Interesting to see this latest biotech deal out of China. $GSK went in and picked up respiratory assets, fitting neatly into its pipeline efforts. And they went with one of China's biggest, most reliable dealmakers, Hengrui. The pipelines in China are being built for global

Vinay Prasad has hit the exit door U.S. FDA. Another casualty of Laura Loomer's loyalty crusade? The $SRPT mess? It's only absolutely clear that a highly politicized agency is in turmoil. Drew Armstrong has the story. endpoints.news/vinay-prasad-o…

Historically one of the best federal agencies, FDA has had chaos and ruin thrust upon it. By fools.

Prasad exits under fire, the FDA flips and then flops on $SRPT, controversial CRLs drawing flack. And that's the last week. Makary, though, is sticking to his talking points. We're all about predictability and streamlining. Morale is great. Just don't talk about the mess. Nothing

Newly appointed CDER chief George Tidmarsh now takes over as acting CBER director, following Vinay Prasad’s departure, per email from Makary

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

When the next pandemic hits, and it could happen at any time, remember that Trump/Kennedy did their best to dismantle mRNA preparedness work. It is insane. endpoints.news/kennedy-says-b…

Governance in quantum technology is needed, according to a new paper in Science Magazine. To read the article, by authors Mateo Aboy, Urs Gasser, I. Glenn Cohen, & Mauritz Kop, click here science.org/doi/10.1126/sc…

And just like that, Vinay Prasad is back at the helm of CBER. From the convos I've been having, it's safe to say that no one in biotech understands which end is up at the FDA. The agency included a swipe at "the fake news" in making the announcement. But a simple chronology of

As Vinay Prasad returns to FDA, I wrote him an open letter about how he can admit humans make mistakes, actually welcome dissent, and serve public health. And also, make it so I don't need to write another Vinay Prasad piece for a while! Dear Vinay: Please embrace dissent, and

I think you're good until Wednesday. Maybe. And then we'll see.

In the last few days we've been treated to a couple of detailed stories about the disarray inside the FDA - topped by Vinay Prasad's second coming - from Zach Brennan and Sarah Karlin-Smith. From the new head of CDER confirming that he's subject to being overruled by politicians to

I've been reading a bit about our new BLS chief and came across this gem in the Financial Times: Even economists on the political right doubt that a man they characterise as an inexperienced stooge of the president will fulfil that mission. WSJ blasted him in the op-ed section. Krugman had a

While the administration is trying to hammer MFN drug pricing into place (I think it's doubtful), maybe they should also focus in on the regulatory environment in Europe and their insistence on a randomized trial for approval/coverage. $AUTL is left trying to painfully scratch a

Two remarkable pieces out on the FDA. Politico has a story linking Susie Wiles to the decision to reverse Prasad's ouster and the The Wall Street Journal has a remarkably deep editorial slamming Makary for a slowdown in approvals -- something the Journal finds repugnant. Prasad also comes in for

Stanford Scientists Decode Inner Speech with 26-54% Accuracy , by Nita Farahany open.substack.com/pub/nitafaraha…

Great start! VERY enjoyable match! Loved the frosh w/3 goals & at least 1 (Harrison, A!) assist. But really loved a brace from Jasmine, doubling her goal total from her (odd) season last year, great scorer playing CB because the team needed it.

Small biotech gets a full approval for a rare disease with data from a tiny study, after seeking accelerated OK. You've got to wonder which end goes up at the FDA. From where I'm sitting, it looks like a loose association of warring clans. endpoints.news/precigens-rare…

Ah, I misread you as saying that it had been done in 2000, but it makes sense that your good records may not go back before 2000. So I take it Marcia Ward (or Nicole Barnhart!) didn't do it in 2000?