Articles
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1 week ago |
biospace.com | Jef Akst |Heather McKenzie |Annalee Armstrong
The uncertainty that came with Donald Trump’s electoral victory in November has only compounded now that he’s in office. Similar question marks have surrounded Robert F. Kennedy Jr., whose anti-vaccine rhetoric and overall criticism of agencies within the Department of Health and Human Services he now heads were potential concerns for the biopharma industry from the first rumors that he’d be Trump’s nominee for HHS secretary.
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1 week ago |
biospace.com | Heather McKenzie
As the FDA faces an uncertain future following massive workforce cuts enacted by Health and Human Services Secretary Robert F. Kennedy Jr., two former agency officials are speaking out, expressing concern over potential drug review delays while also seeking to reassure anxious stakeholders about the state of the FDA.
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1 week ago |
biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky
> Listen on Spotify> Listen on Apple Products> Listen on Amazon Music> Listen on iHeartIt’s all about tariffs again this week. No sooner had Donald Trump announced that “major” tariffs on the pharmaceutical industry would be coming “very shortly”—sending stocks spiraling—the president announced a 90-day pause on most taxes for imports from countries not named China. But this respite was not to last.
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1 week ago |
biospace.com | Heather McKenzie
Hordes of HHS employees, including 3,500 FDA staffers and more than half of its senior leadership, are gone, prompting former FDA Commissioner Robert Califf to write on LinkedIn last week: “The FDA as we’ve known it is finished.” This, of course, begs the question: What will the future FDA look like?
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2 weeks ago |
biospace.com | Heather McKenzie
Once upon a time, in the late 20th century, European patients had a better chance of accessing novel medicines than their U.S. counterparts. This was “not because [Europe] was a more attractive market, rather because . . . the regulatory system of the United States, and that of the FDA in particular, was broadly inefficient,” Alexander Gaffney, regulatory policy and intelligence leader at AgencyIQ, a Politico publication, told BioSpace.
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#biopharma conference season is in full swing, and our very own @JefAkst and @Slabodkin will be at hashtag#ASGCT24 in Baltimore next week. https://t.co/WgYSWHxOtb
Join @Slabodkin, Tyler Patchen and I as we discuss @sanofi #layoffs, #GLP1s, a new boxed warning on CAR-T therapies, and as an added bonus, the proper way to pronounce "Sanofi". @JefAkst https://t.co/DWkFrxwErg
Early data indicate stem cell therapies could help people with Parkinson's disease generate dopamine again. Wouldn't that be something? #Parkinsons @biospace https://t.co/mzVf3MQ6qF