FDA removes clinical trial diversity guidance

Today’s Big News

Jan 27, 2025

Akero's stock doubles as midphase MASH trial generates 'transformational' data: analyst


Metsera eyes $289M IPO to fund phase 3 weight loss trial


Maze rolls out map to $131M IPO, as phase 2 kidney disease trial readies for dosing


After White House transition, FDA’s diversity guidance for clinical trials no longer available


Allakos axes program, lays off 75% of staff and seeks strategic alternatives after phase 1 flop


Veru's drug conserves muscle mass for older patients taking Novo's Wegovy in phase 2 trial


Top 10 most anticipated drug launches of 2025


Nippon Shinyaku to pay $36M to reserve US rights to AB2 Bio's near-approval autoimmune drug


Though prevalent in the lab and middle management, east Asian Americans are underrepresented in biopharma C-suites: report


GSK offers up to £50M to conduct cancer vaccine research with the University of Oxford

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

 

Featured

Akero's stock doubles as midphase MASH trial generates 'transformational' data: analyst

Akero Therapeutics has hit a home run, reporting statistically significant results in two key 96-week metabolic dysfunction-associated steatohepatitis analyses to send its stock up about 100%.
 

Top Stories

Metsera eyes $289M IPO to fund phase 3 weight loss trial

Metsera has set its sights on a hefty $289 million IPO as the next-gen obesity biotech seeks to fund a phase 3 trial of its GLP-1 receptor agonist.

Maze rolls out map to $131M IPO, as phase 2 kidney disease trial readies for dosing

Maze Therapeutics has set out plans for a $131 million IPO as the company prepares to take its lead kidney drug through a phase 2 trial.

After White House transition, FDA’s diversity guidance for clinical trials no longer available

The FDA’s guidance detailing diversity action plans for clinical trials that evaluate drugs, devices and other medical products has been taken down from the agency’s website.

Allakos axes program, lays off 75% of staff and seeks strategic alternatives after phase 1 flop

Allakos is throwing in the towel. After seeing phase 1 data in hives, the biotech has decided to drop the drug candidate and lay off 75% of its employees to hunker down while exploring strategic alternatives.

Veru's drug conserves muscle mass for older patients taking Novo's Wegovy in phase 2 trial

The study hit its primary endpoint of showing a statistically significant preservation of total lean body mass at 16 weeks in patients receiving enobosarm compared to those who received placebo.

Top 10 most anticipated drug launches of 2025

According to Evaluate’s forecasts, the biggest potential drug launches of the coming year stand to generate a collective $29 billion in annual sales by the end of the decade, nearly double the estimate for last year’s top 10.

Nippon Shinyaku to pay $36M to reserve US rights to AB2 Bio's near-approval autoimmune drug

Japan’s Nippon Shinyaku is continuing to scoop up the international rights to some intriguing drugs, this time penning a $650 million biobucks deal for AB2 Bio’s late-stage autoimmune disease therapy.

Though prevalent in the lab and middle management, east Asian Americans are underrepresented in biopharma C-suites: report

Despite making up a sizable chunk of entry-level employees at the biggest U.S. biopharmas, the share of east Asian Americans drops dramatically as you move up the ranks. That’s according to a report from ElevAAte Biotech, a new nonprofit that seeks to boost the biopharma C-suite representation of Americans who descend from countries like China, Japan, South Korea and Taiwan.

GSK offers up to £50M to conduct cancer vaccine research with the University of Oxford

British pharma giant GSK is heading back to school, pledging up to 50 million pounds sterling (about $62.4 million) to work with the University of Oxford on cancer vaccines.

Bristol Myers, Pfizer tout new standards of care in colorectal cancer subtypes

Old drugs from Bristol Myers Squibb and Pfizer have delivered what the companies and researchers believe could establish them as new standard treatments for certain colorectal cancer patients.

UnitedHealth estimates 190M people impacted by Change Healthcare cyberattack

Change Healthcare now estimates that 190 million people were affected in the massive cyberattack that took down its services nearly a year ago.

Gearing up to challenge Lilly in obesity, Kailera picks Zepbound brand leader as new commercial chief

Not long after reporting phase 2 data for one of its obesity candidates that appeared to put it on par with Eli Lilly’s Zepbound, Kailera Therapeutics is preparing for an eventual market launch with a new commercial leader.
 
Fierce podcasts

Don’t miss an episode

Recapping the 2025 J.P. Morgan Healthcare Conference

This week on “The Top Line,” we break down the biggest stories out of JPM, from J&J’s blockbuster acquisition of Intra-Cellular Therapies to former First Lady Jill Biden’s appearance at Fierce JPM Week.
 

Resources

Whitepaper

Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.

 

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