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The U.S. Supreme Court has refused to hear patent infringement cases brought by two drugmakers against Apotex, paving the way for the Canadian company to produce a generic version of Benicar. Read More
Valeant Pharmaceuticals executives tried to allay nervous investors in a hastily called conference call Nov. 10, following weeks of scandal and falling stock value. However, participants sounded skeptical of the company’s upbeat assessment. Read More
Roche’s Genentech unit and partner Exelixis scored a regulatory win Tuesday, with the FDA approving Cotellic as part of combination treatment for advanced melanoma. Read More
Serious deficiencies for producing sterile drug products have landed the Johnson Memorial Cancer Center an FDA warning letter, which was posted on the agency’s website Tuesday. Read More
Mylan may move forward with its proposed hostile takeover bid of Perrigo, so long as it divests seven generic drugs, the FTC determined in a Nov. 3 order. The move is the final regulatory hurdle for Mylan’s bid and eases the FTC’s concerns that the deal would harm competition. Read More
Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an information update that prohibited imports from two Apotex manufacturing facilities in India. Read More
Generic drugs have been touted as a way to help the U.S. healthcare system save money. A new report gives a perspective on just how large that savings is. Read More
Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
Drugmakers are telling the FDA that its proposed biosimilars naming is not necessary, but if four-letter suffixes are needed in the nonproprietary naming of biosimiliars and other biologic products, then make sure those letters are memorable. Read More