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A federal judge has ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by Monday, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More
The Federal Trade Commission Wednesday approved Novartis’ divestiture of its targeted cancer drug business, clearing the way for a portfolio swap with GlaxoSmithKline valued at $21 billion. Read More
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