FDA
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
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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 U.S. FDA approved AVEO Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma (RCC) in people who have had two or more previous systemic therapies.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.
The U.S. FDA approved Gilead and Kite’s Yescarta (axicabtagene ciloleucel) for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Roche announced it was voluntarily withdrawing the U.S. indication Tecentriq for in prior-platinum treated metastatic urothelial carcinoma (mUC) after failing to meet endpoints in confirmatory trials.
The U.S. FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
KemPharm announced this week that the U.S. Food and Drug Administration has approved its novel ADHD drug for use in patients six years and older.
The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 2, 2021.
This approval marks the first treatment indicated for reducing mortality risk in patients with the rare disorder known as molybdenum cofactor deficiency (MoCD) Type A.
The company has agreed to deliver 100 million doses of the vaccines by the end of June.