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The FDA has published 32 new and revised draft product-specific guidances (PSG) which provide recommendations for developing generic drugs and the design of bioequivalence studies to support ANDAs. Read More
Eli Lilly entered into a settlement agreement with Totality Medispa for monetary payment and to halt further sale of unapproved versions of the company’s monumental Type 2 diabetes and weight loss drugs, Mounjaro and Zepbound (tirzepatide). Read More
More than 1,400 patents and patent applications — most filed years after drug approval — protect the US’ 10 top-selling drugs, heading off competition from generics or biosimilars for decades, a new study has found. Read More
Dynavax announced it received an FDA complete response letter (CRL) on its sBLA for Heplisav-B vaccine because the third-party clinical trial site operator destroyed the data for approximately half the subjects. Read More
Sen. Bernie Sanders (I-Vt.) has raised his battle flag against high drug prices on a crumbling hill, according to a conservative think tank that’s picking apart a study supporting Sanders’ views on the matter. Read More
Sandoz is withdrawing from the UK’s Prescription Medicines Code of Practice Authority (PMCPA) after being dinged for promotional wording of its biosimilar natalizumab in official documents presented before the drug received a national marketing authorization. Read More
An updated version of the Biosecure Act gives US businesses until 2032 to decouple from four Chinese biotech companies identified as being of “particular concern” over data mining on behalf of the Chinese government. Read More