
Oct28	Wyeth: One of the U.S. EPA's Best Workplaces for Commuters Gloria Gamat October 28, 2006 Wyeth (NYSE: WYE) has been included in the U.S. Environmental Protection Agency's (EPA) list of "Best Workplaces for Commuters" from the Fortune 500 Companies for the third consecutive year. Jumping six spots to the 13th position on the 2006 ranking,... Continue Reading Posted at 6:21 AM \| Permalink \| Comments
	New Drug for the Treatment of Chronic Hepatitis B Patients: Idenix Pharma, Inc.'s TYZEKA™ (telbivudine), USFDA-Approved Gloria Gamat October 28, 2006 TYZEKA™ (telbivudine), a product of Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), has recently been approved by the USFDA as a new once-a-day oral treatment (taken with or without food) for patients with chronic hepatitis B (CHB). TYZEKA™, which demonstrated abililty to... Continue Reading Posted at 4:15 AM \| Permalink \| Comments
	Laureate Pharma Extended its PROSTASCINT® Manufacture Agreement with Cytogen Corp. Gloria Gamat October 28, 2006 Laureate Pharma, Inc. (11061029) renewed its agreement with Cytogen Corporation (Nasdaq: CYTO) for the cGMP manufacture of ProstaScint®, Cytogen's proprietary monoclonal antibody immunoconjugate that is used for imaging in patients diagnosed with prostate cancer. While Laureate Pharma will provide cGMP protein... Continue Reading Posted at 3:10 AM \| Permalink \| Comments
	Auxilium Pharmaceuticals, Inc.'s Injectable Enzyme against Peyronie's Disease: AA4500, Passed Phase II Studies Gloria Gamat October 28, 2006 Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) reported positive clinical data from two Phase II trials of AA4500 at the American Urology Association's (AUA) western sectional meeting in Maui, Hawaii. An injectable enzyme, AA4500 demonstrated efficacy and safety in treating patients with... Continue Reading Posted at 1:37 AM \| Permalink \| Comments
Oct27	Javelin Pharmaceuticals: Frost & Sullivan’s Entrepreneurial Company of the Year for Intranasal Therapeutics Gloria Gamat October 27, 2006 Because of its role as an emerging leader in intranasal therapeutics --Javelin Pharmaceuticals (Amex: JAV) -- has received the 2006 Frost & Sullivan Award for Entrepreneurial Company of the Year. The said award is granted each year by Frost &... Continue Reading Posted at 7:55 AM \| Permalink \| Comments
	Genmab A/S Initiated Combination Clinical Study of HuMax-EGFr™ With Chemo-Radiation Gloria Gamat October 27, 2006 Danish company, Genmab A/S (CPH: GEN) has initiated a Phase I/II study of HuMax- EGFr™ (zalutumumab) in combination with chemo-radiation as a first line treatment of head and neck cancer. The said clinical study that will include a total of... Continue Reading Posted at 6:41 AM \| Permalink \| Comments
	Treatment Response to Mesalamine = Rapid Mucosal Healing in Moderately Active Ulcerative Colitis (UC) Patients, According to Combined Data Analysis Gloria Gamat October 27, 2006 Data analysis from two clinical trial revealed that the success of treatment is associated with mucosal healing in patients with moderately active ulcerative colitis (UC) who received either 2.4 or 4.8 grams of mesalamine per day. A product of Procter and... Continue Reading Posted at 4:42 AM \| Permalink \| Comments
	New Nexium® Formulation: NEXIUM® For Delayed-Release Oral Suspension, Approved by the USFDA Gloria Gamat October 27, 2006 A new formulation of AstraZeneca (NYSE: AZN)’s prescription proton pump inhibitor -NEXIUM® (esomeprazole magnesium) - has recently been approved by the USFDA. The new NEXIUM® For Delayed-Release Oral Suspension is now approved for the treatment of GERD, including symptomatic gastroesophageal... Continue Reading Posted at 4:00 AM \| Permalink \| Comments
	Clinical Data Demonstrating Additive Anti-Fibrotic Combination Effects of Actimmune® and Pirfenidone, Presented by InterMune, Inc. at CHEST 2006 Gloria Gamat October 27, 2006 InterMune, Inc. (Nasdaq: ITMN) has recently reported the preclinical data of its two Phase III drug candidates for idiopathic pulmonary fibrosis (IPF): Actimmune® (interferon gamma-1b) and pirfenidone, at CHEST 2006 --the annual conference of the American College of Chest Physicians... Continue Reading Posted at 3:24 AM \| Permalink \| Comments
	U.S. District Court Granted Ortho-McNeil Neurologics, Inc.’s Request for Preliminary Injunction for TOPAMAX® Gloria Gamat October 27, 2006 The request of Ortho-McNeil Neurologics, Inc. (a subsidiary of Johnson & Johnson, NYSE: JNJ) for a preliminary injunction against Mylan Laboratories, Inc. (NYSE: MYL) has been granted by a U.S. District court, thereby prohibiting Mylan from launching a generic version of... Continue Reading Posted at 2:12 AM \| Permalink \| Comments
	D-Pharm Ltd. Granted DP-b99 Exclusive License to Yungjin Pharmaceutical Company Ltd. For Korean Acute Stroke Market Gloria Gamat October 27, 2006 D-Pharm Ltd. (691243) has granted Yungjin Pharmaceutical Company Ltd. (SEO: 003520) an exclusive license to develop, register and market DP-b99 in South Korea for the treatment of acute stroke patients. The terms of agreement includes the following: an upfront payment... Continue Reading Posted at 1:09 AM \| Permalink \| Comments
Oct26	Stiefel Laboratories, Inc. Bought Connetics Corporation Gloria Gamat October 26, 2006 The world's largest independent pharmaceutical company specializing in dermatology -Stiefel Laboratories Inc.- has recently signed a definitive merger agreement for the purchase of all the outstanding shares of Connetics Corporation (Nasdaq: CNCT) for $17.50 per share. The said transaction is... Continue Reading Posted at 11:51 PM \| Permalink \| Comments
	BrainCells and Organon Entered Collaboration for Discovery and Development of CNS Drugs Gloria Gamat October 26, 2006 The human health care business unit of Akzo Nobel (Nasdaq: AKZOY) –Oraganon- and BrainCells Inc. (BCI) have recently entered into a collaboration that will discover and develop drugs for the treatment of central nervous system (CNS) disorders. For the identification... Continue Reading Posted at 10:34 PM \| Permalink \| Comments
Oct25	Somaxon Pharmaceuticals' SILENOR™ Passed Phase 3 Transient Insomnia Clinical Trial Gloria Gamat October 25, 2006 Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) recently announced the positive results from its Phase 3 clinical trial that evaluated SILENOR™ (doxepin HCl) in adults with transient insomnia. The Phase III clinical data revealed that SILENOR™ demonstrated statistically significant improvements versus... Continue Reading Posted at 2:40 PM \| Permalink \| Comments
	DelSite Presented Clinical Data on Influenza Nasal Powder Vaccine Gloria Gamat October 25, 2006 During the Second International Conference on Influenza Vaccines for the World (IVW), held October 18-20, 2006 in Vienna, Austria, Yawei Ni, Ph.D., Senior Scientist at DelSite Biotechnologies, gave an oral presentation entitled "An Inactivated Influenza Nasal Powder Vaccine", as... Continue Reading Posted at 12:31 PM \| Permalink \| Comments
	Novartis’ Zelnorm® Demonstrated Relief of Multiple Symptoms of Dysmotility-Type Dyspepsia Gloria Gamat October 25, 2006 According to new clinical presented at the recent American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Zelnorm® (tegaserod maleate) demonstrated potential in the treatment of the multiple symptoms of dysmotility-type dyspepsia. Currently, there are no prescription... Continue Reading Posted at 10:20 AM \| Permalink \| Comments
	AMITIZA™ (lubiprostone) Demonstrated Efficacy Within 24 and 48 Hours of Treatment Gloria Gamat October 25, 2006 60 percent of patients treated with AMITIZA™ (lubiprostone) experienced a spontaneous bowel movement (SBM) within 24 hours of treatment, and 80 percent experienced a SBM within 48 hours of treatment. Such were the results of two pivotal studies presented at... Continue Reading Posted at 8:10 AM \| Permalink \| Comments
	VIVUS' Obesity Pill, Qnexa™ Demonstrated Positive Phase 2 Clinical Data Gloria Gamat October 25, 2006 A pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health – VIVUS, Inc. (Nasdaq: VVUS) – has recently announced positive results from a Phase 2 clinical trial of Qnexa™ (formerly VI-0521). The... Continue Reading Posted at 6:05 AM \| Permalink \| Comments
	Prasugrel Achieved Faster Onset and Higher Levels of Platelet Inhibition than Clopidogrel in a New Study Gloria Gamat October 25, 2006 A 60 mg loading dose of the investigational antiplatelet compound prasugrel showed faster onset of activity and achieved greater inhibition of platelet aggregation than either the approved 300 mg loading dose of clopidogrel (Plavix®) or a higher 600 mg clopidogrel... Continue Reading Posted at 4:48 AM \| Permalink \| Comments
	U.S. Appeals Court Denied Ranbaxy’s Petition for Rehearing of Main Patent in Lipitor Case Gloria Gamat October 25, 2006 According to Pfizer (NYSE: PFE), the Court of Appeals for the Federal Circuit has denied Ranbaxy's petition for rehearing of an August 2 decision upholding the exclusivity of the main patent covering atorvastatin. Atorvastatin is the active ingredient in Lipitor®,... Continue Reading Posted at 2:36 AM \| Permalink \| Comments
	Abbott's HUMIRA® (Adalimumab) Induced Clinical Remission in Infliximab-Intolerant/Unresponsive Crohn's Disease Patients, Phase III Data Says Gloria Gamat October 25, 2006 Abbott (NYSE:ABT)’s new Phase III Study showed that HUMIRA® (adalimumab) induced significantly higher rates of clinical remission compared to placebo in patients with moderately to severely active Crohn's disease who lost response to, or were intolerant to, infliximab (Remicade®) therapy. Crohn's... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Oct24	Schering-Plough’s NOXAFIL® (Posaconazole), USFDA-approved for the Treatment of Oropharyngeal Candidiasis (OPC) Gloria Gamat October 24, 2006 The USFDA has recently approved Schering-Plough Corporation (NYSE: SGP)’s NOXAFIL® (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by... Continue Reading Posted at 9:46 AM \| Permalink \| Comments
	SkinMedica’s Desonate™ (Desonide) Gel 0.05% USFDA-approved for the Treatment of Atopic Dermatitis Gloria Gamat October 24, 2006 SkinMedica, Inc.’s Desonate™ (desonide gel) 0.05% has recently been approved by the USFDA for the treatment of mild to moderate atopic dermatitis (a.k.a. eczema). Free from alcohol, surfactants and fragrance, Desonate is a low potency topical steroid formulated in a... Continue Reading Posted at 7:35 AM \| Permalink \| Comments
	USFDA Approved Expanded Indication of Berlex, Inc.’s Betaseron® Gloria Gamat October 24, 2006 The USFDA has recently approved the expanded indication of Betaseron® (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS. A product of Berlex, Inc. (996344), a... Continue Reading Posted at 5:24 AM \| Permalink \| Comments
	New Purdue Biochip Used in Studying Living Cells: A Tool to Speedy Drug Development Gloria Gamat October 24, 2006 Developed by Purdue University researchers, a new biochip that measures the electrical activities of cells, is capable of obtaining 60 times more data in just one reading than is possible with current technology. The said biochip, in the near future,... Continue Reading Posted at 3:19 AM \| Permalink \| Comments
Oct21	Roche is No. 3 in Science Magazine's list of Top 20 Employers in the Biotech and Pharmaceutical Industry Gloria Gamat October 21, 2006 Roche (OTC: RHHBY, VTX: ROG), for the 5th consecutive year, has been named in the Science Magazine's list of Top 20 Employers in the Biotech and Pharmaceutical Industry, moving up in rank for the fourth straight year to number three... Continue Reading Posted at 11:59 PM \| Permalink \| Comments
	PharmaNova Granted Exclusive U.S. License to Depomed for the Use of Extended Release Gabapentin against Hot Flashes Gloria Gamat October 21, 2006 PharmaNova, Inc. has exclusively licensed certain U.S. patent rights to Depomed, Inc. for the development and commercialization of extended release formulation of gabapentin as a non-hormonal alternative treatment for hot flashes and other vasomotor symptoms of menopause. In exchange for... Continue Reading Posted at 11:48 PM \| Permalink \| Comments
	ELAPRASE™ (idulsulfase) Received Positive Opinion From European Regulatory Agency Gloria Gamat October 21, 2006 ELAPRASE™ (idulsulfase) by Shire plc (LON: SHP, Nasdaq: SHPGY) has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), thereby recommending the approval of ELAPRASE for the long-term... Continue Reading Posted at 11:26 PM \| Permalink \| Comments
	Tm Bioscience Amended License Agreement with Sirius Genomics Gloria Gamat October 21, 2006 A leader in the commercial genetic testing market – Tm Bioscience Corporation (TSE: TMC) – has recently amended its license agreement with Sirius Genomics to defer a $2 million license fee payment originally due on September 5, 2006. This payment... Continue Reading Posted at 11:17 PM \| Permalink \| Comments
	Novocell, Inc. is Creating Insulin-producing Pancreatic Endocrine Cells from Human Embryonic Stem Cells Gloria Gamat October 21, 2006 A stem cell engineering company - Novocell, Inc. - is developing a process that efficiently converts human embryonic stem cells into insulin-producing pancreatic endocrine cells. The said approach could provide a means to produce sufficient quantities of insulin producing cells for... Continue Reading Posted at 10:54 PM \| Permalink \| Comments
	Indication of Centocor, Inc.'s REMICADE®, Now Expanded by the USFDA for Ulcerative Colitis Gloria Gamat October 21, 2006 The USFDA has recently expanded the approval of Centocor, Inc.'s REMICADE® (infliximab) for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response to conventional therapy. The said... Continue Reading Posted at 12:45 AM \| Permalink \| Comments
	PTC Therapeutics Awarded USFDA Orphan Products Development Grant for the Development of PTC124 in Duchenne Muscular Dystrophy Gloria Gamat October 21, 2006 A biopharmaceutical company focused on the discovery and development of small-molecule drugs targeting post-transcriptional control mechanisms--PTC Therapeutics, Inc. (PTC)-- has been awarded a two-year grant from the Office of Orphan Products Development (OOPD) Grant Program of the USFDA. The said... Continue Reading Posted at 12:21 AM \| Permalink \| Comments
	U.S. District Court Granted Mylan a Motion to Dismiss the '909 Patent in the Amlodipine Besylate Litigation Gloria Gamat October 21, 2006 Mylan Laboratories Inc. (NYSE: MYL) has recently been granted by the U.S. District Court for the Western District of Pennsylvania, a motion to dismiss the '909 patent from the patent infringement litigation between Pfizer (NYSE: PFE) and Mylan concerning Amlodipine Besylate... Continue Reading Posted at 12:16 AM \| Permalink \| Comments
Oct20	Cheaper Generics are More Likely to Attract Large Share of Prescription Drug Sales Gloria Gamat October 20, 2006 The low-priced generic drugs soon to be sold by stores such as Wal-Mart, Target and Kmart are likely to attract a big share of the market for prescription drugs --such is the suggestion of a new Wall Street Journal Online/Harris... Continue Reading Posted at 11:53 PM \| Permalink \| Comments
	Medicines for Malaria Venture, Genzyme Corporation and the Broad Institute Expanded Collaboration For the Discovery of New Malaria Drugs Gloria Gamat October 20, 2006 Medicines for Malaria Venture (MMV), Genzyme Corp. (Nasdaq: GENZ), and the Broad Institute of MIT and Harvard have recently agreed to expand their collaboration in order to discover and advance new therapeutic candidates for malaria. The said alliance will build... Continue Reading Posted at 11:48 PM \| Permalink \| Comments
Oct19	Mutual Pharmaceutical Company Filed Counter Suit Against Adams Respiratory Therapeutics on Guaifenesin Case Gloria Gamat October 19, 2006 URL Mutual Pharmaceutical Company, Inc. (Mutual) filed a counter suit against Adams Respiratory Therapeutics (Adams) on antitrust, tortious interference and unfair competition grounds. The counter suit is a response to the filed lawsuits by Adams against Mutual in New Jersey... Continue Reading Posted at 7:36 PM \| Permalink \| Comments
	Genzyme Corp. and AnorMED Inc. Agreed on Acquisition Terms Gloria Gamat October 19, 2006 Genzyme Corporation (Nasdaq: GENZ) and AnorMED Inc. (Nasdaq: ANOR; TSE: AOM) has recently executed a mutually beneficial support agreement under which Genzyme will acquire AnorMED in an all cash transaction valued at $13.50 per outstanding share, or approximately $580 million.... Continue Reading Posted at 7:13 PM \| Permalink \| Comments
	Sanofi- Aventis' Allegra® (fexofenadine hydrochloride) Oral Suspension, USFDA-approved for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria Gloria Gamat October 19, 2006 Sanofi-aventis U.S. recently announced the USFDA approval of its Allegra® (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic... Continue Reading Posted at 3:41 AM \| Permalink \| Comments
	Sanofi Aventis' Taxotere® (docetaxel) Injection Concentrate, USFDA-approved for the Treatment of Patients With Head and Neck Cancer Gloria Gamat October 19, 2006 Reviewed under a supplemental new drug application (sNDA) priority designation, Sanofi Aventis (NYSE: SNY, EPA: SAN)' Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil has been approved by the USFDA for the induction treatment of patients with inoperable... Continue Reading Posted at 3:27 AM \| Permalink \| Comments
	Merck's JANUVIA™, USFDA Approved for Type 2 Diabetes Gloria Gamat October 19, 2006 The USFDA has approved Merck (NYSE: MRK)'s JANUVIA™ (sitagliptin phosphate) -- the first and only DPP-4 inhibitor available in the United States for the treatment of type 2 diabetes. Previously approved as monotherapy and as add-on therapy to either of... Continue Reading Posted at 3:16 AM \| Permalink \| Comments
	Endo Pharmaceuticals Responded to the Lidoderm® Issue Gloria Gamat October 19, 2006 A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:ENDP), Endo Pharmaceuticals Inc. has recently learned that the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research (OGD) has issued (in response to an inquiry) bioequivalence... Continue Reading Posted at 1:59 AM \| Permalink \| Comments
	Lexicon Genetics Initiated Preclinical Development of LX2931 for Autoimmune Diseases Gloria Gamat October 19, 2006 Lexicon Genetics Incorporated (Nasdaq: LEXG) recently announced its commencement of formal preclinical development for LX2931 in preparation for an Investigational New Drug (IND) application. LX2931 is the company's novel, orally-available small molecule compound with potential application in the treatment of... Continue Reading Posted at 1:47 AM \| Permalink \| Comments
Oct18	Diffusion Pharmaceuticals Completed USFDA-Required Toxicology Studies in Support of TSC Phase I Trials and Closed $1.5 Million Private Placement Gloria Gamat October 18, 2006 A drug discovery and development company pioneering a revolutionary mechanism of action to treat life-threatening diseases -- Diffusion Pharmaceuticals LLC -- has recently completed all animal toxicology studies required by the USFDA so that the company can file an investigational... Continue Reading Posted at 9:27 PM \| Permalink \| Comments
	Genta Incorporated’s Genasense® Received Australian Orphan Drug Designation for Advanced Melanoma Patients Gloria Gamat October 18, 2006 Genta Incorporated (Nasdaq: GNTA)’s lead anticancer drug, Genasense® (oblimersen), has received Orphan Drug designation from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia, as treatment for patients with Stage IV malignant melanoma. According to Dr. Raymond P. Warrell,... Continue Reading Posted at 9:16 PM \| Permalink \| Comments
	ARICEPT® (donepezil HCl tablets), USFDA-Approved for Full Spectrum Alzheimer’s Disease Gloria Gamat October 18, 2006 The USFDA has recently approved 10 mg ARICEPT® (donepezil HCl tablets) for the treatment of severe Alzheimer's disease – making ARICEPT® the first and only treatment approved for the full spectrum of Alzheimer’s disease: mild, moderate, severe. According to Sharon... Continue Reading Posted at 9:04 PM \| Permalink \| Comments
	OncoMed Pharmaceuticals Granted USPTO Patent for Identifying Therapeutics Targeting Cancer Stem Cells Gloria Gamat October 18, 2006 Pioneer in the development of novel therapeutics targeting cancer stem cells-- OncoMed Pharmaceuticals -- has been issued U.S. Patent No. 7,115,360 entitled "Isolation and Use of Solid Tumor Stem Cells” by the USPTO. According to John Lewicki, Ph.D., Senior Vice President... Continue Reading Posted at 8:46 PM \| Permalink \| Comments
	Austrian Patent Office Ruled in Favor of Pfizer On Lipitor Basic Patent Gloria Gamat October 18, 2006 Pfizer (NYSE: PFE) recently announced that the Austrian Patent Office has ruled that a claim in the company's basic patent covering the use of atorvastatin, (Lipitor’s active ingredient) would be infringed by generic manufacturer Ranbaxy (BOM: 500359, PINK: RBXLF). Though... Continue Reading Posted at 8:33 PM \| Permalink \| Comments
	Serono and Newron Pharma Entered Into Global Development and Commercialization Agreement for Safinamide Gloria Gamat October 18, 2006 Serono (VTX: SEO and NYSE: SRA) and Newron Pharmaceuticals SpA has entered into an agreement wherein Newron has granted Serono the exclusive worldwide rights for the development, manufacture and commercialization of safinamide in Parkinson's disease (PD), Alzheimer's disease, and other... Continue Reading Posted at 8:21 PM \| Permalink \| Comments
	Foamix, Ltd. and Taro Pharmaceutical Industries Ltd Entered Into License Agreement for the Development and Commercialization of Foamix's PerFoam™ 1% for the Treatment of Head Lice Gloria Gamat October 18, 2006 The leader in the development of stable, alcohol-free, topical foam delivery systems for dermatology and other topical applications- Ness Ziona, Isarael-based Foamix, Ltd. – has licensed a novel topical foam product, PerFoam™ 1% for the contemporary treatment of head lice... Continue Reading Posted at 8:16 PM \| Permalink \| Comments
	TyRx Pharma, Inc. Submitted Premarket Application for PIVIT™ CRM: Novel Mesh Pouch Containing Rifampin and Minocycline Designed to Hold and Reduce Bacterial Colonization of a Pacemaker or ICD Pulse Generator Gloria Gamat October 18, 2006 TyRx Pharma, Inc. has recently submitted a Premarket Application for PIVIT™ CRM, an innovative mesh pouch coated with a proprietary bioresorbable polymer containing the antimicrobial agents, rifampin and minocycline, designed to enclose a pacemaker or ICD pulse generator when implanted... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
	Neurochem Submitted Complete Response in Lieu of USFDA’s Approvable Letter for KIACTA™ Gloria Gamat October 18, 2006 A wholly-owned subsidiary of Neurochem Inc. (Nasdaq: NRMX; TSE: NRM), Neurochem (International) Limited (Neurochem) has submitted a complete response to the USFDA’s August 2006 approvable letter for KIACTA™. Neurochem’s KIACTA™ (eprodisate; formerly FIBRILLEX™) is the company’s investigational product candidate seeking... Continue Reading Posted at 6:43 PM \| Permalink \| Comments
Oct17	Human Genome Sciences Reported Positive Interim Quality-of-Life Data From Phase 2B Trial of Albuferon™ with Ribavirin in Treatment-Naïve Hepatitis C Patients Gloria Gamat October 17, 2006 The Human Genome Sciences, Inc. (Nasdaq: HGSI) has recently reported the 12-week interim quality-of-life results from a Phase 2b clinical trial that evaluated the efficacy, safety and impact on health-related quality of life of Albuferon™ in combination with ribavirin in... Continue Reading Posted at 9:53 PM \| Permalink \| Comments
	Medarex and PharmAthene’s Anthrax Therapeutic Valortim™, Passed Phase I Clinical Trial Gloria Gamat October 17, 2006 Medarex, Inc. (Nasdaq: MEDX) and PharmAthene, Inc. have recently announced the positive results of their Phase I study for Valortim™ (MDX-1303) in healthy volunteers. Valortim™, a fully human antibody against anthrax infection has been developed using Medarex's UltiMAb Human Antibody... Continue Reading Posted at 9:41 PM \| Permalink \| Comments
	Nabi Biopharmaceuticals’ PhosLo® EPICK Study Revealed Positive Results Gloria Gamat October 17, 2006 Nabi Biopharmaceuticals (Nasdaq: NABI) recently announced the positive results from the PhosLo® (calcium acetate) EPICK study in Chronic Kidney Disease (CKD) patients suffering from Stage 4 kidney disease. The EPICK study, designed to demonstrate that PhosLo is effective and safe... Continue Reading Posted at 9:27 PM \| Permalink \| Comments
	Neuren's NNZ-2591, Proved Effective At Memory Loss Reversal Gloria Gamat October 17, 2006 Neuren Pharmaceuticals Ltd (ASX: NEU)’s lead candidate from its diketopiperazine (DKP) family, NNZ-2591, demonstrated positive preclinical effects of improved learning and memory after oral dosing. Memory was improved to pre-injury levels (100%), a statistically significant effect (p<0.03). The following being... Continue Reading Posted at 9:15 PM \| Permalink \| Comments
	PDL BioPharma Presented Physician Survey Results on Heart Attack Treatment Gloria Gamat October 17, 2006 PDL BioPharma, Inc. (Nasdaq: PDLI) recently announced the results of a survey which revealed that a considerable number (24%) of U.S. cardiologists and emergency physicians were unaware of current heart attack treatment guidelines, with a majority (61%) believing that there... Continue Reading Posted at 9:08 PM \| Permalink \| Comments
Oct16	Genta, Inc. Initiated Phase 1 trial of Antisense Drug, G4460, in Advanced Cancer Patients Gloria Gamat October 16, 2006 Genta Incorporated (Nasdaq: GNTA) has initiated the Phase 1 clinical trial using a new anticancer drug derived from the Company's DNA/RNA Medicines program. The new anticancer drug known as G4460 uses antisense technology to target an oncogene known as c-myb... Continue Reading Posted at 10:07 PM \| Permalink \| Comments
	CHEM Rx Announced Acquisition Strategy Gloria Gamat October 16, 2006 The U.S.’s largest privately-owned long-term care pharmacy, CHEM Rx, has retained Melville, New York based Equity Transfers, a business development consulting firm, to provide business development services that include searching the "Long Term Care Industry" for institutional pharmacies available for... Continue Reading Posted at 9:19 PM \| Permalink \| Comments
	Bayer Appointed Independent Investigator for Review of Trasylol® Study Issues Gloria Gamat October 16, 2006 Bayer has appointed an independent counsel to review the company's actions in regards to disclosure of preliminary results from an observational study on Trasylol® to the USFDA. Fred F. Fielding Esq., from the law firm Wiley Rein & Fielding LLP... Continue Reading Posted at 8:48 PM \| Permalink \| Comments
	Isolagen, Inc and the USFDA Has Agreed on Phase III Protocol Design for Isolagen™ Therapy (IT) Gloria Gamat October 16, 2006 Isolagen, Inc. (AMEX: ILE) has recently entered an agreement with the USFDA on the design of the company’s Phase III pivotal study protocol for the use of Isolagen™ Therapy for the treatment of wrinkles. Isolagen’s protocol has been submitted to... Continue Reading Posted at 8:30 PM \| Permalink \| Comments
	New River Pharmaceuticals, Inc. and USFDA Conducted End-of-Phase II Meeting on NRP290 (Product Candidate for Acute Pain) Gloria Gamat October 16, 2006 Company officials of New River Pharmaceuticals Inc. (Nasdaq: NRPH) have met last week on an end-of-phase II meeting with staff members of the Center for Drug Evaluation and Research of the USFDA and discussed NRP290, a hydrocodone derivative under development... Continue Reading Posted at 8:25 PM \| Permalink \| Comments
Oct15	Morphotek Inc Receives $40 Million in Series D Financing Round Gloria Gamat October 15, 2006 Morphotek® Inc. has raised $40 million in Series D financing. The financing was led by Investor Growth Capital of New York and included participation of new investors MDS Capital and Hunt BioVentures as well as existing investors Forward Ventures, Morgenthaler... Continue Reading Posted at 10:51 PM \| Permalink \| Comments
	Clinical Data on Selected Cethromycin Trials Presented by Advanced Life Sciences at IDSA Annual Meeting Gloria Gamat October 15, 2006 At the 44th Annual Meeting of the Infectious Diseases Society of America (IDSA), held this year in (Toronto, Ontario), for the first time Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS) has presented the clinical results comparing the safety and efficacy... Continue Reading Posted at 10:46 PM \| Permalink \| Comments
	Innocoll, Inc. Receives FDA Approval for CollaGUARD™ Collagen-Based Advanced Gloria Gamat October 15, 2006 Innocoll Pharmaceuticals, has received 510k approval from the US FDA for CollaGUARD™, an advanced wound care product indicated for the management of superficial and deep wounds, including coverage of skin ulcers and temporary dermatoplasty in the case of lesion and... Continue Reading Posted at 9:43 PM \| Permalink \| Comments
	Newly Published Data Show Efficacy and Safety of Spracor's Lunesta in Elderly Patients with Insomnia Gloria Gamat October 15, 2006 According to the results of an extensive trial published in the September issue of Current Medical Research and Opinion, LUNESTA (eszopiclone) appears to improve sleep in elderly patients (64-86 years of age) with chronic primary insomnia. Study data showed that... Continue Reading Posted at 9:30 PM \| Permalink \| Comments
	USAMRMC Extended Lexicon Genetics' Grant for Spinal Muscular Atrophy (SMA) Research Program Gloria Gamat October 15, 2006 The United States Army Medical Research & Materiel Command (USAMRMC) has granted another year to Lexicon Genetics Incorporated (Nasdaq: LEXG) to continue its research program to identify targets that may be important in the development of drugs in the prevention... Continue Reading Posted at 7:44 PM \| Permalink \| Comments
	Peregrine Receives Regulatory Approval in India for New Cotara® Brain Cancer Clinical Trial Gloria Gamat October 15, 2006 Peregrine Pharmaceuticals, Inc. (PPHM) has received regulatory approval in India for a new clinical trial of its lead tumor necrosis therapy (TNT) agent Cotara®, to test its safety and efficacy in treating glioblastoma multiforme, a deadly form of brain cancer.... Continue Reading Posted at 7:19 PM \| Permalink \| Comments
	FDA Grants Orphan Drug Designation For Agennix's Talactoferrin Alfa In Renal Cell Carcinoma Gloria Gamat October 15, 2006 The U.S. FDA has granted orphan drug designation to Agennix's oral formulation of Talactoferrin Alfa (talactoferrin or TLF), curently on Phase II clinical development for the treatment of renal cell carcinoma (RCC). Talactoferrin Alfa is a unique recombinant form of... Continue Reading Posted at 6:57 PM \| Permalink \| Comments
	FDA Approves AstraZeneca's NEXIUM® for the Treatment of Zollinger-Ellison Syndrome Gloria Gamat October 15, 2006 The US Food and Drug Administration (FDA) has approved a new indication for the "purple pill", NEXIUM® (esomeprazole magnesium), for the treatment of Zollinger-Ellison Syndrome (ZES). Nexium is a prescription proton pump inhibitor marketed by AstraZeneca (AZN) for the treatment... Continue Reading Posted at 6:40 PM \| Permalink \| Comments
	New Sleeping Pill Rozerem Unlikely to Lead to Dependence or Abuse Gloria Gamat October 15, 2006 According to a new study conducted by researchers from the Johns Hopkins University School of Medicine, Rozerem (ramelteon), a new sleeping medication recently approved for the treatment of insomnia is not likely to cause dependence or abuse. Because of concerns... Continue Reading Posted at 5:56 PM \| Permalink \| Comments
	Bellicum Pharmaceuticals Entered into Commercial Licensing of ARIAD's ARGENT™ Cell-Signaling Regulation Technology for Development of New Cancer Therapies Gloria Gamat October 15, 2006 Bellicum Pharmaceuticals, Inc. has entered into a non-exclusive, royalty-bearing licensing agreement with ARIAD Pharmaceuticals Inc. (Nasdaq: ARIA) for its ARGENT™ cell-signaling regulation technology. The terms of agreement include: AIAD having an equity stake in Bellicum and receiving additional payments. Based... Continue Reading Posted at 5:06 PM \| Permalink \| Comments
	"Humanized" Antibodies May Prevent and Treat Bird Flu Gloria Gamat October 15, 2006 Researchers have come up with bioengineered bird flu antibodies, producing what they refer to as "humanized monoclonal" antibodies. Complete protection from the H5N1 bird flu strain has been confered by one of the two engineered antibodies developed. "We have shown... Continue Reading Posted at 4:56 PM \| Permalink \| Comments
	FDA Grants Tentative Approval to Teva Pharmaceutical's Generic Risperdal Gloria Gamat October 15, 2006 The U.S. Food and Drug Administration has granted tentative approval for the Abbreviated New Drug Application submitted by Teva Pharmaceuticals (TEVA) to market its generic version of Risperdal® (Risperidone) Oral Solution, 1 mg/mL. Final approval is expected on December 29,... Continue Reading Posted at 3:22 PM \| Permalink \| Comments
	Roche Seeks European Marketing Authorization for Herceptin Plus Hormonal Therapy for Advanced HER2-Positive Breast Cancer Gloria Gamat October 15, 2006 Roche has applied for marketing authorisation to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone receptor-positive breast cancer. This application follows the release of results from an extensive trial, which demonstrated that Herceptin... Continue Reading Posted at 3:11 PM \| Permalink \| Comments
	Endo Pharmaceuticals Acquires RxKinetix for $20 Million, Gains Rights to RK-0202 Oral Rinse for Oral Mucositis Gloria Gamat October 15, 2006 Endo Pharmaceuticals Inc. (ENDP) has acquired all of the outstanding stock of RxKinetix, Inc., a Colorado-based company that develops new formulations of approved products for oral mucositis and other supportive care oncology conditions. RxKinetix's lead product, RK-0202, is a topical... Continue Reading Posted at 12:10 PM \| Permalink \| Comments
	FDA Approves Aricept® For Treatment of Severe Alzheimer's Disease Gloria Gamat October 15, 2006 Eisai Medical Research Inc., a subsidiary of Tokyo-based Eisai Co., Ltd (TYO: 4523). has received approval from the U.S. FDA for a supplemental New Drug Application for Aricept® in the treatment of severe Alzheimer's disease (AD). Aricept is currently the... Continue Reading Posted at 10:06 AM \| Permalink \| Comments
	Indevus Submits New Drug Application for SANCTURA XR Once Daily Drug For Overactive Bladders Gloria Gamat October 15, 2006 Indevus Pharmaceuticals, Inc. (IDEV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for SANCTURA XR™, a once-daily version Sanctura (trospium chloride), currently marketed as treatment of patients with overactive bladder. "SANCTURA... Continue Reading Posted at 6:09 AM \| Permalink \| Comments
	Alfred Mann Institute Established at the Technion-Israel Institute of Technology , Technion Receives $100 Million Gloria Gamat October 15, 2006 Biomedical entrepreneur and philanthropist Alfred E. Mann will donate $100 million to establish a biomedical research institute at the Technion-Israel Institute of Technology, making Technion the first and only non-US university chosen to be part of vision of establishing a... Continue Reading Posted at 4:05 AM \| Permalink \| Comments
	BioAlliance Pharma Receives French Marketing Authorization for Its first Product Loramyc® for the Treatment of Oropharyngeal Candidiasis Gloria Gamat October 15, 2006 BioAlliance Pharma SA (EPA:BIO) has received marketing authorization for Loramyc® (miconazole Lauriad) from France's regulatory body, AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé). Loramyc® is the firm's first product, developed for the treatment of oropharyngeal candidiasis (OPC)... Continue Reading Posted at 3:07 AM \| Permalink \| Comments
Oct14	PharmAthene, Inc. Got $1 Million Congressional Appropriation for Continued Development of Anthrax Therapeutic Valortim™ Gloria Gamat October 14, 2006 The FY 2007 Department of Defense (DoD) appropriations law includes $1.0 million payable to PharmAthene, Inc. ( a privately-held biotechnology company) to support ongoing development of Valortim™. An investigational fully human monoclonal antibody being developed for the prevention and treatment... Continue Reading Posted at 8:39 PM \| Permalink \| Comments
	Modified Inteleukin-1 Receptor Antagonist May Offer Prolonged Osteoarthritis Relief Gloria Gamat October 14, 2006 Researchers at Duke University have modified a drug called interleukin-1 receptor antagonist (IL1RA) to prolong its effects and potentially making it useful for providing longer-lasting treatment for osteoarthritis. While current estimates suggest that it would take about 2 injections of... Continue Reading Posted at 8:33 PM \| Permalink \| Comments
	LifeCycle Pharma Entered Into Three Distinct Strategic Collaboration Agreements With Global Pharmaceutical Companies Gloria Gamat October 14, 2006 Horsholm, Denmark- based LifeCycle Pharma A/S, has entered into three strategic collaboration agreements with leading players in the pharmaceutical industry: 1) Sandoz Inc. (an affiliate of Novartis AG) -- an exclusive development and commercialization agreement regarding the US market with... Continue Reading Posted at 8:32 PM \| Permalink \| Comments
	Psychostimulant Methamphetamine May Reduce Stroke Damage Gloria Gamat October 14, 2006 According to a new animal study conducted by researchers from the University of Montana, psychostimulant drug methamphetamine seems to reduce brain damage following stroke. The scientists claim to have small dosages of meth confer 80 to 90 percent protection of... Continue Reading Posted at 6:20 PM \| Permalink \| Comments
	More Than 90% of Pliva Shares Tendered to Barr Pharmaceuticals for $2.5 Billion Gloria Gamat October 14, 2006 More than 90% of the shares of Croatia-based PLIVA d.d. (PLVGF) has been tendered to the European subsidiary of Barr Pharmaceuticals Inc. (BRL) for close to $2.5 billion . The deal is expected to close on October 25. "... Our... Continue Reading Posted at 5:07 PM \| Permalink \| Comments
	Prozac Increases Bone Mass, May Treat Osteoporosis Gloria Gamat October 14, 2006 Prozac, a popular drug used to treat depression, also seems to have the potential to treat osteoporosis. An animal study expected to be published in an upcoming issue of the Journal of Cellular Biochemistry, has demonstrated that in mice, Prozac... Continue Reading Posted at 4:45 PM \| Permalink \| Comments
	Clinical Studies Show Rotigotine Patch Appears to Be a Safe Treatment for Early-Stage Parkinson's Disease Gloria Gamat October 14, 2006 According to the results presented during the 131st Annual Meeting of the American Neurological Association (ANA), Schwarz Pharma's rotigotine transdermal patch showed a favorable safety and tolerability profile for the treatment of Parkinson's Disease in patients over the age of... Continue Reading Posted at 2:06 PM \| Permalink \| Comments
	FDA Approves Colon Cancer Drug Avastin for Treatment of Non-Small Cell Lung Cancer Gloria Gamat October 14, 2006 The U.S. Food and Drug Administration (FDA) has approved Genentech's colon cancer drug Avastin® (bevacizumab) to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC). "Bevacizumab, in combination with chemotherapy,... Continue Reading Posted at 6:05 AM \| Permalink \| Comments
	Antipsychotic Drugs Found Ineffective For Treating Psychotic Symptoms in Alzheimer's Disease Gloria Gamat October 14, 2006 According to a large study conducted at 33 university and hospital clinics and nine doctor's offices in the U.S., antipsychotic drugs originally developed to treat schizophrenia,such as Zyprexa, Seroquel and Risperdal, appears ineffective in treating psychotic symptoms in Alzheimer's Disease... Continue Reading Posted at 3:30 AM \| Permalink \| Comments
	Ambrilla Licenses HIV/AIDA Protease Inhibitor Drug Candidate to Merck for $17 Million Plus $215 Million Milestone Fees Gloria Gamat October 14, 2006 Canada-based Ambrilia Biopharma (AMB) has licensed its HIV/AIDS protease inhibitor (PI) program including its HIV drug lead candidate PPL-100 to Merck & Co., Inc. for $17 million up front fee and up to $215 million in milestone payments on clinical... Continue Reading Posted at 2:52 AM \| Permalink \| Comments
Oct13	Cephalon, Inc.'s FENTORA™ (fentanyl buccal tablet) for Breakthrough Pain in Patients with Chronic Low Back Pain, Passed Phase III Clinical Trial Gloria Gamat October 13, 2006 Cephalon, Inc. (Nasdaq:CEPH) recently announced the postive results of its Phase 3 clinical trial of FENTORA™ (fentanyl buccal tablet) [C-II], demonstrating efficacy in the management of breakthrough pain in opioid-tolerant patients with chronic low back pain. The double-blind placebo controlled... Continue Reading Posted at 10:16 PM \| Permalink \| Comments
	Amarin Corporation plc, Granted USPTO Patent Approval for Miraxion in Huntington's Disease Gloria Gamat October 13, 2006 Amarin Corporation plc (Nasdaq: AMRN) has recently announced the USPTO's approval of its patent application (patent number 7,119,118) covering the use of its proprietary ultra-pure ethyl-EPA compound ("Miraxion") in Huntington's disease. According to Rick Stewart, CEO of Amarin Corporation plc:... Continue Reading Posted at 10:09 PM \| Permalink \| Comments
	GlaxoSmithKLine Submitted Supplemental New Drug Application for Advair Diskus® in COPD Gloria Gamat October 13, 2006 GlaxoSmithKline (GSK) has recently submitted a supplemental new drug application to the USFDA in order to expand the labelling for Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) following results of TORCH (TOwards a Revolution in COPD Health), a three... Continue Reading Posted at 9:52 PM \| Permalink \| Comments
	Novartis Launched 'GALIANT' Study Comparing the Investigational Drug Galvus® and a Leading Class of Oral Anti-Diabetic Medicines (TZDs) Gloria Gamat October 13, 2006 Novartis (NYSE: NVS, VTX: NOVN)recently commenced GALIANT, a a significant clinical trial designed to involve more than 7,500 people in the United States in order to compare the investigational oral type 2 diabetes medication Galvus® (vildagliptin) with commonly prescribed anti- diabetic... Continue Reading Posted at 9:29 PM \| Permalink \| Comments
	CV Therapeutics, Inc. Terminated Co-Promotion of ACEON® (perindopril erbumine) Tablets with Solvay Pharmaceuticals, Inc. Gloria Gamat October 13, 2006 CV Therapeutics, Inc. (Nasdaq: CVTX) has recently terminated its co-promotion agreement with Solvay Pharmaceuticals, Inc. for ACEON® (perindopril erbumine) Tablets. Thus, over the next several weeks, CV Therapeutics will conclude its promotion of ACEON®. According to Louis G. Lange, M.D.,... Continue Reading Posted at 9:20 PM \| Permalink \| Comments
Oct11	Schering-Plough Files Patent Infringement Lawsuit Against GeoPharma Inc Over Generic Version of Clarinex(R) Gloria Gamat October 11, 2006 Schering-Plough Corp (SGP) has filed a lawsuit against GeoPharma Inc (GORX) and its subsidiary Belcher Pharmaceuticals Inc over patent infringement of GeoPharma's generic version of Clarinex, a drug for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, chronic idiopathic... Continue Reading Posted at 2:25 AM \| Permalink \| Comments
	EU Grants Marketing Approval To Schering-Plough's Suboxone Sublingual Tablets for the Treatment of Opioid Addiction Gloria Gamat October 11, 2006 Schering-Plough Corporation (SGP) has received marketing approval from the European Commission for Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets, indicated for the treatment of opioid dependance. "The European Commission's approval of SUBOXONE represents an important advance in public health," said Robert... Continue Reading Posted at 1:20 AM \| Permalink \| Comments
	Theravance Announce Positive Phase III Trials on Telavancin for MRSA Infections Gloria Gamat October 11, 2006 Theravance, Inc (THRX) announced additional results from its Phase III trials of telavancin, a rapidly bactericidal injectable antibiotic with multiple mechanisms of action, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. "Staphylococcal infections,... Continue Reading Posted at 12:05 AM \| Permalink \| Comments
Oct10	Dyanavax Shares Rose Following Publication of Pilot Study On the Efficacy of Tolamba Ragweed Allergy Vaccine Gloria Gamat October 10, 2006 Dynavax (DVAX) stocks rose 26% following the publication of a study showing that its investigational vaccine against ragweed allergies effectively reduced allergic responses. TOLAMBA, consisting of a TLR9 agonist linked to a specific ragweed allergen, required only 6 injections, and... Continue Reading Posted at 5:19 AM \| Permalink \| Comments
	Wyeth Submits NDA and MAA for mTOR Inhibitor Torisel for the Treatment of Advanced Renal Cell Carcinoma Gloria Gamat October 10, 2006 Wyeth Pharmaceuticals (Wyeth) has filed new drug application to the U.S. Food and Drug Administration and marketing authorization application to the European Medicines Agency for Torisel™ (temsirolimus), an mTOR kinase inhibitor for the treatment of advanced renal cancer. If approved,... Continue Reading Posted at 4:15 AM \| Permalink \| Comments
	Edison Pharmaceuticals Collaborate With Brazil's Institute of Vision To Develop Mitochondrial Therapies for Leber's Disease Gloria Gamat October 10, 2006 Edison Pharmaceuticals is collaborating with the Institute of Vision, Federal University of Sao Paulo, Brazil to develop therapeutics for Leber's Hereditary Optic Neuropathy (LHON), a hereditary disorder characterized by sudden loss of vision. LHON arises from impairments in energy production... Continue Reading Posted at 3:12 AM \| Permalink \| Comments
	deCode Pharmaceuticals Suspends Phase III Trial of Heart Attack Drug DG031 Due to Formulation Issues Gloria Gamat October 10, 2006 Iceland-based biopharmaceutical company deCode Genetics Inc. (DCGN) has suspended its Phase III clinical trial for DG031 (veliflapon), a heart attack prevention drug, allegedly due to a formulation problem with the tablets being used in the trial. Routine testing of clinical... Continue Reading Posted at 2:08 AM \| Permalink \| Comments
	GW Pharmaceuticals Announce Positive Phase II Trials of Sativex Oromucosal Spray for Multiple Sclerosis Gloria Gamat October 10, 2006 GW Pharmaceuticals PLC (GPW) announced favorable results from two Phase II studies of Sativex®, a cannabis-based oromucosal spray for the treatment of multiple sclerosis symptoms. The results were presented during the 22nd Congress of the European Committee for Treatment and... Continue Reading Posted at 1:01 AM \| Permalink \| Comments
Oct 9	Out of The Storm Debris Gloria Gamat October 9, 2006 Slow and hicupping every 10 minutes or so, i finally found an online internet shop runnning on electric generator. Pardon the unexpected hiatus on this blog, my little city down south of the Philippine Islands (Sorsogon) has been hardly hit... Continue Reading Posted at 11:46 PM \| Permalink \| Comments

« September 2006 | Main | November 2006 »

Oct31	Shire plc’s ADHD Patch, DAYTRANA™ (methylphenidate transdermal system): Provided Individualized Symptom Management Gloria Gamat October 31, 2006 Know More: Patents and Clinical Trials Shire plc’s Attention Deficit Hyperactivity Disorder (ADHD) patch, DAYTRANA™ (methylphenidate transdermal system), significantly reduced the symptoms of ADHD in children aged 6 to 12 years, even when the ADHD patch is taken off earlier than the recommended nine hours. Being able to remove the patch earlier than the recommended nine-hour wear time enables physicians to manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping. Such were the phase IIIb clinical trial results recently reported by Shire Plc (LON: SHP, Nasdaq: SHPGY) at the 53rd Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in San Diego, California. Timothy E. Wilens, M.D., Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School, explained: "The patch's delivery system offers physicians individualized control of their patients' ADHD symptoms, adding an important dimension to the treatment of ADHD, since a child's schedule often varies between school day and weekend. Because it is a patch, if a child sleeps late on the weekend and the patch is applied later than on a school day, it can still be removed at the usual time. That way, the child receives the benefit of their long-acting ADHD medication for a shorter duration of effect, as well as managing the potential for late-day side effects. The physician, in consultation with the parent, can determine the appropriate patch wear time, up to the recommended nine hours." DAYTRANA™ is the first and only patch medication approved by the USFDA for the treatment of the symptoms of pediatric ADHD and is available in four dosage strengths -- 10 mg, 15 mg, 20 mg and 30 mg -- all designed for once-daily use. Find more details from the press release. Posted at 2:18 AM \| Permalink \| Comments
Oct31	Pharmasset Commenced Phase 1 Study of R7128 for Hepatitis C Virus Gloria Gamat October 31, 2006 This is the last day of the Liver Meeting® 2006 or the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) and so the drug pipeline on the Hepatitis viruses is in focus. Here goes... Continue Reading Posted at 12:52 AM \| Permalink \| Comments
Oct30	Dendreon’s PROVENGE® Demonstrated Prostate Cancer Survival in Phase 3 Studies Gloria Gamat October 30, 2006 Recently announced by Dendreon Corporation (Nasdaq: DNDN) are data from an exploratory analysis of Phase 3 Studies (D9901 and D9902A) which demonstrated significant correlation between cumulative CD54 upregulation and survival for patients treated with Dendreon's investigational active cellular immunotherapy PROVENGE®... Continue Reading Posted at 11:42 PM \| Permalink \| Comments
	Telbivudine (TYZEKA™) Data from Idenix’s GLOBE Study, Presented at AASLD Annual Meeting Gloria Gamat October 30, 2006 New data from three clinical studies of telbivudine for the treatment of chronic hepatitis B (CHB) was presented by Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) at the still ongoing 57th Annual Meeting of the American Association for the Study of Liver... Continue Reading Posted at 10:21 PM \| Permalink \| Comments
	Schering –Plough’s INTRON® and REBETOL® Retreatment Study Results, Presented at AASLD Annual Meeting Gloria Gamat October 30, 2006 Clinical data from Schering-Plough (NYSE: SGP)’s EPIC3 (a large ongoing clincinal study) recently revealed that retreatment with combination therapy of PEG-INTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) can result in sustained virologic response(1) (SVR) in patients with chronic hepatitis C... Continue Reading Posted at 9:23 PM \| Permalink \| Comments
Oct29	NicOx’s Naproxcinod Sucessfully Passed Osteoarthritis Phase 3 Trial Gloria Gamat October 29, 2006 NicOx S.A. (EPA: COX) recently announced the successful top-line results from a phase 3 trial of naproxcinod (HCT 3012) in patients with osteoarthritis of the knee (the 301 study).Naproxcinod is the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class,... Continue Reading Posted at 10:30 PM \| Permalink \| Comments
	Strattera®, Effective in Treating ADHD Symptoms in Children and Adolescents with ADHD and Reading Disorders, New Study Says Gloria Gamat October 29, 2006 As reported recently at a meeting of child and adolescent psychiatrists, new clinical data demonstrated that Strattera® (atomoxetine HCl) improved ADHD symptoms in children and adolescents who had both ADHD and a reading disorder, like dyslexia. The said study measured... Continue Reading Posted at 9:07 PM \| Permalink \| Comments
	European Patent Office Supports Validity of Pfizer's Lipitor® Patent Gloria Gamat October 29, 2006 As if Ranbaxy (BOM: 500359) needed more salt to add to its Lipitor patent wound...Once more another patent office, this time the European Patent Office (EPO) has issued an upholding opinion to Pfizer’s calcium salt patent covering Lipitor®, in its... Continue Reading Posted at 7:48 PM \| Permalink \| Comments
Oct28	Wyeth: One of the U.S. EPA's Best Workplaces for Commuters Gloria Gamat October 28, 2006 Wyeth (NYSE: WYE) has been included in the U.S. Environmental Protection Agency's (EPA) list of "Best Workplaces for Commuters" from the Fortune 500 Companies for the third consecutive year. Jumping six spots to the 13th position on the 2006 ranking,... Continue Reading Posted at 6:21 AM \| Permalink \| Comments
	New Drug for the Treatment of Chronic Hepatitis B Patients: Idenix Pharma, Inc.'s TYZEKA™ (telbivudine), USFDA-Approved Gloria Gamat October 28, 2006 TYZEKA™ (telbivudine), a product of Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), has recently been approved by the USFDA as a new once-a-day oral treatment (taken with or without food) for patients with chronic hepatitis B (CHB). TYZEKA™, which demonstrated abililty to... Continue Reading Posted at 4:15 AM \| Permalink \| Comments
	Laureate Pharma Extended its PROSTASCINT® Manufacture Agreement with Cytogen Corp. Gloria Gamat October 28, 2006 Laureate Pharma, Inc. (11061029) renewed its agreement with Cytogen Corporation (Nasdaq: CYTO) for the cGMP manufacture of ProstaScint®, Cytogen's proprietary monoclonal antibody immunoconjugate that is used for imaging in patients diagnosed with prostate cancer. While Laureate Pharma will provide cGMP protein... Continue Reading Posted at 3:10 AM \| Permalink \| Comments
	Auxilium Pharmaceuticals, Inc.'s Injectable Enzyme against Peyronie's Disease: AA4500, Passed Phase II Studies Gloria Gamat October 28, 2006 Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) reported positive clinical data from two Phase II trials of AA4500 at the American Urology Association's (AUA) western sectional meeting in Maui, Hawaii. An injectable enzyme, AA4500 demonstrated efficacy and safety in treating patients with... Continue Reading Posted at 1:37 AM \| Permalink \| Comments
Oct27	Javelin Pharmaceuticals: Frost & Sullivan’s Entrepreneurial Company of the Year for Intranasal Therapeutics Gloria Gamat October 27, 2006 Because of its role as an emerging leader in intranasal therapeutics --Javelin Pharmaceuticals (Amex: JAV) -- has received the 2006 Frost & Sullivan Award for Entrepreneurial Company of the Year. The said award is granted each year by Frost &... Continue Reading Posted at 7:55 AM \| Permalink \| Comments
	Genmab A/S Initiated Combination Clinical Study of HuMax-EGFr™ With Chemo-Radiation Gloria Gamat October 27, 2006 Danish company, Genmab A/S (CPH: GEN) has initiated a Phase I/II study of HuMax- EGFr™ (zalutumumab) in combination with chemo-radiation as a first line treatment of head and neck cancer. The said clinical study that will include a total of... Continue Reading Posted at 6:41 AM \| Permalink \| Comments
	Treatment Response to Mesalamine = Rapid Mucosal Healing in Moderately Active Ulcerative Colitis (UC) Patients, According to Combined Data Analysis Gloria Gamat October 27, 2006 Data analysis from two clinical trial revealed that the success of treatment is associated with mucosal healing in patients with moderately active ulcerative colitis (UC) who received either 2.4 or 4.8 grams of mesalamine per day. A product of Procter and... Continue Reading Posted at 4:42 AM \| Permalink \| Comments
	New Nexium® Formulation: NEXIUM® For Delayed-Release Oral Suspension, Approved by the USFDA Gloria Gamat October 27, 2006 A new formulation of AstraZeneca (NYSE: AZN)’s prescription proton pump inhibitor -NEXIUM® (esomeprazole magnesium) - has recently been approved by the USFDA. The new NEXIUM® For Delayed-Release Oral Suspension is now approved for the treatment of GERD, including symptomatic gastroesophageal... Continue Reading Posted at 4:00 AM \| Permalink \| Comments
	Clinical Data Demonstrating Additive Anti-Fibrotic Combination Effects of Actimmune® and Pirfenidone, Presented by InterMune, Inc. at CHEST 2006 Gloria Gamat October 27, 2006 InterMune, Inc. (Nasdaq: ITMN) has recently reported the preclinical data of its two Phase III drug candidates for idiopathic pulmonary fibrosis (IPF): Actimmune® (interferon gamma-1b) and pirfenidone, at CHEST 2006 --the annual conference of the American College of Chest Physicians... Continue Reading Posted at 3:24 AM \| Permalink \| Comments
	U.S. District Court Granted Ortho-McNeil Neurologics, Inc.’s Request for Preliminary Injunction for TOPAMAX® Gloria Gamat October 27, 2006 The request of Ortho-McNeil Neurologics, Inc. (a subsidiary of Johnson & Johnson, NYSE: JNJ) for a preliminary injunction against Mylan Laboratories, Inc. (NYSE: MYL) has been granted by a U.S. District court, thereby prohibiting Mylan from launching a generic version of... Continue Reading Posted at 2:12 AM \| Permalink \| Comments
	D-Pharm Ltd. Granted DP-b99 Exclusive License to Yungjin Pharmaceutical Company Ltd. For Korean Acute Stroke Market Gloria Gamat October 27, 2006 D-Pharm Ltd. (691243) has granted Yungjin Pharmaceutical Company Ltd. (SEO: 003520) an exclusive license to develop, register and market DP-b99 in South Korea for the treatment of acute stroke patients. The terms of agreement includes the following: an upfront payment... Continue Reading Posted at 1:09 AM \| Permalink \| Comments
Oct26	Stiefel Laboratories, Inc. Bought Connetics Corporation Gloria Gamat October 26, 2006 The world's largest independent pharmaceutical company specializing in dermatology -Stiefel Laboratories Inc.- has recently signed a definitive merger agreement for the purchase of all the outstanding shares of Connetics Corporation (Nasdaq: CNCT) for $17.50 per share. The said transaction is... Continue Reading Posted at 11:51 PM \| Permalink \| Comments
	BrainCells and Organon Entered Collaboration for Discovery and Development of CNS Drugs Gloria Gamat October 26, 2006 The human health care business unit of Akzo Nobel (Nasdaq: AKZOY) –Oraganon- and BrainCells Inc. (BCI) have recently entered into a collaboration that will discover and develop drugs for the treatment of central nervous system (CNS) disorders. For the identification... Continue Reading Posted at 10:34 PM \| Permalink \| Comments
Oct25	Somaxon Pharmaceuticals' SILENOR™ Passed Phase 3 Transient Insomnia Clinical Trial Gloria Gamat October 25, 2006 Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) recently announced the positive results from its Phase 3 clinical trial that evaluated SILENOR™ (doxepin HCl) in adults with transient insomnia. The Phase III clinical data revealed that SILENOR™ demonstrated statistically significant improvements versus... Continue Reading Posted at 2:40 PM \| Permalink \| Comments
	DelSite Presented Clinical Data on Influenza Nasal Powder Vaccine Gloria Gamat October 25, 2006 During the Second International Conference on Influenza Vaccines for the World (IVW), held October 18-20, 2006 in Vienna, Austria, Yawei Ni, Ph.D., Senior Scientist at DelSite Biotechnologies, gave an oral presentation entitled "An Inactivated Influenza Nasal Powder Vaccine", as... Continue Reading Posted at 12:31 PM \| Permalink \| Comments
	Novartis’ Zelnorm® Demonstrated Relief of Multiple Symptoms of Dysmotility-Type Dyspepsia Gloria Gamat October 25, 2006 According to new clinical presented at the recent American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Zelnorm® (tegaserod maleate) demonstrated potential in the treatment of the multiple symptoms of dysmotility-type dyspepsia. Currently, there are no prescription... Continue Reading Posted at 10:20 AM \| Permalink \| Comments
	AMITIZA™ (lubiprostone) Demonstrated Efficacy Within 24 and 48 Hours of Treatment Gloria Gamat October 25, 2006 60 percent of patients treated with AMITIZA™ (lubiprostone) experienced a spontaneous bowel movement (SBM) within 24 hours of treatment, and 80 percent experienced a SBM within 48 hours of treatment. Such were the results of two pivotal studies presented at... Continue Reading Posted at 8:10 AM \| Permalink \| Comments
	VIVUS' Obesity Pill, Qnexa™ Demonstrated Positive Phase 2 Clinical Data Gloria Gamat October 25, 2006 A pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health – VIVUS, Inc. (Nasdaq: VVUS) – has recently announced positive results from a Phase 2 clinical trial of Qnexa™ (formerly VI-0521). The... Continue Reading Posted at 6:05 AM \| Permalink \| Comments
	Prasugrel Achieved Faster Onset and Higher Levels of Platelet Inhibition than Clopidogrel in a New Study Gloria Gamat October 25, 2006 A 60 mg loading dose of the investigational antiplatelet compound prasugrel showed faster onset of activity and achieved greater inhibition of platelet aggregation than either the approved 300 mg loading dose of clopidogrel (Plavix®) or a higher 600 mg clopidogrel... Continue Reading Posted at 4:48 AM \| Permalink \| Comments
	U.S. Appeals Court Denied Ranbaxy’s Petition for Rehearing of Main Patent in Lipitor Case Gloria Gamat October 25, 2006 According to Pfizer (NYSE: PFE), the Court of Appeals for the Federal Circuit has denied Ranbaxy's petition for rehearing of an August 2 decision upholding the exclusivity of the main patent covering atorvastatin. Atorvastatin is the active ingredient in Lipitor®,... Continue Reading Posted at 2:36 AM \| Permalink \| Comments
	Abbott's HUMIRA® (Adalimumab) Induced Clinical Remission in Infliximab-Intolerant/Unresponsive Crohn's Disease Patients, Phase III Data Says Gloria Gamat October 25, 2006 Abbott (NYSE:ABT)’s new Phase III Study showed that HUMIRA® (adalimumab) induced significantly higher rates of clinical remission compared to placebo in patients with moderately to severely active Crohn's disease who lost response to, or were intolerant to, infliximab (Remicade®) therapy. Crohn's... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Oct24	Schering-Plough’s NOXAFIL® (Posaconazole), USFDA-approved for the Treatment of Oropharyngeal Candidiasis (OPC) Gloria Gamat October 24, 2006 The USFDA has recently approved Schering-Plough Corporation (NYSE: SGP)’s NOXAFIL® (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by... Continue Reading Posted at 9:46 AM \| Permalink \| Comments
	SkinMedica’s Desonate™ (Desonide) Gel 0.05% USFDA-approved for the Treatment of Atopic Dermatitis Gloria Gamat October 24, 2006 SkinMedica, Inc.’s Desonate™ (desonide gel) 0.05% has recently been approved by the USFDA for the treatment of mild to moderate atopic dermatitis (a.k.a. eczema). Free from alcohol, surfactants and fragrance, Desonate is a low potency topical steroid formulated in a... Continue Reading Posted at 7:35 AM \| Permalink \| Comments
	USFDA Approved Expanded Indication of Berlex, Inc.’s Betaseron® Gloria Gamat October 24, 2006 The USFDA has recently approved the expanded indication of Betaseron® (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS. A product of Berlex, Inc. (996344), a... Continue Reading Posted at 5:24 AM \| Permalink \| Comments
	New Purdue Biochip Used in Studying Living Cells: A Tool to Speedy Drug Development Gloria Gamat October 24, 2006 Developed by Purdue University researchers, a new biochip that measures the electrical activities of cells, is capable of obtaining 60 times more data in just one reading than is possible with current technology. The said biochip, in the near future,... Continue Reading Posted at 3:19 AM \| Permalink \| Comments
Oct21	Roche is No. 3 in Science Magazine's list of Top 20 Employers in the Biotech and Pharmaceutical Industry Gloria Gamat October 21, 2006 Roche (OTC: RHHBY, VTX: ROG), for the 5th consecutive year, has been named in the Science Magazine's list of Top 20 Employers in the Biotech and Pharmaceutical Industry, moving up in rank for the fourth straight year to number three... Continue Reading Posted at 11:59 PM \| Permalink \| Comments
	PharmaNova Granted Exclusive U.S. License to Depomed for the Use of Extended Release Gabapentin against Hot Flashes Gloria Gamat October 21, 2006 PharmaNova, Inc. has exclusively licensed certain U.S. patent rights to Depomed, Inc. for the development and commercialization of extended release formulation of gabapentin as a non-hormonal alternative treatment for hot flashes and other vasomotor symptoms of menopause. In exchange for... Continue Reading Posted at 11:48 PM \| Permalink \| Comments
	ELAPRASE™ (idulsulfase) Received Positive Opinion From European Regulatory Agency Gloria Gamat October 21, 2006 ELAPRASE™ (idulsulfase) by Shire plc (LON: SHP, Nasdaq: SHPGY) has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), thereby recommending the approval of ELAPRASE for the long-term... Continue Reading Posted at 11:26 PM \| Permalink \| Comments
	Tm Bioscience Amended License Agreement with Sirius Genomics Gloria Gamat October 21, 2006 A leader in the commercial genetic testing market – Tm Bioscience Corporation (TSE: TMC) – has recently amended its license agreement with Sirius Genomics to defer a $2 million license fee payment originally due on September 5, 2006. This payment... Continue Reading Posted at 11:17 PM \| Permalink \| Comments
	Novocell, Inc. is Creating Insulin-producing Pancreatic Endocrine Cells from Human Embryonic Stem Cells Gloria Gamat October 21, 2006 A stem cell engineering company - Novocell, Inc. - is developing a process that efficiently converts human embryonic stem cells into insulin-producing pancreatic endocrine cells. The said approach could provide a means to produce sufficient quantities of insulin producing cells for... Continue Reading Posted at 10:54 PM \| Permalink \| Comments
	Indication of Centocor, Inc.'s REMICADE®, Now Expanded by the USFDA for Ulcerative Colitis Gloria Gamat October 21, 2006 The USFDA has recently expanded the approval of Centocor, Inc.'s REMICADE® (infliximab) for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response to conventional therapy. The said... Continue Reading Posted at 12:45 AM \| Permalink \| Comments
	PTC Therapeutics Awarded USFDA Orphan Products Development Grant for the Development of PTC124 in Duchenne Muscular Dystrophy Gloria Gamat October 21, 2006 A biopharmaceutical company focused on the discovery and development of small-molecule drugs targeting post-transcriptional control mechanisms--PTC Therapeutics, Inc. (PTC)-- has been awarded a two-year grant from the Office of Orphan Products Development (OOPD) Grant Program of the USFDA. The said... Continue Reading Posted at 12:21 AM \| Permalink \| Comments
	U.S. District Court Granted Mylan a Motion to Dismiss the '909 Patent in the Amlodipine Besylate Litigation Gloria Gamat October 21, 2006 Mylan Laboratories Inc. (NYSE: MYL) has recently been granted by the U.S. District Court for the Western District of Pennsylvania, a motion to dismiss the '909 patent from the patent infringement litigation between Pfizer (NYSE: PFE) and Mylan concerning Amlodipine Besylate... Continue Reading Posted at 12:16 AM \| Permalink \| Comments
Oct20	Cheaper Generics are More Likely to Attract Large Share of Prescription Drug Sales Gloria Gamat October 20, 2006 The low-priced generic drugs soon to be sold by stores such as Wal-Mart, Target and Kmart are likely to attract a big share of the market for prescription drugs --such is the suggestion of a new Wall Street Journal Online/Harris... Continue Reading Posted at 11:53 PM \| Permalink \| Comments
	Medicines for Malaria Venture, Genzyme Corporation and the Broad Institute Expanded Collaboration For the Discovery of New Malaria Drugs Gloria Gamat October 20, 2006 Medicines for Malaria Venture (MMV), Genzyme Corp. (Nasdaq: GENZ), and the Broad Institute of MIT and Harvard have recently agreed to expand their collaboration in order to discover and advance new therapeutic candidates for malaria. The said alliance will build... Continue Reading Posted at 11:48 PM \| Permalink \| Comments
Oct19	Mutual Pharmaceutical Company Filed Counter Suit Against Adams Respiratory Therapeutics on Guaifenesin Case Gloria Gamat October 19, 2006 URL Mutual Pharmaceutical Company, Inc. (Mutual) filed a counter suit against Adams Respiratory Therapeutics (Adams) on antitrust, tortious interference and unfair competition grounds. The counter suit is a response to the filed lawsuits by Adams against Mutual in New Jersey... Continue Reading Posted at 7:36 PM \| Permalink \| Comments
	Genzyme Corp. and AnorMED Inc. Agreed on Acquisition Terms Gloria Gamat October 19, 2006 Genzyme Corporation (Nasdaq: GENZ) and AnorMED Inc. (Nasdaq: ANOR; TSE: AOM) has recently executed a mutually beneficial support agreement under which Genzyme will acquire AnorMED in an all cash transaction valued at $13.50 per outstanding share, or approximately $580 million.... Continue Reading Posted at 7:13 PM \| Permalink \| Comments
	Sanofi- Aventis' Allegra® (fexofenadine hydrochloride) Oral Suspension, USFDA-approved for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria Gloria Gamat October 19, 2006 Sanofi-aventis U.S. recently announced the USFDA approval of its Allegra® (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic... Continue Reading Posted at 3:41 AM \| Permalink \| Comments
	Sanofi Aventis' Taxotere® (docetaxel) Injection Concentrate, USFDA-approved for the Treatment of Patients With Head and Neck Cancer Gloria Gamat October 19, 2006 Reviewed under a supplemental new drug application (sNDA) priority designation, Sanofi Aventis (NYSE: SNY, EPA: SAN)' Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil has been approved by the USFDA for the induction treatment of patients with inoperable... Continue Reading Posted at 3:27 AM \| Permalink \| Comments
	Merck's JANUVIA™, USFDA Approved for Type 2 Diabetes Gloria Gamat October 19, 2006 The USFDA has approved Merck (NYSE: MRK)'s JANUVIA™ (sitagliptin phosphate) -- the first and only DPP-4 inhibitor available in the United States for the treatment of type 2 diabetes. Previously approved as monotherapy and as add-on therapy to either of... Continue Reading Posted at 3:16 AM \| Permalink \| Comments
	Endo Pharmaceuticals Responded to the Lidoderm® Issue Gloria Gamat October 19, 2006 A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:ENDP), Endo Pharmaceuticals Inc. has recently learned that the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research (OGD) has issued (in response to an inquiry) bioequivalence... Continue Reading Posted at 1:59 AM \| Permalink \| Comments
	Lexicon Genetics Initiated Preclinical Development of LX2931 for Autoimmune Diseases Gloria Gamat October 19, 2006 Lexicon Genetics Incorporated (Nasdaq: LEXG) recently announced its commencement of formal preclinical development for LX2931 in preparation for an Investigational New Drug (IND) application. LX2931 is the company's novel, orally-available small molecule compound with potential application in the treatment of... Continue Reading Posted at 1:47 AM \| Permalink \| Comments
Oct18	Diffusion Pharmaceuticals Completed USFDA-Required Toxicology Studies in Support of TSC Phase I Trials and Closed $1.5 Million Private Placement Gloria Gamat October 18, 2006 A drug discovery and development company pioneering a revolutionary mechanism of action to treat life-threatening diseases -- Diffusion Pharmaceuticals LLC -- has recently completed all animal toxicology studies required by the USFDA so that the company can file an investigational... Continue Reading Posted at 9:27 PM \| Permalink \| Comments
	Genta Incorporated’s Genasense® Received Australian Orphan Drug Designation for Advanced Melanoma Patients Gloria Gamat October 18, 2006 Genta Incorporated (Nasdaq: GNTA)’s lead anticancer drug, Genasense® (oblimersen), has received Orphan Drug designation from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia, as treatment for patients with Stage IV malignant melanoma. According to Dr. Raymond P. Warrell,... Continue Reading Posted at 9:16 PM \| Permalink \| Comments
	ARICEPT® (donepezil HCl tablets), USFDA-Approved for Full Spectrum Alzheimer’s Disease Gloria Gamat October 18, 2006 The USFDA has recently approved 10 mg ARICEPT® (donepezil HCl tablets) for the treatment of severe Alzheimer's disease – making ARICEPT® the first and only treatment approved for the full spectrum of Alzheimer’s disease: mild, moderate, severe. According to Sharon... Continue Reading Posted at 9:04 PM \| Permalink \| Comments
	OncoMed Pharmaceuticals Granted USPTO Patent for Identifying Therapeutics Targeting Cancer Stem Cells Gloria Gamat October 18, 2006 Pioneer in the development of novel therapeutics targeting cancer stem cells-- OncoMed Pharmaceuticals -- has been issued U.S. Patent No. 7,115,360 entitled "Isolation and Use of Solid Tumor Stem Cells” by the USPTO. According to John Lewicki, Ph.D., Senior Vice President... Continue Reading Posted at 8:46 PM \| Permalink \| Comments
	Austrian Patent Office Ruled in Favor of Pfizer On Lipitor Basic Patent Gloria Gamat October 18, 2006 Pfizer (NYSE: PFE) recently announced that the Austrian Patent Office has ruled that a claim in the company's basic patent covering the use of atorvastatin, (Lipitor’s active ingredient) would be infringed by generic manufacturer Ranbaxy (BOM: 500359, PINK: RBXLF). Though... Continue Reading Posted at 8:33 PM \| Permalink \| Comments
	Serono and Newron Pharma Entered Into Global Development and Commercialization Agreement for Safinamide Gloria Gamat October 18, 2006 Serono (VTX: SEO and NYSE: SRA) and Newron Pharmaceuticals SpA has entered into an agreement wherein Newron has granted Serono the exclusive worldwide rights for the development, manufacture and commercialization of safinamide in Parkinson's disease (PD), Alzheimer's disease, and other... Continue Reading Posted at 8:21 PM \| Permalink \| Comments
	Foamix, Ltd. and Taro Pharmaceutical Industries Ltd Entered Into License Agreement for the Development and Commercialization of Foamix's PerFoam™ 1% for the Treatment of Head Lice Gloria Gamat October 18, 2006 The leader in the development of stable, alcohol-free, topical foam delivery systems for dermatology and other topical applications- Ness Ziona, Isarael-based Foamix, Ltd. – has licensed a novel topical foam product, PerFoam™ 1% for the contemporary treatment of head lice... Continue Reading Posted at 8:16 PM \| Permalink \| Comments
	TyRx Pharma, Inc. Submitted Premarket Application for PIVIT™ CRM: Novel Mesh Pouch Containing Rifampin and Minocycline Designed to Hold and Reduce Bacterial Colonization of a Pacemaker or ICD Pulse Generator Gloria Gamat October 18, 2006 TyRx Pharma, Inc. has recently submitted a Premarket Application for PIVIT™ CRM, an innovative mesh pouch coated with a proprietary bioresorbable polymer containing the antimicrobial agents, rifampin and minocycline, designed to enclose a pacemaker or ICD pulse generator when implanted... Continue Reading Posted at 6:51 PM \| Permalink \| Comments
	Neurochem Submitted Complete Response in Lieu of USFDA’s Approvable Letter for KIACTA™ Gloria Gamat October 18, 2006 A wholly-owned subsidiary of Neurochem Inc. (Nasdaq: NRMX; TSE: NRM), Neurochem (International) Limited (Neurochem) has submitted a complete response to the USFDA’s August 2006 approvable letter for KIACTA™. Neurochem’s KIACTA™ (eprodisate; formerly FIBRILLEX™) is the company’s investigational product candidate seeking... Continue Reading Posted at 6:43 PM \| Permalink \| Comments
Oct17	Human Genome Sciences Reported Positive Interim Quality-of-Life Data From Phase 2B Trial of Albuferon™ with Ribavirin in Treatment-Naïve Hepatitis C Patients Gloria Gamat October 17, 2006 The Human Genome Sciences, Inc. (Nasdaq: HGSI) has recently reported the 12-week interim quality-of-life results from a Phase 2b clinical trial that evaluated the efficacy, safety and impact on health-related quality of life of Albuferon™ in combination with ribavirin in... Continue Reading Posted at 9:53 PM \| Permalink \| Comments
	Medarex and PharmAthene’s Anthrax Therapeutic Valortim™, Passed Phase I Clinical Trial Gloria Gamat October 17, 2006 Medarex, Inc. (Nasdaq: MEDX) and PharmAthene, Inc. have recently announced the positive results of their Phase I study for Valortim™ (MDX-1303) in healthy volunteers. Valortim™, a fully human antibody against anthrax infection has been developed using Medarex's UltiMAb Human Antibody... Continue Reading Posted at 9:41 PM \| Permalink \| Comments
	Nabi Biopharmaceuticals’ PhosLo® EPICK Study Revealed Positive Results Gloria Gamat October 17, 2006 Nabi Biopharmaceuticals (Nasdaq: NABI) recently announced the positive results from the PhosLo® (calcium acetate) EPICK study in Chronic Kidney Disease (CKD) patients suffering from Stage 4 kidney disease. The EPICK study, designed to demonstrate that PhosLo is effective and safe... Continue Reading Posted at 9:27 PM \| Permalink \| Comments
	Neuren's NNZ-2591, Proved Effective At Memory Loss Reversal Gloria Gamat October 17, 2006 Neuren Pharmaceuticals Ltd (ASX: NEU)’s lead candidate from its diketopiperazine (DKP) family, NNZ-2591, demonstrated positive preclinical effects of improved learning and memory after oral dosing. Memory was improved to pre-injury levels (100%), a statistically significant effect (p<0.03). The following being... Continue Reading Posted at 9:15 PM \| Permalink \| Comments
	PDL BioPharma Presented Physician Survey Results on Heart Attack Treatment Gloria Gamat October 17, 2006 PDL BioPharma, Inc. (Nasdaq: PDLI) recently announced the results of a survey which revealed that a considerable number (24%) of U.S. cardiologists and emergency physicians were unaware of current heart attack treatment guidelines, with a majority (61%) believing that there... Continue Reading Posted at 9:08 PM \| Permalink \| Comments
Oct16	Genta, Inc. Initiated Phase 1 trial of Antisense Drug, G4460, in Advanced Cancer Patients Gloria Gamat October 16, 2006 Genta Incorporated (Nasdaq: GNTA) has initiated the Phase 1 clinical trial using a new anticancer drug derived from the Company's DNA/RNA Medicines program. The new anticancer drug known as G4460 uses antisense technology to target an oncogene known as c-myb... Continue Reading Posted at 10:07 PM \| Permalink \| Comments
	CHEM Rx Announced Acquisition Strategy Gloria Gamat October 16, 2006 The U.S.’s largest privately-owned long-term care pharmacy, CHEM Rx, has retained Melville, New York based Equity Transfers, a business development consulting firm, to provide business development services that include searching the "Long Term Care Industry" for institutional pharmacies available for... Continue Reading Posted at 9:19 PM \| Permalink \| Comments
	Bayer Appointed Independent Investigator for Review of Trasylol® Study Issues Gloria Gamat October 16, 2006 Bayer has appointed an independent counsel to review the company's actions in regards to disclosure of preliminary results from an observational study on Trasylol® to the USFDA. Fred F. Fielding Esq., from the law firm Wiley Rein & Fielding LLP... Continue Reading Posted at 8:48 PM \| Permalink \| Comments
	Isolagen, Inc and the USFDA Has Agreed on Phase III Protocol Design for Isolagen™ Therapy (IT) Gloria Gamat October 16, 2006 Isolagen, Inc. (AMEX: ILE) has recently entered an agreement with the USFDA on the design of the company’s Phase III pivotal study protocol for the use of Isolagen™ Therapy for the treatment of wrinkles. Isolagen’s protocol has been submitted to... Continue Reading Posted at 8:30 PM \| Permalink \| Comments
	New River Pharmaceuticals, Inc. and USFDA Conducted End-of-Phase II Meeting on NRP290 (Product Candidate for Acute Pain) Gloria Gamat October 16, 2006 Company officials of New River Pharmaceuticals Inc. (Nasdaq: NRPH) have met last week on an end-of-phase II meeting with staff members of the Center for Drug Evaluation and Research of the USFDA and discussed NRP290, a hydrocodone derivative under development... Continue Reading Posted at 8:25 PM \| Permalink \| Comments
Oct15	Morphotek Inc Receives $40 Million in Series D Financing Round Gloria Gamat October 15, 2006 Morphotek® Inc. has raised $40 million in Series D financing. The financing was led by Investor Growth Capital of New York and included participation of new investors MDS Capital and Hunt BioVentures as well as existing investors Forward Ventures, Morgenthaler... Continue Reading Posted at 10:51 PM \| Permalink \| Comments
	Clinical Data on Selected Cethromycin Trials Presented by Advanced Life Sciences at IDSA Annual Meeting Gloria Gamat October 15, 2006 At the 44th Annual Meeting of the Infectious Diseases Society of America (IDSA), held this year in (Toronto, Ontario), for the first time Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS) has presented the clinical results comparing the safety and efficacy... Continue Reading Posted at 10:46 PM \| Permalink \| Comments
	Innocoll, Inc. Receives FDA Approval for CollaGUARD™ Collagen-Based Advanced Gloria Gamat October 15, 2006 Innocoll Pharmaceuticals, has received 510k approval from the US FDA for CollaGUARD™, an advanced wound care product indicated for the management of superficial and deep wounds, including coverage of skin ulcers and temporary dermatoplasty in the case of lesion and... Continue Reading Posted at 9:43 PM \| Permalink \| Comments
	Newly Published Data Show Efficacy and Safety of Spracor's Lunesta in Elderly Patients with Insomnia Gloria Gamat October 15, 2006 According to the results of an extensive trial published in the September issue of Current Medical Research and Opinion, LUNESTA (eszopiclone) appears to improve sleep in elderly patients (64-86 years of age) with chronic primary insomnia. Study data showed that... Continue Reading Posted at 9:30 PM \| Permalink \| Comments
	USAMRMC Extended Lexicon Genetics' Grant for Spinal Muscular Atrophy (SMA) Research Program Gloria Gamat October 15, 2006 The United States Army Medical Research & Materiel Command (USAMRMC) has granted another year to Lexicon Genetics Incorporated (Nasdaq: LEXG) to continue its research program to identify targets that may be important in the development of drugs in the prevention... Continue Reading Posted at 7:44 PM \| Permalink \| Comments
	Peregrine Receives Regulatory Approval in India for New Cotara® Brain Cancer Clinical Trial Gloria Gamat October 15, 2006 Peregrine Pharmaceuticals, Inc. (PPHM) has received regulatory approval in India for a new clinical trial of its lead tumor necrosis therapy (TNT) agent Cotara®, to test its safety and efficacy in treating glioblastoma multiforme, a deadly form of brain cancer.... Continue Reading Posted at 7:19 PM \| Permalink \| Comments
	FDA Grants Orphan Drug Designation For Agennix's Talactoferrin Alfa In Renal Cell Carcinoma Gloria Gamat October 15, 2006 The U.S. FDA has granted orphan drug designation to Agennix's oral formulation of Talactoferrin Alfa (talactoferrin or TLF), curently on Phase II clinical development for the treatment of renal cell carcinoma (RCC). Talactoferrin Alfa is a unique recombinant form of... Continue Reading Posted at 6:57 PM \| Permalink \| Comments
	FDA Approves AstraZeneca's NEXIUM® for the Treatment of Zollinger-Ellison Syndrome Gloria Gamat October 15, 2006 The US Food and Drug Administration (FDA) has approved a new indication for the "purple pill", NEXIUM® (esomeprazole magnesium), for the treatment of Zollinger-Ellison Syndrome (ZES). Nexium is a prescription proton pump inhibitor marketed by AstraZeneca (AZN) for the treatment... Continue Reading Posted at 6:40 PM \| Permalink \| Comments
	New Sleeping Pill Rozerem Unlikely to Lead to Dependence or Abuse Gloria Gamat October 15, 2006 According to a new study conducted by researchers from the Johns Hopkins University School of Medicine, Rozerem (ramelteon), a new sleeping medication recently approved for the treatment of insomnia is not likely to cause dependence or abuse. Because of concerns... Continue Reading Posted at 5:56 PM \| Permalink \| Comments
	Bellicum Pharmaceuticals Entered into Commercial Licensing of ARIAD's ARGENT™ Cell-Signaling Regulation Technology for Development of New Cancer Therapies Gloria Gamat October 15, 2006 Bellicum Pharmaceuticals, Inc. has entered into a non-exclusive, royalty-bearing licensing agreement with ARIAD Pharmaceuticals Inc. (Nasdaq: ARIA) for its ARGENT™ cell-signaling regulation technology. The terms of agreement include: AIAD having an equity stake in Bellicum and receiving additional payments. Based... Continue Reading Posted at 5:06 PM \| Permalink \| Comments
	"Humanized" Antibodies May Prevent and Treat Bird Flu Gloria Gamat October 15, 2006 Researchers have come up with bioengineered bird flu antibodies, producing what they refer to as "humanized monoclonal" antibodies. Complete protection from the H5N1 bird flu strain has been confered by one of the two engineered antibodies developed. "We have shown... Continue Reading Posted at 4:56 PM \| Permalink \| Comments
	FDA Grants Tentative Approval to Teva Pharmaceutical's Generic Risperdal Gloria Gamat October 15, 2006 The U.S. Food and Drug Administration has granted tentative approval for the Abbreviated New Drug Application submitted by Teva Pharmaceuticals (TEVA) to market its generic version of Risperdal® (Risperidone) Oral Solution, 1 mg/mL. Final approval is expected on December 29,... Continue Reading Posted at 3:22 PM \| Permalink \| Comments
	Roche Seeks European Marketing Authorization for Herceptin Plus Hormonal Therapy for Advanced HER2-Positive Breast Cancer Gloria Gamat October 15, 2006 Roche has applied for marketing authorisation to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone receptor-positive breast cancer. This application follows the release of results from an extensive trial, which demonstrated that Herceptin... Continue Reading Posted at 3:11 PM \| Permalink \| Comments
	Endo Pharmaceuticals Acquires RxKinetix for $20 Million, Gains Rights to RK-0202 Oral Rinse for Oral Mucositis Gloria Gamat October 15, 2006 Endo Pharmaceuticals Inc. (ENDP) has acquired all of the outstanding stock of RxKinetix, Inc., a Colorado-based company that develops new formulations of approved products for oral mucositis and other supportive care oncology conditions. RxKinetix's lead product, RK-0202, is a topical... Continue Reading Posted at 12:10 PM \| Permalink \| Comments
	FDA Approves Aricept® For Treatment of Severe Alzheimer's Disease Gloria Gamat October 15, 2006 Eisai Medical Research Inc., a subsidiary of Tokyo-based Eisai Co., Ltd (TYO: 4523). has received approval from the U.S. FDA for a supplemental New Drug Application for Aricept® in the treatment of severe Alzheimer's disease (AD). Aricept is currently the... Continue Reading Posted at 10:06 AM \| Permalink \| Comments
	Indevus Submits New Drug Application for SANCTURA XR Once Daily Drug For Overactive Bladders Gloria Gamat October 15, 2006 Indevus Pharmaceuticals, Inc. (IDEV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for SANCTURA XR™, a once-daily version Sanctura (trospium chloride), currently marketed as treatment of patients with overactive bladder. "SANCTURA... Continue Reading Posted at 6:09 AM \| Permalink \| Comments
	Alfred Mann Institute Established at the Technion-Israel Institute of Technology , Technion Receives $100 Million Gloria Gamat October 15, 2006 Biomedical entrepreneur and philanthropist Alfred E. Mann will donate $100 million to establish a biomedical research institute at the Technion-Israel Institute of Technology, making Technion the first and only non-US university chosen to be part of vision of establishing a... Continue Reading Posted at 4:05 AM \| Permalink \| Comments
	BioAlliance Pharma Receives French Marketing Authorization for Its first Product Loramyc® for the Treatment of Oropharyngeal Candidiasis Gloria Gamat October 15, 2006 BioAlliance Pharma SA (EPA:BIO) has received marketing authorization for Loramyc® (miconazole Lauriad) from France's regulatory body, AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé). Loramyc® is the firm's first product, developed for the treatment of oropharyngeal candidiasis (OPC)... Continue Reading Posted at 3:07 AM \| Permalink \| Comments
Oct14	PharmAthene, Inc. Got $1 Million Congressional Appropriation for Continued Development of Anthrax Therapeutic Valortim™ Gloria Gamat October 14, 2006 The FY 2007 Department of Defense (DoD) appropriations law includes $1.0 million payable to PharmAthene, Inc. ( a privately-held biotechnology company) to support ongoing development of Valortim™. An investigational fully human monoclonal antibody being developed for the prevention and treatment... Continue Reading Posted at 8:39 PM \| Permalink \| Comments
	Modified Inteleukin-1 Receptor Antagonist May Offer Prolonged Osteoarthritis Relief Gloria Gamat October 14, 2006 Researchers at Duke University have modified a drug called interleukin-1 receptor antagonist (IL1RA) to prolong its effects and potentially making it useful for providing longer-lasting treatment for osteoarthritis. While current estimates suggest that it would take about 2 injections of... Continue Reading Posted at 8:33 PM \| Permalink \| Comments
	LifeCycle Pharma Entered Into Three Distinct Strategic Collaboration Agreements With Global Pharmaceutical Companies Gloria Gamat October 14, 2006 Horsholm, Denmark- based LifeCycle Pharma A/S, has entered into three strategic collaboration agreements with leading players in the pharmaceutical industry: 1) Sandoz Inc. (an affiliate of Novartis AG) -- an exclusive development and commercialization agreement regarding the US market with... Continue Reading Posted at 8:32 PM \| Permalink \| Comments
	Psychostimulant Methamphetamine May Reduce Stroke Damage Gloria Gamat October 14, 2006 According to a new animal study conducted by researchers from the University of Montana, psychostimulant drug methamphetamine seems to reduce brain damage following stroke. The scientists claim to have small dosages of meth confer 80 to 90 percent protection of... Continue Reading Posted at 6:20 PM \| Permalink \| Comments
	More Than 90% of Pliva Shares Tendered to Barr Pharmaceuticals for $2.5 Billion Gloria Gamat October 14, 2006 More than 90% of the shares of Croatia-based PLIVA d.d. (PLVGF) has been tendered to the European subsidiary of Barr Pharmaceuticals Inc. (BRL) for close to $2.5 billion . The deal is expected to close on October 25. "... Our... Continue Reading Posted at 5:07 PM \| Permalink \| Comments
	Prozac Increases Bone Mass, May Treat Osteoporosis Gloria Gamat October 14, 2006 Prozac, a popular drug used to treat depression, also seems to have the potential to treat osteoporosis. An animal study expected to be published in an upcoming issue of the Journal of Cellular Biochemistry, has demonstrated that in mice, Prozac... Continue Reading Posted at 4:45 PM \| Permalink \| Comments
	Clinical Studies Show Rotigotine Patch Appears to Be a Safe Treatment for Early-Stage Parkinson's Disease Gloria Gamat October 14, 2006 According to the results presented during the 131st Annual Meeting of the American Neurological Association (ANA), Schwarz Pharma's rotigotine transdermal patch showed a favorable safety and tolerability profile for the treatment of Parkinson's Disease in patients over the age of... Continue Reading Posted at 2:06 PM \| Permalink \| Comments
	FDA Approves Colon Cancer Drug Avastin for Treatment of Non-Small Cell Lung Cancer Gloria Gamat October 14, 2006 The U.S. Food and Drug Administration (FDA) has approved Genentech's colon cancer drug Avastin® (bevacizumab) to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC). "Bevacizumab, in combination with chemotherapy,... Continue Reading Posted at 6:05 AM \| Permalink \| Comments
	Antipsychotic Drugs Found Ineffective For Treating Psychotic Symptoms in Alzheimer's Disease Gloria Gamat October 14, 2006 According to a large study conducted at 33 university and hospital clinics and nine doctor's offices in the U.S., antipsychotic drugs originally developed to treat schizophrenia,such as Zyprexa, Seroquel and Risperdal, appears ineffective in treating psychotic symptoms in Alzheimer's Disease... Continue Reading Posted at 3:30 AM \| Permalink \| Comments
	Ambrilla Licenses HIV/AIDA Protease Inhibitor Drug Candidate to Merck for $17 Million Plus $215 Million Milestone Fees Gloria Gamat October 14, 2006 Canada-based Ambrilia Biopharma (AMB) has licensed its HIV/AIDS protease inhibitor (PI) program including its HIV drug lead candidate PPL-100 to Merck & Co., Inc. for $17 million up front fee and up to $215 million in milestone payments on clinical... Continue Reading Posted at 2:52 AM \| Permalink \| Comments
Oct13	Cephalon, Inc.'s FENTORA™ (fentanyl buccal tablet) for Breakthrough Pain in Patients with Chronic Low Back Pain, Passed Phase III Clinical Trial Gloria Gamat October 13, 2006 Cephalon, Inc. (Nasdaq:CEPH) recently announced the postive results of its Phase 3 clinical trial of FENTORA™ (fentanyl buccal tablet) [C-II], demonstrating efficacy in the management of breakthrough pain in opioid-tolerant patients with chronic low back pain. The double-blind placebo controlled... Continue Reading Posted at 10:16 PM \| Permalink \| Comments
	Amarin Corporation plc, Granted USPTO Patent Approval for Miraxion in Huntington's Disease Gloria Gamat October 13, 2006 Amarin Corporation plc (Nasdaq: AMRN) has recently announced the USPTO's approval of its patent application (patent number 7,119,118) covering the use of its proprietary ultra-pure ethyl-EPA compound ("Miraxion") in Huntington's disease. According to Rick Stewart, CEO of Amarin Corporation plc:... Continue Reading Posted at 10:09 PM \| Permalink \| Comments
	GlaxoSmithKLine Submitted Supplemental New Drug Application for Advair Diskus® in COPD Gloria Gamat October 13, 2006 GlaxoSmithKline (GSK) has recently submitted a supplemental new drug application to the USFDA in order to expand the labelling for Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) following results of TORCH (TOwards a Revolution in COPD Health), a three... Continue Reading Posted at 9:52 PM \| Permalink \| Comments
	Novartis Launched 'GALIANT' Study Comparing the Investigational Drug Galvus® and a Leading Class of Oral Anti-Diabetic Medicines (TZDs) Gloria Gamat October 13, 2006 Novartis (NYSE: NVS, VTX: NOVN)recently commenced GALIANT, a a significant clinical trial designed to involve more than 7,500 people in the United States in order to compare the investigational oral type 2 diabetes medication Galvus® (vildagliptin) with commonly prescribed anti- diabetic... Continue Reading Posted at 9:29 PM \| Permalink \| Comments
	CV Therapeutics, Inc. Terminated Co-Promotion of ACEON® (perindopril erbumine) Tablets with Solvay Pharmaceuticals, Inc. Gloria Gamat October 13, 2006 CV Therapeutics, Inc. (Nasdaq: CVTX) has recently terminated its co-promotion agreement with Solvay Pharmaceuticals, Inc. for ACEON® (perindopril erbumine) Tablets. Thus, over the next several weeks, CV Therapeutics will conclude its promotion of ACEON®. According to Louis G. Lange, M.D.,... Continue Reading Posted at 9:20 PM \| Permalink \| Comments
Oct11	Schering-Plough Files Patent Infringement Lawsuit Against GeoPharma Inc Over Generic Version of Clarinex(R) Gloria Gamat October 11, 2006 Schering-Plough Corp (SGP) has filed a lawsuit against GeoPharma Inc (GORX) and its subsidiary Belcher Pharmaceuticals Inc over patent infringement of GeoPharma's generic version of Clarinex, a drug for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, chronic idiopathic... Continue Reading Posted at 2:25 AM \| Permalink \| Comments
	EU Grants Marketing Approval To Schering-Plough's Suboxone Sublingual Tablets for the Treatment of Opioid Addiction Gloria Gamat October 11, 2006 Schering-Plough Corporation (SGP) has received marketing approval from the European Commission for Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets, indicated for the treatment of opioid dependance. "The European Commission's approval of SUBOXONE represents an important advance in public health," said Robert... Continue Reading Posted at 1:20 AM \| Permalink \| Comments
	Theravance Announce Positive Phase III Trials on Telavancin for MRSA Infections Gloria Gamat October 11, 2006 Theravance, Inc (THRX) announced additional results from its Phase III trials of telavancin, a rapidly bactericidal injectable antibiotic with multiple mechanisms of action, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. "Staphylococcal infections,... Continue Reading Posted at 12:05 AM \| Permalink \| Comments
Oct10	Dyanavax Shares Rose Following Publication of Pilot Study On the Efficacy of Tolamba Ragweed Allergy Vaccine Gloria Gamat October 10, 2006 Dynavax (DVAX) stocks rose 26% following the publication of a study showing that its investigational vaccine against ragweed allergies effectively reduced allergic responses. TOLAMBA, consisting of a TLR9 agonist linked to a specific ragweed allergen, required only 6 injections, and... Continue Reading Posted at 5:19 AM \| Permalink \| Comments
	Wyeth Submits NDA and MAA for mTOR Inhibitor Torisel for the Treatment of Advanced Renal Cell Carcinoma Gloria Gamat October 10, 2006 Wyeth Pharmaceuticals (Wyeth) has filed new drug application to the U.S. Food and Drug Administration and marketing authorization application to the European Medicines Agency for Torisel™ (temsirolimus), an mTOR kinase inhibitor for the treatment of advanced renal cancer. If approved,... Continue Reading Posted at 4:15 AM \| Permalink \| Comments
	Edison Pharmaceuticals Collaborate With Brazil's Institute of Vision To Develop Mitochondrial Therapies for Leber's Disease Gloria Gamat October 10, 2006 Edison Pharmaceuticals is collaborating with the Institute of Vision, Federal University of Sao Paulo, Brazil to develop therapeutics for Leber's Hereditary Optic Neuropathy (LHON), a hereditary disorder characterized by sudden loss of vision. LHON arises from impairments in energy production... Continue Reading Posted at 3:12 AM \| Permalink \| Comments
	deCode Pharmaceuticals Suspends Phase III Trial of Heart Attack Drug DG031 Due to Formulation Issues Gloria Gamat October 10, 2006 Iceland-based biopharmaceutical company deCode Genetics Inc. (DCGN) has suspended its Phase III clinical trial for DG031 (veliflapon), a heart attack prevention drug, allegedly due to a formulation problem with the tablets being used in the trial. Routine testing of clinical... Continue Reading Posted at 2:08 AM \| Permalink \| Comments
	GW Pharmaceuticals Announce Positive Phase II Trials of Sativex Oromucosal Spray for Multiple Sclerosis Gloria Gamat October 10, 2006 GW Pharmaceuticals PLC (GPW) announced favorable results from two Phase II studies of Sativex®, a cannabis-based oromucosal spray for the treatment of multiple sclerosis symptoms. The results were presented during the 22nd Congress of the European Committee for Treatment and... Continue Reading Posted at 1:01 AM \| Permalink \| Comments
Oct 9	Out of The Storm Debris Gloria Gamat October 9, 2006 Slow and hicupping every 10 minutes or so, i finally found an online internet shop runnning on electric generator. Pardon the unexpected hiatus on this blog, my little city down south of the Philippine Islands (Sorsogon) has been hardly hit... Continue Reading Posted at 11:46 PM \| Permalink \| Comments

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