Daiichi, Merck pull ADC filing after overall survival miss

Today’s Big News

May 29, 2025

‘Hanging on by our fingernails’: Stealth CEO questions efficiency behind FDA rejection of rare disease drug 


Drugmakers, trade groups and others voice concerns with pharma-specific tariffs 


Daiichi, Merck pull HER3-DXd filing at FDA after confirmatory trial misses survival endpoint 


Alcon gains first FDA prescription drug nod since Novartis split, scoring with drops for dry eye disease 


Pfizer again found to have discredited pharma industry with COVID-19 vaccine tweets 


HHS axes Moderna's $590M pandemic bird flu vaccine contract, ending funding for late-phase trials 

 

Featured

'Hanging on by our fingernails': Stealth CEO questions efficiency behind FDA rejection of rare disease drug

After communicating with the FDA about font sizes for potential packaging on its investigational injection, Stealth Biotherapeutics’ CEO thought approval for the ultrarare genetic disease treatment was imminent.
 

Top Stories

Drugmakers, trade groups and others voice concerns with pharma-specific tariffs

Some two weeks after the public comment period closed for the Trump administration’s Section 232 investigation into the national security implications of pharmaceutical imports, a wide range of drugmakers, trade groups and foreign governments have largely aligned in opposition to potential industry-specific tariffs.

Daiichi, Merck pull HER3-DXd filing at FDA after confirmatory trial misses survival endpoint

After Merck paid a hefty sum to co-develop and co-commercialize HER3-DXd, the drug has suffered notable setbacks in consecutive years.

Alcon gains first FDA prescription drug nod since Novartis split, scoring with drops for dry eye disease

Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease treatment Tryptyr.

Pfizer again found to have discredited pharma industry with COVID-19 vaccine tweets

COVID-19 tweets from November 2020 have come back to haunt Pfizer once again. Fourteen months after an old tweet caused Pfizer new problems, pandemic-era social media posts linked to the drugmaker have again been found to have brought discredit to the pharma industry.

HHS axes Moderna's $590M pandemic bird flu vaccine contract, ending funding for late-phase trials

The Department of Health and Human Services has axed a $590 million contract with Moderna, raising doubts about how the biotech will fund late-phase development of a pandemic bird flu vaccine.

Salvia BioElectronics nets $60M to develop minimally invasive migraine implant

Salvia BioElectronics’ neuromodulation device, with paper-thin implants placed under the skin at the front and back of the head, is being tested in a blinded study.

Regulatory tracker: Eton wins FDA nod for Khindivi, the first hydrocortisone oral solution

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

Keros culls PAH asset, prompting layoffs for 70 workers

Keros Therapeutics is ending development of a phase 2 candidate designed to treat high blood pressure in the lungs, a move that has triggered layoffs for 45% of the biotech’s team.

Sanofi spices up Type 1 diabetes awareness with sponsorship of new UK girl group

Sanofi is harnessing the power of pop music to boost awareness of the experience of living with Type 1 diabetes.
 
Fierce podcasts

Don’t miss an episode

A Fierce breakdown of the 'most favored nation' executive order

This week on "The Top Line," Fierce Pharma breaks down President Donald Trump’s executive order targeting drug prices and what it could mean for the industry as broader policy shifts unfold.
 

Resources

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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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