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Novo Nordisk is moving forward two years after the FDA rejected two insulin therapies, with the agency’s agreement to review Class II resubmissions of its NDAs for Tresiba and Ryzodeg drugs based on an interim analysis of data from a cardiovascular outcomes study. Read More
Merck’s investigational hepatitis C grazoprevir/elbasvir combination pill has picked up two new breakthrough designations, just three months after the FDA threatened to rescind one it had already granted to the drugs. Read More
The European Commission has approved Roche's Avastin plus chemotherapy for women with persistent, recurrent or metastatic cervical cancer, the company said Wednesday. Read More
The Federal Circuit affirmed most of a 2013 U.S. district court ruling that ordered Apotex to pay AstraZeneca slightly more than $76 million for infringing on patents for its heartburn drug Prilosec. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More