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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With a busy August on the U.S. Food and Drug Administration’s schedule, this week is no exception. Here’s a look at some of what’s on the agency’s calendar.
Novavax entered into an agreement to provide the United Kingdom with 60 million doses of the vaccine should it be approved, as well as a late-stage efficacy study in that country.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
Passage Bio’s first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold.
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
Moderna signed a contract worth up to $1.525 billion with the U.S. government to supply 100 million doses of mRNA-1273, the company’s experimental COVID-19 vaccine.
The government of Russia has approved a vaccine for COVID-19, marking the first preventative treatment for the novel coronavirus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 10, 2020.