Regulatory
The choice for the new FDA commissioner will tell the public about the Biden administration’s battle plan with regards to handling the global pandemic.
London-based Freeline Therapeutics announced that after receiving feedback from the U.S. Food and Drug Administration (FDA), it was modifying its clinical trial program for FLT180a for Hemophilia B.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 9, 2021.
Bristol Myers picked up the therapy when it acquired Celgene in 2019 for $74 billion.
The Swiss health authority Swissmedic rejected AstraZeneca’s rolling authorization application for its COVID-19 vaccine a few days ago, saying more data is needed “to obtain more information about safety, efficacy, and quality.”
Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration.
For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals.
Eagle Pharmaceuticals is still struggling to get its generic vasopressin to market, announcing both a regulatory stall and an additional trial delay for a patent case with Endo Par Innovation Company over the drug.
There were two reported cases of trials restarting and one pausing this week. Here’s a look.
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