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International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Read More
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More
The FDA’s Office of Generic Drugs received 57 ANDAs in January, marking a nearly 76 percent decrease in submissions from the previous month, when the agency experienced a surge in applications. Read More
The head of the brand-name pharmaceutical industry’s trade group called for streamlining the generics approval process, and a greater shift to value-based payments. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
Eli Lilly & Co. had their patent sustained by a federal appeals court, barring generics manufacturer Teva Pharmaceuticals from marketing its own version of the billion-dollar cancer drug Alimta. Read More
A federal judge validated Shire’s patent on its delayed-release Lialda, ruling that Mylan infringed two of the patent’s claims when seeking to launch a generic of the bowel disease drug. Read More
Merck has agreed to pay Bristol Myers Squibb and Ono Pharmaceutical $625 million, plus royalties on global Keytruda sales, to resolve patent-infringement allegations involving an antibody designed to treat cancer by reactivating the body’s anti-tumor immune response. Read More
Teva’s subsidiary Barr Laboratories agreed to pay $225 million to settle a class action lawsuit alleging it reached pay-for-delay settlements that postponed the launch of generic versions of Bayer’s antibiotic Cipro. Read More