Government
Although problems with actually getting shots into arms have been described thoroughly, manufacturing problems and scale-up haven’t been the focus of much reporting.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 23, 2021.
On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.
The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus.
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).
PRESS RELEASES