Hear the shouts of joy from Shire? The FDA has validated five years of market exclusivity for Shire’s attention-deficit drug Vyvanse. That’s big news; the company is relying on Vyvanse to help make up lost revenue from the off-patent Adderall. And Shire has had Actavis nipping at its heels,…
Remember that consultant’s report that found drugmakers’ post-marketing studies were usually on time and on track? Well, the Government Accountability Office has come to a different conclusion. The GAO says that some of those studies are years late and that the FDA doesn’t flog companies for missing their deadlines….
On the H1N1 pandemic vaccine, Big Pharma made a classic mistake. It over-promised and under-delivered. After pledging to deliver the pandemic shots at lightning speed, vaccine makers such as Novartis, GlaxoSmithKline, and Sanofi-Aventis ran into manufacturing trouble. The hang-ups have hamstrung production, delaying delivery by weeks or even months….
Years ago, Japanese car manufacturers turned to management gurus to make their plants more efficient. Now, AstraZeneca is hiring automotive gurus to apply their efficiencies to drug production, the Financial Times reports. It’s yet another example of how pharma is borrowing from other industries in an effort to cut…
A web browser that can understand technical terms in life sciences and automatically find additional resources and services has been developed by European researchers. It could lead to a new generation of intelligent search engines. The life sciences community has built numerous databases – such as for gene sequencing and…
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Wellstat Therapeutics Corporation announced a global licensing agreement on PN2034, a novel oral first-in-class, insulin sensitizer, for the treatment of Type II Diabetes. As a sensitizer, PN2034 is expected to normalize and therefore enhance insulin action in the liver of diabetic patients. The…
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the companies have begun enrolling patients in an international Phase III trial to evaluate Nexavar® (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer.
Original Source of Bayer and Onyx Initiate Phase…
Most of Novartis’ swine flu vaccine may not reach the U.S. until the first quarter of 2010, almost at the end of flu season, CEO Daniel Vasella said. Report
Original Source of Novartis flu vax late to the party
Remember the rumor that Bristol-Myers Squibb might sell off the 83 percent stake it still holds in nutritional subsidiary Mead Johnson? The talk was that Group Danone had hired investment bankers to work on a bid. Deal speculation ratcheted up Mead Johnson stock by 10 percent. But as Bristol…
October hasn’t been a good month for Big Pharma in liability court. First, GlaxoSmithKline lost its bellwether case over Paxil’s alleged potential to cause birth defects. Now, Novartis has come out on the losing end of a Montana case over its bone-strengthening drug Zometa. A Missoula jury awarded $3.2…