FDA reportedly flagged Neuralink testing issues last year

Today’s Big News

Feb 29, 2024

Novo Nordisk's new Boston-area campus reflects 'competitive' R&D growth, and not just for GLP-1s


Endo agrees to $465M bankruptcy deal with federal government, inks 2 opioid settlements


FDA flagged animal testing issues at Neuralink lab last year: Reuters


Pfizer’s Abrysvo maintains strong efficacy through second RSV season, study finds


After saving Yumanity's assets, Kineta faces shutdown as private placement fails to show up

 

Featured

Novo Nordisk's new Boston-area campus reflects 'competitive' R&D growth, and not just for GLP-1s

Novo Nordisk executives unveiled the company's U.S. R&D hub on Wednesday, repurposing Dicerna's old headquarters as the new regional outpost. The event comes as Novo's R&D investments are skyrocketing, thanks to the revenue flooding in from the metabolic franchise.
 

Top Stories

Endo agrees to $465M bankruptcy deal with federal government, inks 2 opioid settlements

As it looks to emerge from bankruptcy, Endo agreed to fork over up to $464.9 million to the federal government, which had been investigating the marketing of opioid Opana ER.

FDA flagged animal testing issues at Neuralink lab last year: Reuters

Shortly after signing off on the first human trial of Neuralink’s brain-computer interface system last year, the FDA reportedly discovered a handful of quality control issues related to the Elon Musk-founded company’s animal experiments of the technology, according to Reuters.

Pfizer's Abrysvo maintains strong efficacy through 2nd RSV season, study finds

Pfizer’s respiratory syncytial virus vaccine Abrysvo has shown its staying power in a trial of patients who received a single dose before the previous virus season. In season two, Abrysvo provided efficacy of 78% against lower respiratory tract disease in adults 60 and older, according to trial results released Thursday.

After saving Yumanity's assets, Kineta faces shutdown as private placement fails to show up

In 2022, Kineta swooped in to rescue Yumanity’s immunotherapy from the scrapheap. Now, Kineta needs some rescuing itself. After a strategic review, the small oncology biotech is conducting a corporate restructuring and reducing its workforce by 64%.

With J&J settlement, Biocon Biologics gets a license to challenge Stelara in the US

As Johnson & Johnson's U.S. exclusivity period on Stelara ticks away, another biosimilar player has lined up for a piece of the blockbuster's sales pie.

CytoDyn finally clears FDA hold on HIV program after two years

After two years, CytoDyn’s HIV program is finally free of the FDA clinical hold. In a short update Thursday, CEO Jacob Lalezari, M.D., heralded the lifting of the hold as a “new chapter” for lead asset leronlimab.

J&J secures European afib approval for Varipulse pulsed field ablation system

Johnson & Johnson MedTech’s Biosense Webster division has tallied up another regulatory clearance for its pulsed field ablation system, with a CE mark opening up access to Europe.

In atypical Big Pharma-VC pact, Gilead secures $210M from Abingworth to fund Trodelvy trials

Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. But a new funding pact between Carlyle’s Abingworth and Gilead Sciences is somewhat unconventional.

Medtronic asks ITC to wade into Axonics patent spat, filing request for exclusion order

As Medtronic and Axonics’ legal battle over alleged similarities between their sacral neuromodulation devices drags on, Medtronic is getting the U.S. International Trade Commission involved.

Ironwood seeing STARS as $1B bet hits in phase 3—and triggers 30% stock drop

Ironwood Pharmaceuticals’ $1 billion short bowel syndrome bet has delivered a phase 3 win—and wiped 30% off the company’s share price. While the study met its primary endpoint, the results failed to convince investors it can win out over Takeda’s Gattex, its potential generic copies and Zealand Pharma’s glepaglutide.
 
Fierce podcasts

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'The Top Line': Breaking down Eli Lilly’s ESG formula

This week on "The Top Line," we explore the impact of environmental, social, and governance measures, commonly known as ESG, on the pharmaceutical industry. Fierce Pharma's Fraiser Kansteiner engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights and discuss Lilly's specific ESG initiatives.
 

Resources

Whitepaper

The Oncology Market – 2023 Year in Review

This paper offers a detailed review of key events and developments in the oncology market during 2023.  It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more.

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Developing and Manufacturing Drugs with HPAPIs

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

 

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