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The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More
Sandoz has run out of legal recourse and will have to wait for the Enbrel patents to expire before it can launch biosimilar Erelzi, which has been FDA-approved since August 2016. Read More
G20 leaders are expected to call for patent-pooling whereby drugmakers will share patents voluntarily, allowing developing nations to manufacture COVID-19 products. Read More
The FDA clarified in a new guidance released yesterday when it is appropriate for drug sponsors to submit an abbreviated new drug application (ANDA) for a synthetic peptide drug product that references an already approved synthetic peptide of recombinant DNA origin. Read More
The House of Representatives on Wednesday voted 402 to 23 to pass bipartisan legislation that would close an orphan drug exclusivity loophole — just one week after the bill was denied passage by House Republicans. Read More
Emergent BioSolutions CEO Robert Kramer said Wednesday that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year. Read More
The FDA issued a warning letter to Everett, Wash.-based North American Hirudin Biotech Products for marketing unapproved and misbranded drugs. Read More
The FDA refuted CytoDyn’s claims about the efficacy of the company’s experimental HIV drug leronlimab as a COVID-19 treatment based on data from two late-stage trials. Read More
The U.S. is expected to agree with other large wealthy countries to push for voluntary licensing of COVID-19 vaccine patents instead of waivers, according to a draft statement set to be adopted by G20 countries on Friday. Read More