Trump admin demanding again that pharma CEOs implement 'most favored nation' pricing within 60 days - "industry proposals have fallen short" endpoints.news/trump-demands-…

FDA chief wants more harmony between CBER and CDER - endpoints.news/fda-chief-want…

🎙️We've got a great show coming up this morning on Endpoints News Post-Hoc Live: I'll be chatting with Jefferies China biotech analyst Cui Cui, who wrote the "Shopping in China's biotech supermarket" report that I keep sending to people. Live at 930am ET! endpoints.news/endpoints-live…

I completely agree with Len here! “The solution is simply not to lower cost prices in the US without some equilibrating in Europe, because then there’ll be no innovation.” endpoints.news/regeneron-ceo-…

$REPL says it's waiting for an FDA response before taking a more formal path forward on its recently rejected advanced melanoma treatment - endpoints.news/replimune-says…

We scooped the Pazdur news on Friday…btw

Merkel cell carcinoma log. Day #373. For today’s column, I spoke with Mike Wong, my original oncologist at MDAnderson, who I know to be an expert guided by the data. He and his colleagues in the $REPL study have organized an open letter to the FDA detailing their objections to

Also: New details on Vinay Prasad’s exit at FDA -Susie Wiles called Makary to tell him to let Prasad go -The abrupt move came after the WH decided it needed to happen before Trump returned from Scotland -After, Makary and RFK discussed enlisting Dr Oz to ask Trump to reverse it

Trump: "We'll be putting an initially small tariffs on pharmaceuticals. But in one year, one in a half years maximum, it's gonna go to 150% and then it's gonna go to 250%, because we want pharmaceuticals made in our country."

The public deserves to see the science Sec Kennedy is using to make these statements.

BARDA invested in mRNA technology precisely because it could deliver safe, scalable vaccines in record time, a capability proven during COVID. By dismantling that platform, we’re crippling our front-line defense, just ahead of unknown biological threats. hhs.gov/press-room/hhs…

Eli Lilly’s obesity pill is less effective than Novo Nordisk’s, pivotal data suggest - endpoints.news/eli-lillys-obe…

Kennedy’s mRNA cuts challenge Trump's Warp Speed achievements - endpoints.news/kennedy-mrna-c…

So…the White House didn’t push him out?!

Still unclear what roles Prasad is returning to, why staff haven’t been notified internally, or why Richard Forshee, acting office director for CBER’s Office of Biostats and Pharmacovig., was moved over the weekend to a new role in the FDA’s drugs center- endpoints.news/what-does-pras…

Tough spot for any biopharma co. to be in. Your off-the-shelf cancer vaccine fails in Ph3 (they all fail), but you tease out subgroup data (uh-oh) and talk up safety (they're all safe), planning for a filing. In this FDA? Or any FDA? Stock drops 37% today -- now down 92% from

TODAY at 11:30am ET, Adm. Brett Giroir joins Post-Hoc Live to talk to Drew Armstrong and I about the US' exiling of mRNA research. Giroir was the Assistant Secretary for Health in Trump 1.0, and worked at DARPA earlier in his career. endpoints.news/endpoints-live…

50+ biotech startups secured $50M+ IPOs from Feb. 13 to Aug. 13 in 2021 There have been 0 in the same six-month stretch this year (in the US) endpoints.news/biotech-indust…

Walking away from mRNA is not just bad science, it's a national security risk. Pandemics and bioterror threats are rising. This is the tool that can protect America before disaster strikes. Ignoring it leaves us exposed. Essay in New York Times Opinion: nytimes.com/2025/08/18/opi…

But seriously: who is this helping? FAERS data is so messy…