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The FDA will not approve generics referring to the original and discontinued formulation of Protonix IV, after a review of scientific data confirmed that therapy for gastroesophageal reflux disease was pulled off the market for safety reasons. Read More
The PTO’s Patient Trial and Appeal Board said it was not persuaded by Coherus Biosciences’ challenge over the patentability of methods for manufacturing Humira, and ruled in favor of AbbVie in a trial proceeding. Read More
The antitrust division of the Justice Department has issued subpoenas to a Mylan executive and certain employees over the pricing of four generic drugs. Read More
Generics sponsors hoping to submit the ICH’s alternative postmarket report, known as the the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said. Read More
The FDA has made several amendments to the requirements for filing citizen petitions and petitions for stay of action when used to delay ANDA applications. Read More
Allergan, along with Ironwood Pharmaceuticals, filed a suit against five generics companies, alleging infringement of nine patents covering its irritable bowel syndrome drug, Linzess. Read More
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Read More
Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what generics sponsors must do to ensure that their agreements with CMOs are clear and enforceable. Read More
The U.S. Supreme Court refused to hear appeals brought by Purdue Pharma LP for a patent infringement case centered on reformulations of the painkiller OxyContin, clearing several barriers to the development of generics. Read More
The development process for biosimilar blood thinners no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More