FDA puts hold on Amgen Ph. 1 obesity trial

Today’s Big News

Feb 5, 2025

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


Novo Nordisk predicts milder growth in 2025 after obesity star Wegovy doubles sales in Q4


With Blenrep's revival, GSK dials up long-term sales goal—again—despite RSV vaccine woes


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


Boston Scientific clocks over $1B in Farapulse revenue for the afib therapy’s first year


Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory hurdles


TV drug ad spending reached new heights in January, as Novartis’ Pluvicto toppled AbbVie’s Skyrizi for top spot


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

 

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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

Novo Nordisk predicts milder growth in 2025 after obesity star Wegovy doubles sales in Q4

With sales of Novo Nordisk’s obesity blockbuster Wegovy more than doubling in 2024’s fourth quarter, the Danish drugmaker feels confident that it can maintain its edge over chief rival Eli Lilly in the year to come. Still, the company caveated that it expects sales growth in 2025 to be a bit milder than last year.

With Blenrep's revival, GSK dials up long-term sales goal—again—despite RSV vaccine woes

After re-adding Blenrep to its portfolio, GSK now expects sales to reach more than £40 billion in 2031. The company's previous target was £38 billion.

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.

Boston Scientific clocks over $1B in Farapulse revenue for the afib therapy's first year

That includes treating more than 200,000 patients with the irregular heartbeat known as atrial fibrillation—and the sum more than makes up for the $295 million that Boston Scientific put down to acquire the technology in mid-2021.

Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory stumbles

The company is in talks with individual regulatory authorities after its decision to withdraw a European approval application for Izervay prompted a $760 million impairment charge.

TV drug ad spending reached new heights in January, as Novartis' Pluvicto toppled AbbVie's Skyrizi for top spot

AbbVie’s Skyrizi was responsible for the highest TV advertising outlay in pharma in most months of 2024, but 2025 is starting off on a very different note.

'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.

Supernus' 4th try proves the charm with long-awaited FDA approval for Parkinson's infusion pump Onapgo

The device is meant to allow patients more control over their "off" time, or the instances when medicine wears off and symptoms return or worsen.

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.

CDC Foundation taps ex-NFL star ‘The Bus’ to drive home heart health message in Black community

The CDC Foundation has added muscle to its “Live to the Beat” campaign, enlisting former NFL star Jerome “The Bus” Bettis to drive home its message about heart disease in the Black community.

Glucotrack’s 3-year diabetes sensor implant clears initial human safety trial

Glucotrack has cleared the first human clinical study of its long-term continuous glucose monitoring implant, designed to live under the skin for as long as three years.

Avalere refocuses on ensuring access to care under new CEO

Amar Urhekar has reset Avalere Health’s mission. Weeks after naming Urhekar as CEO, the biopharma commercialization partner has aligned its teams behind the goal of ensuring “every patient is identified, supported, treated and cared for.”

With recent launches and more to come, Amgen's biosimilar business is trending up

After recent launches of biosimilar versions of Eylea and Stelara, Amgen projects its biosimilar sales will reach $4 billion by the end of the decade.

Moderna picks Merck KGaA, Roivant alum as marketing chief

As Moderna maps out a more cautious future amid lower-than-expected sales of its current products, the company is bolstering its marketing team.
 
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The Oncology Market: 2024 Year in Review

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