FDA
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
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The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.