Makary says AI-powered product reviews coming in June

Today’s Big News

May 15, 2025

'Unbelievably blessed': First custom CRISPR therapy alleviates worst of rare genetic disease for infant


Merck KGaA cites Trump tariffs, funding cuts as it scales back 2025 contracting forecast


Makary outlines AI plans and the broader vision for his term as FDA commissioner


Pathos AI secures $365M series D to fund trial of Novo Nordisk solid tumor drug


Consumers remain averse to GLP-1 costs, with most unwilling to pay more than $100 out of pocket per month: KPMG

 

Featured

'Unbelievably blessed': First custom CRISPR therapy alleviates worst of rare genetic disease for infant

An infant named KJ has made history as the first patient to be treated with an in vivo CRISPR gene editing therapy designed specifically for him.
 

Top Stories

Merck KGaA cites Trump tariffs, funding cuts as it scales back 2025 contracting forecast

Citing tariff threats, Merck KGaA has lowered its sales guidance for its life science arm, which offers various R&D and CDMO services, plus key materials for partners.

Martin Makary outlines AI plans and the broader vision for his term as FDA commissioner

WASHINGTON, D.C.—Speaking at the annual Food & Drug Law Institute conference in Washington, D.C., Martin Makary, M.D., said implementing AI is one of the agency’s top priorities.

Pathos AI secures $365M series D to fund trial of Novo Nordisk solid tumor drug

Pathos AI has secured $365 million in series D funds as the artificial-intelligence-powered biotech looks to fund trials of solid tumor drugs sourced from Novo Nordisk and Prelude Therapeutics.

Consumers remain averse to GLP-1 costs, with most unwilling to pay more than $100 out of pocket per month: KPMG

Though Eli Lilly and Novo Nordisk have recently taken steps to make their uber-popular GLP-1 drugs more affordable for certain consumers, many are still turned off by the meds’ sticker shock.

FDA delays decision on Biohaven's rare disease drug filing, plans adcomm

Biohaven is giving investors whiplash. Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed a decision on its rare disease candidate troriluzole and plans to hold an advisory committee to discuss the application.

Merck's Keytruda finds a path in ovarian cancer with phase 3 win in certain recurrent patients

Merck's cancer superstar Keytruda has not yet been able to add an ovarian cancer-specific nod to its impressive lineup of approved indications. Now, the drug has shown benefits for patients with platinum-resistant recurrent ovarian cancer.

Kinase inhibitor biotech Enliven calls time on phase 1 HER2 solid tumor program

Enliven Therapeutics has decided against taking its phase 1-stage solid tumor drug into further development next year in order to keep resources flowing toward its leukemia candidate.

GSK sponsors Lifetime movie for meningitis B vaccine awareness, with help from 'Buffy' stars

GSK tapped "Buffy the Vampire Slayer" actresses Alyson Hannigan and Sarah Michelle Gellar to promote the upcoming company-sponsored Lifetime Original Movie "Pretty Hurts," in which a pageant girl and her mom are hit with the reality of meningitis B.

AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis

The FDA granted an accelerated approval to AbbVie’s c-Met-directed ADC Emrelis as a new treatment option for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer who’ve previously received systemic therapy. The green light equips AbbVie with a second commercial ADC after Elahere, which it acquired in its $10.1 billion buyout of ImmunoGen.

Philips survey illustrates trust gaps in AI among patients, providers

The medtech’s 10th annual Future Health Index report polled nearly 2,000 professionals and more than 16,000 patients across 16 countries.

Novartis, Sarepta tipped to drive genomic therapy sales toward $90B

GlobalData analysts have tipped the global market for genomic therapies to balloon to almost $90 billion by 2030, driven by gene therapies such as Sarepta Therapeutics’ Elevidys and Novartis’ Zolgensma.

Riding its Peloton buyout, Merck rolls to third FDA nod for potential blockbuster Welireg

Six years after Merck bought out Peloton Therapeutics, the New Jersey drugmaker is not remaining stationary with the crown jewel of the deal. The FDA has approved a third indication for Welireg, signing off on the hypoxia-inducible factor-2 alpha inhibitor to treat patients with rare pheochromocytoma or paraganglioma tumors in the endocrine system.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Angela Hwang on her pivot from Big Pharma to biotech

This week on "The Top Line," Angela Hwang reflects on her leap from nearly 30 years at Pfizer to leading a biotech startup—and the career lessons that continue to guide her leadership and commitment to developing diverse talent.

 

Resources

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Accelerating Clinical Trial Excellence: A Seamless IRB & IBC Collaboration

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SpyLock Technology: A cutting-Edge Solution for Rapid Bispecific Antibody Screening

Learn how the SpyLock service can offer fast bispecific generation, reduce workload, and accelerate candidate selection.
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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.
 

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