Pfizer has big expectations for its oral rheumatoid arthritis treatment Xeljanz--about $3 billion worth. But those expectations were struck a serious blow when European Medicines Agency regulators Thursday turned it down for approval.
While the FDA continues its slow-motion release of new guidelines for producing biosimilars in the U.S., India's Cipla has stepped up with a knockoff of the rheumatoid arthritis blockbuster Enbrel, which it will sell in the subcontinent at a 30% discount.
Just two months after Merck dropped out of a snake-bit biosimilar development program for Enbrel, the pharma giant--which has experienced a number of setbacks in the field--has stepped back up with a new, high-profile partnership, teaming up with a new venture formed by the South Korean conglomerate Samsung and Biogen Idec.
In Hollywood, when undercover agents are planning to secretly record a meeting, there's often a scene meant to engage the audience's fear and sympathy: "Are you wearing a wire?" someone accuses, usually someone armed with a gun or enormous fists.
Amgen's long-brewing settlement with the U.S. Justice Department is close at hand. The drugmaker pleaded guilty today to a misdemeanor misbranding charge for mismarketing its anemia drug Aranesp.
Some of the biggest blockbusters known to the pharma industry have dropped off the patent cliff and tumbled into the brutal land of generic therapies, where low-priced competition lays sales to...
Some of the biggest blockbusters known to the pharma industry have been swept off the patent cliff and tumbled into the brutal land of generic therapies, where low-priced competition awaits to chop up markets. Barring the development of new megablockbusters this list is likely to remain stable for some time. That's positive for the companies and their investors. It will also help fund major R&D operations around the globe. And the drive to improve performance should continue to drive innovation. Click here to check out the full report >>
The Thousand Oaks, CA-base drugmaker is one of 30 organizations on the docket today for the FDA's informal stakeholder meeting to discuss regulation of biosimilars.
FDA staffers raised concerns about increased risks of malignant cancers--particularly lymphomas--and infections tied to the drug.
Pfizer and Amgen are sorting out responsibilities, and people, over Enbrel.