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FDA medical officers — including those involved with product review and post-market safety monitoring across CDER, CBER and CDRH — will be exempt from the federal hiring freeze, according to an HHS memo. Read More
The International Council on Harmonisation announced several new international members, in a Feb. 2 report on its November meeting in Osaka, Japan. 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 Trump administration is being sued over the president’s executive order requiring federal agencies to cut two regulations for every one they issue. 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