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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Kevin Mulleady and Jason Aryeh attempted to back a slate of candidates for the Phoenixus Board of Directors but failed as shareholders overwhelmingly supported the current board.
The U.S. appears to be beating back COVID-19 but it’s still raging in many parts of the world, and studies and trials are still ongoing. Here’s a look at some of today’s top COVID-19 stories.
The data may show the need for one, but vaccine and immunologists are pushing back against Pfizer and BioNTech’s contention that one is necessary now.
The WHO panel recommends adopting global standards, giving structure to prevent the unscrupulous, inequitable, and possibly dangerous uses of CRISPR technology.
Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention.
HHS issued their announcement, saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
A former CEO of Vyera and other activist investors are pushing a slate of new company directors who would steer control of Phoenixus and Vyera away from Shkreli.
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
The move by the 15 states’ attorneys general comes about a month ahead of a court hearing set for Aug. 5.
The two companies said a booster dose given six months after the second dose had a consistent tolerability profile while still creating high immune responses against the Alpha and Beta variant.