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The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.” Read More
A Merck subsidiary could lose patent protection on the popular antibiotic Cubicin next year, after a federal appellate court invalidated four of the company’s five patents on the drug. Read More
During clinical development, biosimilars makers can request as many meetings with FDA reviewers as necessary but they need to be outcomes-based with a priority on narrowly defined questions that the FDA can answer. Read More
Generic manufacturer Heritage Pharmaceuticals has been hit with a warning letter for what the FDA calls “serious violations” of postmarket reporting requirements. Read More
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
Drugmakers engaging in anticompetitive practices don’t get a free pass simply because federal regulators failed to act, the Federal Trade Commission has asserted in a pending court case. Read More
Allergan is taking its dispute with the state of New York over mandatory access to an older medication amid generic substitution all the way to the Supreme Court. Read More
A federal court has placed a temporary sales ban on Indian drugmaker Dr. Reddy’s Laboratories’ generic form of heartburn drug Nexium in the U.S. Read More
The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, supported Robert Califf’s nomination as the next FDA commissioner during a two-hour confirmation hearing Nov. 17. Read More
Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More