Presented by OSMOS…

• Genzyme (GENZ) has resubmitted its manufacturing documentation to the FDA for Lumizyme. Back in March, the FDA rejected GENZ’s application to produce the Pompe disease drug at a 2,000 L bioreactor scale. The FDA has also begun inspections at GENZ’s manufacturing plant to verify all deficiencies have been addressed. [MassHighTech]

• Johnson & Johnson wants out. The drugmaker will ask an arbitrator to dissolve its Remicade partnership with Schering-Plough. [Pharmalive]

• Novartis’ new phase 3 drug, QAB149 (indacaterol), for COPD shows blockbuster results. [Genetic Engineering & Biotechnology News]

• NeurogesX’s pain patch, Qutenza, gets EMEA approval, but still without a partner. [BizJournals]

• Uh-oh!! FDA looking into liver toxicity associated with OTC weight loss drug Orlistat. [Scrip]

• Dr. Reddy’s is closing the door at its Atlants research facility, but no word on axes. An email to the company was not immediately returned. [India Infoline]

• Vical advances its H1N1 pandemic influenza (Swine Flu) vaccine, shares soar. [Yahoo!Finance]

• A $106M payout awaits Schering-Plough execs once the ink dries with Merck. [WSJ]

• It’s not just the common folk that have beef with the IRS — GSK owes $1.9B and doesn’t want to pony up. [WSJ]

• Finally, Jim Edwards at BNET Pharma is keeping tabs on all the Astra Seroquel documents. He’s even got the real email printouts between execs!! [jimedwardsnrx]

ASCO Watch

• Medivation will present Phase 1/2 data on MDV3100, biotech’s next most promising prostate cancer drug (now that Cougar has been scooped up). [Yahoo!Finance]

• Roche has a whole bunch of presentations: Tarceva (erlotinib), the famed Avastin study in the CRC adjuvant setting, and trastuzumab-DM1 (T-DM1) [MedicalNewsToday]

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