We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Manufacturers of new biologics could receive up to eight years of exclusivity in twelve counties under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Obama inked with 11 other countries back in October, were publicly released Nov. 6. Read More
The biopharmaceutical industry isn’t hiding its displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
President Barack Obama signed off on a budget bill Nov. 2 that will require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More