FDA Staff Predicts Low Morale After Makary’s Departure
Here's the last quote from Politico's piece on Makary's abrupt (reportedly soon) exit: “He will not be missed by a single career person,” said an FDA staffer granted anonymity to discuss Makary’s tenure prior to the news of his pending departure. “And we will only regret it when they manage to find someone worse.” I'm guessing morale is a little low among the rank and file. https://t.co/bRDHmWqpMH
Top 15 Biopharma R&D Players and Late‑Stage Prospects
My annual report on the top 15 R&D players in biopharma is out. It's a beast at some 9000 words, but if you're interested in the top prospects in the late-stage pipeline, I got a bunch for you. The stakes...
Late‑Stage Drug Development Trends: Phase III, AI, Global Partnerships
LOOKING forward to tomorrow's webinar on late-stage drug development trends with Susan Galbraith (AstraZeneca), Levi Garraway (Roche) and Ken Getz (Tufts). We'll be discussing the fundamentals of Phase III, with thoughts on efficiencies, interplay with biotech partners, China, AI, and...
Charting FDA‑Guided Trial Pathways for Merkel Cell Carcinoma
Really enjoyed my fireside chat at MCC4 with Harpreet Singh, MD, the CMO at Precision Medicine, focused on establishing pathways for clinical trials in Merkel cell carcinoma. The physician-scientists in the audience were clearly excited about the prospect of working...
Rare Cancer Patients Demand Systemic Oncology Revolution
Merkel cell carcinoma log, day #637. I’m participating in the 4th annual Merkel cell carcinoma conference (MCC4) in Boston today. Most of the top people in the field are here. Had a roundtable conversation with a group of patients and...
Trump Cuts Crucial Health Research Funding, Fueling Crisis
This piece in the WaPo summarizes what I've been say. The feds under Trump are choking off research dollars -- particularly for women's health, cancer and mental health. Young researchers are particularly hard hit, steering scientists into other work. It's...
Chinese Biotechs Lead Licensing as M&A Surges
M&A is sizzling right along, with the Q1 numbers looking good for biotech. IPOs got started on the year with a spike in offerings and some mixed results on the Street. Dealmaking remains solid. And shall we just call it...
WSJ Defends Replimune Drug Amid Mounting Criticism
@WSJ is not giving up the fight for Replimune's cancer drug. Second CRL draws another rebuke and a direct attack on @MartyMakary (Prasad gets another swipe as well, but he's about out the door now.) I often disagree with the...
Trump Targets NIH Funding Amid $1.5T War Spend
Trump once again going for draconian cuts to NIH, though not as catastrophic as he sought for the last round (and didn't get). Meanwhile, he wants $1.5T for war. I doubt he'll be any more successful with NIH cuts than...
Insurers' AI Denials Delay Life‑saving Cancer Care
The mother of an angiosarcoma patient reached out this weekend to see if I could help her daughter get a second opinion at Dana-Farber after it was rejected by her insurer. I'll do what I can. Dana-Farber has made a...
In‑vivo CAR‑T Achieves 4/5 MRD‑Negative Remissions
Outstanding piece here from @leilei_wuu on AstraZeneca's in vivo CAR-T for multiple myeloma. There's data on 5 patients, which is pretty lean, but 4 come out MRD negative in two months, which is extraordinary. We're going to see a lot...
Pfizer's Lyme Vaccine Data Remains Ambiguous, FDA Review Looms
As someone who lived in Vermont and still spends the summer there, it's disappointing to see the ambiguity in Pfizer's data on a new Lyme disease vaccine. It's a serious threat. Now we can move on to speculating on the...
FT's Iran War Analysis Illuminates Europe's Strategic Dilemma
I'm biased, of course, but hats off to the @FT for some truly groundbreaking work on the Iran war. Ed Luce's commentary has been essential to understanding the dilemma Europe finds itself in as its leaders try to edge away...
Patients Should Drive Aggressive Immunotherapy Post-Remission
Merkel cell carcinoma log, day #594. Yesterday, I was at Dana-Farber for my first infusion of avelumab in more than 3 months. Aside from two botched blood tests — the buzz is the blood tests are being done with recently...
Healthcare Costs Forcing Debt, Hunger, and Retirement Delays
Such a dismal conclusion. Taking on debt, skipping meals, delaying retirement, etc, etc, in order to cover healthcare costs. When does America come to grips with healthcare costs? Something has to give. https://t.co/L48u4W2CDG