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.
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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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CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
The speakers extolled the benefits of telehealth while noting the challenges posed by a lack of high-speed Internet in some parts of the country.
kENUP had called the mRNA vaccine efforts in Africa “doomed to fail” since the project likely infringes on BioNTech and Moderna patents on the vaccine.
Ardelyx has reported in a regulatory filing that the FDA sent an Appeal Denied Letter for its drug tenapanor, a therapeutic intended for chronic kidney disease.
As AstraZeneca released its 2021 annual financial report, a BBC documentary suggested that the way scientists and politicians politicized its COVID-19 vaccine may have cost lives.
It’s uncertain if the origins of COVID-19 will ever be determined, but the current top theories split about evenly between a lab leak from the Wuhan Institute of Virology and a natural evolution from bats to animals to humans at a Wuhan “wet market.”
The FDA is slowing down the process of potentially approving dozens of new medications initially developed for the Chinese market.
WuXi Biologics was amongst those on the list, with the U.S. stating that it was unable to verify the legitimacy and reliability of the company in its use of U.S. exports.
After allegations of bullying became public, Dr. Eric Lander, the director of the federal government’s Office of Science and Technology Policy, resigned from his executive branch role.