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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
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
With reports that as many as 40 percent of Americans may have some difficulty swallowing tablets, the FDA released multiple guidances for sponsors of generic drugs on Monday, including a final guidance on how the physical attributes of generics may affect patients’ compliance with their drug regimens. Read More
The FDA has launched an external review to find out what the agency can do to better support the appropriate use of opioid analgesics in the U.S. Read More
The European Medicines Agency’s (EMA) safety committee last week recommended adding a warning to the product information for three types of drug products: terlipressin, Imbruvica and combinations of codeine with ibuprofen. Read More
Medicare and Medicaid have spent an estimated $23.8 billion on 18 FDA accelerated approval (AA) drugs with incomplete confirmatory trials that missed their planned completion dates, the HHS Office of Inspector General (OIG) said in a new report released Friday, adding that the drugs have been “staying on the market — and being administered to patients — for years without the predicted clinical benefit being verified.” Read More