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Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More
A workers’ benefits fund filed a lawsuit claiming Johnson & Johnson maintained an illegal monopoly for its blockbuster drug Remicade, employing anticompetitive schemes involving insurer contracts, rebate protocols and bundling. Read More
A multistate price-fixing lawsuit against generic drugmakers should be dramatically expanded to target more drugs, more companies and, for the first time, individual company executives, the attorneys general who filed the litigation told a federal court. Read More
The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Read More
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs, Commissioner Scott Gottlieb said. Read More
Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity that is awarded to a first-to-file generic drug. Read More
The Hatch-Waxman amendments did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. Read More