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The UK’s healthcare cost agency affirmed its June recommendation to cover Novartis’ cancer drug Glivec as an adjuvant treatment for patients at high risk of post-surgery recurrence of gastrointestinal stromal tumors. Read More
The European Medicines Agency has approved Janssen and Pharmacyclics’ blood cancer drug Imbruvica for two indications, a move that follows similar approvals in the U.S. this summer. Read More
Amgen is looking to head off future competition to a high cholesterol therapy, evolocumab, that hasn’t even been approved yet, with a patent infringement lawsuit against fellow biologics makers Sanofi and Regeneron. Read More
Spectrum Pharmaceuticals wants an extra four months of market exclusivity on its cancer drug Fusilev, arguing the FDA’s delay in approving the drug’s name entitles it to a revised approval clock. Read More
Canadian generics makers have promised to cap the costs of 18 top-selling, high-volume products to 18 percent of their brand reference’s price, under a sweeping drug pricing deal that will result in a roughly $3.8 billion industry-wide revenue reduction. Read More
The FDA’s proposal that drugmakers add microbiology and pharmacogenics information to product labels should apply only to new prescription drugs and biologics, said industry experts. Read More
The FDA did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More