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Zealand Pharma’s investigational glucagon-like peptide (GLP)-2 analog glepaglutide hit its primary phase 3 endpoint of reducing parenteral nutrition volume in patients with short bowel syndrome, but only when given twice a week. Read More
Currently idle U.S. generic drug manufacturing capacity could keep the nation’s drug supply chain “secure, robust and resilient,” according to researchers at Washington University’s Olin Business School in St. Louis. Read More
The U.S. Supreme Court has refused to hear Biogen’s argument that its patent on the blockbuster multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) should be reinstated as part of the company’s ongoing fight with Mylan Pharmaceuticals, which has for two years marketed a generic version of the drug. Read More
Just days after Congress reauthorized the third iteration of the biosimilar user fee act, BsUFA III, the FDA has announced that it’s launching a pilot program to improve the efficiency of biosimilar product development and advance the development of interchangeable products. Read More
AstraZeneca is spending $68 million to acquire LogicBio Therapeutics, a move that brings two innovative gene editing platforms to the pharma giant’s fold. Read More
A European pharma group is calling on the EU to establish a mechanism comparable to the U.S.-based Priority Review voucher system to facilitate the development of new antimicrobial drugs. Read More