Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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After months of urging the public to wear masks and facial coverings to help stop infected people from spreading COVID-19, the Centers for Disease Control and Prevention now states in newly released guidance that masks also protected the mask wearer from being infected.
Days after Pfizer and BioNTech announced their mRNA vaccine for COVID-19 demonstrated 90% efficacy at an interim analysis, Russia is claiming the vaccine it authorized in the fight against the novel coronavirus is 92% effective following an interim analysis of its ongoing Phase III study.
Several states have pledged to review COVID-19 vaccines themselves, after FDA emergency use authorizations, to ensure safety and efficacy. A robust review, however, is unlikely.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 10, 2020.
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
President-elect Joe Biden hit the ground running this morning with the announcement of his transition team’s COVID-19 advisory board.
Here’s a look at some of the upcoming target action dates on the U.S. FDA’s calendar.
When it comes to a novel virus like SARS-CoV2, a certain amount of “rolling with the punches” is required, and governments and global organizations like the World Health Organization are beginning to dismiss certain treatments and devote themselves wholeheartedly to others.
The company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration for two more years.
Abbott is suing their former VP Jerome Clavel over allegations of trade secret theft with intent to share with his new employer, rival diagnostics company Bio-Rad.