Sarepta gene therapy wins over FDA advisers

This Week

May 19, 2023

UPDATED: FTC sues to block Amgen's $28B Horizon buy in alarming sign for biopharma M&A 


Ozempic and Wegovy have taken over obesity treatment. Can they help with cancer, too? 


UPDATED: FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy 


Identifying 'gems' before others do: J&J exec gives insider's look at dealmaking spree 


'The Top Line': 2023's biopharma layoffs, plus this week's headlines 

 

Featured

UPDATED: FTC sues to block Amgen's $28B Horizon buy in alarming sign for biopharma M&A

The FTC has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, raising an argument that serves as an alarming sign for M&A scrutiny to come. The move comes just as biopharma's dealmaking prospects seemed to be improving.
 

Top Stories

Ozempic and Wegovy have taken over obesity treatment. Can they help with cancer, too?

Novo Nordisk’s Ozempic and Wegovy may have benefits beyond helping patients shed pounds: They appear to reverse the impairments in cancer-fighting natural killer cells seen in people with obesity, independent of weight loss.

UPDATED: FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy

FDA advisers have narrowly voted in favor of Sarepta’s gene therapy for patients with Duchenne muscular dystrophy, a stunning decision that runs counter to regulators who expressed skepticism heading into the meeting. 

Identifying 'gems' before others do: J&J exec gives insider's look at dealmaking spree

Whether it’s returning to CAR-Ts, swooping in to pick up a Parkinson’s asset from a sinking biotech or setting up a spinout company to pursue its neuroscience ambitions, Janssen has been busy in recent months.

Astellas' menopause drug crosses FDA finish line after costly delay

The decision came nearly three months after the drug's original FDA decision date.

Is space the place for stem cell manufacturing? Scientists will soon test that on the ISS

The world’s second-ever private astronaut mission to the International Space Station will ferry a first-of-its-kind experiment that will test whether scientists can create induced pluripotent stem cells in microgravity.

It's the end of the line for J&J's COVID shot in the US, CDC says

Johnson & Johnson's COVID-19 vaccine is “no longer available in the U.S.,” the Centers for Disease Control and Prevention (CDC) said. The last remaining doses in the U.S. stockpile expired on May 7, 2023, with the CDC now giving instructions to “[d]ispose of any remaining Janssen COVID-19 vaccine in accordance with local, state and federal regulations.”

Fierce Biotech Layoff Tracker 2023: Athenex lets go of 123 employees amid bankruptcy; Novavax lays off hundreds

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.

AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA

After AbbVie and Teva scratched their memberships with the influential trade group, AstraZeneca is now the latest to ditch PhRMA.

New Eli Lilly-backed neurological disease biotech Nido unveils with $109M

Nido Biosciences is exiting stealth mode with $109 million in hand to develop new precision medicines for neurological diseases, with a lead asset that takes aim at Kennedy’s disease, a rare degenerative disorder.

FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists

On the heels of an FDA citation and export halt at Sun Pharma’s Mohali, India, manufacturing operations, the U.S. drug regulator is making clear that its demands for corrective actions are nonnegotiable.

Flatiron expands service with 'data empathy' aimed at oncology trials

Flatiron Health debuted the latest offering of its real-world evidence platform to include data and end-to-end services focused on growing needs in the arena of oncology clinical trials.
 
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'The Top Line': 2023's biopharma layoffs, plus the headlines

This week on "The Top Line," we''ll discuss the recent biopharma layoff trends, plus Elizabeth Holmes, Sarepta Therapeutics, Abbott's FDA approval, and the rest of the week's headlines.

 

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