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Poor People Can Be Pushed Further Into Poverty By The Need To Buy Common Medicines

Wed, 09/01/2010 - 15:30 — Correspondent

A substantial proportion (up to 86%) of the population living in low and middle income countries would be pushed into poverty as a result of purchasing common life-saving medicines. These are the findings of a study by Laurens Niens from Erasmus University Rotterdam and colleagues and published in this week's PLoS Medicine...

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Glenmark Announces The Discovery Of A Novel Chemical Entity 'GRC 17536', A TRPA1 Receptor Antagonist, A Potential First-in-Class Molecule Globally

Wed, 09/01/2010 - 14:30 — Correspondent

Glenmark Pharmaceuticals announced the discovery of a Novel Chemical Entity(NCE) 'GRC 17536'. The new NCE program is targeting TRPA1 receptor antagonists for pain and respiratory disorders...

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Naurex's Novel Antidepressant GLYX-13 Recognized As One Of Windhover's Top 10 Neuroscience Projects To Watch

Wed, 09/01/2010 - 14:30 — Correspondent

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, reported that its clinical stage candidate for the treatment of depression, GLYX-13, and its second-generation NRX-1050 series have been selected for inclusion on Windhover's list of the "Top 10 Most Interesting Neuroscience Projects to Watch...

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GSK And Valeant Announce New U.S. FDA PDUFA Goal Date For Ezogabine

Wed, 09/01/2010 - 14:30 — Correspondent

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine to 30 November 2010. The original goal date was 30 August 2010...

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Bionovo Receives Positive Guidance From FDA On Menerba®

Wed, 09/01/2010 - 14:30 — Correspondent

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo's plan...

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BioMarin Receives Orphan Drug Designation From The FDA For BMN-701 For The Treatment Of Pompe Disease

Wed, 09/01/2010 - 14:30 — Correspondent

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease...

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Sangart Reports Positive Phase IIa Data For Novel Oxygen Therapeutic Agent MP4OX In Severe Trauma Patients

Wed, 09/01/2010 - 13:30 — Correspondent

Sangart, Inc., announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in treated patients...

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Full Issue

Wed, 09/01/2010 - 01:30 — Correspondent

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Sun Warned Over Several GMP Issues at N.J. Plant

Wed, 09/01/2010 - 01:30 — Correspondent

Sun Pharmaceutical has received a warning letter after an FDA inspection found several good manufacturing practice (GMP) issues related to the production of its lipid-lowering drug gemfibrozil.

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FDA Delays Decision on GSK, Valeant Epilepsy Drug Potiga

Wed, 09/01/2010 - 01:30 — Correspondent

The FDA has pushed back the user fee action goal date for GlaxoSmithKline’s (GSK) and Valeant Pharmaceuticals’ epilepsy drug ezogabine to Nov. 30, giving the agency more time to review a recently submitted risk evaluation and mitigation strategy (REMS).

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Bionovo Drug Gets FDA OK for Phase III

Wed, 09/01/2010 - 01:30 — Correspondent

The FDA has agreed to Bionovo’s chemistry, manufacturing and controls (CMC) plan for its menopause treatment Menerba, allowing its lead drug candidate to move into Phase III.

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BMS, Pfizer Release Strong Efficacy Results for Apixaban to Prevent Stroke

Wed, 09/01/2010 - 01:30 — Correspondent

Bristol-Myers Squibb (BMS) and Pfizer’s anticoagulant apixaban proved superior to aspirin in preventing stroke and systemic embolism in a Phase III trial.

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Judge Denies Matrixx’s Proposed Settlement of Zicam Class Actions

Wed, 09/01/2010 - 01:30 — Correspondent

A federal judge has declined to approve Matrixx Initiatives’ proposed settlement for a series of class action lawsuits concerning its recalled OTC cold remedy Zicam.

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Baxter Stops Distributing Aralast Brochure After Third FDA Enforcement Letter

Wed, 09/01/2010 - 01:30 — Correspondent

Baxter has halted distribution of a physician brochure for its alpha1-antitrypsin deficiency (AATD) treatment Aralast NP following a third FDA enforcement letter over unsubstantiated efficacy claims.

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Novartis Gets FDA Nod for Combo of Tekturna and Generic Norvasc

Tue, 08/31/2010 - 20:30 — Correspondent

The FDA has approved Novartis’ Tekamlo, a pill containing its renin inhibitor, Tekturna (aliskiren) and a generic version of Pfizer’s Norvasc.

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Merck Hits Impax With Patent Suit for Generic Vytorin Application

Tue, 08/31/2010 - 20:30 — Correspondent

Merck has filed a patent infringement suit against Impax Laboratories after the generic-drug maker applied for FDA approval of a generic version of the blockbuster cholesterol drug Vytorin.

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Pfizer Sues Actavis Over ANDA for Best-Selling Drug Lipitor

Tue, 08/31/2010 - 20:30 — Correspondent

Pfizer has filed a patent-infringement lawsuit against Actavis after the Icelandic drugmaker submitted an ANDA to market a generic version of the blockbuster cholesterol drug Lipitor.

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FDA Gives Mixed Judgment on Mesalamine Petitions

Tue, 08/31/2010 - 20:30 — Correspondent

The FDA has partially granted citizen petitions from Shire and Warner Chilcott on how generic-drug makers should prove bioequivalence for generic formulations of extended-release mesalamine, used to treat ulcerative colitis.

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FDA Reveals First Generic Challenge to Celgene’s Cancer Drug Revlimid

Tue, 08/31/2010 - 20:30 — Correspondent

The FDA has received an ANDA to market a generic version of Revlimid 25 mg, the first challenge to Celgene’s blockbuster cancer drug.

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Judge Blocks Generic Strattera Until Lilly’s Appeal is Heard

Tue, 08/31/2010 - 20:30 — Correspondent

A federal judge has agreed to stop generic-drug makers from making versions of Eli Lilly’s attention-deficit treatment Strattera until the company’s appeal of a decision invalidating its patent on the drug is heard.

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Judge Orders Watson CEO Bisaro to Testify in FTC Investigation

Tue, 08/31/2010 - 20:30 — Correspondent

A federal judge has ordered Watson Pharmaceuticals CEO Paul Bisaro to testify in the ongoing FTC investigation into an alleged pay-for-delay deal between the company and the brand-drug maker Cephalon.

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CMS Paid $43 Million for Drugs Considered Less-Than-Effective

Tue, 08/31/2010 - 20:30 — Correspondent

The Centers for Medicare & Medicaid Services (CMS) has paid more than $43 million through Medicare Part D for “less-than-effective” (LTE) prescription drugs that should not have been covered, according to a government report.

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Federal Court Refuses Sanofi Motion to Block Sale of Generic Lovenox

Tue, 08/31/2010 - 20:30 — Correspondent

Sanofi-Aventis will continue its fight to keep generic versions of its blood thinner Lovenox off the market despite a federal court’s refusal to intervene in the matter.

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Watson False Marking Suit Is Latest in a Worrying Trend for Drugmakers

Tue, 08/31/2010 - 20:30 — Correspondent

For brand and generic pharmaceutical companies alike, defending patent litigation is an expected and often necessary part of doing business. But a new cottage industry of suing drugmakers for labeling their products with expired patents has emerged seemingly overnight and has the potential to inflict significant financial damage.

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