
Jef Akst
Managing Editor at BioSpace
Managing Editor at @BioSpace | [email protected]
Articles
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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 iHeartIn his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints.
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2 weeks ago |
biospace.com | Jef Akst
The vaccine space has become so politically charged it’s hard to find the truth in the facts. Citing two people familiar with the discussions, Politico reported last week that HHS Secretary Robert F. Kennedy Jr. is considering removing the COVID-19 vaccine from the childhood vaccine schedule maintained by the Centers for Disease Control and Prevention.
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2 weeks ago |
biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky
> Listen on Spotify> Listen on Apple Products> Listen on Amazon Music> Listen on iHeartPolicy issues—particularly tariffs—loom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizer’s call, CEO Albert Bourla called the Trump administration’s national security concerns “legitimate,” but objected to the proposed tariffs in general.
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3 weeks ago |
biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky
> Listen on Spotify> Listen on Apple Products> Listen on Amazon Music> Listen on iHeartWhile much of the country was off celebrating Easter and Passover this weekend, the FDA—and its new leader Marty Makary—were busy making news. Makary, who was confirmed as FDA commissioner last month, gave his first major interview, where he unveiled a new regulatory pathway for rare disease therapies and addressed the “epidemic of distrust” he feels is imperiling the agency.
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3 weeks 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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I'm looking for an editor to join our team here @biospace. If you are a journalist with an interest in the business of biopharma, let me know! https://t.co/HahZTQSVKf

FDA's Peter Marks once again from #ASGCT2024, this time on global regulatory convergence, saying that for rare diseases in particular, lack of regulatory standardization presents big challenges. @Slabodkin reporting for @BioSpace https://t.co/LCRy428ZPK #ASGCT #ASGCT24

“$4.25 million!!!” That’s the email FDA’s Peter Marks said he received from Commissioner Robert Califf when Orchard revealed the price tag of its newly approved gene therapy Lenmeldy. Check out my @biospace recap of the #ASGCT2024 fireside chat: https://t.co/PlR8mCDuxS