Philips agrees to CPAP consent decree

Today’s Big News

Jan 29, 2024

Top 10 most anticipated drug launches of 2024 


Sarepta's next DMD drug seems to get the job done, but Elevidys casts long shadow 


Philips agrees to FDA consent decree halting US sales of CPAP respiratory care devices 


Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month 


Fractyl sets out $99M IPO ambitions after busy week of biotechs going public

 

Featured

Top 10 most anticipated drug launches of 2024

Every year, we tap Evaluate Vantage’s annual preview report to assess the biggest potential new drugs of the year ahead. Typically, major pharmaceutical and biotechnology companies are featured, each presenting potential blockbuster launches. In 2024, however, things are set to play out a little differently.
 

Top Stories

Sarepta's next DMD drug seems to get the job done, but Elevidys casts long shadow

Sarepta Therapeutics' next Duchenne muscular dystrophy med seems to be doing the job of spurring dystrophin expression. But does any of the data for SRP-5051 matter given the recent approval of the biotech’s gene therapy for the same condition, Elevidys?

Philips agrees to FDA consent decree halting US sales of CPAP respiratory care devices

Though both Philips and the FDA have agreed to the terms of the decree, it’s still in the process of being finalized, after which it’ll be sent off for court approval.

Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

Fractyl sets out $99M IPO ambitions after busy week of biotechs going public

With last week seeing back-to-back oversized biotech IPOs to kick off the new year, it’s no surprise that Fractyl Health is now kicking its own offering plans up a gear.

After GSK and Novartis handoffs, Laekna's drug fails ovarian cancer trial

Shanghai-based biotech Laekna's oral cancer drug afuresertib has failed to significantly improve progression-free survival for patients with ovarian cancer in a phase 2 trial.

Merck's Keytruda extends life for kidney cancer patients after surgery, while Bristol's Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. This comes just as the drug’s rival, Bristol Myers Squibb’s Odpivo, chalked up another trial failure.

FDA accepts first AI algorithm to drug development tool pilot, with Deliberate AI’s anxiety and depression assessment

The Innovative Science and Technology Approaches for New Drugs pilot was designed to create a new pathway to FDA review for novel tools that may not fit into currently existing routes of evaluation, but that could potentially improve the development of new drugs.

J&J, Merck CEOs dodge subpoenas by agreeing to testify at Senate committee's pricing hearing

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP).

Samsung taps Lunit to bring AI detection to its chest X-ray scanners

The electronics giant signed a three-year contract through its Boston Imaging unit.

Less corporate, more human: How Sanofi is using the Olympics to change public perceptions

Pharma watchers know Sanofi has changed how it presents itself to the world. Under CEO Paul Hudson, Sanofi has pitched itself as humble, authentic, a bit unconventional—and changed its branding to match. But people in the wider world? Well, reaching them poses a different challenge. Sanofi’s attempt to rise to that challenge is supported by a once-in-a-lifetime opportunity: a Summer Olympics in France.

Hookipa, reeling from Roche’s KRAS cull, lays off 30% of workforce, deprioritizes programs

Roche has waved goodbye to one of its KRAS prospects, terminating an alliance with Hookipa Pharma 15 months after betting $25 million on its novel approach to the oncogene. Shortly after receiving the news, Hookipa decided to lay off 30% of its employees and focus on a slimmed-down list of candidates.

Bristol Myers reveals subcutaneous Opdivo data in kidney cancer as I-O battle heads to new front

Bristol Myers Squibb is offering a detailed look at pivotal data showing an under-the-skin version of its PD-1 inhibitor Opdivo works as well as the original intravenous formulation in kidney cancer.

Next-gen prostate cancer test maker Cleveland Diagnostics rocks to $75M fundraising

The Cleveland Clinic portfolio company said the proceeds will help it meet rising demand for its IsoPSA test and expand into other types of cancer.
 
Fierce podcasts

Don’t miss an episode

‘The Top Line’: Closing the $1 trillion women’s health gap

While it’s a known fact that women, on average, live longer than men, a recent report unveils a nuanced reality—women also spend more of their lives grappling with poor health. This week on “The Top Line,” Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, explores the root causes behind this disparity and the multifacted nature of the women’s health gap.
 

Resources

Whitepaper

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.

eBook

7 “Make or Break” Factors for Emerging Biopharma Companies

This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products.  It’s an essential resource for emerging companies with products in all stages of development.
 

 

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