. @matthewherper is so damn reasonable. Smart, too. 5 lessons from Vinay Prasad’s turbulent tenure at the FDA https://t.co/R65vPj5ep5
The #VRBPAC committee is scheduled to meet Thursday to advise #FDA on #flu vaccine strain selection. VRBPAC is supposed to have at least 15 members. It currently has 7 voting members & no chair. It has met only twice since...

We will solve aging or will die trying. Check out the TopTown SuperDNA project. It is no longer a concept - projected launch in Q3 2028. Fully-integrated residential-biotechnology-clinical infrastructure is key to longitudinal AI-powered drug discovery. https://t.co/LK5XaTci29
The $RLMD bladder cancer data (phase 2) reported this morning look very good. Another competitive blow to $IBRX particularly at its bloated valuation. https://t.co/wYThfwIpG8
9March: What a roller-coaster ride with $QURE and @US_FDA ! I sum up a wild week--plus $MRNA's could've-been-worse settlement with $ABUS & $ROIV (w/ insights from CEO Matt Gline) and updates from $DAWN and $TNGX in my latest StockWatch for...
Macro: drug-safety shock; Key factor: SYMPHONY‑1 found secondary hematologic malignancies; Risk: regulatory re‑rating and pipeline impairment; Insight: trim Ipsen (IPN) exposure; favor defensive pharma 📉 — Viktor Kopylov, PhD, CFA. More insights: t.me/si14Kopylov
#GSK to get $300m upfront and $100m upon US FDA approval plus $20m for EU approval and up to $270m sales based payments from Alfasigma who will acquire rights to Linerixibat, a bile acid transporter inhibitor, currently under development.
Comparative analysis of senolytic drugs reveals mitochondrial determinants of efficacy and resistance "findings suggest that mitochondrial quality control is a key determinant of resistance to ABT263-induced and ARV825-induced senolysis, providing a possible framework for rational combination senotherapies." https://t.co/xB0wFkzIW9
Too funny. @emilyakopp (below) outs Vinay Prasad as the host of Thursday’s HHS/FDA media call to discuss $QURE.

Osteoarthritis & back pain affects millions of people. Instead of managing symptoms, imagine rebuilding joints by making them young New study shows the reprogramming gene combo OSK regrows joints in mice & effect depends on TET2 so it's epigenetic...🧵 https://t.co/AlOIwcEXEQ
stated as a critique but what does this mean as no drug has been demonstrated to have anti-aging effects in human clinical trials NR is active versus inflammaging and PAD, which is an age-related conditions affecting 10s of millions of americans you...
GLP-1s already have market cap close to 1/3 of the top 10 biopharma companies combined. Consumer health biotech products will dwarf disease-focused biotech products.
On Prasad’s last few weeks as CBER chief: 1. It was absurdly inappropriate to bring a large group of reporters together and rail on a pending application “on background” 2. The walk back of the Moderna RTF was a bad...
Patent Fights, GLP-1 Turf Wars, and the FDA Tightens the Screws | Ep. 952 https://t.co/v0fulR3NfB https://t.co/9gGdkAVvlv

There's a lot you can learn about sleep. Like 83% hadn't heard of DORAs. https://t.co/2lV3Fw6cwg https://t.co/IWRTdPTMOL
One of the most impressive advances we've ever seen for some autoimmune diseases: cures https://t.co/OZDuq4Iooy
Even with AlphaFold, protein structure is not a solved problem. And protein structure was never the bottleneck for drug development anyway. Let me explain.
Bitter Compounds as Multifunctional Agents against Diabetes-associated Cognitive Dysfunction: Bridging Metabolic Regulation and Neuroprotection https://t.co/Xv3xItlP20

Baylor did some new pics photos by my friend Agapito Sanchez Jr. Gosh I’m old, estoy viejo, but still making new vaccines, hope to have results of our hookworm anemia vaccine soon, hoping to reproduce our low cost Covid vaccine...
Human Growth Hormone May Be Detrimental When Used to Accelerate Recovery from Acute Tendon-Bone Interface Injuries https://t.co/L4EOFMKjys
Assuming this is real it may have something to do with their “must pay by Venmo to the following name” (at least that’s how it used to be). FDA is easing up on some aspects of peptides but gray market...

PEP protects against age-related inflammation, puts the brake on the aging process in mice, high levels in humans correlate with low inflammation So what is PEP, you ask? phosphoenolpyruvate, from glucose metabolism, a, master regulator, blocks cGAS-STING https://t.co/glMvaHSjOq https://t.co/MSVMBJbHm4
Roche, Zealand shares fall on ‘undifferentiated’ obesity drug results https://t.co/5pSR2vcHBD by @Lilah_Alvarado $RHHBY $ZEAL $LLY $NVO #obesity
Servier to build cancer drug pipeline with $2.5B purchase of Day One https://t.co/aH0z8jt9tr by @realJacobBell $DAWN #biotech
Gee, who could this "senior FDA official" be? It's a head scratcher. But he might tell Vinay Prasad that thinly veiled attacks against, oh, UniQure, and going off on advisory councils is a great way of keeping the political pot...
New from me on $QURE and FDA. Free, no paywall. The FDA, urged to avoid controversy, creates a new headache with attack against UniQure Anonymous diatribe from a senior official plunges agency back into headlines https://t.co/ceDE0TXjdI

HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial https://t.co/Jr90iovVeo https://t.co/Nl2WkprjU3
The edge is always weirder and more surprising than we can imagine, excited to follow the work of these 14 scientists and innovators. My personal favorite innovator is @ceeceeboom and her 10 biobanks 👀

$DAWN acquisition by Servier for $2.5bn is quite the ending for Ojemda. Who remembers this RAF inhibitor's bizarre & convoluted history? $BIIB $TAK https://t.co/uD5drO9ymr
Jake puts it crisply: >If discovery and early development move abroad, the nation risks locking in a massive trade imbalance: Foreign countries develop the drugs, and Americans pay the bills.

Especially after the recent disappointing regulatory update regarding $QURE AMT-130 clinical candidate for treating Huntington disease and the FDA refusal to move forward 🧵👇- here is an excellent Infograph by the BBC which explains how exactly the mechanism of @uniQure_NV’s...

Ergostane steroid, as one of the major contributor to cranberry derived extracellular vesicle nanoparticles, restores ovarian function of murine premature ovarian failure https://t.co/CFcjDvzMnU https://t.co/le7VTHjEKa
Boosted Brain Cells Erase Dementia-Linked Proteins “At nearly six months of age, when untreated mice normally have brains saturated with harmful plaques, brains of treated mice were plaque-free. Meanwhile, older mice with plaque-saturated brains at the time of treatment saw a...
UT San Antonio has been given a $38biin ARPA-H grant to study the health benefit effects of three drugs in humans, namely, rapamycin, dapagliflozin and semaglutide …🧵 https://t.co/fAX14ngoyD
Ribosomes as Drug Targets. The Quiet Rewrite of Psychiatry and Beyond. | Ep. 950 https://t.co/gKlWpzO1Ci https://t.co/ImGOmUVrSO

stunning week in cell and gene therapy: in vivo base editing of PCSK9 delivered via LNP, w clinical data (Nat Med), preclinical POC of CAR-astrocytes engineered w AAV (Science) and of self-amplifying RNA delivered IM (also Science), Japan approves gene...
Doesn’t look like $LLY and $NVO have much to worry about from $RHHBY obesity 🤷🏻♂️

Will we give a shot of protective, self-amplifying RNA in patients with a heart attack in the future? @ScienceMagazine an intriguing innovation https://t.co/FcJme1ElyU https://t.co/lABFRkR3qg

When cancer niches are rapidly changing they create both a vacuum of indecision and fresh opportunities for smart players. Here we explore bladder cancer and look at where the field is headed... https://t.co/cf93Qb8dhe https://t.co/fx5V1MVwYN
Lilly targets employers in new bid to broaden access to obesity drugs https://t.co/Y6fmcmTcf1 @ByJonGardner $LLY $NVO #obesity
China competition is coming for the US's multimillion-dollar gene therapies -- a must-read from @Jared_Whitlock about what's happening there and how it will affect access around the world: https://t.co/F7KaMv3Kkp

20 years of Yamanaka stem cell factor research culminates in 2 conditional approvals for heart disease and Parkinson's disease in Japan https://t.co/8oxKxXYafu by Shinya Yamanaka @CellStemCell https://t.co/U878IxSfSi @ScienceMagazine https://t.co/HCCPaTEP7e
I speculated last month that HMPL-A580 was an anti-EGFR ADC https://t.co/XFDtZfWWkH and $HCM just confirmed that this is the case. Relevant for $ALXO
5March: Back in 2021, I wrote about a significant round of layoffs at Theravance Biopharma ( $TBPH). The company is cutting jobs again, and has begun a strategic review, after a Phase III failure. Details in my latest for @GENbio:...

Erythrocyte–anti-PD1 conjugates in persons with advanced solid tumors resistant to anti-PD1/PDL1: preclinical characterization and results of a phase 1 trial https://t.co/1GQMlUHn4Y https://t.co/0it5nTvUm0
Amazing quote in this NYT story on the FDA from @By_CJewett. Janet Woodcock, a top drug regulator for decades, said reversals for a promising therapy send shock waves through the industry. “The Huntington’s refusal I thought was truly evil,” she told NYT....
My friend @adamfeuerstein delivers some great reporting and smart commentary on the FDA's direction that $QURE conduct a new randomized trial for its Huntington's drug. A senior FDA official and the company disagree on the basic question of whether the...
In this week's Biotech Scorecard newsletter: The extremism of the FDA’s Peter Marks and Vinay Prasad has come with costs Two regulators, two extreme regulatory philosophies, one replacing the other. The rare disease community is suffering whiplash. Drugmakers ( $QURE...

Best evidence yet that GLP-1 drugs reduce the risk of substance abuse, from >600,00 US Veterans across alcohol, nicotine, opioid, cocaine, cannabis @bmj_latest @zalaly @Miao_Cai_SLU https://t.co/rcqUt0kY77

We've used a blood test—cell free DNA—for detecting cancer or prenatal fetal abnormalities. It turns out it can be used to detect liver diseases and all-cause mortality from other conditions @ScienceTM https://t.co/IJxPMq7hGU