Trump, FDA Plan to Expedite Psychedelic Development
President Donald Trump publicly endorsed psychedelic medicines as a breakthrough for severe mental health disorders, pledging to fast‑track their research and development. The White House announcement coincides with the FDA’s plan to create an accelerated review pathway for psychedelic drug candidates. The move builds on recent FDA Breakthrough Therapy Designations for psilocybin and MDMA treatments targeting depression, PTSD, and addiction. Industry observers see the political backing as a catalyst for increased funding, clinical trials, and eventual market entry.
Regulatory Tips From a Breakthrough Noninvasive Device Startup
Compremium’s Quantis CVP, a noninvasive central venous pressure monitor, received FDA Breakthrough Device designation in January 2026 and subsequently joined the agency’s Total Product Life Cycle Advisory Program (TAP). The CTO explained that TAP eligibility hinges on prior acceptance into the...
SynBioBeta Fuels Boom Capital’s Top Biotech Deals
@SynBioBeta draws one of the densest concentrations of biotech investors of any conference in the world. So what keeps them coming back? Celestine “Cee Cee” Schnugg has the answer. Cee Cee is the Founding Managing Partner of Boom Capital, an early-stage deep...
FDA Grants Priority Review for Padcev Plus Keytruda in Bladder Cancer Treatment
The U.S. Food and Drug Administration has granted Priority Review to the peri‑operative combination of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for muscle‑invasive bladder cancer (MIBC). The Phase 3 EV‑304 trial demonstrated a 47% reduction in recurrence, progression or death and a...
Novartis Cuts Two Programs in Cancer-Related Blood Clots
Novartis announced the termination of two late‑stage programs targeting cancer‑related blood clots after a pivotal trial demonstrated inferior efficacy versus existing anticoagulants. The candidates, one of which Novartis out‑licensed in 2019, were being developed to address the high unmet need...
Brain Stimulation Improves PTSD Symptoms
A two‑week, MRI‑guided low‑frequency transcranial magnetic stimulation (TMS) trial at Emory University showed a marked reduction in right amygdala reactivity and significant alleviation of PTSD symptoms. Forty‑seven participants completed the double‑blind, placebo‑controlled study, with 74% of the active‑TMS group achieving...
AACR 2026: Cancers of Unknown Primary Identified by DNA Methylation AI Model
Researchers at Kindai University unveiled a machine‑learning model that reads CpG‑based DNA methylation to pinpoint the tissue of origin for cancers of unknown primary (CUP). In a test set the model achieved roughly 95% accuracy, and it maintained 87% accuracy...
CRISPR Advances Outpace Ethics in Germline Editing Debate
In 2018, He Jiankui edited the genomes of two human embryos, brought them to term, and went to prison for it. The babies are now children. We don't know how they're doing. Seven years later, base editing and prime editing can...
Viatris Recalls Extended-Release Xanax over Dissolution Test Failure
Viatris has issued a Class II recall of a single batch of its extended‑release Xanax (Xanax XR) after dissolution testing showed the tablets did not meet release specifications. The affected bottles, each containing 60 3‑mg tablets, were manufactured in Ireland and are being...
Substack Live | Flagship Pioneering Announcement: Building on the Code of Life
Flagship Pioneering is hosting a Substack Live session on April 21 at 12:30 pm ET featuring origination partner Jake Rubens. The event will unveil a new initiative that leverages the "code of life" to advance synthetic‑biology‑based therapeutics. Rubens, an MIT‑trained synthetic biologist...
Elisrasib Shows Strong Response Rates in Advanced KRAS‑G12C Lung Cancer
Elisrasib, a next‑generation KRAS‑G12C inhibitor, produced clinical benefit in a 165‑patient cohort of advanced non‑small cell lung cancer at the AACR 2026 meeting. The oral drug, given at a 600 mg daily dose, showed durable responses in patients previously treated with...
FDA Accepts Ultragenyx BLA for UX111 Gene Therapy Targeting Sanfilippo A
Ultragenyx announced that the U.S. Food and Drug Administration has accepted its resubmitted Biologics License Application for UX111, an AAV9 gene therapy for Sanfilippo syndrome Type A. The agency set a PDUFA action date of September 19, positioning UX111 as...
STAT+: Eli Lilly’s $3.25 Billion Acquisition of Kelonia Therapeutics Caps Startup’s Tortuous Ride
Eli Lilly announced a $3.25 billion acquisition of Kelonia Therapeutics, a small biotech focused on cell therapies for cancer and autoimmune diseases. The deal may include additional payments if Kelonia meets clinical, regulatory, and commercial milestones. Kelonia, formerly Elcano Therapeutics, survived on...
Merck Partner Reveals Bispecific Data; Biogen Pays $100M for Antibody Rights
Merck’s partner Sino Biopharm disclosed first‑in‑human results for its PD‑1×VEGF bispecific antibody, MK‑2010, reporting that six of 11 lung‑cancer patients achieved a response at a low dose. A second cohort showed four responses among nine patients, indicating activity across dosing...
STORM-PE: Mechanical Thrombectomy Boosts Walking and Daily Living Gains
The STORM‑PE interim analysis shows that computer‑assisted vacuum thrombectomy (CAVT) markedly improves functional recovery in acute intermediate‑high‑risk pulmonary embolism. At 90 days, patients receiving mechanical thrombectomy walked an average of 479 m versus 368 m for anticoagulation alone, and 97% achieved NYHA class I...
What Patients Value in Data Reuse for Oncology Research: A Multi-Stakeholder Qualitative Study to Inform the European Health Data Space...
A new multi‑stakeholder qualitative study examined what oncology patients value when their health data are reused for research. Conducted in Belgium, the research highlights patients’ demand for transparent consent, robust data security, and clear societal benefits. Findings are intended to...
2018 Study Predicts Psilocybin Should Move to Schedule 4
The psychedelic executive order requires government to "initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials ... so that rescheduling ... may proceed as quickly as practicable". My 2018...
Gut Microbiome Can Reveal Risk of Parkinson’s, Scientists Say
A multinational study has identified a distinct gut‑microbiome signature that can flag individuals at heightened risk of Parkinson’s disease years before clinical symptoms appear. The microbial pattern is especially pronounced in people carrying known Parkinson’s risk genes and intensifies as...
Israel's SynBio Surge: CEOs Reveal Scaling Success
Israel has built one of the most concentrated synbio ecosystems outside the US. The country's National Bioconvergence Program, run through the Israel Innovation Authority, is specifically designed to close the gap between lab-scale innovation and commercial biomanufacturing. This session at @SynBioBeta 2026...
Kelonia Investor Venrock Will Clear a 45-Fold Return on Startup's Sale to Lilly
Venture capital firm Venrock is set to pocket roughly $900 million after its modest $20 million seed investment in Kelonia Therapeutics paid off. Kelonia agreed to an all‑cash acquisition by Eli Lilly valued at $3.25 billion, delivering an upfront payment that triggers the windfall....
Tebentafusp Shows Durable Survival in Metastatic Uveal Melanoma, Immunocore Reports
Immunocore reported five‑year overall survival data from its phase 3 trial of tebentafusp‑tebn (Kimmtrak) in HLA‑A*02:01‑positive metastatic uveal melanoma. The study showed 16% of patients on tebentafusp were alive at five years versus 8% on standard therapy, with a hazard ratio...
Biotech Must Prioritize Collaboration, Not Nationalism, for Patients
After a week in Washington DC at one of the best new annual events by @semafor , I came to China for just 2 nights to meet some of my friends from Washington. I even had to skip this year's...
Funding Boosts AI for 3D Protein and RNA Mapping
Funding will support the development of advanced AI methods to map proteins and RNA structures in three dimensions. https://t.co/L6ZSpg8iMW #infrastructure #IoT #AI #5G #cloud #edge #futureofwork @virginia_tech https://t.co/7K7X1E9NpH
AACR 2026: Revolution’s Next Prospect, Merck’s Reveal and a Lung Cancer Battle
At AACR 2026, Revolution Medicines reported that its RAS‑G12D inhibitor zoldonrasib produced a 52% response rate and a median 11.1‑month progression‑free survival in heavily pre‑treated non‑small cell lung cancer (NSCLC) patients, hinting at accelerated‑approval potential. Merck presented early data on...
GLP‑1s Preserve Muscle Better Than Diet‑Only Weight Loss
Summary for patients on GLP-1 drugs and non-drug weight loss re: muscle mass impact @AnnalsofIM https://t.co/pSDhbKkXwb https://t.co/qM7OgVJwQg
JRT: LSD-Derived Antidepressant Boosts Brain Spines without Hallucinations
One dose: > 46% more dendritic spines in prefrontal cortex > 100x more potent than ketamine as an antidepressant What is it? LSD with a two atom swap. > no trip > no hallucinations > no schizophrenia signature It's called JRT. https://t.co/sozMqlJctc
Biotech Has Become a Good News Story. Let the Sun Shine
Biotech is back in the spotlight as Revolution Medicines reported a Phase 3 trial that doubled survival for patients with advanced pancreatic cancer, a disease with a historically low five‑year survival rate. In March, Denali Therapeutics earned the first FDA approval...
Balaji Predicts Booming Market for Bro Biotech
.@theojaffee asks Balajis for his thoughts on Clavicular, Balajis says he’s cheering for Clavicular because he’s tapping into bro biotech/bro science and that’s set to be a major market. Peptides, etc https://t.co/CgSt6rg1zI
Free Virtual Summit on Multiomics & NGS – Register Now
Join @julemieux1 and as we co-host THE STATE OF MULTIOMICS & NGS @Genbio virtual summit next Wednesday, April 29th: Sponsored by @illumina - registration is free. https://t.co/NJErGGe5qb https://t.co/dJuRqy8Np7
Gilead Declines Another Arcus Option After Phase 3 TIGIT Fail
Gilead Sciences has declined another development option with Arcus Biosciences following the Phase 3 failure of their joint TIGIT immunotherapy. The setback ends a key pillar of a long‑standing collaboration and signals Gilead’s intent to trim external programs. Both companies will...
LLY's Second in Vivo CAR‑T Deal via Kelonia Buyout
Kelonia turns #ASH25 late-breaker into buyout, with $LLY's second move into in vivo Car-T. Via @ApexOnco -> https://t.co/NPhdnuhPu3 $AZN $GILD
Rejuvenated CD4 T Cells Promote Longevity, Infections Accelerate Senescence
Rejuvenated CD4 T cells--> longevity https://t.co/FH5XTQc3zl On the other hand, infection-->increased senescent T cells, shorter lifespan? https://t.co/wtsDnmIdnh
Lilly Adds Gene Delivery Technology to CAR T in up to $7B Kelonia Deal
Eli Lilly announced an up‑to $7 billion acquisition of Kelonia Therapeutics, securing its Phase 1 lentiviral in‑vivo CAR‑T candidate KLN‑1010 and the iGPS gene‑delivery platform. iGPS uses lentiviral particles to program a patient’s own T‑cells, potentially eliminating ex‑vivo manufacturing and pre‑treatment chemotherapy. The deal...
Key Overlooked Factors in Clinical Trial Design
New presentation on things we often forget to consider when designing a clinical trial: https://t.co/BVlSCIHdLu #Statistics #clinicaltrials
First Gut Microbiome Signature Predicts Parkinson’s Risk in Healthy Carriers
We've known the gut-brain axis is a key underpinning of Parkinson's disease. Today, for the 1st time, a gut microbiome signature denoting risk found in healthy individuals with genetic predisposition @NatureMedicine https://t.co/oDTItnis5L
Scientists Identify Main Cause of Extreme Nausea and Vomiting in Pregnancy
Scientists have pinpointed the growth differentiation factor 15 (GDF15) gene as the leading cause of hyperemesis gravidarum (HG), the most severe form of pregnancy nausea and vomiting. The genome‑wide study of nearly 11,000 HG cases and 420,000 controls also highlighted...
AACR 2026 Unveils Merck Breakthrough and Lung Cancer Hope
AACR 2026: Revolution’s next prospect, Merck’s reveal and a lung cancer battle https://t.co/u2iwCd3DKv #AACR26 $RVMD $MRK $NUVL $NUVB
Agenus Cancer Cocktail Records 0% Response Rate, Missing Midstage Goal
Agenus and its spin‑out MiNK Therapeutics reported a zero percent overall response rate in a Phase 2 trial of a three‑drug cocktail for advanced gastroesophageal adenocarcinoma. The regimen combined two experimental immunotherapies, botensilimab and balstilimab, with MiNK’s allogeneic iNKT cell therapy...
PSIL Surges as Trump Fast‑tracks Psychedelic Research
Far Out Man: The Psychedelics ETF $PSIL has destroyed its daily volume record in first 30min of trading.. Trump just signed ex order expediting research/access to psyche drugs to cure depression. The sector has been in dog house, waiting for...
Molecular Glue Daraxonrasib Shows Promise Against Pancreatic Cancer
Good summary of the marked benefit of the molecular glue drug (daraxonrasib) vs pancreatic cancer, from Revolution Medicines, and other progress (adds to the neoantigen vaccine with 6-year survival) gift link https://t.co/qk7Ar9dCAQ https://t.co/SMiA51fiwX
Novo’s Late-Stage Sickle Cell Win Piles Pressure on Competitors
Novo Nordisk reported that its oral pyruvate kinase‑R activator etavopivat reduced vaso‑occlusive crises by 27% in the Phase 3 HIBISCUS trial and more than doubled hemoglobin response rates versus placebo. The data support a regulatory filing slated for the second half...
Scientists Reverse Mouse Aging by 75%, Promising Human Breakthroughs
Dr. David Sinclair just dropped a two-hour masterclass on Tom Bilyeu's podcast. He shared 10 mind-blowing insights on how to reverse biological age in animals (and why it should work in humans too). 1) They already reversed a mice's age by 75%...
Psychedelics Go Mainstream
President Donald Trump issued an executive order to speed up research and access to psychedelic therapies, allocating $50 million in federal funding and instructing regulators to dismantle long‑standing barriers. The move validates a growing investment thesis that the psychedelic sector will...
Beyond GLP-1Rs: Emerging Targets Poised to Gain Share of Obesity Market
The global obesity drug market is projected to reach $172.6 bn by 2031, up 139% from 2026, driven by GLP‑1R giants like Wegovy and Zepbound. Non‑GLP‑1R therapeutics, currently a niche at $310 m, are forecast to surge 50‑fold, hitting $15.5 bn by 2031....
In Brain Tumors, New Use for CSF cfDNA
Cerebrospinal fluid (CSF) cell‑free DNA is emerging as a reliable source for genomic profiling of brain tumors, offering a less invasive alternative to surgical biopsies. Compared with plasma, CSF provides a higher signal‑to‑noise ratio, improving detection of tumor‑derived mutations. The...
STAT+: Finally Cracking KRAS as a Druggable Target
Revolution Medicines announced that its KRAS inhibitor daraxonrasib produced tumor shrinkage in a Phase 2 trial for pancreatic cancer, marking the first clear efficacy signal for an oral drug targeting the once‑undruggable KRAS protein. The result follows a wave of...
LLY Acquires Kelonia for $3.25bn After ASH25 Insights
It's official: $LLY buying Kelonia for $3.25bn + milestones. @ByMadeleineA take on the #ASH25 dataset that triggered this move: https://t.co/nVUNlq7YlO
Researchers Map Mediterranean Diet’s Multi‑Pathway Longevity Networks
Scientists from KGK Science Inc. and partner institutions published a review on April 19, 2026 that maps the complex network of polyphenols in the Mediterranean diet and their combined effects on longevity. Using liquid chromatography‑mass spectrometry and network‑biology analysis, the...
Four‑Week Orange Trial Shows Lipid Shifts in Fatty‑Liver Patients
Researchers at Italy’s National Institute of Gastroenterology completed a randomized 4‑week trial in which 60 patients with metabolic dysfunction‑associated steatotic liver disease ate 400 g of Navelina oranges daily. The study documented measurable changes in serum lipid species without affecting weight...
Regeneron Expands Dupixent to Pediatric Immunology and Teams with Telix on Radiopharma
Regeneron announced a label expansion for Dupixent in Europe to cover pediatric chronic inflammatory diseases and disclosed a strategic partnership with Telix Pharmaceuticals to develop radiopharmaceutical oncology agents. The moves broaden the company's biologic footprint and add a new oncology...