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.
In a win for branded drugmakers, President Barack Obama signed into law a bill extending the exclusivity periods for many new drugs and biologics. The measure — H.R. 639, referred to as the “Improving Regulatory Transparency for New Medical Therapies Act” — was signed into law Nov. 25, congressional records show. Read More
The FDA is receiving criticism for again delaying a final rule on generic labeling, with some accusing the agency of putting patients at risk. Read More
A new report is predicting that spending on prescription and OTC medications will climb 30 percent in the next five years, fueled largely by improved generic sales in emerging markets. 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