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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The executives, convicted under the RICO Act, were found guilty of bribing prescribers and defrauding insurers in order to increase sales of Subsys, a powerful opioid pain killer intended for use with cancer patients.
The Management team of MorphoSys AG will host a conference call and webcast on May 8, 2019 at 2:00pm CEST (1:00pm BST; 8:00am EDT) to present MorphoSys’s first quarter interim statement 2019 and provide an outlook for 2019.
A recent detailed inspection by the United States Department of Agriculture has again found that Primate Research Organization Alpha Genesis is in full compliance with ALL regulations and standards of the Animal Welfare Act, company officials announced.
Neos Therapeutics, Inc. announced that it will report its first quarter 2019 financial results prior to the opening of U.S. financial markets on Thursday, May 9, 2019.
MyoKardia, Inc. announced that it will report first quarter 2019 financial and operating results on Thursday, May 9, 2019.
There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.
Biopharma has several unique challenges, but one of them is the patent cliff. In an industry where only about one in 10 compounds actually makes it to market on average, those drugs aren’t able to stay on the market very long before their patents end and generic competition begins.
Days after the Federal Bureau of Investigation raided the offices of Bay Area-based uBiome over allegations of illegal billing practices, the company’s board of directors placed Jessica Richman and Zac Apte, the co-founders and co-chief executive officers of the company, on administrative leave.
Dengvaxia is approved for dengue disease caused by serotypes 1-4 in people 9 through 16 years of age who are living in areas of the U.S. who have had a laboratory-documented previous infection.
Blythedale Children’s Hospital and Burke Neurological Institute announce the appointment of Dianna E. Willis, Ph.D., as Director of Research for the Burke-Blythedale Pediatric Neuroscience Research Collaboration.