FDA
Novartis has grown weary of waiting, dropping out of its deal to fund Mesoblast’s floundering COVID-19 treatment.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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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.
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
The FDA approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive. About 80% of all NMOSD patients test positive for anti-AQP4 antibodies.