Edwards’ TAVR approved in asymptomatic patients

Today’s Big News

May 1, 2025

In major blow for Lilly, Novo strikes deal giving Wegovy preferred access on CVS Caremark formulary


HHS unveils $500M universal vaccine initiative, calls Biden-era COVID vax accelerator ‘wasteful’


Edwards Lifesciences nets FDA approval opening up TAVR to patients before they show symptoms


Phathom cuts commercial chief, pares down DTC promotion in cost-saving drive


Moderna targets more cost cuts amid broader vaccine market uncertainty under HHS secretary RFK Jr.


Concentra acquires struggling small molecule biotech Kronos


Dynavax-sponsored survey shows lack of awareness of hepatitis B risks, vaccine options

 

Featured

In major blow for Lilly, Novo strikes deal giving Wegovy preferred access on CVS Caremark formulary

Just as Eli Lilly appeared to be gaining an edge over its metabolic medicine rival Novo Nordisk in the U.S. obesity market, Novo has locked in a new formulary access deal that could give its star weight loss drug Wegovy a major advantage over its Lilly counterpart.
 

Top Stories

HHS unveils $500M universal vaccine initiative, calls Biden-era COVID vax accelerator ‘wasteful’

The U.S. government is putting down $500 million toward the development of a “universal” vaccine—a shot designed to protect against multiple strains of a pandemic-prone virus at once. The concept is one scientists have chased for decades to no avail and represents a shift away from the government prioritizing next-gen COVID-19 vaccines.

Edwards Lifesciences nets FDA approval opening up TAVR to patients before they show symptoms

The current standard of care is monitoring the patient with regular check-ups, to see if they begin to develop chest pain or shortness of breath, before planning a valve replacement procedure.

Phathom cuts commercial chief, pares down DTC promotion in cost-saving drive

After seeing its spending soar and net loss grow to over $90 million in the first quarter, Phathom Pharmaceuticals is making cost-cutting moves—including significant changes to its marketing department.

Moderna targets more cost cuts amid broader vaccine market uncertainty under HHS secretary RFK Jr.

Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the mRNA biotech faces multiple regulatory uncertainties around vaccines under the Trump administration.

Concentra acquires struggling small molecule biotech Kronos

With the walls quickly closing in, Kronos Bio has accepted a buyout from notorious biotech acquirer Concentra Biosciences.

Dynavax-sponsored survey shows lack of awareness of hepatitis B risks, vaccine options

Dynavax is kicking off May’s Hepatitis Awareness Month with a new push to improve education around hepatitis B and the benefits of vaccination.

After years of sales declines, 'a new Biogen' emerges as launches take flight: CEO

The company posted 6% revenue growth during the quarter thanks to three launches. Looking forward, Biogen said it's insulated from potential pharmaceutical tariffs.

Moderna's flu/COVID combination vax hit by deprioritization, FDA delay as R&D spend sinks 19%

Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its operating expenses. The biotech disclosed the changes alongside news of a delay to the expected approval of the vaccine in older adults.

FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports

It's not immediately clear if COVID-19 vaccine makers could meet the agency's new requirement in order to release their updated vaccines by the time virus circulation typically ramps up in the fall and winter.

Arvinas lays off 33% of staff, axes Pfizer-partnered phase 3 trials after seeing mixed data

Pfizer and Arvinas have axed two phase 3 trials from their estrogen receptor degrader R&D plan in the wake of mixed data. Arvinas disclosed the rethink alongside news that it is laying off one-third of its staff to cut costs and extend its cash runway.
 
Fierce podcasts

Don’t miss an episode

Angus on Angus: A Fierce oncology discussion

Two journalists, one name and a candid conversation—Angus Liu and Angus Chen talk cancer reporting, racial identity and being mistaken for each other.
 

Resources

Whitepaper

Best Practice Medical Affairs Organization Study Report

We interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned.
eBook

Through a CRO's perspective: Innovative, Agile Solutions In Vaccine Efficacy Testing

Typical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic.
Whitepaper

Protect Your Trial Data: Endpoint, Imaging, and Safety Review

Is your clinical trial data truly reliable? Learn how a combined approach using Imaging Core Labs and Endpoint Adjudication Committees (EAC) can minimize risk, control costs, and strengthen your study from the ground up. Don’t leave success to chance—arm yourself with the insights to stay ahead.
 

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