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After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More
The U.S. government and life sciences industry groups have asked Japan not to change the country’s drug pricing system to annual price reviews and cuts, instead of the current two-year review. Read More
The FTC is urging a D.C. federal court not to postpone an order that requires Boehringer Ingelheim to hand over documents in a pay-for-delay lawsuit involving the blood thinner, Aggrenox. Read More
A federal judge awarded the Federal Trade Commission its request to dismiss a pay-for-delay suit that alleges generics drugmaker Watson Laboratories entered an illegal deal with Endo to block the market entry of Opana ER and Lidoderm generics. Read More
The U.S. Supreme Court has paved the way for non-cash patent settlements, which are often reached by branded and generics drugmakers, to trigger antitrust scrutiny after it refused to hear a case involving GlaxoSmithKline’s epilepsy therapy Lamictal. Read More
A federal judge ruled that a generic version of Merck’s Nasonex developed by Teva Pharmaceuticals does not infringe patent claims covering the allergy treatment’s active ingredient. 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
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
Spanish drugmaker Grifols is accused of defrauding the government of millions of dollars for promoting the use of its antithrombin drug, Thrombate III, in unapproved indications. Read More
The U.S. solicitor general has urged the Supreme Court to review a Federal Circuit decision that requires biosimilar makers wait six months after receiving FDA approval to launch a product. Read More