Exact Sciences rides high on cancer test launches

Today’s Big News

May 2, 2025

Trump plans $18B NIH budget cut, wants 27 centers consolidated into 5


Madrigal's Rezdiffra, the first-ever MASH drug, beats sales projections for 4 quarters in a row


Exact Sciences plans 'transformative year' with 3 cancer test debuts


As Journavx rollout begins, Vertex kicks off unbranded pain campaign with NFL alum Alex Smith


President Trump outlines health agency cuts in annual FY26 budget proposal


BMS scales back at former Novartis plant, shifting cell therapy vector production to MA


FDA delays decision date on Cytokinetics’ heart drug to year’s end in unusual safety program reversal


Cancer-destroying sound beam developer HistoSonics considering a sale to major medtechs: report

 

Featured

Trump plans $18B NIH budget cut, wants 27 centers consolidated into 5

The leaked drafts have proven true. President Donald Trump’s proposed federal budget for 2026 would nearly halve funds for the National Institutes of Health, dropping the agency’s financing from about $48 billion to $27 billion.
 

Top Stories

Madrigal's Rezdiffra, the first-ever MASH drug, beats sales projections for 4 quarters in a row

Since its historic FDA approval in March 2024 as the first medication for MASH, Madrigal’s Rezdiffra has handily beat Wall Street’s sales projections for the fourth straight quarter.

Exact Sciences plans 'transformative year' with 3 cancer test debuts

Following the launch of two new cancer tests—plus a third planned for before the end of 2025—Exact Sciences is nudging up its financial expectations.

As Journavx rollout begins, Vertex kicks off unbranded pain campaign with NFL alum Alex Smith

Amid the launch of its non-opioid pain med Journavx, Vertex Pharmaceuticals has begun an awareness-raising blitz focused on acute pain management.

President Trump outlines health agency cuts in annual FY26 budget proposal

President Trump sent his annual budget request to congressional appropriators on Friday morning. The document is a wish list for the discretionary spending cuts the executive branch wishes to see Congress make in annual appropriations.

BMS scales back at former Novartis plant, shifting cell therapy vector production to MA

Bristol Myers Squibb will cease production of viral vectors from its plant in Libertyville, Illinois, the company has told Fierce Pharma. The facility, which was previously used by Novartis to manufacture the gene therapy Zolgensma, was picked up by BMS in early 2023 to bolster viral vector capacity for its commercial cell therapy portfolio.

FDA delays decision date on Cytokinetics' heart drug to year-end in unusual safety program back-and-forth

To REMS, or not to REMS. That, apparently, was the question for Cytokinetics, which has seen any potential approval for its experimental heart drug delayed by an extra three months over an unusual safety program omission and addition.

Cancer-destroying sound beam developer HistoSonics considering a sale to major medtechs: report

HistoSonics is shopping for a potential buyer of its approach to destroying liver tumors with focused sound waves, according to the Financial Times.

Sanofi and McLaren Racing drive full speed ahead to bring meningitis awareness to the racetrack

This year's 24 Hours of Le Mans endurance car race in France in June will see a United Autosports McLaren clad with a Sanofi-created meningitis awareness flag in a campaign meant to illustrate how "every second counts" when it comes to meningitis.

As Amgen's trio of Horizon drugs disappoints, execs urge analysts to give them more time

While Amgen’s legacy products are thriving, those gained from the company’s $27.8 billion buyout of Horizon Therapeutics in 2023 are struggling, especially blockbuster eye disease treatment Tepezza, which saw a 17% sequential decline in the first quarter.

NIH tightens reins on subawards, ending the process for foreign recipients

The National Institutes of Health is making a major change to how grant recipients can use their funds. The agency plans to end the subaward process that has been under increased scrutiny since the beginning of the COVID-19 pandemic.

Almirall, Biofrontera encourage sun protection in actinic keratosis social media challenge

Far from doffing their caps to actinic keratosis (AK), dermatology drug developers Almirall and Biofrontera are keeping things firmly covered to raise awareness of the skin cancer precursor.

'No one else should do what Tim did': Antibodies from man who injected himself with snake toxins produce a potent new antivenom

Eighteen years ago, Tim Friede began willingly injecting himself with escalating doses of venom from 16 snake species. Now, antibodies in his blood have led to the development of a three-part antivenom cocktail capable of protecting mice from the toxins of 19 dangerous snakes.

Government cuts could help spark surge in M&A activity

Reductions in staff at the FDA are putting pressure on biotech companies, especially those strapped for cash, and could lead to more M&A activity, according to Andrew Goodman, a partner in the M&A practice at business law firm Paul Hastings.

FDA frees Amgen's phase 1 obesity asset from clinical trial hold

The FDA has freed Amgen’s mysterious early-stage obesity asset from a clinical hold, with the phase 1 study now enrolling participants.

Chutes & Ladders—Scholar Rock rocks the boat with new execs

Scholar Rock is shaking up its executive team as it prepares to enter the commercial arena with the expected launch of spinal muscular atrophy drug apitegromab later this year. CEO Jay Backstrom, M.D., is stepping down, making room for longtime board chairman David Hallal to take over. Hallal previously spent more than a decade in C-suite roles at what is now AstraZeneca’s Alexion, culminating in nearly two years as CEO.

Fierce Pharma Asia—Akeso bispecific's first survival readout; AstraZeneca's China probes; Ono's layoffs

Akeso's first overall survival readout for its Keytruda challenger caused a violent market reaction. AstraZeneca disclosed another potential fine in China. Ono unveiled layoffs in a notice filed in Massachusetts. And more.
 
Fierce podcasts

Don’t miss an episode

ElevAAte and the push for East Asian American biopharma leaders

This week on "The Top Line," hear how the founders of ElevAAte are turning shared East Asian American experiences into collective power for the next generation of biopharma leaders.

 

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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