Endpoints News
FDA leaders want more scrutiny on foreign data Read in browser
Endpoints News
Thank you for reading, dupa dupackia!
basic
UPGRADE
M T Wed Th F
2 September, 2026
GLOBAL PHARMA AND BIOTECH SUMMIT - Rewriting the rules of growth, access and innovation - Register now
Drugs worth $180bn in annual revenue are heading off patent, and the industry holds an estimated $1.3tn to fill the gap. Hear how leaders from Novartis, Novo Nordisk and GSK are positioning for what comes next. Register now.
top stories
1. Deaths in Novartis CAR-T trial force a reckoning over acceptable risk in autoimmune disease
2. FDA conveys tougher clamp down of foreign trial data coinciding with China’s rise
3. CBER official overruled review team's rejection of new Replimune melanoma drug
4.
in focus
China deaths reignite debate about using viruses to deliver CRISPR therapies
5.
news briefing
UK regulator halts sales of Tavneos; UniQure seeks approval for Huntington's gene therapy
more stories
 
Zachary Brennan
.

As President Trump pushes the Senate to confirm Heidi Overton as the next FDA commissioner before the November elections, her latest financial disclosure report likely won't tip the scale in either direction. Overton made about $300,000 from the America First Policy Institute in 2024 and roughly $40,000 for consulting on the Trump-Vance transition, before bringing in about $155,000 in salary as a domestic policy advisor to Trump beginning in January 2025. She didn't disclose any investments in health care or biopharma companies.

.
Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
1
by Nicole DeFeudis

Many re­searchers be­lieve can­cer cell ther­a­pies called CAR-Ts could shift the treat­ment par­a­digm for pa­tients with au­toim­mune dis­ease. But three re­cent­ly dis­closed deaths in No­var­tis’...

Read the full story
2
by Max Bayer

Top FDA lead­ers are dou­bling down on clin­i­cal tri­al over­sight mea­sures to en­sure that re­search da­ta gen­er­at­ed out­side the US are ad­e­quate, as law­mak­ers and...

Read the full story
3
by Zachary Brennan

Asha Das, di­rec­tor of the FDA bi­o­log­ics cen­ter's of­fice of clin­i­cal eval­u­a­tion, over­ruled the agen­cy's re­view team in grant­i­ng an ac­cel­er­at­ed ap­proval to Replimune's melanoma...

Read the full story
women in BIOPHARMA '26 - Register Now
Twenty new honorees join the 140-plus women Endpoints News has recognized for reshaping biopharma. How did they get there, and what's changed? Join us for exclusive interviews, in-depth profiles and a frank look at gender representation in the industry today. Register now.
.
Endpoints In Focus
4
by Ryan Cross

The deaths of two chil­dren who re­ceived CRISPR ther­a­pies in Chi­na have rat­tled sci­en­tists who work on sim­i­lar ge­net­ic med­i­cines in the US, adding new...

Read the full story
News Briefing: Quick hits from the biopharma web
5
by ENDPOINTS

Plus, news about Re­gen­eron, Novo­cure, Jaz­z's Zi­ihera, Bio­Marin, As­cendis, As­traZeneca, Hutchmed and TScan Ther­a­peu­tics.

An­oth­er road bump for Tavneos: The Med­i­cines and Health­care prod­ucts...

Read the full story
Endpoints News
2029 Becker Drive; Lawrence, Kansas 66047 USA Privacy and deletion: help@endpointsnews.com
web twitter linkedin