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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 U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More
Neither side in the fight over the last patent protecting Teva’s blockbuster MS drug Copaxone appeared to gain an advantage during oral arguments last week before the U.S. Supreme Court. Read More
Canadian generics firm Apotex has asked the full U.S. Court of Appeals for the Federal Circuit to rehear a case alleging brandmaker UCB’s hypertension drug Univasc infringed on one of Apotex’s patents. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. 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
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
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 should make its consideration of ANDA first-filer status a far more public process, say generics firms that continue to seek more transparency and communications from the agency in general on the generic drug application process. Read More
The FDA has expanded market exclusivity from three to five years on all fixed-dose combination drugs that contain a new active ingredient, bowing to industry pressure for new incentives to develop the costly products. Read More