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The U.S. solicitor general has urged the Supreme Court to review a Federal Circuit decision that requires some biosimilar makers wait six months after receiving FDA approval to launch a product. Read More
Gilead will have to pay Merck $2.5 billion for infringing a patent that covers the active ingredient of its blockbuster hepatitis C drugs, Salvadi and Harvoni, in the country’s largest ever judgment for an infringement. 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
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
The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar launch. Read More
Following tradition, FDA Commissioner Robert Califf will leave the agency on Inauguration Day, when Stephen Ostroff — deputy commissioner for foods and veterinary medicine — will temporarily assume the role. Read More