Otsuka, Click nab FDA clearance for depression app

Today’s Big News

Apr 3, 2024

‘We’re open for business’: FDA’s Peter Marks says agency ready to review novel cancer vaccines despite unknowns


Eli Lilly's popular diabetes drug Mounjaro to face continued supply squeeze through April, FDA says


Otsuka, Click Therapeutics snag FDA clearance for depression therapy app 


Genmab inks $1.8B ProfoundBio buyout for would-be Elahere rival, teeing up scrap for ADC market


#FierceMadness: Pfizer loses its last 2 drugs as front-runner Daxxify succumbs to Mounjaro: Now vote in the Final 4 round 


Fierce Biotech's Quarterly IPO and M&A Roundup: Q1'24


Thermo Fisher plots layoffs at CA plasmid manufacturing site as demand swings

 

Featured

‘We’re open for business’: FDA’s Peter Marks says agency ready to review novel cancer vaccines despite unknowns

As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks said the agency is ready to review the shots despite AI-related unknowns.
 

Top Stories

Eli Lilly's popular diabetes drug Mounjaro to face continued supply squeeze through April, FDA says

Four dose strengths are now expected to be in short supply through April, according to the FDA. The agency previously expected the squeeze to let up at the end of March.

Otsuka, Click Therapeutics snag FDA clearance for depression therapy app

The Rejoyn app aims to further reduce major depressive disorder symptoms by complementing standard antidepressants, with a six-week digital treatment schedule.

Genmab inks $1.8B ProfoundBio buyout for would-be Elahere rival, teeing up scrap for ADC market

Genmab is mounting a $1.8 billion challenge against its close collaborator AbbVie. The Danish biotech is using the money to buy ProfoundBio and gain control of a midphase antibody-drug conjugate that could compete against AbbVie’s Elahere.

#FierceMadness: Pfizer loses its last 2 drugs as front-runner Daxxify succumbs to Mounjaro: Now vote in the Final 4 round

It’s March, so it’s time for some #FierceMadness. Last year, we channeled the NCAA tournament for the best pharma ad campaigns, but this year we’re looking for the best of the best in drug names.

Fierce Biotech's Quarterly IPO and M&A Roundup: Q1'24

The biggest M&A deal of the quarter award goes to Gilead Sciences, which acquired CymaBay Therapeutics for $4.43 billion in February. The largest—and first—IPO was CG Oncology, which had a total transaction value of $380 million.

Thermo Fisher plots layoffs at CA plasmid manufacturing site as demand swings

Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping block.

Asensus Surgical mulls acquisition offer from Karl Storz

The German medtech staked its claim for Asensus with a deal to buy out all its shares at 35 cents apiece, representing a 66.7% premium over its recent trading price of 23 cents—for a total in the ballpark of $95 million.

Novo Nordisk triumphs in UK probe of 'hyperbolic' Wegovy claims

Novo Nordisk has emerged unscathed from a probe into claims it ran an “orchestrated PR campaign” to shape the obesity debate in the U.K. The U.K. drug promotion watchdog carried out the investigation in response to media reports about Novo’s links to experts but found no evidence of wrongdoing.

#FierceMadness: The Best Biotech Name Tournament—Elite 8 RESULTS

What's the best biotech name? It's time to vote in the Fierce Madness #biotechbracket.

Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

J&J doubles down on health equity with 100+ partnerships and renewed local health initiatives

As April’s National Minority Health Month begins, Johnson & Johnson is picking up the pace in its “race to health equity.”

Oruka spins out of Paragon with 3 assets, reverse merger and cash

Oruka Therapeutics is jumping onto the biotech stage with a bang, going public via a reverse merger and tacking on $275 million through a private placement.

Gilead finds new way to raise HIV awareness, locking in with dancer for voguing workshop

Gilead is bringing its HIV awareness campaign to the ballroom, partnering with actor and dancer Jason A. Rodriguez for a workshop about the dance style voguing and sexual health.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': The top money raisers in biotech

This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode.
 

Resources

Whitepaper

Oncology Market Outlook 2024

This paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation.
Whitepaper

Guidance for Biotechs Choosing Next-Gen Contract GMP/CMC Labs

Choosing the right contract lab can help drug developers accelerate their timelines and generate cost-efficiencies. For insights into what to look for when selecting a GMP/CMC lab partner read this white paper which delves into a range of factors that can support your needs in both the short-term and in planning for the future.
 

Industry Events

Drug Development Boot Camp® VIRTUAL | Spring 2024

April ‌10-11, ‌2024

On Helix

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

 

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