Tempest, Inc. 8510 Bessemer Ave.  Cleveland, OH 44127  Ph: 216-883-6500To HOME
 



FDA News

FDA Drug Daily Bulletin

  • Shire Requests FDA Hearing, Will Keep Marketing ProAmatine
    Shire will keep its low blood pressure treatment ProAmatine on the market while the FDA moves forward with a formal process that could result in withdrawal of the drug’s approval, the company said this week.

  • MedImmune Asked to Conduct Another Trial for RSV Drug
    The FDA has asked MedImmune to conduct an additional clinical trial of its drug candidate motavizumab, under review to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

  • Pfizer Sues Actavis Over ANDA for Best-Selling Drug Lipitor
    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. In its complaint, Pfizer alleges that Actavis’ ANDA would infringe its ’156 patent on Lipitor (atorvastatin).

  • Pharma Blog Watch


  • Glaxo Hires Goldman’s Dingemans as CFO
    GlaxoSmithKline Plc named Simon Dingemans, a Goldman Sachs Group Inc. investment banker, as chief financial officer at a time when the U.K. drugmaker is counting on acquisitions to help boost sales.

  • Elan Activist Identifies Four Candidates for Board
    Elan Corp Plc investor Ib Sonderby has proposed four candidates for the Irish drugmaker’s board, including Athena Neurosciences co-founder Larry Fritz.

  • Onyx Pharma Gets Japanese Drug Development Deal
    Onyx Pharmaceuticals Inc. said Wednesday it could receive more than $300 million through an agreement with Ono Pharmaceutical Co. Ltd. to develop and sell two potential cancer treatments in Japan.

  • Lonza Signs Production Deal With Glaxo
    Lonza said it would manufacture a number of drug compounds for Britain’s GlaxoSmithKline, adding to signs of a revival in demand from pharmaceutical clients.

  • Mylan Completes $550 Million Acquisition of Bioniche Pharma
    Pittsburgh’s Mylan Inc. has completed its acquisition of Bioniche Pharma Holdings Ltd. sooner than expected, launching a North American institutional business that includes the Irish company’s injectable drugs.

  • Sanofi Pitched $71 Offer to Genzyme
    Sanofi-Aventis SA pitched a new offer to acquire U.S. biotechnology company Genzyme Corp for $71 a share in exchange for the opportunity to conduct “partial due diligence,” according to DealReporter.

FDA News
0