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The 1,246-page trade agreement also includes mutual commitments on intellectual property, including patents, trademarks and designs, and unregistered rights, such as copyright, trade secrets and unregistered designs. Read More
Pfizer/BioNTech’s COVID-19 vaccine should ideally be given in two doses 21 to 28 days apart, but due to ongoing shortages, an interval of up to 42 days is acceptable, the World Health Organization (WHO) said Friday. Read More
The Center for Drug Evaluation and Research (CDER) is set to reorganize its Office of Generic Drugs (OGD) to help keep up with the high volume of generic drug applications. Read More
Bristol Myers Squibb has withdrawn the U.S. indication for its blockbuster drug Opdivo (nivolumab) for treatment of small cell lung cancer, following disappointing clinical trial results. Read More
A federal appeals court ruling last year against Teva Pharmaceuticals threatens other generic drugmakers, according to an amicus brief filed Dec. 22 by a roll call of professors of law, economics, business, health and medicine. Read More
The long-time director of the FDA’s Center for Drug Evaluation and Research (CDER), Janet Woodcock, who stepped aside last year to head the therapeutics arm of the U.S. government’s Operation Warp Speed (OWS) initiative, is taking up a new role as principal medical adviser to FDA Commissioner Stephen Hahn. Read More
Effective Jan. 1, drugmakers can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). Read More
HHS has made it known that pharma companies are required to offer 340B discounts for covered drugs even when they’re distributed by contract pharmacies, speaking out after several big drugmakers began withholding them. Read More
HHS has ordered the FDA to “cease further collection efforts” related to the Over-the-Counter Drug Monograph User Fee Program and has withdrawn the agency’s Dec. 29 Federal Register notice on user fee rates. Read More
The FDA made the right call in strongly advising against using a half-dose regimen of Moderna’s COVID-19 vaccine to stretch supply and vaccinate more Americans, members of the agency’s vaccine advisory panel told FDAnews. Read More
FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More