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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
A story in the Oct. 15th issue of DID incorrectly stated that the U.S. had introduced a framework this month for drugmakers to report payments to physicians and teaching hospitals. The article should have said a website for reporting such data under the Sunshine Act went live this month. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
A UK healthcare cost watchdog has recommended against national coverage of Dendreon’s novel prostate cancer treatment Provenge, deeming it too expensive. Read More
Drug sponsors conducting a clinical trial should take efforts to better understand the effects of a particular disease on patients when designing ways to measure patient-reported outcomes, says an FDA clinical trials official. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
The FDA late Wednesday approved two breakthrough therapies for idiopathic pulmonary fibrosis: Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said. Read More