Ascletis' unveils competitive oral GLP-1 data

Today’s Big News

Feb 19, 2025

Merck pens $300M-per-product collab with Epitopea to locate 'hidden' tumor antigens


Cabaletta’s CAR-T shows ‘robust benefit’ in lupus patients, teeing up registrational trial plans  


Ascletis' swift surge into obesity continues with competitive oral GLP-1 data


FDA’s clinical trial diversity guidance carries new message from Trump administration 


Novo Nordisk to sue KBP Biosciences over alleged fraudulent claims on kidney disease drug


Options shrink for Supernus depression drug candidate after key trial failure


Radiance rolls into ROR1 race, paying $15M for ADC rival to Merck’s frontrunner


Australian biotech points to potential superbug use as gel treats skin infections in phase 2 trial

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Featured

Merck pens $300M-per-product collab with Epitopea to locate 'hidden' tumor antigens

Merck & Co. has penned a $300 million biobucks-per-product deal with cancer biotech Epitopea to identify previously secret antigens that could form the backbone of off-the-shelf immunotherapies.
 

Top Stories

Cabaletta’s CAR-T shows ‘robust benefit’ in lupus patients, teeing up registrational trial plans

Cabaletta’s new data slice for its investigational CD19-CAR T cell therapy shows “robust benefit” for patients with lupus and dermatomyositis without the need for steroids or immunosuppressants, according to William Blair analysts.

Ascletis' swift surge into obesity continues with competitive oral GLP-1 data

Ascletis Pharma’s rapid-fire expansion into obesity drug development has passed another milestone. The Chinese biotech ticked the publication of multiple ascending dose data off its to-do list Wednesday, linking its oral GLP-1 prospect to 6.3% mean body weight loss after 28 days.

Grifols, through pioneering plasma research, looks to reveal early warning signs of Parkinson's

Nearly one million people in the U.S. and more than six million people worldwide have Parkinson's disease (PD), a debilitating neurological condition characterized by progressive motor and non-motor symptoms that significantly affects patients and their loved ones.

FDA's clinical trial diversity guidance carries new message from Trump administration

While the FDA’s diversity guidance for clinical trials has been temporarily restored, the page its housed on now carries a message from the Trump administration that the guidance “does not reflect biological reality.”

Novo Nordisk to sue KBP Biosciences over alleged fraudulent claims on kidney disease drug

After its potential kidney disease drug went down in flames late last year, Novo Nordisk is pinning the blame on alleged fraudulent claims by the drug’s original maker. The Danish pharma giant plans to seek $830 million in damages from Singapore-based KBP Biosciences and KBP’s founder and executive chairman, Zhenhua Huang, Ph.D.

Options shrink for Supernus depression drug candidate after key trial failure

Supernus Pharmaceuticals may have had a potential path forward for its depression drug candidate cut off after the asset missed its primary endpoint in a phase 2b trial. SPN-820 failed to improve the symptoms of patients with treatment-resistant depression after four weeks, the company announced on Feb. 18.

Radiance rolls into ROR1 race, paying $15M for ADC rival to Merck’s frontrunner

Radiance Biopharma is heating up the ROR1 race. The U.S. biotech is paying China’s CSPC Megalith Biopharmaceutical $15 million upfront for rights to an antibody-drug conjugate, securing itself a shot at challenging Merck & Co. for the opportunity.

Australian biotech points to potential superbug use as gel treats skin infections in phase 2 trial

Recce Pharmaceuticals’ synthetic anti-infective gel successfully treated a range of skin infections in a mid-stage test, setting the Australian biotech’s sights on a registrational phase 3 trial.

Trump administration layoffs hit FDA's device center

It’s unclear how many staff at the FDA have been affected. There have also been estimates of thousands of dismissals spanning the NIH, the CDC and other agencies across the HHS.

Novartis, Roche grant CEO pay raises for 2024 as sales grew at the Swiss pharma giants

After Novartis and Roche grew their sales last year, the Swiss pharma giants are handing their CEOs larger compensation packages for 2024.

FTC, SEC and other independent federal agencies must clear regulations by White House, Trump orders

The White House's latest executive order would give the president greater control over federal agencies typically shielded by cross-term leadership appointments and dismissal protections.
 
Fierce podcasts

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A heartwarming roundup of cardiovascular news and most-loved stories

This week on "The Top Line," we celebrate Valentine's Day with a discussion about heart-related updates and the stories we've loved covering so far this year.
 

Resources

Whitepaper

The Oncology Market: 2024 Year in Review

This paper reviews key developments in the oncology market during 2024 and outlines what they mean for the future.

 

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