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I find these small cancer trials really intriguing, because you can tease out activity without blowing the bankroll. So why does Candel's stock nosedive 20% on a successful, albeit small, 13-person trial (7 on drug, 6 on soc in the control arm) in pancreatic cancer -- a tough nut

After rejection, Regeneron seeks accelerated approval of bispecific for only one of two types of lymphoma endpts.com/regeneron-shak…

Breaking: FDA's March meeting to select flu shot strains for 2025-2026 season has been canceled per email sent to committee members, a VRBPAC member told me. drug companies need about 6 months leeway to make shots in time for fall vax campaigns.

DOGE cuts the lease on FDA's 52k sq-ft St. Louis pharma quality lab - unclear if the 70 scientists will be cut. One worker at the lab tells me it serves all of OPQ and other FDA offices, "I’m not even sure how the logistics of relocating would even work" endpts.com/doge-shutters-…

Scoop: Trump admin reverses course on FDA drug quality lab lease termination - endpts.com/trump-administ…

"A person who was briefed on the meeting said Kennedy didn’t want to turn stem cell regulation into the 'Wild West.'" Great details on last week's meeting with stem cell reps and advocates, from Lei Lei Wu: endpts.com/rfk-jr-convene…

HHS Secretary Robert F. Kennedy Jr. and his staff last Wednesday hosted a regenerative medicine roundtable primarily to discuss how to lower regulatory barriers for stem cell treatments My story in Endpoints News: endpts.com/rfk-jr-convene…

Stem cell arena has a big problem with bogus claims and b.s. treatments.

Scoop: Trump has decided to pick Dr. Susan Monarez to be the new nominee to head the Centers for Disease Control and Prevention, sources tell Alexander Tin and me. CBS News

Cantor biotech team breaks with their boss’ administration.

Some good news for gene editing. Verve Therapeutics unveils positive (albeit early) data from its 2nd attempt at heart disease gene editing, with strong cholesterol reduction and no safety concerns that hurt its 1st attempt. Lei Lei Wu has the story for Endpoints News - endpts.com/verve-unveils-…

Two in vivo CAR-T trials in China have delivered early human data, the first clinical readouts of a competitive field. endpts.com/early-in-vivo-…

BREAKING: Vinay Prasad MD MPH named CBER director, per internal email

Wondering what Vinay Prasad might mean for CBER? Come join Drew Armstrong, Lei Lei Wu and I as we discuss in a live conversation at 11 AM youtube.com/watch?v=grOohD…

Lilly's top oncology execs: If a cancer program needs a mid-stage trial, its too mid for Lilly. My look at Lilly's cancer pipeline revamp and its unconventional strategy: endpoints.news/phase-3-or-bus…

Phase 2 is for cowards $LLY

At the direction of Secretary Kennedy, every ACIP member has been removed: wsj.com/opinion/rfk-jr…

Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say My latest — endpoints.news/sources-fda-ch…

If you work at the FDA, I am interested to hear more about your perspective. Please consider reaching out to me on Signal: my username is adunn123.30 endpoints.news/sources-fda-ch…

“If the second biggest [pharmaceutical] company in the world is reticent about trying to get approvals, what on earth does that mean for rare disease?” Advocates urge J&J to apply for approval of a rare eye disease gene therapy despite a failed trial endpoints.news/advocates-urge…