Jef Akst

Fredericksburg

Managing Editor at BioSpace

Managing Editor at @BioSpace | [email protected]

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Articles

Here Today, Gone Tomorrow: Trump’s Policies Give Biopharma Whiplash

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.
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed

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.
Tariff-Triggered Recession Fears, Fallout From HHS Cuts, Knockoff GLP-1s and More

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 iHeartPushback against the Trump administration’s massive government cuts exploded this weekend across America—and biopharma is no exception. Taking a deep dive into the leadership cuts, we found that more than half of the senior FDA leaders from six months ago are no longer there, and that’s just the leadership.
FDA Gutted Under Trump, RFK Jr., With More Than Half of Senior Leadership Now Gone

2 weeks ago | biospace.com | Jef Akst |Heather McKenzie

Former director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni is looking pretty smart right now, having gotten out of the agency before what our colleague Annalee Armstrong has dubbed “the Marks massacre.”Cavazzoni—who resigned as head of CDER two days before Donald Trump was sworn in again as U.S. president—wasn’t alone in abandoning the soon-to-be sinking ship.
FDA on Fire, Novo’s Mixed Bag of Semaglutide Cardio Data, Kisunla’s EU Miss, More

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 iHeartBiopharma’s reaction to the forced resignation of venerable CBER director Peter Marks has been swift and furious, with former FDA Commissioner Robert Califf saying on LinkedIn that “the FDA as we’ve known it is finished.” Analysts, meanwhile, called Marks’ exit “arguably biotech investors’ greatest fear,” as company shares across the industry tumbled.
Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio

1 month ago | biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky

> Listen on Spotify> Listen on Apple Podcasts> Listen on Amazon Music> Listen on iHeartA patient with Duchenne muscular dystrophy taking Sarepta’s gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys’ label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited.
COVID Reflections, Novo’s Next-Gen Weight Loss Struggles, Another Depression Miss, More

1 month ago | biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky

> Listen on Spotify> Listen on Apple Podcasts> Listen on Amazon Music> Listen on iHeartAs we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market.
The Shape of a Pandemic: Boom, Bust and Recover

1 month ago | biospace.com | Jef Akst |Heather McKenzie |Annalee Armstrong |Dan Samorodnitsky

At the peak of the pandemic boom for biopharma in 2021, venture capital dollars topped $30 billion for biotechs over 446 deals. There were 99 initial public offering with $15.6 billion total raised. But the volume of deals and cash flying around proved to be unsustainable. Those sky-high values have come down precipitously. Meanwhile, biotech bankruptcies have spiked in recent years, with experts tying them back to the sector’s gold rush.
FDA Weathers Bait-and-Switch Storm as Staff and Sites Come and Go

1 month ago | biospace.com | Jef Akst |Heather McKenzie

First it was individuals: multiple rounds of job cuts at the FDA only for some of those staffers to be hired back. Now it’s groups of FDA employees getting the bait-and-switch en masse. As the Department of Government Efficiency (DOGE) began cutting leases on federal sites, 30 FDA facilities appeared to be facing closure. But at at least one facility, FDA officials reportedly told scientists of such a fate on Monday, but by Wednesday they said, essentially, never mind.
Tariff Threat Continues, More Meetings Cancelled, AbbVie Makes Obesity Play, More

1 month ago | biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong

> Listen on Spotify> Listen on Apple Podcasts> Listen on Amazon Music> Listen on iHeartDonald Trump’s tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla’s claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity.

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Jef Akst @JefAkst

9 May 24

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

Jef Akst @JefAkst

9 May 24

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

Jef Akst @JefAkst

8 May 24

“$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

Jef Akst

Articles

Here Today, Gone Tomorrow: Trump’s Policies Give Biopharma Whiplash

Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed

Tariff-Triggered Recession Fears, Fallout From HHS Cuts, Knockoff GLP-1s and More

FDA Gutted Under Trump, RFK Jr., With More Than Half of Senior Leadership Now Gone

FDA on Fire, Novo’s Mixed Bag of Semaglutide Cardio Data, Kisunla’s EU Miss, More

Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio

COVID Reflections, Novo’s Next-Gen Weight Loss Struggles, Another Depression Miss, More

The Shape of a Pandemic: Boom, Bust and Recover

FDA Weathers Bait-and-Switch Storm as Staff and Sites Come and Go

Tariff Threat Continues, More Meetings Cancelled, AbbVie Makes Obesity Play, More

Contact details

Emails

Socials & Sites

X (formerly Twitter)