Government
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.
The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.
AstraZeneca will voluntarily withdraw the use of its checkpoint inhibitor Imfinzi (durvalumab) as a treatment for bladder cancer in the United States following a failure to meet endpoints in a post-approval clinical study.
The tebentafusp has earned a breakthrough designation for ocular cancer. The company is planning regulatory filings in the U.S. later this year and in Europe thereafter.
An open letter from a group of academics is urging the Biden administration to implement updates to guidance and standards that will better protect high-risk workers from the novel coronavirus that causes coronavirus disease 2019 (COVID-19).
In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D., the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., Ph.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several serology tests.
The U.S. FDA granted Amgen Priority Review for sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), after at least one previous systemic therapy.
According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 16, 2021.
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