FDA
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.
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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.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
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The latest approval for Brilinta is based on the Phase III THALES trial that showed aspirin plus 90 mg of Brilinta significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA.
While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 3, 2020.
EYSUVIS is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease. Know more about how it got approval and the complete development timeline here.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.
The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.