FDA places Amgen obesity drug on hold

Today’s Big News

Feb 5, 2025

Novo flunks kidney disease trial, again linking obesity prospect to neuropsychiatric side effects


'Tough but necessary decisions': Frontier Medicines lays off staff to streamline operations


Amgen's early-stage obesity asset slapped with FDA hold


GSK drops one potential 'functional cure' for hep B as it goes all-in on bepirovirsen


Qlaris sees double as drug reduces eye pressure in pair of phase 2 trials


French biotech discontinues all clinical activities, shuts down US site


Fierce Biotech Layoff Tracker 2025: BMS lets go of 67 staffers; Turnstone trims team

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

Novo flunks kidney disease trial, again linking obesity prospect to neuropsychiatric side effects

Novo Nordisk’s cannabinoid CB1 receptor blocker has run into another problem. Months after sharing obesity data that left investors underwhelmed, the Danish drugmaker has reported the failure of a midphase diabetic kidney disease trial of the molecule.
 

Top Stories

'Tough but necessary decisions': Frontier Medicines lays off staff to streamline operations

Precision medicines biotech Frontier Medicines is leaving behind an unknown number of staffers as it refocuses resources to optimize operations.

Amgen's early-stage obesity asset slapped with FDA hold

Amgen’s mysterious obesity asset will remain a mystery for a bit longer—the FDA has put the candidate’s phase 1 trial on a clinical hold, the biotech announced Feb. 4. Amgen didn’t disclose the reason for the hold.

GSK drops one potential 'functional cure' for hep B as it goes all-in on bepirovirsen

GSK is prioritizing development of its hepatitis B treatment bepirovirsen, even as the pharma ends work on another potential functional cure for the infectious disease.

Qlaris sees double as drug reduces eye pressure in pair of phase 2 trials

Qlaris Bio hit the primary endpoints in two mid-stage trials that both spanned primary open-angle glaucoma and ocular hypertension.

French biotech discontinues all clinical activities, shuts down US site

Valerio Therapeutics is ending all clinical trials, including an ongoing phase 1/2 study for its investigational “DNA decoy” candidate designed to treat recurrent solid tumor cancers.

Fierce Biotech Layoff Tracker 2025: BMS lets go of 67 staffers; Turnstone trims team

As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team.

Canadian CRO Innovaderm seeks to grow in rheumatology field with new CEO

Canadian CRO Innovaderm Research is looking to grow with new CEO Jeff Smith leading the way. Smith is taking over the top spot from founder Robert Bissonnette, M.D., who will stay on as executive chairman.

Roche gains label expansion for eye implant Susvimo to treat diabetic macular edema

Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema, which is the leading cause of diabetes-related blindness.

'Biggest data breach in history': Labor unions sue Trump admin over Treasury takeover, with healthcare privacy impacts far-ranging

Government unions and cybersecurity experts are disturbed by Elon Musk's newfound access to personal information and the country's payment infrastructure, which coordinates funds for government health programs like Medicare and Medicaid.
 
Fierce podcasts

Don’t miss an episode

What to expect from the biotech IPO market in 2025

This week on “The Top Line,” we zoom in on a Fierce JPM Week panel of industry experts discussing what it will take for biotechs to pull off a successful IPO in 2025.
 

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.

 

Upcoming Fierce Events

29-1
Apr-May
San Diego, CA
7-9
May
Free Virtual Event
8-11
Sep
Philadelphia, PA
7-9
Oct
Boston, MA

View all events