Masimo workers threaten exit if CEO ousted

Today’s Big News

Jul 2, 2024

Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod


Masimo leaders, engineers threaten to walk if CEO Joe Kiani is ousted in proxy fight


Cartesian claims phase 2b autoimmune CAR-T win after changing endpoint


Departing FDA staffers told they can still influence the agency in Big Pharma jobs: BMJ report


BARDA hands Moderna $176M to push avian flu vaccine through trials


High-flying Samsung Biologics inks $1B production pact with unnamed US pharma


BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey

 

Featured

Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.
 

Top Stories

Masimo leaders, engineers threaten to walk if CEO Joe Kiani is ousted in proxy fight

Nearly 300 of Masimo's engineers and managers—as well as its COO—have signed letters saying they might follow the company's founder out the door.

Cartesian claims phase 2b autoimmune CAR-T win after changing endpoint

Cartesian Therapeutics has claimed a phase 2b win for its BCMA-directed CAR-T therapy in generalized myasthenia gravis. But the biotech’s victory came on a primary endpoint it changed in May and in a population that excluded the 25% of participants treated at community clinics.

Departing FDA staffers told they can still influence the agency in Big Pharma jobs: BMJ report

Under federal law, former FDA employees are prohibited from engaging in certain lobbying activities—but an investigation published in the BMJ on Monday claims that the agency’s staffers are often advised of loopholes in those regulations on their way out the door.

BARDA hands Moderna $176M to push avian flu vaccine through trials

Moderna has become the latest biopharma to benefit from the U.S. Department of Health and Human Services’ concerns about avian flu, awarding the company $176 million to fund the clinical development of a potential vaccine.

High-flying Samsung Biologics inks $1B production pact with unnamed US pharma

As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap.

BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey

Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

FDA clears its first fingerstick hepatitis C diagnostic, enabling test-to-treat approach

The FDA has greenlit its first point-of-care diagnostic test for hepatitis C, capable of using only a fingerstick blood sample, in a bid to quickly connect patients with antiviral drugs.

Rexulti reclaims TV drug ad spending top spot as Otsuka, Lundbeck eat away at AbbVie’s dominance

Otsuka and Lundbeck’s CNS drug Rexulti has for the second time this year claimed the top spot as the leading TV drug ad spender.

Fierce Biotech Layoff Tracker 2024: Takeda axes another 220 jobs; Ovid undergoes 43% reduction

We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. 

Lilly, Novo rank 3rd and 4th on list of pharmas associated with weight loss drugs in US

Which companies do Americans associate most with weight loss medication? If you answered Eli Lilly or Novo Nordisk, think again. The two leading obesity drug makers were relegated to third and fourth spot behind a pair of companies without an authorized weight loss medicine between them.

Pfizer bops to the top with new Ashley Tisdale collab around alopecia areata

For its latest celebrity partnership, Pfizer went in a “Fabulous” direction.
 
Fierce podcasts

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The best biopharma M&A deals 

In today’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest biopharma acquisitions in recent years.  
 

Resources

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An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing

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2024 Life Sciences Industry Outlook

The definitive report on the state of our industry.  Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.
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The “Best Practice Organization” & Its Importance for Success in Today’s Biopharma Industry

In a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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