Agrees to review Moderna flu vaccine
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Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
The whiplash over a new potential flu vaccine from Moderna, which went from rejected to approved for review in a matter of days, has illustrated a new reality plaguing the Cambridge biotech company and other vaccine makers: Political headwinds are now an unavoidable and unpredictable factor in their business model.
The FDA agreed to review Moderna's seasonal flu shot after the vaccine maker said it would run extra tests in the elderly.
(This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays.) Feb 18 (Reuters) - A two-in-one mRNA vaccine developed by Moderna that targets seasonal influenza and COVID-19 produced robust and durable immune responses without safety concerns in a small mid-stage trial,
Shares of Moderna climbed after the Food and Drug Administration accepted for review a revised application for the company's new flu vaccine. The stock gained 6.7%, to $46.89, in premarket trading Wednesday. Through Tuesday's close, shares are up 22% over the past year.
Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review