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XOMA Ltd. announced that, in light of Cubist Pharmaceuticals, Inc.'s recently announced decision to cease investment in its HepeX-B product because of stringent FDA requirements for regulatory approval, XOMA has placed its production process development work for Cubist on hold and has issued a notice of contract termination to Cubist.
Sanofi-aventis and Bristol-Myers Squibb announced that their agreement, as amended, with Apotex Inc. and Apotex Corp., ("Apotex") to settle the patent infringement lawsuit pending between the parties in the U.S. District Court for the Southern District of New York has failed to receive required antitrust clearance from the state attorneys general.
Predix Pharmaceuticals Inc. has inked a development deal with biotechnology giant Amgen Inc. worth more than $300 million assuming certain milestones are met.
The Generic Pharmaceutical Association (GPhA) unveiled an independent analysis of authorized generics that conclusively demonstrates that the anti-competitive brand pharmaceutical practice of introducing authorized generics (AGs) "significantly reduce incentives for independent generic firms to challenge invalid brand name patents and to develop non-infringing processes."
Pfizer Inc.'s board of directors named Jeffrey Kindler, the company's general counsel and vice chairman, to replace Hank McKinnell as chief executive, the drug maker said Friday evening.
The government revived efforts Monday to widen access to the morning-after pill, but only to women 18 and older, issuing a surprise announcement that it was reconsidering over-the-counter sale of the emergency contraceptive almost a year after it was thought doomed.
Berlex announced a voluntary nationwide recall of a single lot of its intravenous X-ray contrast agent, Ultravist Injection (iopromide injection), due to the "presence of particulate matter in conjunction with crystallization."
An activist group that is suing the FDA over its handling of the controversial contraceptive Plan B is asking to subpoena all White House documents related to the issue after a top agency official allegedly acknowledged that its decision on the drug was made to "appease the administration's constituents," according to documents obtained by FDAnews.