A Dose of Psilocybin Helps Smokers Quit in New Study
Researchers at Johns Hopkins found a single dose of psilocybin dramatically increased smoking cessation rates compared with nicotine patches. In a randomized trial of 82 smokers, 17 of 41 participants who received psilocybin remained abstinent after six months versus four of 41 on patches, a more than six‑fold advantage. All participants also received 13 weeks of cognitive‑behavioral therapy, and the study was published in JAMA Network Open. The authors note the need for larger, more diverse trials to confirm findings.
First-of-Its-Kind Vaccine Protects Children From Deadly E. Coli Infections
Scientists announced ETVAX, the first oral vaccine that targets enterotoxigenic *E. coli* (ETEC) in children, after a large‑scale trial in The Gambia. The study involved 4,936 infants aged six to 18 months and demonstrated a 48% reduction in moderate‑to‑severe ETEC...
STAT+: Novo Nordisk Is Warned by the FDA for Failing to Report Side Effects Tied to GLP-1 Drugs
Novo Nordisk received an FDA warning letter on March 5, 2026 for failing to report suspected side effects of its GLP‑1 medicines. The violations were uncovered during a 2025 inspection of the company’s facilities and were described as “serious.” The agency warned...
Building for Decades: Dubai’s Long Game in Life Sciences
Dubai is positioning itself as a long‑term hub for healthcare and life sciences through two complementary free‑zone clusters – Dubai Healthcare City (DHCC) and Dubai Science Park (DSP). DHCC is undergoing a $1.3 bn expansion that will create six tightly linked...
FDA Sets Scope for Attempt To Reduce Manufacturing-Related Approval Rejections
The FDA has defined the scope of pre‑submission facility meetings to curb manufacturing‑related complete response letters that delay drug approvals. It agreed to cover prior production‑site inspections, novel process elements and supply‑chain node strategies, while rejecting topics such as alternative...
Desert to Discovery: Five Hot Biotechs in Arizona
Arizona's biotech sector is booming, with $3.7 billion invested over the past seven years and a growing pipeline of innovative companies. Nectero Therapeutics secured a $96 million Series D to develop a fast‑track, breakthrough‑designated endovascular treatment for abdominal aortic aneurysms, while Humabiologics obtained...
Researchers Track Mineral Growth on Bioorganic Coatings in Real Time at Nanoscale
Researchers at Jeonbuk National University used a quartz crystal microbalance to compare calcium‑phosphate mineralization on titanium dioxide nanoparticles coated with polydopamine (PDA) versus zein. Real‑time measurements showed PDA‑coated particles accumulated 7,780 ng of mineral, roughly 37% more than the 5,641 ng recorded...
BioNTech Founders' Exit Needed as Sales Plunge
This morning's BioNTech news strikes me as very odd. Certainly, founder Ugur Sahin and Ozlem Tureci shouldn't feel compelled to run the company forever, and they may not be the right people to manage both the continued decline of Covid-19...
STAT+: Pharmalittle: We’re Reading About a U.S. Senator Probing FDA, BioNTech Founders Leaving, and Much More
BioNTech co‑founders Ugur Sahin and Özlem Türeci will leave the company by year‑end to launch an unnamed mRNA‑focused venture, with BioNTech retaining a minority stake and licensing key technology. The split allows BioNTech to concentrate on its late‑stage cancer pipeline...
Deaminet 2026: Breakthroughs in Base Editing, Deaminase Biology, and Therapeutic Translation
Deaminet 2026 showcased accelerating advances in base and prime editing, highlighted by rapid Addgene distribution growth and new mechanistic insights such as PE6d’s heightened processivity and ABE8e’s dimer‑driven efficiency. Novel off‑target detection platforms like beCasKAS and Inrich‑seq revealed far more unintended...
BioNTech Founders Launch New Biotech, Eye FDA Acceptance
Sticking with the science. I find that really impressive. BioNTech founders Uğur Şahin and Özlem Türeci are leaving the biotech they founded to start a new one. Maybe by the time they have something for the clinic, the FDA will...
China Is Going After the World's Most Expensive Drugs: Endpoints Signal
China is actively targeting ultra‑expensive gene therapies, challenging the notion that these treatments are immune to price competition. Recent regulatory approvals and centralized procurement initiatives have forced manufacturers to negotiate steep discounts on therapies that once commanded multi‑million‑dollar price tags....
FDA Widens Use of Leucovorin without New Trial Data
The U.S. Food and Drug Administration has approved the generic form of leucovorin, also known as folinic acid, for treating cerebral folate deficiency (CFD). The decision widens the drug’s label despite the absence of new clinical trial data, relying on...
Cell and Gene Therapy Manufacturing Market to Skyrocket to $146B by 2032
Credence Research forecasts the global cell and gene therapy manufacturing market to surge from $19.3 billion in 2024 to $146.2 billion by 2032. The compound annual growth rate is estimated at 28.8%, propelled by rising demand for advanced therapies, expanding commercialization, and...
AI-Focused Fund Breakout Raises $114M To Support Early-Stage Biotechs
Breakout Ventures announced the close of its third fund, raising $114 million to back AI‑driven biotech startups. The capital will be deployed to early‑stage companies, including a University of Chicago spin‑out focused on computational small‑molecule design and a stealth venture tackling...
Statement on Biomedical Countermeasures Initiative
BIOTECanada welcomes the launch of the National Research Council of Canada’s Biomedical Countermeasures Initiative, a key component of the federal Defence Industrial Strategy. The program is designed to strengthen Canada’s domestic capacity to develop and manufacture diagnostics, vaccines, and therapeutics...
Rising Amid Flurry of CAR T Deals, Stylus Proves Cell Therapy Is Not Dead
Stylus Medicine entered the cell‑therapy arena in May 2025 with an in‑vivo CAR‑T platform that delivers a lipid nanoparticle‑encapsulated recombinase to engineer T cells inside patients. The move comes after major pharma acquisitions—BMS buying Orbital Therapeutics for $1.5 billion and Gilead...
Pharma Pulse: Ipsen’s Global Tazemetostat Withdrawal and FDA Approval of Deucravacitinib for Psoriatic Arthritis
French biotech Ipsen announced an immediate, global voluntary withdrawal of its oncology drug tazemetostat (Tazverik) after safety signals in the SYMPHONY‑1 confirmatory trial indicated a rise in secondary hematologic malignancies. The company is coordinating with the FDA to manage the...
Samsung Biologics, Eli Lilly to Establish Biotech Incubator in Incheon
Samsung Biologics and U.S. pharma leader Eli Lilly have signed an agreement to launch a biotech incubator in Incheon’s Songdo district. The facility will host Lilly’s Gateway Labs platform, offering lab space, equipment, funding and R&D collaboration to emerging biotech firms....
3D Printing Meets Embryo Screening: Additive Manufacturing in IVF and Reproductive Medicine
Additive manufacturing is reshaping IVF and embryo screening by enabling high‑resolution microfluidic chips, biocompatible scaffolds, and precision tools. Two‑photon polymerization printers can produce sub‑50 µm channels in hours, cutting device lead times from weeks to days and improving embryo handling consistency....
Dyne Plans Post-Prasad FDA Run as Duchenne Exon Skipper Sustains Benefit in Long Term Data
Dyne Therapeutics reported that its exon‑skipping candidate z‑rostudirsen sustained respiratory and cardiac benefits through 24 months in the Phase 1/2 DELIVER study for Duchenne muscular dystrophy. The therapy maintained forced vital capacity, circumferential strain and left‑ventricular ejection fraction improvements compared with...
Junshi Receives China’s NMPA Acceptance for Toripalimab Injection
Junshi Biosciences has received acceptance from China’s National Medical Products Administration for its subcutaneous toripalimab injection (JS001sc), covering 12 cancer indications. The filing marks the first domestic anti‑PD‑1 monoclonal antibody in a subcutaneous formulation to reach the marketing application stage....
Ascletis Announces Positive Topline Results From U.S. Phase II, 24-Week Study for Its Ultra-Long-Acting Subcutaneous Depot Formulations of Small Molecule...
Ascletis Pharma reported positive topline data from a U.S. Phase II, 24‑week study of its ultra‑long‑acting subcutaneous depot GLP‑1R agonist ASC30. The once‑monthly formulation A1 produced a placebo‑adjusted mean weight loss of 7.5% at week 16 and sustained a 5.8%...
BioNTech Co-Founders to Exit Company and Start a New One
Uğur Şahin and Özlem Türeci announced they will leave BioNTech by the end of 2026 to launch a new company focused on next‑generation mRNA technologies. BioNTech will concurrently narrow its portfolio, concentrating on late‑stage therapeutic candidates and its existing vaccine...
STAT+: Large Drugmakers Are Developing Fewer Antibiotics, Analysis Finds
A new analysis shows the world’s largest pharmaceutical firms cut antimicrobial development by 35% over the past five years, dropping from 92 to 60 candidates. Only five of the 39 pipeline projects aimed at WHO priority pathogens include pediatric formulations...
How FDA's Removal of the Two-Trial Requirement Affects Development Programs
The FDA has eliminated the longstanding requirement for two pivotal clinical trials, adopting a single‑trial default to speed drug approvals. The agency pairs this change with a mandate for more rigorous post‑market surveillance to catch safety signals after launch. Pharmaceutical...
NewcelX and Eledon Partner for NCEL-101 Programme
NewcelX has entered a collaborative research agreement with Eledon Pharmaceuticals to advance its NCEL‑101 cell therapy for type‑1 diabetes. The partnership integrates NewcelX’s off‑the‑shelf islet replacement product with Eledon’s anti‑CD40L monoclonal antibody, tegoprubart, which has been used in over 100...
For the First Time, Ferring Reports Revenue of Over €2.5 Billion in 2025
Ferring Pharmaceuticals reported revenue above €2.5 billion for 2025, a 7% increase at actual exchange rates and 10% at constant rates. Growth was powered by its flagship reproductive medicine Menopur and the U.S. ramp‑up of gene‑based bladder‑cancer therapy Adstiladrin. Operating profit...
Researchers Take a Step Closer to Finding a Treatment for a Rare Genetic Neurodevelopmental Condition
Researchers at Texas Children’s Duncan Neurological Research Institute and Baylor College of Medicine demonstrated that skipping exon e2 of the MECP2 gene boosts MeCP2 protein production by 50‑60%, rescuing neuronal function in Rett syndrome mouse models and patient‑derived cells. The study...
Why the FDA Is Embracing Old Math for New Drugs
The FDA released draft guidance encouraging the use of Bayesian statistics in drug and biologic clinical trials, aiming to shorten development timelines and lower costs. By allowing external data—known as priors—to be incorporated, the approach promises more efficient, adaptive studies,...
Single Pivotal Trials Demand Stronger Data and Risk Strategies
Following the FDA’s recent shift to require only one pivotal trial for new drug applications, sponsors now face heightened pressure to generate robust efficacy and safety data. Regulators expect a single, bullet‑proof study rather than two less conclusive trials, mirroring...
Rapport Therapeutics Partners with Tenacia Biotechnology to Advance RAP-219 in Greater China
Rapport Therapeutics has granted Tenacia Biotechnology exclusive rights to develop and commercialize its TARPγ8‑specific AMPA receptor negative allosteric modulator RAP‑219 in Greater China, covering indications such as focal onset seizures and bipolar mania. The agreement provides Rapport with a $20 million...
Ubiquitin Gene PCR Works, Other Primers Unreliable
I used the extracted gDNA from tonight's prep to try and PCR a larger chunk of petunia genome hunting for one of its ubiquitin genes. I'm using a published genome as reference but its not my cultivar so need to...
DNA Repair Mutations Predict Response to Chemo‑Immunotherapy in Pancreatic Cancer
DNA Repair gene alterations and efficacy from gemcitabine and nab-paclitaxel with/without durvalumab and tremelimumab in metastatic pancreatic ductal adenocarcinoma https://t.co/v39bOreJwu
How Voluntary Exercise Reshapes Tryptophan Metabolism Through the Gut Microbiota
A study in *Brain Medicine* shows that eight weeks of voluntary wheel running in adult male rats reshapes the gut microbiota, notably decreasing the tryptophan‑metabolizing genera Alistipes and Clostridium. The microbial shift coincides with altered serum metabolites, including a rise...
ATAI: Top‑Positioned Psychedelic Biotech Leader
Good moment to resurface this blog post explaining why I believe $ATAI is the best-positioned company in the psychedelic biotech sector 😉🚀
Whole‑cell Cycle Simulation Demands Years, GPUs, Six Days
Why simulating an entire cell cycle took years, multiple GPUs and six days per run https://t.co/41xr8Bnn4C https://t.co/9LcRqDswYT
Mouse Brain Study Reveals Why Blockbuster Weight-Loss Drugs May Work Differently in Females and Males
Researchers at Icahn School of Medicine created the first sex‑specific atlas of GLP‑1 expression in the mouse brain using RNAscope, mapping the peptide across 25 nuclei. The atlas shows pronounced differences between females and males, especially in hindbrain nuclei of...
FDA Adds Six Former Members, Total Nine Voters
Correction: I took down a post about Thursday's #VRBPAC meeting because it contained an error. #FDA has named 6 temporary voting members (not 2), which will bring the number for the meeting to 9. The temps are all former members....
FDA Accepts CAPR's Deramiocel Resubmission, Decision Aug 22
$CAPR resubmission of the deramiocel application accepted by the FDA. New decision date: Aug. 22. https://t.co/mWSyyXg8di
Cost–Benefit Analysis for Synthetic Nucleic Acid Screening in the European Union
RAND Europe, commissioned by Sentinel Bio, delivered a EU‑wide cost‑benefit analysis of synthetic nucleic acid synthesis screening. The study compares three policy options—voluntary guidance, EU‑funding conditionality, and mandatory regulation—over a ten‑year horizon. Results show all options generate net societal benefits,...
Coding Beats Pipettes: The Biologist’s Ultimate Lab Tool
1/ Your most powerful lab tool isn't a pipette. It's a keyboard. If you're a biologist who hasn't learned to code yet, here are 10 rules that changed everything for me: https://t.co/DhSXBXGitk
CRISPR's Natural Blueprint Powers Gene‑Therapy Breakthroughs
How CRISPR works (in nature) and how it’s being leveraged as a tool for gene editing to cure and prevent diseases. Dr Alex Marson MD PhD of UCSF on the Huberman Lab podcast out now. https://t.co/fiL48JHxSL
The Skin We’re In: Microfluidics, Bubbles, and Healthcare Solutions with Prof. David Fernández Rivas
In this episode, Professor David Fernández‑Rivas discusses the role of engineers as problem‑solvers and the necessity of interdisciplinary collaboration, especially between physics, chemistry, and bioengineering. He explains microfluidics—manipulating fluids at the micrometer scale—and its parallels with microelectronics, then delves into...
GSK Secures Approval Yet Refuses to Produce Drug
$GSK is ostensibly the "sponsor" that won the approval but is once again saying it won't produce the drug.
Nonprofit Aims To Modernize Manufacturing by Clearing Capital Hurdle
A nonprofit, the API Innovation Center (APIIC), is tackling the capital barrier that prevents U.S. drug makers from adopting continuous manufacturing. By pooling state, federal, philanthropic and private funds, APIIC installs equipment at manufacturers at no upfront cost, de‑risking the...
Finding Calm at VISTEC's Global SynBio Symposium
Back at peaceful campus of VISTEC 🇹🇭 all this week for their SynBio/Biocatalysis symposium with speakers from around the world. Nice to escape the heat and hustle of Bangkok. https://t.co/s9ZRM3uyDu
Portfolio of SCN2A Gene Variants, and More
A new preprint maps a broad portfolio of SCN2A gene variants onto the Nav1.2 sodium channel, revealing distinct functional impacts that correspond to neurodevelopmental outcomes. Loss‑of‑function mutations linked to non‑syndromic autism reduce channel activity, while co‑expression with wild‑type proteins produces...
Other News to Note for March 10, 2026
Merck released phase III data from its Litespark‑011 trial, showing a potent HIF‑2α inhibitor that could reshape renal‑cell carcinoma therapy. Researchers at INSERM uncovered hypothalamic tanycytes as a primary mechanism for clearing pathological tau, opening new avenues for Alzheimer’s treatment....
Resident Macrophages Play a Role in Maintaining Murine Intraocular Pressure
Duke University researchers discovered that resident tissue macrophages (RTMs) are essential for maintaining intraocular pressure (IOP) in mice. Fluorescent tagging showed that selective removal of RTMs clogged the eye's outflow pathway, causing fluid buildup and elevated IOP, while depletion of...