PharmaGazette: September 2006 Archives

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Sep27	Sanofi-Aventis U.S. LLC’s Dermik Laboratories Submitted USFDA Supplemental Premarket Approval Application (s-PMA) for Sculptra® Gloria Gamat September 27, 2006 Know More: Drug Marketing, Drug Regulations & Approval The dermatology business of sanofi-aventis U.S. LLC, Dermik Laboratories, has recently submitted a supplemental premarket approval application (s-PMA) to the USFDA for Sculptra® (injectable poly-L-lactic acid) for facial cosmetic use. Sculptra®, sold under the trade name NEW-FILL™, was approved in Europe in 1999 to increase volume, particularly for the correction of skin depression, including skin creases, wrinkles, folds and scars. Sculptra®, a synthetic, biocompatible, bioabsorbable material that is naturally degraded by the body over time, was approved in the in 2004 for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Source: PR Newswire Posted at 1:19 AM \| Permalink \| Comments
Sep27	Nastech Pharma Co. Inc. Initiated Clinical Development of Rapid Acting Diabetic Insulin Nasal Spray Gloria Gamat September 27, 2006 Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) has recently initiated the Phase I pharmacokinetic study designed to evaluate the safety, bioavailability and glucose response of Nastech's proprietary, rapid acting intranasal insulin formulation. The Phase 1 study will compare Nastech's intranasal formulation... Continue Reading Posted at 1:15 AM \| Permalink \| Comments
	Cardinal Health Agreed to Scale-Up and Manufacture Clinical Supplies for Bentley Pharmaceuticals, Inc.'s Intranasal Insulin Program Gloria Gamat September 27, 2006 Bentley Pharmaceuticals, Inc. (NYSE: BNT) has secured capacity at Cardinal Health (NYSE: CAH)'s new North Raleigh facility for the scale-up and manufacture of clinical supplies of Bentley's intranasal insulin product candidate, thereby facilitating the expansion of clinical trials. The product... Continue Reading Posted at 1:06 AM \| Permalink \| Comments
	Sigma-Aldrich Corp. Reached Settlement with Enzo Gloria Gamat September 27, 2006 Sigma-Aldrich Corporation (Nasdaq: SIAL) and named subsidiaries has reached a settlement with Enzo Biochem, Inc. (NYSE: ENZ), Enzo Life Sciences, and Yale University . The settlement between the parties and the stipulation and order of dismissal with prejudice of all... Continue Reading Posted at 12:47 AM \| Permalink \| Comments
	ExonHit Therapeutics and Allergan, Inc. Extended Strategic Alliance Gloria Gamat September 27, 2006 A drug and diagnostic discovery company, ExonHit Therapeutics S.A. (EPA: ALEHT), has extended its strategic collaboration with Allergan, Inc. (NYSE: AGN) for the identification, development and commercialization of drugs targeted at the treatment of neurodegenerative diseases, pain and ophthalmology based... Continue Reading Posted at 12:40 AM \| Permalink \| Comments
	Serono's Oral Cladribine, Granted USFDA Fast Track Status for the Treatment of Multiple Sclerosis (MS) Gloria Gamat September 27, 2006 Serono (NYSE: SRA)’s oral cladribine has been granted Fast Track Status by the USFDA for the treatment of patients with relapsing forms of multiple sclerosis. The novel oral formulation of cladribine for the treatment of MS is currently being investigated... Continue Reading Posted at 12:30 AM \| Permalink \| Comments
	Serono, To be Acquired by Merck KGaA Gloria Gamat September 27, 2006 Merck KGaA (FRA:MRK) of Darmstadt, Germany announced on 21st September that it has entered into an agreement with the Bertarelli Family (owner of the majority stake of Serono SA) to purchase their Serono (NYSE:SRA) shares to create a strategically compelling... Continue Reading Posted at 12:20 AM \| Permalink \| Comments
	Debiopharm Group’s Debio-0513 (PTR-262) Received European Orphan Drug Status for Myasthenia Gravis (MG) Gloria Gamat September 27, 2006 The Debiopharm Group (Debiopharm) has recently received European orphan drug designation from the Commission of the European Community (EC) for Debio-0513 (formerly known as PTR-262), a dual altered ligand peptide analog of the myasthenogenic epitopes of the acetylcholine receptor (AchR)... Continue Reading Posted at 12:08 AM \| Permalink \| Comments
Sep25	Top 8 Medicinal Products in My Toddlers’ Cabinet Gloria Gamat September 25, 2006 1) Ceelin® (Ascorbic Acid)/Vitamin C Ascorbic Acid (Ceelin®) is indicated for the prevention and treatment of Vitamin C deficiency in children , it increases body resistance to stress and infections and hastens recovery from illnesses and the healing of wounds,... Continue Reading Posted at 3:58 AM \| Permalink \| Comments
	Chromos and Y's Theraputic Agreed on Cell Line Engineering Contract Gloria Gamat September 25, 2006 Chromos Molecular Systems Inc. (TSX: CHR) has entered into a cell line engineering service agreement with Y's Therapeutics, Inc. (Burlingame, California) to develop a cell line using Chromos' ACE System (a pdf file) for potential use in the clinical and commercial... Continue Reading Posted at 3:42 AM \| Permalink \| Comments
	ChemBridge Corporation and ChemBridge Research Laboratories, Inc. (CRL) Entered Into Strategic Alliance on Discovery Chemistry with AstraZeneca Gloria Gamat September 25, 2006 ChemBridge Corporation and ChemBridge Research Laboratories, Inc. (CRL) have entered into a multi-year collaboration in discovery chemistry with AstraZeneca (LON:AZN). The terms of agreement included that ChemBridge and CRL scientists at Moscow and San Diego research sites will work closely... Continue Reading Posted at 3:37 AM \| Permalink \| Comments
	MannKind Corp.’s Technosphere® Insulin System, Showed Safety and Efficacy in Phase III Clinical Trial in Type 2 Diabetes Patients Gloria Gamat September 25, 2006 The results of a Phase III study (in patients with type 2 diabetes) designed to evaluate whether MannKind Corporation (Nasdaq: MNKD)’s Technosphere® Insulin System showed similar safety and efficacy compared to patients treated with insulin aspart (NovoLog®), an injected rapid-acting... Continue Reading Posted at 3:14 AM \| Permalink \| Comments
	CoFactor®/ Uftoral® (UFT) Combination Showed Positive Results in Colorectal Cancer Model Gloria Gamat September 25, 2006 Treatment of metastatic colorectal cancer in mice with CoFactor® in combination with Uftoral® (UFT) as demonstrated by clinical data recently reported by ADVENTRX Pharmaceuticals, Inc. (Amex: ANX). CoFactor® is a folate-based drug designed to improve the efficacy and safety of... Continue Reading Posted at 3:01 AM \| Permalink \| Comments
Sep23	Itax (Itopride) Fails Phase III Clinical Trials, Axcan Pharma Shares Fall Gloria Gamat September 23, 2006 Axcan Pharma Inc. (AXCA) halts the clinical development of ITAX (Itopride), a drug candidate for the treatment of functional dyspepsia, after failing to meet its co-primary endpoints in a North American Phase III clinical trial. "Although we are disappointed by... Continue Reading Posted at 1:30 AM \| Permalink \| Comments
	Long-term Alendronate (Bisphosphonate) Use in Patients with Osteoporosis Do Not Increase Vertebral Microcracks Gloria Gamat September 23, 2006 Bisphosphonates, a class of drugs commonly prescribed for the treatment of osteoporosis, have been linke dto the formation of microcracks in the skeleton, which appeared to increase proportionately to bisphosphonate treatment. However, a recent animal study presented during the 28th... Continue Reading Posted at 12:28 AM \| Permalink \| Comments
Sep22	Tranzyme Pharma Expands Clinical Program of Post-Operative Ileus Drug Candidate, TZP-101, to Include Patients with Gastroparesis Gloria Gamat September 22, 2006 Tranzyme Pharma has amended the IND for its novel small molecule ghrelin agonist, TZP-101, a potent prokinetic agent being developed for the treatment of post-operative ileus (POI), to include patients with gastroparesis. Gastroparesis is a gastrointestinal disorder characterized by delayed... Continue Reading Posted at 4:26 AM \| Permalink \| Comments
	Sebivo (Telbivudine) Approved in Switzerland for Chronic Hepatitis B Gloria Gamat September 22, 2006 Sebivo® (telbivudine), a new treatment for patients with chronic hepatitis B co-developed by Idenix Pharmaceuticals, Inc. (IDIX) and Novartis Pharma AG (NVS), has been approved in Swizerland. This approval is based primarily on one-year data from the GLOBE study, the... Continue Reading Posted at 3:23 AM \| Permalink \| Comments
	Altana AG Sells Pharmaceutical Business to Nycomed Gloria Gamat September 22, 2006 Altana AG (ALT) announced it has sold its unit, Altana Pharma AG and its entire pharmaceuticals business to Denmark's Nycomed for approximately €4.5 billion. The total purchase price to ALTANA AG is expected to amount to approx. EUR4.5 billion. This... Continue Reading Posted at 2:21 AM \| Permalink \| Comments
	Hospira Agrees to Buy Mayne Pharma Limited for $2 Billion Gloria Gamat September 22, 2006 Illinois-based, specialty pharmaceutical and medication delivery company Hospira (HSP) agreed to acquire Australia-based Mayne Pharma Limited (MYP), a specialty injectable pharmaceuticals company, for $2 billion. Under the terms of the agreement, Mayne shareholders will receive AUD$4.10 cash per outstanding ordinary... Continue Reading Posted at 1:18 AM \| Permalink \| Comments
	Nucryst Pharmaceutical's NPI 32101 Drug Candidate Against Atopic Dermatitis Fails Phase II Clinical Trials Gloria Gamat September 22, 2006 Nucryst Pharmaceuticals Corp. (NCST) announced the preliminary results of the Phase II clinical trials examining the safety and efficacy of NPI 32101, a drug candidate for the treatment of atopic dermatitis. According to the data, the success rates of both... Continue Reading Posted at 12:15 AM \| Permalink \| Comments
Sep21	Wal-Mart to Cut Prices On Almost 300 Generic Prescription Drugs, Drugstore chains Shares Falls Gloria Gamat September 21, 2006 Wal-Mart, the world's largest retailer, plans to drop the prices of 291 generic prescription drugs, luring bargain-seeking customers and presenting a challenge to competing pharmacy chains and makers of generic drugs. the 291 generic drugs include "the most commonly prescribed... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Angiotech Pharmaceuticals Presents Positive Preclinical Study On Vascular Wrap ™ Paclitaxel-Eluting Mesh for Inhibiting Neointimal Hyperplasia Gloria Gamat September 21, 2006 During the The Western Vascular Society 2006 Annual Meeting, Angiotech Pharmaceuticals Inc. (ANPI) presented the results of a preclinilal study showing the efficacy of its Vascular Wrap™ paclitaxel-eluting mesh and Lifespan® graft technology platform. Results demonstrated that neointimal hyperplasia was... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
	BioMarin Completes Enrollment for Phase II Clinical Trials of 6R-BH4 for Treatment of Hypertension Gloria Gamat September 21, 2006 BioMarin Pharmaceutical Inc. (BMRN) has completed the enrollment of patients for the Phase II clinical study of 6R-BH4 for the treatment of poorly controlled hypertension. 6R-BH4, commonly known as BH4 or tetrahydrobiopterin, is a naturally occurring enzyme cofactor that is... Continue Reading Posted at 9:09 PM \| Permalink \| Comments
	Novogen's Investigational Cancer Drug Phenoxodiol Targets Prostate Cancer Protein Gloria Gamat September 21, 2006 A preliminary study involving 19 patients with late-stage, hormone- refractory prostate cancer demonstrated that phenoxodiol, an investigational drug being developed by Novogen Limited (ASX: NRT), may be effective in the treatment of prostate cancer. According to the researchers, phenoxodiol specifically... Continue Reading Posted at 8:56 PM \| Permalink \| Comments
	Five Wyeth Research Scientists: Honored by Science Spectrum Magazine Gloria Gamat September 21, 2006 Five research scientists of Wyeth Pharmaceuticals, the pharmaceutical division of Wyeth (NYSE: WYE) have received the prestigious recognition from Science Spectrum Magazine at the 2006 Annual Minorities in Research Science Awards Conference, held September 14 to 16 in Baltimore, Md.... Continue Reading Posted at 8:39 PM \| Permalink \| Comments
	Fosrenol Approved in Germany, AnorMed Receives $3 Million Milestone Payment Gloria Gamat September 21, 2006 Fosrenol, a drug for treating high phosphate levels in the blood in patients undergoing dialysis as a result of chronic kidney failure, has been approved in Germany. As a result, AnorMED(AOM) will receive a U.S.$3 million milestone payment from Shire... Continue Reading Posted at 8:31 PM \| Permalink \| Comments
	Jury Favored Wyeth in Hormone Therapy Case v. Linda Reeves Gloria Gamat September 21, 2006 The jury in the case of Linda Reeves v. Wyeth found in favor of Wyeth (NYSE: WYE). The said trial began on August 23, before Judge Bill Wilson in the U.S. District Court, Eastern District of Arkansas when the plaintiff... Continue Reading Posted at 8:23 PM \| Permalink \| Comments
Sep20	ZymoGenetics Reported the Positive Results of Phase 3 Trial Evaluating rhThrombin as a Potential Treatment for Surgical Bleeding Gloria Gamat September 20, 2006 ZymoGenetics, Inc. (Nasdaq: ZGEN) has recently announced the detailed results of its pivotal Phase 3 trial of recombinant human Thrombin (rhThrombin) as an aid to controlling bleeding during surgery. The said trial, which compared rhThrombin to bovine thrombin, yielded positive... Continue Reading Posted at 9:54 PM \| Permalink \| Comments
	Schering-Plough’s NOXAFIL® (Posaconazole): USFDA-Approved for the Prevention of Invasive Fungal Infections (IFIs) Gloria Gamat September 20, 2006 Schering-Plough Corporation (NYSE: SGP)’s NOXAFIL® (posaconazole) Oral Suspension has recently been approved by the USFDA for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients aged 13 and older who are at high risk of developing these infections due to... Continue Reading Posted at 9:37 PM \| Permalink \| Comments
	GlaxoSmithKline Submitted USFDA NDA of Tykerb® (Lapatinib Ditosylate) for Advanced Breast Cancer Treatment Gloria Gamat September 20, 2006 GlaxoSmithKline plc (NYSE: GSK) has recently submitted a New Drug Application (NDA) to the USFDA, seeking approval to market Tykerb® (lapatinib ditosylate), in combination with Xeloda® (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in... Continue Reading Posted at 9:22 PM \| Permalink \| Comments
	Serono and Syntonix Pharmaceuticals, Inc Joined Forces to Pursue Development of a Long-Acting, Inhaleable FSH Therapy for the Treatment of Infertility Gloria Gamat September 20, 2006 Serono (virt-x: SEO and NYSE: SRA) and Syntonix Pharmaceuticals Inc. have entered into an agreement under which the companies will evaluate Syntonix' FSH:Fc SynFusion™ products for further development. The SynFusion™ and Transceptor™ technologies of Syntonix could lead to the development... Continue Reading Posted at 9:09 PM \| Permalink \| Comments
	Cell Therapeutics Inc. and Novartis Entered Worldwide License and Co-Development Agreement to Develop and Commercialize XYOTAX™ Gloria Gamat September 20, 2006 Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) have entered into an exclusive worldwide licensing agreement with Novartis (VTX: NOVN, NYSE: NVS)for the development and commercialization of XYOTAX™ (poliglumex paclitaxel), an investigational agent under Phase III Clinical Trial for the treatment of... Continue Reading Posted at 8:46 PM \| Permalink \| Comments
	Pfizer and TransTech Pharma Agreed to Develop and Commercialize RAGE (Receptor for Advanced Glycation End products) Modulators Gloria Gamat September 20, 2006 Pfizer, Inc. (NYSE: PFE) and TransTech Pharma, Inc. have entered into a license agreement to develop and commercialize small and large molecule compounds under development by TransTech. The said compounds target the receptor for advanced glycation end products (RAGE) which... Continue Reading Posted at 8:39 PM \| Permalink \| Comments
Sep18	Somanta Pharmaceuticals Completed SEC Registration and Received Stock Trading Symbol Gloria Gamat September 18, 2006 Somanta Pharmaceuticals (OTCBB:SMPM) has recently been assigned the stock trading symbol "SMPM" following the effectiveness of its Form SB-2 Registration Statement filed with the Securities and Exchange Commission. Somanta Pharmaceuticals’ common stock is now quoted on the Over-the-Counter Bulletin Board... Continue Reading Posted at 9:24 PM \| Permalink \| Comments
	Pharmion Corporation and MethylGene, Inc. Initiated Phase II Clinical Trial of Proprietary HDAC Inhibitor MGCD0103 in B-Cell Lymphomas Gloria Gamat September 18, 2006 Pharmion Corporation (Nasdaq: PHRM) together with its partner MethylGene, Inc. (TSE: MYG), has initiated the enrollment of patients with relapsed or refractory B-cell lymphomas for its Phase II clinical trial of MGCD0103, the company’s lead histone deacetylase (HDAC) inhibitor product... Continue Reading Posted at 9:17 PM \| Permalink \| Comments
	Schering AG and AstraZeneca Entered Strategic Alliance to Develop SERDs: Novel Anti-Cancer Drug Gloria Gamat September 18, 2006 Schering AG, Germany (NYSE: SHR) and AstraZeneca (NYSE: AZN, LON: AZN) joined forces to co-develop and jointly commercialize Schering AG's novel SERD. The selective estrogen receptor downregulators (SERDs) are a new class of compounds that can potentially be used as monotherapy... Continue Reading Posted at 9:03 PM \| Permalink \| Comments
	GlaxoSmithKline’s DREAM Trial Revealed Avandia® (rosiglitazone maleate) Reduced Risk of Progression from Pre-Diabetes to Type 2 Diabetes by 62 Percent Relative to Placebo Gloria Gamat September 18, 2006 The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial demonstrated that GlaxoSmithKline (NYSE: GSK, LON: GSK)’s Avandia® (rosiglitazone maleate) reduced the risk of developing type 2 diabetes by 62 percent compared to placebo in individuals at high risk of... Continue Reading Posted at 8:49 PM \| Permalink \| Comments
	Unimed Pharmaceuticals, Inc. Settled Pending AndroGel® Patent Litigation with Watson Pharmaceuticals, Inc. and Paddock Laboratories/Par Pharmaceutical Companies, Inc. Gloria Gamat September 18, 2006 A wholly owned subsidiary of Solvay Pharmaceuticals, Inc. (9014905), Unimed Pharmaceuticals, Inc. (6806472), has settled all pending patent litigation with Watson Pharmaceuticals, Inc. (NYSE: WPI) and Paddock Laboratories (16236904) /Par Pharmaceutical Companies, Inc. (NYSE: PRX) in connection with each company's... Continue Reading Posted at 8:36 PM \| Permalink \| Comments
Sep17	Dutch Court Ruled in Favor of Pfizer, Inc. Upholding Basic Lipitor Patent and Preventing Launch of Ranbaxy Generic Version Before November 2011 Gloria Gamat September 17, 2006 The District Court of The Hague in the Netherlands has ruled in favor of Pfizer, Inc. (NYSE: PFE) that the basic patent covering atorvastatin (the active ingredient in Lipitor) would be infringed by a competitor product from generics manufacturer Ranbaxy... Continue Reading Posted at 9:39 PM \| Permalink \| Comments
	Vical, Inc. Received Extended Patent Coverage for Vaxfectin™ Adjuvant to Conventional Vaccines Gloria Gamat September 17, 2006 Vical Incorporated (Nasdaq: VICL) has been recently issued U.S. Patent No. 7,105,574 covering both the novel Vaxfectin™ adjuvant and its use with conventional vaccines against infectious diseases and cancer. Vical, Inc. holds previously issued patents in the United States and... Continue Reading Posted at 9:25 PM \| Permalink \| Comments
	Bristol-Myers Squibb Company and Medivir AB Entered Worldwide Collaboration to Develop and Commercialize MIV-170 for the Treatment of HIV-1 Infection in Adults Gloria Gamat September 17, 2006 Bristol-Myers Squibb Company (NYSE: BMY, BMYPR) and Medivir AB ( STO : MVIRB) have entered into a worldwide collaboration for the development and commercialization of MIV-170. MV-170 is a preclinical non-nucleoside reverse transcriptase inhibitor (NNRTI) intended for the treatment of... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
Sep15	Transition Therapeutics Inc. and JDRF Partnered for the Development of Diabetes Regenerative Product GLP1-I.N.T.™ Gloria Gamat September 15, 2006 Transition Therapeutics Inc. (TSE: TTH) has entered into a partnership with the Juvenile Diabetes Research Foundation (JDRF) to support a clinical development plan for Transition's diabetes regenerative product, GLP1-I.N.T.™ The world's leading charitable funder of type 1 diabetes research, JDRF,... Continue Reading Posted at 9:25 PM \| Permalink \| Comments
	Cardiome Pharma Corp.’s Oral RSD1235 Passed Phase 2a Pilot Study Gloria Gamat September 15, 2006 Cardiome Pharma Corp. (NASDAQ: CRME (USA), TSE: COM, OTC: COMRF)’s Phase 2a pilot study of RSD1235 (oral) revealed positive results from both the 300mg and 600mg dosing groups: For the 300mg dosing group, 61% (33 of 54) of patients receiving... Continue Reading Posted at 9:14 PM \| Permalink \| Comments
	Radius and Karo Bio Entered Into Licensing Agreement for Novel SARM Compounds Gloria Gamat September 15, 2006 Radius and Karo Bio (STO: KARO) have entered into a licensing agreement wherein Radius acquires the exclusive worldwide rights (excluding the Nordic countries) to a new class of selective androgen receptor modulators (SARMs) discovered by Karo Bio. The SARM compounds... Continue Reading Posted at 9:01 PM \| Permalink \| Comments
	VIRTUE, Largest Clinical Trial of Subcutaneous Immunoglobulin (Ig) Therapy: Launched and Now Open to Primary Immunodeficiency (IP) Patients Across the United States Gloria Gamat September 15, 2006 ZLB Behring (5950871) has launched VIRTUE Trial, a Phase IV clinical trial of the study medication Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only USFDA-approved subcutaneous immunoglobulin (Ig) treatment for patients with primary immunodeficiency (PI). VIRTUE [Vivaglobin Investigator Research... Continue Reading Posted at 12:10 AM \| Permalink \| Comments
Sep14	KV Pharmaceutical Co. Received USFDA ANDA Approval To Market Six Strengths of Diltiazem HCl ER Capsules (Generic Tiazac®) Gloria Gamat September 14, 2006 KV Pharmaceutical Company (NYSE: KV.A/KV.B) has recently received USFDA approval to market six strengths of Diltiazem HCl ER Capsules through its wholly-owned generic/non-branded subsidiary, ETHEX Corporation. Diltiazem HCl ER Capsules is the AB rated generic version of Forest Pharmaceuticals, Inc.’s... Continue Reading Posted at 8:04 PM \| Permalink \| Comments
	BioMarin and Serono Announced Positive Clinical Trial Results of Phenoptin™ in PKU to be Presented at the 56th Annual Meeting of ASHG Gloria Gamat September 14, 2006 The positive results of BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) and Serono S.A. (NYSE: SRA, VTX: SEO))’s clinical studies of Phenoptin™ (sapropterin dihydrochloride), an investigational oral small-molecule therapeutic for the treatment of phenylketonuria (PKU), will be presented at the 56th Annual Meeting... Continue Reading Posted at 7:59 PM \| Permalink \| Comments
	Ortec International Inc. Announced Positive Results of Orcel® in Confirmatory Venous Leg Ulcer Trial Gloria Gamat September 14, 2006 A company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, Ortec International, Inc. (OTC: OTCI), announced the positive results of its preliminary review of the un-audited data of all the patients treated in... Continue Reading Posted at 7:54 PM \| Permalink \| Comments
	Neurocrine Biosciences, Inc.’s Orally Active GnRH Receptor Antagonist in Endometriosis (NBI-56418) Passed Follow-Up Phase II Study Gloria Gamat September 14, 2006 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has recently announced the positive safety and efficacy results with completion of the second off-treatment 3-month period of its 6-month 'proof of concept', safety, efficacy and dose-finding Phase II clinical trial using NBI-56418. NBI-56418 is... Continue Reading Posted at 7:49 PM \| Permalink \| Comments
	Peter R. Dolan Left Bristol-Myers Squibb as CEO, James M. Cornelius Appointed by Board of Directors as Interim CEO Gloria Gamat September 14, 2006 Earlier this week, the Board of Directors of Bristol-Myers Squibb Company (NYSE: BMY) have announced that Peter R. Dolan will leave the position of chief executive officer, effective immediately. James M. Cornelius, a director of the company since January 2005... Continue Reading Posted at 7:44 PM \| Permalink \| Comments
Sep13	Douglas Laboratories Canada: Acquired by Atrium Biotechnologies, Inc. Gloria Gamat September 13, 2006 Effective September 11, 2006 Atrium Biotechnologies Inc. (TSE: ATB) has acquired the assets of the London, Ontario-based Douglas Laboratories Canada. According to Richard Bordeleau, President of Atrium's Health & Nutrition Division: This acquisition provides Atrium with a platform to develop... Continue Reading Posted at 8:45 PM \| Permalink \| Comments
	Positive Genotoxicity Studies of Somaxon Pharmaceuticals’ SILENOR™ May Lead to its USFDA NDA for the Treatment of Insomnia Gloria Gamat September 13, 2006 Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) has recently completed the genotoxicity studies for its lead product candidate for the treatment of insomnia, SILENOR™ (doxepin HCl), as requested by the USFDA. The said studies consisted of an in vitro bacterial reverse mutation... Continue Reading Posted at 8:40 PM \| Permalink \| Comments
	Biomarin Pharmaceutical Inc. Announced Promising Preclinical Outcome of Phenylase™ (Enzyme Substitution Therapy For PKU) Gloria Gamat September 13, 2006 Biomarin Pharmaceutical Inc. (Nasdaq: BMRN)’s preclinical studies of Phenylase™ (phenylalalanine ammonia lyase) suggests a successful accomplishment in addressing key technical challenges associated with the company’s research development for the treatment of phenylketonuria (PKU). Affecting about 50,000 diagnosed patients in the... Continue Reading Posted at 8:02 PM \| Permalink \| Comments
	Acuity Pharmaceuticals Announced the Positive Phase II Results for Bevasiranib in Wet AMD Gloria Gamat September 13, 2006 Acuity Pharmaceuticals has recently reported the positive results of its Phase II C.A.R.E™ trial for bevasiranib sodium (formerly Cand5), Acuity's lead compound for the treatment of wet age-related macular degeneration (wet AMD), the major cause of blindness. Bevasiranib is a... Continue Reading Posted at 1:19 AM \| Permalink \| Comments
	Ranbaxy’s Ohm Laboratories, Inc. Received USFDA Approval to Manufacture and Market Loperamide Hydrochloride and Simethicone Tablets (Generic Imodium® Advanced) Gloria Gamat September 13, 2006 A wholly owned subsidiary of New Delhi, India-based Ranbaxy Laboratories Limited (BOM: 500359), Ohm Laboratories, Inc. (Ohm), has received USFDA approval for the manufacture and marketing of market Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC). The USFDA’s... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Sep12	CIP-Tramadol Fails Phase III Clinical Trials, Cipher Pharma Stocks Plunges 24 Percent Gloria Gamat September 12, 2006 CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol, failed to meet Phase III clinical trial endpoints. According to Cipher Pharamaceuticals (CND), it's manufacturer, although treatment groups in the study demonstrated a reduction in pain from baseline, the... Continue Reading Posted at 7:55 PM \| Permalink \| Comments
	Synta Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results for STA-4783 in Metastatic Melanoma Gloria Gamat September 12, 2006 Synta Pharmaceuticals Corp. (SNTA) announced positive data from a Phase 2b study in metastatic melanoma for STA-4783, a first-in-class heat shock protein 70 (Hsp70) inducer that activates natural killer (NK) cell-mediated tumor killing. According to Steven O'Day, MD, Chief of Research... Continue Reading Posted at 7:49 PM \| Permalink \| Comments
	Introgen Therapeutics, Inc. and Gendux AB’s ADVEXIN Therapy, Granted EU Orphan Designation Gloria Gamat September 12, 2006 Gendux AB and Introgen Therapeutics, Inc. was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that ADVEXIN® p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS). Gendux AB is... Continue Reading Posted at 2:46 AM \| Permalink \| Comments
	Abbott Submitted Both U.S. and E.U. Regulatory Applications for the Approval of HUMIRA® (Adalimumab) as Treatment for Crohn's Disease Gloria Gamat September 12, 2006 Abbott (NYSE: ABT) has simultaneously submitted a supplemental Biologics License Application (sBLA) with the USFDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate-to-severe Crohn's disease. There... Continue Reading Posted at 1:35 AM \| Permalink \| Comments
	Northwest Biotherapeutics, Inc., USFDA-Cleared to Proceed Lung Cancer Trial of DCVax®-LB Personalized Therapeutic Vaccine Gloria Gamat September 12, 2006 Northwest Biotherapeutics, Inc. (OTC: NWBT) has recently received USFDA clearance to proceed with Phase I clinical testing of its personalized therapeutic cancer vaccine, DCVax®-LB, in non-small cell lung cancer, with progression-free survival (i.e., delay in progression of the cancer) and... Continue Reading Posted at 12:28 AM \| Permalink \| Comments
Sep11	Jazz Pharmaceuticals Initiated Phase III Clinical Trial of Xyrem® (Sodium Oxybate) in Fibromyalgia Syndrome Patients Gloria Gamat September 11, 2006 Jazz Pharmaceuticals, Inc. (15809101) has recently initiated a Phase III clinical trial that will evaluate the safety and efficacy of Xyrem® (sodium oxybate) oral solution as a treatment for fibromyalgia syndrome. The said Phase III clinical trial is a randomized, double-blind,... Continue Reading Posted at 6:20 AM \| Permalink \| Comments
	ExonHit Therapeutics S. A.’s RNA Splicing Microarray Patent Rights, Licensed to Merck & Co., Inc. Gloria Gamat September 11, 2006 A drug and diagnostic discovery company, ExonHit Therapeutics S.A. (EPA: ALEHT), has granted Merck & Co., Inc. (NYSE: MRK) a non-exclusive license to rights for research only under Patent US 6,881,571, where it is not anticipated that the revenues received... Continue Reading Posted at 5:13 AM \| Permalink \| Comments
	GTx, Inc. Entered Partnership Agreement with Ipsen for Acapodene®’s European Rights Gloria Gamat September 11, 2006 The Men’s Health Biotech Company and a European pharmaceutical group, GTx, Inc. (Nasdaq: GTXI) and Ipsen (EPA: IPN) respectively, have entered into a definitive agreement under which Ipsen will have an exclusive license to develop and market GTx's Acapodene® (toremifene... Continue Reading Posted at 4:05 AM \| Permalink \| Comments
	Introgen Therapeutics, Inc.’s ADVEXIN Therapy (p53 tumor suppressor) Showing Potential in Breast Cancer Treatment Gloria Gamat September 11, 2006 The results of a Phase 2 study with Introgen Therapeutics, Inc. (Nasdaq: INGN)’s ADVEXIN therapy in the treatment of women with locally advanced breast cancer has been published in Cancer, the journal of the American Cancer Society. In the said... Continue Reading Posted at 1:43 AM \| Permalink \| Comments
	Nextrials, Inc.’s Co-Founder Will Discuss Benefits of Integrating Electronic Healthcare and Clinical Trial Data at ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference Gloria Gamat September 11, 2006 At the upcoming ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference slated on September 18-19 in Washington DC, Anthony J. Costello, Nextrials, Inc.’s co-founder and vice president and Society for Clinical Data Management... Continue Reading Posted at 12:32 AM \| Permalink \| Comments
Sep10	STEEPLE Study Revealed Superior Safety Profile of Sanofi-Aventis’ LOVENOX® (Enoxaparin Sodium Injection) Over Unfractionated Heparin (UFH) in Non-Emergent Percutaneous Coronary Intervention (PCI) Patients Gloria Gamat September 10, 2006 The results of the international STEEPLE trial (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI): An International Randomized Evaluation), has been published in The New England Journal of Medicine. The said trial revealed that a single intravenous bolus... Continue Reading Posted at 10:29 PM \| Permalink \| Comments
	Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference Gloria Gamat September 10, 2006 What: ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and > DC. In a session entitled "The Benefits and Advantages," Costello and> other industry experts will discuss the merits of merging EHR and EDC,> which include a potential reduction... Continue Reading Posted at 8:24 PM \| Permalink \| Comments
	Labopharm Inc. Presented at the Clinical Meeting of American Academy of Pain Management, the Safety Data from 3 U.S. Phase III Trials for Once-Daily Tramadol Gloria Gamat September 10, 2006 Labopharm Inc. (Nasdaq: DDSS, TSE: DDS) has presented the 12-week safety data from its three U.S. Phase III clinical trials for once-daily tramadol in a poster at the recent 17th Annual Clinical Meeting of the American Academy of Pain Management... Continue Reading Posted at 8:15 PM \| Permalink \| Comments
	Review Period for Shire plc’s MESAVANCE™ (mesalamine) NDA, Extended by USFDA Gloria Gamat September 10, 2006 The review period for Shire plc’s new drug application (NDA) for MESAVANCE™ has been extended by 90 days by the USFDA. An extension sought by the USFDA in order to allow additional time to review the supplemental Phase I data... Continue Reading Posted at 7:59 PM \| Permalink \| Comments
	In Product Acquisition Agreement with Ligand Pharmaceuticals: Eisai, Inc. Gains Four Oncology-Related Products Gloria Gamat September 10, 2006 Eisai Co., Ltd. (Tokyo, Japan) and Eisai, Inc. (New Jersey, USA) have signed a U.S. $205 million product acquisition agreement with Ligand Pharmaceuticals (Nasdaq: LGND; California, USA) where Eisai obtained exclusive global rights for ONTAK® (denileukin diftitox) (a pdf file), Targretin®... Continue Reading Posted at 7:46 PM \| Permalink \| Comments
	EuroPharma Entered Exclusive Agreement with New Chapter for the Distribution of Vectomega® Into Health Food/Natural Product Retail Channel Gloria Gamat September 10, 2006 EuroPharma have signed an agreement making New Chapter the exclusive distributor of Vectomega® for the health food/natural product retail channel. Vectomega®, a natural marine complex made up of five different phospholipids, DHA, and EPA, along with proteins and amino acids... Continue Reading Posted at 7:19 PM \| Permalink \| Comments
Sep 9	Manufacture of OVATION Pharmaceuticals, Inc.’s Panhematin® (hemin for injection) at Cardinal Health, Inc.’s New Facility, Received USFDA Approvable Letter Gloria Gamat September 9, 2006 OVATION Pharmaceuticals, Inc. (6630680) and Cardinal Health, Inc. (NYSE:CAH) have recently received a USFDA approval letter for Cardinal Health's new sterile facility in North Raleigh, N.C. for the manufacture of Panhematin® (hemin for injection), OVATION Pharma, Inc.’s biologic therapy for the... Continue Reading Posted at 9:44 PM \| Permalink \| Comments
	Cordis Endovascular’s CYPHER SELECT™ Sirolimus- eluting Stent: First Drug-Eluting Stent Approved in Europe for Most Severe Form of Leg Arterial Disease Gloria Gamat September 9, 2006 Cordis Endovascular’s CYPHER SELECT™ Sirolimus- eluting stent has recently received CE (Communite European) Mark in Europe for use in the treatment of severe claudication and critical limb ischemia (CLI) of infrapopliteal lesions -- the most severe form of arterial disease... Continue Reading Posted at 9:32 PM \| Permalink \| Comments
	Pfizer’s Lipitor® Found More Effective Than Simvastatin® in Reducing Risk of Additional Heart Attacks in Patients Who Had a Recent Heart Attack Gloria Gamat September 9, 2006 According to the results of a new analysis presented recently at the World Congress of Cardiology in Barcelona, Spain, Pfizer's Lipitor® (atorvastatin calcium) 80mg dose is found more effective in significantly lowering the heart attack recurrences in patients who already... Continue Reading Posted at 8:44 PM \| Permalink \| Comments
	Lentigen Corporation Signed Second Collaborative Research Agreement with the University of Pennsylvania Gloria Gamat September 9, 2006 Lentigen Corporation has signed a second collaborative research agreement (CRA) with the University of Pennsylvania , enabling Lentigen to work with Carl H. June M.D., Professor, Department of Pathology and Laboratory Medicine of the University Of Pennsylvania School Of Medicine... Continue Reading Posted at 8:35 PM \| Permalink \| Comments
Sep 8	SkyePharma and Mundipharma Entered Exclusive Licence Agreement for European Marketing and Distribution of Flutiform™ Gloria Gamat September 8, 2006 SkyePharma PLC (Nasdaq: SKYE) has entered into an agreement with Mundipharma International Corporation Limited (Mundipharma) for the European (and other international markets) development, marketing and distribution of Flutiform™, its novel combination product for asthma and chronic obstructive pulmonary disease (COPD).... Continue Reading Posted at 9:19 PM \| Permalink \| Comments
	U.S. Court of Appeals favored Mylan Laboratories, Inc. in Oxybutynin Patent Litigation Gloria Gamat September 8, 2006 The U.S. Court of Appeals for the Federal Circuit has favored Mylan Laboratories, Inc. (NYSE: MYL) by upholding a district court decision stating that Mylan's Oxybutynin products do not infringe a patent for Ortho-McNeil Pharmaceutical, Inc.’s DITROPAN XL® and that... Continue Reading Posted at 9:04 PM \| Permalink \| Comments
	Watson Pharmaceuticals’ Generic Seasonale®, USFDA Approved Gloria Gamat September 8, 2006 Watson Pharmaceuticals, Inc. (NYSE: WPI) has been granted final approval by the USFDA for its Abbreviated New Drug Application (ANDA) for levonorgestrel / ethinyl estradiol tablets USP, 0.15 mg / 0.03 mg. A Levonorgestrel / ethinyl estradiol tablet, USP is... Continue Reading Posted at 8:51 PM \| Permalink \| Comments
	FDA Advisory Committee Gives Negative Review on Genta Incorporated's Genasense® for Treatment of Chronic Lymphocytic Leukemia Gloria Gamat September 8, 2006 The US Food and Drug Administration's (USFDA) Oncologic Drugs Advisory Committee (ODAC) voted not to recommend approval of Genta Inc.'s Genasense® (oblimersen sodium) Injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). "While we are... Continue Reading Posted at 1:25 AM \| Permalink \| Comments
	Dynavax and AstraZeneca to Co-Develop TLR-9 Agonists for Asthma and COPD Gloria Gamat September 8, 2006 Dynavax Technologies Corporation (DVAX) has entered into a research collaboration and license agreement with AstraZeneca (AZN) for the discovery and development of TLR-9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Financial terms of the... Continue Reading Posted at 12:22 AM \| Permalink \| Comments
Sep 7	Claris LifeSciences to Expand in Europe, Ties up with STADA Arzneimittel Subsidiaries Gloria Gamat September 7, 2006 Ahmedabad-based Claris Lifesciences, a producer of large and small volume Injectables, has tied up with the subsidiary companies of Germany's third largest generic drug manufacturer, STADA Arzneimittel AG (SAZ). Under the agreement, Claris will supply four products each to STADA's... Continue Reading Posted at 8:18 PM \| Permalink \| Comments
	Pfizer Won Norvasc Patent Against Synthon Pharmaceuticals Gloria Gamat September 7, 2006 Norvasc (amlodipine besylate) by Pfizer (NYSE: PFE) is the world’s most prescribed medicine for the treatment of hypertension. The patent of which has been recently challenged by the generic manufacturer, Synthon Pharmaceuticals. However, a federal court in the Middle District... Continue Reading Posted at 4:17 AM \| Permalink \| Comments
	Tentative Approval For Clobetasol Propionate Foam (Generic Olux® Foam, 0.05%) Granted to Perrigo Gloria Gamat September 7, 2006 A subsidiary of The Perrigo Company (Nasdaq: PRGO), Perrigo Israel Pharmaceuticals, has been granted USFDA tentative approval on its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%. Clobetasol Propionate Topical Foam, 0.05% would be the generic version... Continue Reading Posted at 2:51 AM \| Permalink \| Comments
	Sabinsa Corp.’s Ocufors™, Approved for Indian Market and Manufacturing Gloria Gamat September 7, 2006 Manufacturer and supplier of high quality herbal extracts, cosmeceuticals, minerals and specialty fine chemicals, Sabinsa Corporation, has been granted approval by the Drugs Controller General of India to manufacture and market Ocufors™, an ophthalmic solution containing one percent forskolin, for... Continue Reading Posted at 1:32 AM \| Permalink \| Comments
	Debiopharm and Salix Pharmaceuticals Signed SANVAR® IR (Immediate Release Formulation) License Agreement Gloria Gamat September 7, 2006 The Debiopharm Group (Debiopharm) and Salix Pharmaceuticals, Ltd. (Nasdaq: SLXP) have signed an exclusive license agreement granting Salix the U.S. rights for sales, marketing and distribution of SANVAR® IR (immediate release formulation) developed by Debiopharm for the treatment of acute... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Sep 6	Anthera Pharmaceuticals Acquires Rights to Anti-Inflammatory Drug Portfolio Developed By Eli Lilly and Shionogi Gloria Gamat September 6, 2006 San Francisco-based Anthera Pharmaceuticals has entered into a licensing agreement with Eli Lilly and Company and Shionogi & Co., Ltd., gaining Anthera worldwide rights (except Japan) to develop and commercialize clinical and preclinical inhibitors of phospholipase A2. These compounds are... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
	ZymoGenetics Reports Positive Phase 3 Clinical Trial Results of Recombinant Thrombin Gloria Gamat September 6, 2006 ZymoGenetics (ZGEN) announced that a pivotal Phase III study of recombinant human Thrombin (rhThrombin) showed that it was as effective as bovine thrombin in stopping surgical bleeding. "We are very pleased with these positive results, which are in line with... Continue Reading Posted at 9:09 PM \| Permalink \| Comments
	EpiCept's LidoPAIN SP Analgesic Patch Fails European Phase III Trial Gloria Gamat September 6, 2006 LidoPAIN SP, a sterile prescription analgesic patch developed by EpiCept (EPCT), has failed Phase III clinical trials in Europe. The patch has been designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wounds. The trial... Continue Reading Posted at 9:06 PM \| Permalink \| Comments
	Cenestra Health Releases High-Purity Omega-3 Fatty Acid Supplement Gloria Gamat September 6, 2006 Cenestra Health, a Connecticut-based firm, has released Omax3, a high-purity and pharmaceutical grade Omega-3 fatty acid health supplement. According to the firm, Omax3 softgels are over 91 percent pure and is third party tested to ensure unsurpassed freshness, quality and... Continue Reading Posted at 9:00 PM \| Permalink \| Comments
	Rheumatoid Arthritis Drugs May Be More Efficient If Delivered Into the CNS Gloria Gamat September 6, 2006 A new study published in the Public Library of Science , demonstrated in rat studies, that rheumatoid arthritis drugs work better when delivered into the central nervous system. Based on the observation by other scientists that p38 is activated in... Continue Reading Posted at 8:44 PM \| Permalink \| Comments
Sep 5	Sanofi pasteur Started Shipment of Fluzone®, Influenza Virus Vaccine Gloria Gamat September 5, 2006 The vaccines business of the Sanofi-Aventis Group (NYSE: SNY), Sanofi Pasteur, has already started the shipment of influenza vaccine (Fluzone®, Influenza Virus Vaccine) to the U.S. market for the 2006-2007 season. Sanofi Pasteur is the most consistent and reliable supplier... Continue Reading Posted at 8:34 PM \| Permalink \| Comments
	Plavix® Patent Infringement Case’s Preliminary Injunction, Ordered Apotex to Stop Sales of Generic Plavix® Gloria Gamat September 5, 2006 Sanofi-aventis (NYSE: SNY) and Bristol-Myers Squibb (NYSE: BMY) gained favor on the Plavix® patent infringement case when the U.S. District Court for the Southern District of New York has recently granted a preliminary injunction ordering Apotex Inc. and Apotex Corp.... Continue Reading Posted at 8:13 PM \| Permalink \| Comments
Sep 4	Emergent BioSolutions Awarded Two NIAID Grants to Support Development of Anthrax Immune Globulin (AIG) Therapeutic Product Gloria Gamat September 4, 2006 Emergent BioSolutions, Inc. has been awarded two grants from the National Institute of Allergy and Infectious Diseases (NIAID) totaling $3.8 million to support the development of the company's anthrax immune globulin (AIG) therapeutic product. Emergent BioSolutions, Inc. is developing its... Continue Reading Posted at 6:42 PM \| Permalink \| Comments
	Exelixis, Inc. Submitted USFDA IND for Novel Anticancer Compound, XL228 Gloria Gamat September 4, 2006 Exelixis, Inc. (Nasdaq: EXEL) has recently submitted an investigational new drug application (IND) to the USFDA for XL228, the company’s novel anticancer compound designed to inhibit the insulin-like growth factor type-1 receptor (IGF1R), Src and Abl tyrosine kinases – targets... Continue Reading Posted at 6:35 PM \| Permalink \| Comments
	Velcura Therapeutics, Inc., Awarded NIA SBIR Grant for More Research on Human Bone Formation Processes Gloria Gamat September 4, 2006 Velcura Therapeutics, Inc. has received a $274,000 worth Phase 1 Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) for further identification of the genes and/or protein networks modulated during human bone formation. The first corporation... Continue Reading Posted at 6:28 PM \| Permalink \| Comments
	Vanda Pharmaceuticals, Inc. Successfully Completed Enrollment of Volunteers for its Iloperidone and VEC-162 Phase III Trials for Treatment of Schizophrenia and Insomnia, Respectively Gloria Gamat September 4, 2006 Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), has recently completed the enrollment of subject patients in its iloperidone Phase III clinical trial for the treatment of schizophrenia and VEC-162 Phase III clinical trial for the treatment of transient insomnia. The enrollment of... Continue Reading Posted at 6:21 PM \| Permalink \| Comments
	Mylan Lab Inc.’s Fluoxetine Capsules, USP, Granted USFDA Tentative Approval Gloria Gamat September 4, 2006 Mylan Laboratories Inc. (NYSE: MYL) has recently been granted tentative USFDA approval for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules, USP, 10mg and 20mg. The AB-rated generic version of Eli Lilly and Company (NYSE: LLY)'s Sarafem™ Pulvules® Capsules,... Continue Reading Posted at 6:10 PM \| Permalink \| Comments
Sep 3	Lentigen Corp. and Dharmacon, Inc. Joint Forces to Develop Custom Lentiviral Reagents for RNAi Research Gloria Gamat September 3, 2006 Lentigen Corporation and Dharmacon, Inc. have entered into a multi-year collaboration for the development and manufacture of lentiviral expression reagents to deliver short hairpin RNA (shRNA) expression vectors into cells using RNA interference (RNAi) mediated gene silencing. Where long-term gene... Continue Reading Posted at 11:21 PM \| Permalink \| Comments
	Nastech Pharma Co. Inc. Received Development Grant for siRNA Therapeutics for the Prevention and Treatment of Influenza Gloria Gamat September 3, 2006 Continue Reading Posted at 9:41 PM \| Permalink \| Comments
	Purdue Pharma L.P. and Teva Pharmaceuticals Agreed to End OxyContin® Patent Lawsuit Gloria Gamat September 3, 2006 Purdue Pharma L.P. (Stamford, Connecticut) and Teva Pharmaceuticals USA, Inc. (North Wales, Pennsylvania) have agreed to end their lawsuit concerning certain Purdue Pharma patents on OxyContin® (oxycodone HCl controlled-release) Tablets. The terms of the settlement agreement include the following: Teva... Continue Reading Posted at 9:30 PM \| Permalink \| Comments
Sep 2	Emergent BioSolutions, Inc.’s BioThrax® (Anthrax Vaccine Adsorbed), Certified by U.S. Department of Homeland Security As An Approved Product For Homeland Security Gloria Gamat September 2, 2006 Emergent BioSolutions, Inc.’s application for designation and certification of BioThrax® (Anthrax Vaccine Adsorbed) as a "qualified anti-terrorism technology" under the "Support Anti- Terrorism by Fostering Effective Technology Act" (SAFETY Act), has been granted approval by the United States Department of... Continue Reading Posted at 12:24 AM \| Permalink \| Comments
Sep 1	Sinovac Biotech Annouces Positive Phase I Trials of H5N1 Influenza Vaccine, Prepares for Mass Production Gloria Gamat September 1, 2006 Early this week, chine pharmaceutical company Sinovac Biotech Ltd. (SVA, also known as Beijing Kexing Bioproducts in China) announced the results of a Phase I clinical trial showing that its Pandemic Influenza (H5N1) Vaccine can induce an immune response, with... Continue Reading Posted at 12:12 AM \| Permalink \| Comments

« August 2006 | Main | October 2006 »

Sep27	Sanofi-Aventis U.S. LLC’s Dermik Laboratories Submitted USFDA Supplemental Premarket Approval Application (s-PMA) for Sculptra® Gloria Gamat September 27, 2006 Know More: Drug Marketing, Drug Regulations & Approval The dermatology business of sanofi-aventis U.S. LLC, Dermik Laboratories, has recently submitted a supplemental premarket approval application (s-PMA) to the USFDA for Sculptra® (injectable poly-L-lactic acid) for facial cosmetic use. Sculptra®, sold under the trade name NEW-FILL™, was approved in Europe in 1999 to increase volume, particularly for the correction of skin depression, including skin creases, wrinkles, folds and scars. Sculptra®, a synthetic, biocompatible, bioabsorbable material that is naturally degraded by the body over time, was approved in the in 2004 for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Source: PR Newswire Posted at 1:19 AM \| Permalink \| Comments
Sep27	Nastech Pharma Co. Inc. Initiated Clinical Development of Rapid Acting Diabetic Insulin Nasal Spray Gloria Gamat September 27, 2006 Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) has recently initiated the Phase I pharmacokinetic study designed to evaluate the safety, bioavailability and glucose response of Nastech's proprietary, rapid acting intranasal insulin formulation. The Phase 1 study will compare Nastech's intranasal formulation... Continue Reading Posted at 1:15 AM \| Permalink \| Comments
	Cardinal Health Agreed to Scale-Up and Manufacture Clinical Supplies for Bentley Pharmaceuticals, Inc.'s Intranasal Insulin Program Gloria Gamat September 27, 2006 Bentley Pharmaceuticals, Inc. (NYSE: BNT) has secured capacity at Cardinal Health (NYSE: CAH)'s new North Raleigh facility for the scale-up and manufacture of clinical supplies of Bentley's intranasal insulin product candidate, thereby facilitating the expansion of clinical trials. The product... Continue Reading Posted at 1:06 AM \| Permalink \| Comments
	Sigma-Aldrich Corp. Reached Settlement with Enzo Gloria Gamat September 27, 2006 Sigma-Aldrich Corporation (Nasdaq: SIAL) and named subsidiaries has reached a settlement with Enzo Biochem, Inc. (NYSE: ENZ), Enzo Life Sciences, and Yale University . The settlement between the parties and the stipulation and order of dismissal with prejudice of all... Continue Reading Posted at 12:47 AM \| Permalink \| Comments
	ExonHit Therapeutics and Allergan, Inc. Extended Strategic Alliance Gloria Gamat September 27, 2006 A drug and diagnostic discovery company, ExonHit Therapeutics S.A. (EPA: ALEHT), has extended its strategic collaboration with Allergan, Inc. (NYSE: AGN) for the identification, development and commercialization of drugs targeted at the treatment of neurodegenerative diseases, pain and ophthalmology based... Continue Reading Posted at 12:40 AM \| Permalink \| Comments
	Serono's Oral Cladribine, Granted USFDA Fast Track Status for the Treatment of Multiple Sclerosis (MS) Gloria Gamat September 27, 2006 Serono (NYSE: SRA)’s oral cladribine has been granted Fast Track Status by the USFDA for the treatment of patients with relapsing forms of multiple sclerosis. The novel oral formulation of cladribine for the treatment of MS is currently being investigated... Continue Reading Posted at 12:30 AM \| Permalink \| Comments
	Serono, To be Acquired by Merck KGaA Gloria Gamat September 27, 2006 Merck KGaA (FRA:MRK) of Darmstadt, Germany announced on 21st September that it has entered into an agreement with the Bertarelli Family (owner of the majority stake of Serono SA) to purchase their Serono (NYSE:SRA) shares to create a strategically compelling... Continue Reading Posted at 12:20 AM \| Permalink \| Comments
	Debiopharm Group’s Debio-0513 (PTR-262) Received European Orphan Drug Status for Myasthenia Gravis (MG) Gloria Gamat September 27, 2006 The Debiopharm Group (Debiopharm) has recently received European orphan drug designation from the Commission of the European Community (EC) for Debio-0513 (formerly known as PTR-262), a dual altered ligand peptide analog of the myasthenogenic epitopes of the acetylcholine receptor (AchR)... Continue Reading Posted at 12:08 AM \| Permalink \| Comments
Sep25	Top 8 Medicinal Products in My Toddlers’ Cabinet Gloria Gamat September 25, 2006 1) Ceelin® (Ascorbic Acid)/Vitamin C Ascorbic Acid (Ceelin®) is indicated for the prevention and treatment of Vitamin C deficiency in children , it increases body resistance to stress and infections and hastens recovery from illnesses and the healing of wounds,... Continue Reading Posted at 3:58 AM \| Permalink \| Comments
	Chromos and Y's Theraputic Agreed on Cell Line Engineering Contract Gloria Gamat September 25, 2006 Chromos Molecular Systems Inc. (TSX: CHR) has entered into a cell line engineering service agreement with Y's Therapeutics, Inc. (Burlingame, California) to develop a cell line using Chromos' ACE System (a pdf file) for potential use in the clinical and commercial... Continue Reading Posted at 3:42 AM \| Permalink \| Comments
	ChemBridge Corporation and ChemBridge Research Laboratories, Inc. (CRL) Entered Into Strategic Alliance on Discovery Chemistry with AstraZeneca Gloria Gamat September 25, 2006 ChemBridge Corporation and ChemBridge Research Laboratories, Inc. (CRL) have entered into a multi-year collaboration in discovery chemistry with AstraZeneca (LON:AZN). The terms of agreement included that ChemBridge and CRL scientists at Moscow and San Diego research sites will work closely... Continue Reading Posted at 3:37 AM \| Permalink \| Comments
	MannKind Corp.’s Technosphere® Insulin System, Showed Safety and Efficacy in Phase III Clinical Trial in Type 2 Diabetes Patients Gloria Gamat September 25, 2006 The results of a Phase III study (in patients with type 2 diabetes) designed to evaluate whether MannKind Corporation (Nasdaq: MNKD)’s Technosphere® Insulin System showed similar safety and efficacy compared to patients treated with insulin aspart (NovoLog®), an injected rapid-acting... Continue Reading Posted at 3:14 AM \| Permalink \| Comments
	CoFactor®/ Uftoral® (UFT) Combination Showed Positive Results in Colorectal Cancer Model Gloria Gamat September 25, 2006 Treatment of metastatic colorectal cancer in mice with CoFactor® in combination with Uftoral® (UFT) as demonstrated by clinical data recently reported by ADVENTRX Pharmaceuticals, Inc. (Amex: ANX). CoFactor® is a folate-based drug designed to improve the efficacy and safety of... Continue Reading Posted at 3:01 AM \| Permalink \| Comments
Sep23	Itax (Itopride) Fails Phase III Clinical Trials, Axcan Pharma Shares Fall Gloria Gamat September 23, 2006 Axcan Pharma Inc. (AXCA) halts the clinical development of ITAX (Itopride), a drug candidate for the treatment of functional dyspepsia, after failing to meet its co-primary endpoints in a North American Phase III clinical trial. "Although we are disappointed by... Continue Reading Posted at 1:30 AM \| Permalink \| Comments
	Long-term Alendronate (Bisphosphonate) Use in Patients with Osteoporosis Do Not Increase Vertebral Microcracks Gloria Gamat September 23, 2006 Bisphosphonates, a class of drugs commonly prescribed for the treatment of osteoporosis, have been linke dto the formation of microcracks in the skeleton, which appeared to increase proportionately to bisphosphonate treatment. However, a recent animal study presented during the 28th... Continue Reading Posted at 12:28 AM \| Permalink \| Comments
Sep22	Tranzyme Pharma Expands Clinical Program of Post-Operative Ileus Drug Candidate, TZP-101, to Include Patients with Gastroparesis Gloria Gamat September 22, 2006 Tranzyme Pharma has amended the IND for its novel small molecule ghrelin agonist, TZP-101, a potent prokinetic agent being developed for the treatment of post-operative ileus (POI), to include patients with gastroparesis. Gastroparesis is a gastrointestinal disorder characterized by delayed... Continue Reading Posted at 4:26 AM \| Permalink \| Comments
	Sebivo (Telbivudine) Approved in Switzerland for Chronic Hepatitis B Gloria Gamat September 22, 2006 Sebivo® (telbivudine), a new treatment for patients with chronic hepatitis B co-developed by Idenix Pharmaceuticals, Inc. (IDIX) and Novartis Pharma AG (NVS), has been approved in Swizerland. This approval is based primarily on one-year data from the GLOBE study, the... Continue Reading Posted at 3:23 AM \| Permalink \| Comments
	Altana AG Sells Pharmaceutical Business to Nycomed Gloria Gamat September 22, 2006 Altana AG (ALT) announced it has sold its unit, Altana Pharma AG and its entire pharmaceuticals business to Denmark's Nycomed for approximately €4.5 billion. The total purchase price to ALTANA AG is expected to amount to approx. EUR4.5 billion. This... Continue Reading Posted at 2:21 AM \| Permalink \| Comments
	Hospira Agrees to Buy Mayne Pharma Limited for $2 Billion Gloria Gamat September 22, 2006 Illinois-based, specialty pharmaceutical and medication delivery company Hospira (HSP) agreed to acquire Australia-based Mayne Pharma Limited (MYP), a specialty injectable pharmaceuticals company, for $2 billion. Under the terms of the agreement, Mayne shareholders will receive AUD$4.10 cash per outstanding ordinary... Continue Reading Posted at 1:18 AM \| Permalink \| Comments
	Nucryst Pharmaceutical's NPI 32101 Drug Candidate Against Atopic Dermatitis Fails Phase II Clinical Trials Gloria Gamat September 22, 2006 Nucryst Pharmaceuticals Corp. (NCST) announced the preliminary results of the Phase II clinical trials examining the safety and efficacy of NPI 32101, a drug candidate for the treatment of atopic dermatitis. According to the data, the success rates of both... Continue Reading Posted at 12:15 AM \| Permalink \| Comments
Sep21	Wal-Mart to Cut Prices On Almost 300 Generic Prescription Drugs, Drugstore chains Shares Falls Gloria Gamat September 21, 2006 Wal-Mart, the world's largest retailer, plans to drop the prices of 291 generic prescription drugs, luring bargain-seeking customers and presenting a challenge to competing pharmacy chains and makers of generic drugs. the 291 generic drugs include "the most commonly prescribed... Continue Reading Posted at 9:33 PM \| Permalink \| Comments
	Angiotech Pharmaceuticals Presents Positive Preclinical Study On Vascular Wrap ™ Paclitaxel-Eluting Mesh for Inhibiting Neointimal Hyperplasia Gloria Gamat September 21, 2006 During the The Western Vascular Society 2006 Annual Meeting, Angiotech Pharmaceuticals Inc. (ANPI) presented the results of a preclinilal study showing the efficacy of its Vascular Wrap™ paclitaxel-eluting mesh and Lifespan® graft technology platform. Results demonstrated that neointimal hyperplasia was... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
	BioMarin Completes Enrollment for Phase II Clinical Trials of 6R-BH4 for Treatment of Hypertension Gloria Gamat September 21, 2006 BioMarin Pharmaceutical Inc. (BMRN) has completed the enrollment of patients for the Phase II clinical study of 6R-BH4 for the treatment of poorly controlled hypertension. 6R-BH4, commonly known as BH4 or tetrahydrobiopterin, is a naturally occurring enzyme cofactor that is... Continue Reading Posted at 9:09 PM \| Permalink \| Comments
	Novogen's Investigational Cancer Drug Phenoxodiol Targets Prostate Cancer Protein Gloria Gamat September 21, 2006 A preliminary study involving 19 patients with late-stage, hormone- refractory prostate cancer demonstrated that phenoxodiol, an investigational drug being developed by Novogen Limited (ASX: NRT), may be effective in the treatment of prostate cancer. According to the researchers, phenoxodiol specifically... Continue Reading Posted at 8:56 PM \| Permalink \| Comments
	Five Wyeth Research Scientists: Honored by Science Spectrum Magazine Gloria Gamat September 21, 2006 Five research scientists of Wyeth Pharmaceuticals, the pharmaceutical division of Wyeth (NYSE: WYE) have received the prestigious recognition from Science Spectrum Magazine at the 2006 Annual Minorities in Research Science Awards Conference, held September 14 to 16 in Baltimore, Md.... Continue Reading Posted at 8:39 PM \| Permalink \| Comments
	Fosrenol Approved in Germany, AnorMed Receives $3 Million Milestone Payment Gloria Gamat September 21, 2006 Fosrenol, a drug for treating high phosphate levels in the blood in patients undergoing dialysis as a result of chronic kidney failure, has been approved in Germany. As a result, AnorMED(AOM) will receive a U.S.$3 million milestone payment from Shire... Continue Reading Posted at 8:31 PM \| Permalink \| Comments
	Jury Favored Wyeth in Hormone Therapy Case v. Linda Reeves Gloria Gamat September 21, 2006 The jury in the case of Linda Reeves v. Wyeth found in favor of Wyeth (NYSE: WYE). The said trial began on August 23, before Judge Bill Wilson in the U.S. District Court, Eastern District of Arkansas when the plaintiff... Continue Reading Posted at 8:23 PM \| Permalink \| Comments
Sep20	ZymoGenetics Reported the Positive Results of Phase 3 Trial Evaluating rhThrombin as a Potential Treatment for Surgical Bleeding Gloria Gamat September 20, 2006 ZymoGenetics, Inc. (Nasdaq: ZGEN) has recently announced the detailed results of its pivotal Phase 3 trial of recombinant human Thrombin (rhThrombin) as an aid to controlling bleeding during surgery. The said trial, which compared rhThrombin to bovine thrombin, yielded positive... Continue Reading Posted at 9:54 PM \| Permalink \| Comments
	Schering-Plough’s NOXAFIL® (Posaconazole): USFDA-Approved for the Prevention of Invasive Fungal Infections (IFIs) Gloria Gamat September 20, 2006 Schering-Plough Corporation (NYSE: SGP)’s NOXAFIL® (posaconazole) Oral Suspension has recently been approved by the USFDA for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients aged 13 and older who are at high risk of developing these infections due to... Continue Reading Posted at 9:37 PM \| Permalink \| Comments
	GlaxoSmithKline Submitted USFDA NDA of Tykerb® (Lapatinib Ditosylate) for Advanced Breast Cancer Treatment Gloria Gamat September 20, 2006 GlaxoSmithKline plc (NYSE: GSK) has recently submitted a New Drug Application (NDA) to the USFDA, seeking approval to market Tykerb® (lapatinib ditosylate), in combination with Xeloda® (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in... Continue Reading Posted at 9:22 PM \| Permalink \| Comments
	Serono and Syntonix Pharmaceuticals, Inc Joined Forces to Pursue Development of a Long-Acting, Inhaleable FSH Therapy for the Treatment of Infertility Gloria Gamat September 20, 2006 Serono (virt-x: SEO and NYSE: SRA) and Syntonix Pharmaceuticals Inc. have entered into an agreement under which the companies will evaluate Syntonix' FSH:Fc SynFusion™ products for further development. The SynFusion™ and Transceptor™ technologies of Syntonix could lead to the development... Continue Reading Posted at 9:09 PM \| Permalink \| Comments
	Cell Therapeutics Inc. and Novartis Entered Worldwide License and Co-Development Agreement to Develop and Commercialize XYOTAX™ Gloria Gamat September 20, 2006 Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) have entered into an exclusive worldwide licensing agreement with Novartis (VTX: NOVN, NYSE: NVS)for the development and commercialization of XYOTAX™ (poliglumex paclitaxel), an investigational agent under Phase III Clinical Trial for the treatment of... Continue Reading Posted at 8:46 PM \| Permalink \| Comments
	Pfizer and TransTech Pharma Agreed to Develop and Commercialize RAGE (Receptor for Advanced Glycation End products) Modulators Gloria Gamat September 20, 2006 Pfizer, Inc. (NYSE: PFE) and TransTech Pharma, Inc. have entered into a license agreement to develop and commercialize small and large molecule compounds under development by TransTech. The said compounds target the receptor for advanced glycation end products (RAGE) which... Continue Reading Posted at 8:39 PM \| Permalink \| Comments
Sep18	Somanta Pharmaceuticals Completed SEC Registration and Received Stock Trading Symbol Gloria Gamat September 18, 2006 Somanta Pharmaceuticals (OTCBB:SMPM) has recently been assigned the stock trading symbol "SMPM" following the effectiveness of its Form SB-2 Registration Statement filed with the Securities and Exchange Commission. Somanta Pharmaceuticals’ common stock is now quoted on the Over-the-Counter Bulletin Board... Continue Reading Posted at 9:24 PM \| Permalink \| Comments
	Pharmion Corporation and MethylGene, Inc. Initiated Phase II Clinical Trial of Proprietary HDAC Inhibitor MGCD0103 in B-Cell Lymphomas Gloria Gamat September 18, 2006 Pharmion Corporation (Nasdaq: PHRM) together with its partner MethylGene, Inc. (TSE: MYG), has initiated the enrollment of patients with relapsed or refractory B-cell lymphomas for its Phase II clinical trial of MGCD0103, the company’s lead histone deacetylase (HDAC) inhibitor product... Continue Reading Posted at 9:17 PM \| Permalink \| Comments
	Schering AG and AstraZeneca Entered Strategic Alliance to Develop SERDs: Novel Anti-Cancer Drug Gloria Gamat September 18, 2006 Schering AG, Germany (NYSE: SHR) and AstraZeneca (NYSE: AZN, LON: AZN) joined forces to co-develop and jointly commercialize Schering AG's novel SERD. The selective estrogen receptor downregulators (SERDs) are a new class of compounds that can potentially be used as monotherapy... Continue Reading Posted at 9:03 PM \| Permalink \| Comments
	GlaxoSmithKline’s DREAM Trial Revealed Avandia® (rosiglitazone maleate) Reduced Risk of Progression from Pre-Diabetes to Type 2 Diabetes by 62 Percent Relative to Placebo Gloria Gamat September 18, 2006 The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial demonstrated that GlaxoSmithKline (NYSE: GSK, LON: GSK)’s Avandia® (rosiglitazone maleate) reduced the risk of developing type 2 diabetes by 62 percent compared to placebo in individuals at high risk of... Continue Reading Posted at 8:49 PM \| Permalink \| Comments
	Unimed Pharmaceuticals, Inc. Settled Pending AndroGel® Patent Litigation with Watson Pharmaceuticals, Inc. and Paddock Laboratories/Par Pharmaceutical Companies, Inc. Gloria Gamat September 18, 2006 A wholly owned subsidiary of Solvay Pharmaceuticals, Inc. (9014905), Unimed Pharmaceuticals, Inc. (6806472), has settled all pending patent litigation with Watson Pharmaceuticals, Inc. (NYSE: WPI) and Paddock Laboratories (16236904) /Par Pharmaceutical Companies, Inc. (NYSE: PRX) in connection with each company's... Continue Reading Posted at 8:36 PM \| Permalink \| Comments
Sep17	Dutch Court Ruled in Favor of Pfizer, Inc. Upholding Basic Lipitor Patent and Preventing Launch of Ranbaxy Generic Version Before November 2011 Gloria Gamat September 17, 2006 The District Court of The Hague in the Netherlands has ruled in favor of Pfizer, Inc. (NYSE: PFE) that the basic patent covering atorvastatin (the active ingredient in Lipitor) would be infringed by a competitor product from generics manufacturer Ranbaxy... Continue Reading Posted at 9:39 PM \| Permalink \| Comments
	Vical, Inc. Received Extended Patent Coverage for Vaxfectin™ Adjuvant to Conventional Vaccines Gloria Gamat September 17, 2006 Vical Incorporated (Nasdaq: VICL) has been recently issued U.S. Patent No. 7,105,574 covering both the novel Vaxfectin™ adjuvant and its use with conventional vaccines against infectious diseases and cancer. Vical, Inc. holds previously issued patents in the United States and... Continue Reading Posted at 9:25 PM \| Permalink \| Comments
	Bristol-Myers Squibb Company and Medivir AB Entered Worldwide Collaboration to Develop and Commercialize MIV-170 for the Treatment of HIV-1 Infection in Adults Gloria Gamat September 17, 2006 Bristol-Myers Squibb Company (NYSE: BMY, BMYPR) and Medivir AB ( STO : MVIRB) have entered into a worldwide collaboration for the development and commercialization of MIV-170. MV-170 is a preclinical non-nucleoside reverse transcriptase inhibitor (NNRTI) intended for the treatment of... Continue Reading Posted at 9:13 PM \| Permalink \| Comments
Sep15	Transition Therapeutics Inc. and JDRF Partnered for the Development of Diabetes Regenerative Product GLP1-I.N.T.™ Gloria Gamat September 15, 2006 Transition Therapeutics Inc. (TSE: TTH) has entered into a partnership with the Juvenile Diabetes Research Foundation (JDRF) to support a clinical development plan for Transition's diabetes regenerative product, GLP1-I.N.T.™ The world's leading charitable funder of type 1 diabetes research, JDRF,... Continue Reading Posted at 9:25 PM \| Permalink \| Comments
	Cardiome Pharma Corp.’s Oral RSD1235 Passed Phase 2a Pilot Study Gloria Gamat September 15, 2006 Cardiome Pharma Corp. (NASDAQ: CRME (USA), TSE: COM, OTC: COMRF)’s Phase 2a pilot study of RSD1235 (oral) revealed positive results from both the 300mg and 600mg dosing groups: For the 300mg dosing group, 61% (33 of 54) of patients receiving... Continue Reading Posted at 9:14 PM \| Permalink \| Comments
	Radius and Karo Bio Entered Into Licensing Agreement for Novel SARM Compounds Gloria Gamat September 15, 2006 Radius and Karo Bio (STO: KARO) have entered into a licensing agreement wherein Radius acquires the exclusive worldwide rights (excluding the Nordic countries) to a new class of selective androgen receptor modulators (SARMs) discovered by Karo Bio. The SARM compounds... Continue Reading Posted at 9:01 PM \| Permalink \| Comments
	VIRTUE, Largest Clinical Trial of Subcutaneous Immunoglobulin (Ig) Therapy: Launched and Now Open to Primary Immunodeficiency (IP) Patients Across the United States Gloria Gamat September 15, 2006 ZLB Behring (5950871) has launched VIRTUE Trial, a Phase IV clinical trial of the study medication Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only USFDA-approved subcutaneous immunoglobulin (Ig) treatment for patients with primary immunodeficiency (PI). VIRTUE [Vivaglobin Investigator Research... Continue Reading Posted at 12:10 AM \| Permalink \| Comments
Sep14	KV Pharmaceutical Co. Received USFDA ANDA Approval To Market Six Strengths of Diltiazem HCl ER Capsules (Generic Tiazac®) Gloria Gamat September 14, 2006 KV Pharmaceutical Company (NYSE: KV.A/KV.B) has recently received USFDA approval to market six strengths of Diltiazem HCl ER Capsules through its wholly-owned generic/non-branded subsidiary, ETHEX Corporation. Diltiazem HCl ER Capsules is the AB rated generic version of Forest Pharmaceuticals, Inc.’s... Continue Reading Posted at 8:04 PM \| Permalink \| Comments
	BioMarin and Serono Announced Positive Clinical Trial Results of Phenoptin™ in PKU to be Presented at the 56th Annual Meeting of ASHG Gloria Gamat September 14, 2006 The positive results of BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) and Serono S.A. (NYSE: SRA, VTX: SEO))’s clinical studies of Phenoptin™ (sapropterin dihydrochloride), an investigational oral small-molecule therapeutic for the treatment of phenylketonuria (PKU), will be presented at the 56th Annual Meeting... Continue Reading Posted at 7:59 PM \| Permalink \| Comments
	Ortec International Inc. Announced Positive Results of Orcel® in Confirmatory Venous Leg Ulcer Trial Gloria Gamat September 14, 2006 A company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, Ortec International, Inc. (OTC: OTCI), announced the positive results of its preliminary review of the un-audited data of all the patients treated in... Continue Reading Posted at 7:54 PM \| Permalink \| Comments
	Neurocrine Biosciences, Inc.’s Orally Active GnRH Receptor Antagonist in Endometriosis (NBI-56418) Passed Follow-Up Phase II Study Gloria Gamat September 14, 2006 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has recently announced the positive safety and efficacy results with completion of the second off-treatment 3-month period of its 6-month 'proof of concept', safety, efficacy and dose-finding Phase II clinical trial using NBI-56418. NBI-56418 is... Continue Reading Posted at 7:49 PM \| Permalink \| Comments
	Peter R. Dolan Left Bristol-Myers Squibb as CEO, James M. Cornelius Appointed by Board of Directors as Interim CEO Gloria Gamat September 14, 2006 Earlier this week, the Board of Directors of Bristol-Myers Squibb Company (NYSE: BMY) have announced that Peter R. Dolan will leave the position of chief executive officer, effective immediately. James M. Cornelius, a director of the company since January 2005... Continue Reading Posted at 7:44 PM \| Permalink \| Comments
Sep13	Douglas Laboratories Canada: Acquired by Atrium Biotechnologies, Inc. Gloria Gamat September 13, 2006 Effective September 11, 2006 Atrium Biotechnologies Inc. (TSE: ATB) has acquired the assets of the London, Ontario-based Douglas Laboratories Canada. According to Richard Bordeleau, President of Atrium's Health & Nutrition Division: This acquisition provides Atrium with a platform to develop... Continue Reading Posted at 8:45 PM \| Permalink \| Comments
	Positive Genotoxicity Studies of Somaxon Pharmaceuticals’ SILENOR™ May Lead to its USFDA NDA for the Treatment of Insomnia Gloria Gamat September 13, 2006 Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) has recently completed the genotoxicity studies for its lead product candidate for the treatment of insomnia, SILENOR™ (doxepin HCl), as requested by the USFDA. The said studies consisted of an in vitro bacterial reverse mutation... Continue Reading Posted at 8:40 PM \| Permalink \| Comments
	Biomarin Pharmaceutical Inc. Announced Promising Preclinical Outcome of Phenylase™ (Enzyme Substitution Therapy For PKU) Gloria Gamat September 13, 2006 Biomarin Pharmaceutical Inc. (Nasdaq: BMRN)’s preclinical studies of Phenylase™ (phenylalalanine ammonia lyase) suggests a successful accomplishment in addressing key technical challenges associated with the company’s research development for the treatment of phenylketonuria (PKU). Affecting about 50,000 diagnosed patients in the... Continue Reading Posted at 8:02 PM \| Permalink \| Comments
	Acuity Pharmaceuticals Announced the Positive Phase II Results for Bevasiranib in Wet AMD Gloria Gamat September 13, 2006 Acuity Pharmaceuticals has recently reported the positive results of its Phase II C.A.R.E™ trial for bevasiranib sodium (formerly Cand5), Acuity's lead compound for the treatment of wet age-related macular degeneration (wet AMD), the major cause of blindness. Bevasiranib is a... Continue Reading Posted at 1:19 AM \| Permalink \| Comments
	Ranbaxy’s Ohm Laboratories, Inc. Received USFDA Approval to Manufacture and Market Loperamide Hydrochloride and Simethicone Tablets (Generic Imodium® Advanced) Gloria Gamat September 13, 2006 A wholly owned subsidiary of New Delhi, India-based Ranbaxy Laboratories Limited (BOM: 500359), Ohm Laboratories, Inc. (Ohm), has received USFDA approval for the manufacture and marketing of market Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC). The USFDA’s... Continue Reading Posted at 12:00 AM \| Permalink \| Comments
Sep12	CIP-Tramadol Fails Phase III Clinical Trials, Cipher Pharma Stocks Plunges 24 Percent Gloria Gamat September 12, 2006 CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol, failed to meet Phase III clinical trial endpoints. According to Cipher Pharamaceuticals (CND), it's manufacturer, although treatment groups in the study demonstrated a reduction in pain from baseline, the... Continue Reading Posted at 7:55 PM \| Permalink \| Comments
	Synta Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results for STA-4783 in Metastatic Melanoma Gloria Gamat September 12, 2006 Synta Pharmaceuticals Corp. (SNTA) announced positive data from a Phase 2b study in metastatic melanoma for STA-4783, a first-in-class heat shock protein 70 (Hsp70) inducer that activates natural killer (NK) cell-mediated tumor killing. According to Steven O'Day, MD, Chief of Research... Continue Reading Posted at 7:49 PM \| Permalink \| Comments
	Introgen Therapeutics, Inc. and Gendux AB’s ADVEXIN Therapy, Granted EU Orphan Designation Gloria Gamat September 12, 2006 Gendux AB and Introgen Therapeutics, Inc. was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that ADVEXIN® p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS). Gendux AB is... Continue Reading Posted at 2:46 AM \| Permalink \| Comments
	Abbott Submitted Both U.S. and E.U. Regulatory Applications for the Approval of HUMIRA® (Adalimumab) as Treatment for Crohn's Disease Gloria Gamat September 12, 2006 Abbott (NYSE: ABT) has simultaneously submitted a supplemental Biologics License Application (sBLA) with the USFDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate-to-severe Crohn's disease. There... Continue Reading Posted at 1:35 AM \| Permalink \| Comments
	Northwest Biotherapeutics, Inc., USFDA-Cleared to Proceed Lung Cancer Trial of DCVax®-LB Personalized Therapeutic Vaccine Gloria Gamat September 12, 2006 Northwest Biotherapeutics, Inc. (OTC: NWBT) has recently received USFDA clearance to proceed with Phase I clinical testing of its personalized therapeutic cancer vaccine, DCVax®-LB, in non-small cell lung cancer, with progression-free survival (i.e., delay in progression of the cancer) and... Continue Reading Posted at 12:28 AM \| Permalink \| Comments
Sep11	Jazz Pharmaceuticals Initiated Phase III Clinical Trial of Xyrem® (Sodium Oxybate) in Fibromyalgia Syndrome Patients Gloria Gamat September 11, 2006 Jazz Pharmaceuticals, Inc. (15809101) has recently initiated a Phase III clinical trial that will evaluate the safety and efficacy of Xyrem® (sodium oxybate) oral solution as a treatment for fibromyalgia syndrome. The said Phase III clinical trial is a randomized, double-blind,... Continue Reading Posted at 6:20 AM \| Permalink \| Comments
	ExonHit Therapeutics S. A.’s RNA Splicing Microarray Patent Rights, Licensed to Merck & Co., Inc. Gloria Gamat September 11, 2006 A drug and diagnostic discovery company, ExonHit Therapeutics S.A. (EPA: ALEHT), has granted Merck & Co., Inc. (NYSE: MRK) a non-exclusive license to rights for research only under Patent US 6,881,571, where it is not anticipated that the revenues received... Continue Reading Posted at 5:13 AM \| Permalink \| Comments
	GTx, Inc. Entered Partnership Agreement with Ipsen for Acapodene®’s European Rights Gloria Gamat September 11, 2006 The Men’s Health Biotech Company and a European pharmaceutical group, GTx, Inc. (Nasdaq: GTXI) and Ipsen (EPA: IPN) respectively, have entered into a definitive agreement under which Ipsen will have an exclusive license to develop and market GTx's Acapodene® (toremifene... Continue Reading Posted at 4:05 AM \| Permalink \| Comments
	Introgen Therapeutics, Inc.’s ADVEXIN Therapy (p53 tumor suppressor) Showing Potential in Breast Cancer Treatment Gloria Gamat September 11, 2006 The results of a Phase 2 study with Introgen Therapeutics, Inc. (Nasdaq: INGN)’s ADVEXIN therapy in the treatment of women with locally advanced breast cancer has been published in Cancer, the journal of the American Cancer Society. In the said... Continue Reading Posted at 1:43 AM \| Permalink \| Comments
	Nextrials, Inc.’s Co-Founder Will Discuss Benefits of Integrating Electronic Healthcare and Clinical Trial Data at ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference Gloria Gamat September 11, 2006 At the upcoming ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference slated on September 18-19 in Washington DC, Anthony J. Costello, Nextrials, Inc.’s co-founder and vice president and Society for Clinical Data Management... Continue Reading Posted at 12:32 AM \| Permalink \| Comments
Sep10	STEEPLE Study Revealed Superior Safety Profile of Sanofi-Aventis’ LOVENOX® (Enoxaparin Sodium Injection) Over Unfractionated Heparin (UFH) in Non-Emergent Percutaneous Coronary Intervention (PCI) Patients Gloria Gamat September 10, 2006 The results of the international STEEPLE trial (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI): An International Randomized Evaluation), has been published in The New England Journal of Medicine. The said trial revealed that a single intravenous bolus... Continue Reading Posted at 10:29 PM \| Permalink \| Comments
	Annual Merging Electronic Health Records (EHR) and Electronic Data Capture (EDC) Conference Gloria Gamat September 10, 2006 What: ExL Pharma's Second Annual Merging Electronic Health Records (EHR) and > DC. In a session entitled "The Benefits and Advantages," Costello and> other industry experts will discuss the merits of merging EHR and EDC,> which include a potential reduction... Continue Reading Posted at 8:24 PM \| Permalink \| Comments
	Labopharm Inc. Presented at the Clinical Meeting of American Academy of Pain Management, the Safety Data from 3 U.S. Phase III Trials for Once-Daily Tramadol Gloria Gamat September 10, 2006 Labopharm Inc. (Nasdaq: DDSS, TSE: DDS) has presented the 12-week safety data from its three U.S. Phase III clinical trials for once-daily tramadol in a poster at the recent 17th Annual Clinical Meeting of the American Academy of Pain Management... Continue Reading Posted at 8:15 PM \| Permalink \| Comments
	Review Period for Shire plc’s MESAVANCE™ (mesalamine) NDA, Extended by USFDA Gloria Gamat September 10, 2006 The review period for Shire plc’s new drug application (NDA) for MESAVANCE™ has been extended by 90 days by the USFDA. An extension sought by the USFDA in order to allow additional time to review the supplemental Phase I data... Continue Reading Posted at 7:59 PM \| Permalink \| Comments
	In Product Acquisition Agreement with Ligand Pharmaceuticals: Eisai, Inc. Gains Four Oncology-Related Products Gloria Gamat September 10, 2006 Eisai Co., Ltd. (Tokyo, Japan) and Eisai, Inc. (New Jersey, USA) have signed a U.S. $205 million product acquisition agreement with Ligand Pharmaceuticals (Nasdaq: LGND; California, USA) where Eisai obtained exclusive global rights for ONTAK® (denileukin diftitox) (a pdf file), Targretin®... Continue Reading Posted at 7:46 PM \| Permalink \| Comments
	EuroPharma Entered Exclusive Agreement with New Chapter for the Distribution of Vectomega® Into Health Food/Natural Product Retail Channel Gloria Gamat September 10, 2006 EuroPharma have signed an agreement making New Chapter the exclusive distributor of Vectomega® for the health food/natural product retail channel. Vectomega®, a natural marine complex made up of five different phospholipids, DHA, and EPA, along with proteins and amino acids... Continue Reading Posted at 7:19 PM \| Permalink \| Comments
Sep 9	Manufacture of OVATION Pharmaceuticals, Inc.’s Panhematin® (hemin for injection) at Cardinal Health, Inc.’s New Facility, Received USFDA Approvable Letter Gloria Gamat September 9, 2006 OVATION Pharmaceuticals, Inc. (6630680) and Cardinal Health, Inc. (NYSE:CAH) have recently received a USFDA approval letter for Cardinal Health's new sterile facility in North Raleigh, N.C. for the manufacture of Panhematin® (hemin for injection), OVATION Pharma, Inc.’s biologic therapy for the... Continue Reading Posted at 9:44 PM \| Permalink \| Comments
	Cordis Endovascular’s CYPHER SELECT™ Sirolimus- eluting Stent: First Drug-Eluting Stent Approved in Europe for Most Severe Form of Leg Arterial Disease Gloria Gamat September 9, 2006 Cordis Endovascular’s CYPHER SELECT™ Sirolimus- eluting stent has recently received CE (Communite European) Mark in Europe for use in the treatment of severe claudication and critical limb ischemia (CLI) of infrapopliteal lesions -- the most severe form of arterial disease... Continue Reading Posted at 9:32 PM \| Permalink \| Comments
	Pfizer’s Lipitor® Found More Effective Than Simvastatin® in Reducing Risk of Additional Heart Attacks in Patients Who Had a Recent Heart Attack Gloria Gamat September 9, 2006 According to the results of a new analysis presented recently at the World Congress of Cardiology in Barcelona, Spain, Pfizer's Lipitor® (atorvastatin calcium) 80mg dose is found more effective in significantly lowering the heart attack recurrences in patients who already... Continue Reading Posted at 8:44 PM \| Permalink \| Comments
	Lentigen Corporation Signed Second Collaborative Research Agreement with the University of Pennsylvania Gloria Gamat September 9, 2006 Lentigen Corporation has signed a second collaborative research agreement (CRA) with the University of Pennsylvania , enabling Lentigen to work with Carl H. June M.D., Professor, Department of Pathology and Laboratory Medicine of the University Of Pennsylvania School Of Medicine... Continue Reading Posted at 8:35 PM \| Permalink \| Comments
Sep 8	SkyePharma and Mundipharma Entered Exclusive Licence Agreement for European Marketing and Distribution of Flutiform™ Gloria Gamat September 8, 2006 SkyePharma PLC (Nasdaq: SKYE) has entered into an agreement with Mundipharma International Corporation Limited (Mundipharma) for the European (and other international markets) development, marketing and distribution of Flutiform™, its novel combination product for asthma and chronic obstructive pulmonary disease (COPD).... Continue Reading Posted at 9:19 PM \| Permalink \| Comments
	U.S. Court of Appeals favored Mylan Laboratories, Inc. in Oxybutynin Patent Litigation Gloria Gamat September 8, 2006 The U.S. Court of Appeals for the Federal Circuit has favored Mylan Laboratories, Inc. (NYSE: MYL) by upholding a district court decision stating that Mylan's Oxybutynin products do not infringe a patent for Ortho-McNeil Pharmaceutical, Inc.’s DITROPAN XL® and that... Continue Reading Posted at 9:04 PM \| Permalink \| Comments
	Watson Pharmaceuticals’ Generic Seasonale®, USFDA Approved Gloria Gamat September 8, 2006 Watson Pharmaceuticals, Inc. (NYSE: WPI) has been granted final approval by the USFDA for its Abbreviated New Drug Application (ANDA) for levonorgestrel / ethinyl estradiol tablets USP, 0.15 mg / 0.03 mg. A Levonorgestrel / ethinyl estradiol tablet, USP is... Continue Reading Posted at 8:51 PM \| Permalink \| Comments
	FDA Advisory Committee Gives Negative Review on Genta Incorporated's Genasense® for Treatment of Chronic Lymphocytic Leukemia Gloria Gamat September 8, 2006 The US Food and Drug Administration's (USFDA) Oncologic Drugs Advisory Committee (ODAC) voted not to recommend approval of Genta Inc.'s Genasense® (oblimersen sodium) Injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). "While we are... Continue Reading Posted at 1:25 AM \| Permalink \| Comments
	Dynavax and AstraZeneca to Co-Develop TLR-9 Agonists for Asthma and COPD Gloria Gamat September 8, 2006 Dynavax Technologies Corporation (DVAX) has entered into a research collaboration and license agreement with AstraZeneca (AZN) for the discovery and development of TLR-9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Financial terms of the... Continue Reading Posted at 12:22 AM \| Permalink \| Comments
Sep 7	Claris LifeSciences to Expand in Europe, Ties up with STADA Arzneimittel Subsidiaries Gloria Gamat September 7, 2006 Ahmedabad-based Claris Lifesciences, a producer of large and small volume Injectables, has tied up with the subsidiary companies of Germany's third largest generic drug manufacturer, STADA Arzneimittel AG (SAZ). Under the agreement, Claris will supply four products each to STADA's... Continue Reading Posted at 8:18 PM \| Permalink \| Comments
	Pfizer Won Norvasc Patent Against Synthon Pharmaceuticals Gloria Gamat September 7, 2006 Norvasc (amlodipine besylate) by Pfizer (NYSE: PFE) is the world’s most prescribed medicine for the treatment of hypertension. The patent of which has been recently challenged by the generic manufacturer, Synthon Pharmaceuticals. However, a federal court in the Middle District... Continue Reading Posted at 4:17 AM \| Permalink \| Comments
	Tentative Approval For Clobetasol Propionate Foam (Generic Olux® Foam, 0.05%) Granted to Perrigo Gloria Gamat September 7, 2006 A subsidiary of The Perrigo Company (Nasdaq: PRGO), Perrigo Israel Pharmaceuticals, has been granted USFDA tentative approval on its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%. Clobetasol Propionate Topical Foam, 0.05% would be the generic version... Continue Reading Posted at 2:51 AM \| Permalink \| Comments
	Sabinsa Corp.’s Ocufors™, Approved for Indian Market and Manufacturing Gloria Gamat September 7, 2006 Manufacturer and supplier of high quality herbal extracts, cosmeceuticals, minerals and specialty fine chemicals, Sabinsa Corporation, has been granted approval by the Drugs Controller General of India to manufacture and market Ocufors™, an ophthalmic solution containing one percent forskolin, for... Continue Reading Posted at 1:32 AM \| Permalink \| Comments
	Debiopharm and Salix Pharmaceuticals Signed SANVAR® IR (Immediate Release Formulation) License Agreement Gloria Gamat September 7, 2006 The Debiopharm Group (Debiopharm) and Salix Pharmaceuticals, Ltd. (Nasdaq: SLXP) have signed an exclusive license agreement granting Salix the U.S. rights for sales, marketing and distribution of SANVAR® IR (immediate release formulation) developed by Debiopharm for the treatment of acute... Continue Reading Posted at 12:18 AM \| Permalink \| Comments
Sep 6	Anthera Pharmaceuticals Acquires Rights to Anti-Inflammatory Drug Portfolio Developed By Eli Lilly and Shionogi Gloria Gamat September 6, 2006 San Francisco-based Anthera Pharmaceuticals has entered into a licensing agreement with Eli Lilly and Company and Shionogi & Co., Ltd., gaining Anthera worldwide rights (except Japan) to develop and commercialize clinical and preclinical inhibitors of phospholipase A2. These compounds are... Continue Reading Posted at 9:12 PM \| Permalink \| Comments
	ZymoGenetics Reports Positive Phase 3 Clinical Trial Results of Recombinant Thrombin Gloria Gamat September 6, 2006 ZymoGenetics (ZGEN) announced that a pivotal Phase III study of recombinant human Thrombin (rhThrombin) showed that it was as effective as bovine thrombin in stopping surgical bleeding. "We are very pleased with these positive results, which are in line with... Continue Reading Posted at 9:09 PM \| Permalink \| Comments
	EpiCept's LidoPAIN SP Analgesic Patch Fails European Phase III Trial Gloria Gamat September 6, 2006 LidoPAIN SP, a sterile prescription analgesic patch developed by EpiCept (EPCT), has failed Phase III clinical trials in Europe. The patch has been designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wounds. The trial... Continue Reading Posted at 9:06 PM \| Permalink \| Comments
	Cenestra Health Releases High-Purity Omega-3 Fatty Acid Supplement Gloria Gamat September 6, 2006 Cenestra Health, a Connecticut-based firm, has released Omax3, a high-purity and pharmaceutical grade Omega-3 fatty acid health supplement. According to the firm, Omax3 softgels are over 91 percent pure and is third party tested to ensure unsurpassed freshness, quality and... Continue Reading Posted at 9:00 PM \| Permalink \| Comments
	Rheumatoid Arthritis Drugs May Be More Efficient If Delivered Into the CNS Gloria Gamat September 6, 2006 A new study published in the Public Library of Science , demonstrated in rat studies, that rheumatoid arthritis drugs work better when delivered into the central nervous system. Based on the observation by other scientists that p38 is activated in... Continue Reading Posted at 8:44 PM \| Permalink \| Comments
Sep 5	Sanofi pasteur Started Shipment of Fluzone®, Influenza Virus Vaccine Gloria Gamat September 5, 2006 The vaccines business of the Sanofi-Aventis Group (NYSE: SNY), Sanofi Pasteur, has already started the shipment of influenza vaccine (Fluzone®, Influenza Virus Vaccine) to the U.S. market for the 2006-2007 season. Sanofi Pasteur is the most consistent and reliable supplier... Continue Reading Posted at 8:34 PM \| Permalink \| Comments
	Plavix® Patent Infringement Case’s Preliminary Injunction, Ordered Apotex to Stop Sales of Generic Plavix® Gloria Gamat September 5, 2006 Sanofi-aventis (NYSE: SNY) and Bristol-Myers Squibb (NYSE: BMY) gained favor on the Plavix® patent infringement case when the U.S. District Court for the Southern District of New York has recently granted a preliminary injunction ordering Apotex Inc. and Apotex Corp.... Continue Reading Posted at 8:13 PM \| Permalink \| Comments
Sep 4	Emergent BioSolutions Awarded Two NIAID Grants to Support Development of Anthrax Immune Globulin (AIG) Therapeutic Product Gloria Gamat September 4, 2006 Emergent BioSolutions, Inc. has been awarded two grants from the National Institute of Allergy and Infectious Diseases (NIAID) totaling $3.8 million to support the development of the company's anthrax immune globulin (AIG) therapeutic product. Emergent BioSolutions, Inc. is developing its... Continue Reading Posted at 6:42 PM \| Permalink \| Comments
	Exelixis, Inc. Submitted USFDA IND for Novel Anticancer Compound, XL228 Gloria Gamat September 4, 2006 Exelixis, Inc. (Nasdaq: EXEL) has recently submitted an investigational new drug application (IND) to the USFDA for XL228, the company’s novel anticancer compound designed to inhibit the insulin-like growth factor type-1 receptor (IGF1R), Src and Abl tyrosine kinases – targets... Continue Reading Posted at 6:35 PM \| Permalink \| Comments
	Velcura Therapeutics, Inc., Awarded NIA SBIR Grant for More Research on Human Bone Formation Processes Gloria Gamat September 4, 2006 Velcura Therapeutics, Inc. has received a $274,000 worth Phase 1 Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) for further identification of the genes and/or protein networks modulated during human bone formation. The first corporation... Continue Reading Posted at 6:28 PM \| Permalink \| Comments
	Vanda Pharmaceuticals, Inc. Successfully Completed Enrollment of Volunteers for its Iloperidone and VEC-162 Phase III Trials for Treatment of Schizophrenia and Insomnia, Respectively Gloria Gamat September 4, 2006 Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), has recently completed the enrollment of subject patients in its iloperidone Phase III clinical trial for the treatment of schizophrenia and VEC-162 Phase III clinical trial for the treatment of transient insomnia. The enrollment of... Continue Reading Posted at 6:21 PM \| Permalink \| Comments
	Mylan Lab Inc.’s Fluoxetine Capsules, USP, Granted USFDA Tentative Approval Gloria Gamat September 4, 2006 Mylan Laboratories Inc. (NYSE: MYL) has recently been granted tentative USFDA approval for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules, USP, 10mg and 20mg. The AB-rated generic version of Eli Lilly and Company (NYSE: LLY)'s Sarafem™ Pulvules® Capsules,... Continue Reading Posted at 6:10 PM \| Permalink \| Comments
Sep 3	Lentigen Corp. and Dharmacon, Inc. Joint Forces to Develop Custom Lentiviral Reagents for RNAi Research Gloria Gamat September 3, 2006 Lentigen Corporation and Dharmacon, Inc. have entered into a multi-year collaboration for the development and manufacture of lentiviral expression reagents to deliver short hairpin RNA (shRNA) expression vectors into cells using RNA interference (RNAi) mediated gene silencing. Where long-term gene... Continue Reading Posted at 11:21 PM \| Permalink \| Comments
	Nastech Pharma Co. Inc. Received Development Grant for siRNA Therapeutics for the Prevention and Treatment of Influenza Gloria Gamat September 3, 2006 Continue Reading Posted at 9:41 PM \| Permalink \| Comments
	Purdue Pharma L.P. and Teva Pharmaceuticals Agreed to End OxyContin® Patent Lawsuit Gloria Gamat September 3, 2006 Purdue Pharma L.P. (Stamford, Connecticut) and Teva Pharmaceuticals USA, Inc. (North Wales, Pennsylvania) have agreed to end their lawsuit concerning certain Purdue Pharma patents on OxyContin® (oxycodone HCl controlled-release) Tablets. The terms of the settlement agreement include the following: Teva... Continue Reading Posted at 9:30 PM \| Permalink \| Comments
Sep 2	Emergent BioSolutions, Inc.’s BioThrax® (Anthrax Vaccine Adsorbed), Certified by U.S. Department of Homeland Security As An Approved Product For Homeland Security Gloria Gamat September 2, 2006 Emergent BioSolutions, Inc.’s application for designation and certification of BioThrax® (Anthrax Vaccine Adsorbed) as a "qualified anti-terrorism technology" under the "Support Anti- Terrorism by Fostering Effective Technology Act" (SAFETY Act), has been granted approval by the United States Department of... Continue Reading Posted at 12:24 AM \| Permalink \| Comments
Sep 1	Sinovac Biotech Annouces Positive Phase I Trials of H5N1 Influenza Vaccine, Prepares for Mass Production Gloria Gamat September 1, 2006 Early this week, chine pharmaceutical company Sinovac Biotech Ltd. (SVA, also known as Beijing Kexing Bioproducts in China) announced the results of a Phase I clinical trial showing that its Pandemic Influenza (H5N1) Vaccine can induce an immune response, with... Continue Reading Posted at 12:12 AM \| Permalink \| Comments

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