Bridging Promise and Evidence in Psychedelic Medicine
Jacobs and colleagues present a state‑of‑the‑art review of psilocybin and MDMA‑assisted therapies, highlighting their potential for treatment‑resistant depression and PTSD. The authors emphasize the distinct, session‑based paradigm that leverages acute neurobiological changes to produce lasting clinical benefits. However, they also flag critical methodological flaws such as functional unblinding, restrictive eligibility, and the intensive therapist involvement required for delivery. The review calls for larger, more diverse randomized trials and standardized protocols to bridge the gap between early promise and robust evidence.
New FDA Guidance Could Elevate Pharma’s Biosimilar Market
The FDA issued draft guidance that could lower biosimilar testing requirements by permitting foreign comparator data, potentially cutting development costs by about half. Over 80 biosimilars have been approved in the U.S. since the first approval 11 years ago, yet...
FDA Cracks Down on Misleading GLP‑1 Telehealth Marketing
The FDA is targeting telehealth marketing of GLP-1 drugs. Who’s prescribing them? Medical groups face ‘tricky’ questions when partners make misleading claims via @KatieMPalmer https://t.co/pf4Fwa7W7r
Bavarian Nordic and SII Sign Agreement for Chikungunya Vaccine Production
Bavarian Nordic has signed a manufacturing agreement with the Serum Institute of India to transfer full technology for its chikungunya vaccine, CHIKV VLP (branded Vimkunya). The deal replaces an earlier partnership with Biological E and builds on the companies' existing mpox‑vaccine collaboration....
Breakthrough Capsule Technology Offers New Insights Into Individual Cells
Researchers at Umeå University have unveiled a capsule‑based platform that encapsulates individual cells in semi‑permeable shells, enabling multiple, sequential molecular assays on the same cell. The design permits small reagents to diffuse in while retaining DNA and RNA, and it...
Generic GLP-1s Are Coming, but Americans Don’t Want to Wait
GLP‑1 drugs such as semaglutide have surged from diabetes treatment to a mass‑market weight‑loss solution, with roughly 12.4% of Americans now using them. Global sales are projected to climb from $50‑60 billion today to over $135 billion within a decade, driven largely...
Pharma Pulse: FDA Launches AEMS and the Rise of Direct-to-Employer Drug Purchasing
The FDA unveiled the Adverse Event Monitoring System (AEMS), a unified platform that shifts drug safety surveillance from quarterly updates to real‑time reporting and is expected to save roughly $120 million over five years. Simultaneously, a direct‑to‑employer drug‑purchasing model is gaining...
Lilly Warns of Impurity Risk in Certain Compounded Forms of Mounjaro and Zepbound
Eli Lilly warned that compounded versions of its GLP‑1 drugs Mounjaro and Zepbound, when mixed with vitamin B12, may contain unsafe impurities. The alert follows growing off‑label compounding as demand outpaces supply. Lilly’s notice urges clinicians and patients to verify product sources...
From Two Trials to One, Sponsors Face a Higher Standard
The FDA announced that a single pivotal trial can now satisfy efficacy requirements for new drug applications, replacing the previous two‑study mandate. This change raises expectations for data depth, quality, and risk‑based management throughout the trial lifecycle. Guests Oxana Iliach...
Rethinking Endocrine Therapy in ER-Positive Breast Cancer
Dr. Steven Quay, CEO of Atossa Therapeutics, highlighted a new focus on tolerability and prevention in estrogen‑receptor‑positive breast cancer, where five‑year survival now exceeds 90%. Atossa is developing a next‑generation SERM that aims to reduce side‑effects while maintaining efficacy and...
Injectable Mini-Livers as an Alternative to Liver Regeneration
Researchers have introduced INSITE, an injectable platform that combines primary human hepatocytes with hydrogel microspheres to form self‑assembling, vascularizable tissue ensembles in situ. Using ultrasound guidance, the scaffold is delivered to an ectopic site where it integrates with host vasculature...
FAST‐CRISPR: Fusogenic Association and Secured Transfection of CRISPR/Cas9 Ribonucleoproteins Using Lipid‐Silica Hybrid Nanoparticles for Therapeutic Genome Editing
Researchers introduced FAST‑CRISPR, a lipid‑silica hybrid nanoparticle that fuses directly with cell membranes to deliver CRISPR/Cas9 ribonucleoproteins. By combining a 1:1 weight ratio of cationic DOTAP and ionizable DODMA lipids with large‑pore silica cores, the platform achieves high RNP loading...
FAST‐CRISPR: Fusogenic Association and Secured Transfection of CRISPR/Cas9 Ribonucleoproteins Using Lipid‐Silica Hybrid Nanoparticles for Therapeutic Genome Editing (Small 15/2026)
Researchers at UNIST and collaborators introduced FAST‑CRISPR, a lipid‑silica hybrid nanoparticle system designed to ferry CRISPR/Cas9 ribonucleoproteins into cells. The platform leverages a fusogenic lipid coating that promotes rapid endosomal escape, securing high‑efficiency genome editing while preserving RNP integrity. Preclinical...
GSK Backs £11m Centre to Build Digital Twins of Organs for Faster Drug Discovery
GSK has pledged £11 million to launch the Modelling‑Informed Medicine Centre (MiMeC), a joint venture with Imperial College London and the University of Oxford. The centre will develop digital twins—computer‑based replicas of lungs, liver and kidneys—to run in‑silico experiments and speed...
Long-Term Neurodevelopment Effects of Antenatal COVID-19
A new longitudinal study finds that children born to mothers infected with COVID-19 during pregnancy exhibit measurable neurodevelopmental deficits. Brain scans at two years reveal reduced cortical thickness and lower IQ scores compared with unexposed peers. The research, spanning over...
Moving CAR-T Beyond Oncology
Researchers are expanding CAR‑T cell therapy beyond cancer to treat autoimmune diseases such as lupus and rheumatoid arthritis. Sail Biomedicine’s chief products and operations officer highlighted on the Pharmaceutical Executive podcast that the company has pivoted to RNA‑based CAR‑T platforms,...
Early Life Probiotics May Support Gut and Immune Development, Study Suggests
A randomized controlled trial of 119 infants showed that daily supplementation with Bifidobacterium infantis YLGB‑1496 for 12 weeks markedly improved gastrointestinal health, reducing stomach aches, diarrhea episodes, and related clinic visits. The probiotic also sustained higher fecal sIgA levels and...
George Medicines Partners with Ahngook Pharmaceutical to Commercialize GMRx2 in Korea
George Medicines has signed an exclusive licensing and supply agreement with South Korea’s Ahngook Pharmaceutical to bring its triple‑combination antihypertensive pill, GMRx2, to the Korean market. The single‑pill formulation blends telmisartan, amlodipine and indapamide in three dose strengths, aiming for...
In Vitro Generation of Highly Infectious Recombinant Prions Adopting Structural Architectures of Bona Fide Prions
Researchers have developed a protein misfolding cyclic amplification (PMCA) assay that reliably produces recombinant prion fibrils with infectivity comparable to the RML brain‑derived strain. Cryo‑EM analysis shows these fibrils adopt the characteristic V‑shaped, parallel in‑register β‑sheet architecture, though the C‑terminal...
C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea
C2N Diagnostics has signed a partnership with BeauBrain Healthcare to introduce its PrecivityAD2 blood test for Alzheimer’s disease in South Korea, targeting patients aged 50 and older with mild cognitive impairment or dementia. Clinical studies published in JAMA and npj...
Experimental Study on the Construction of a Rabbit Biliary Stent Model via Transduodenal Puncture and the Placement of an Modified...
Researchers have created a New Zealand rabbit model that mimics biliary stenting by using a transduodenal wall puncture and a modified intravenous catheter. The experimental group achieved an 86.7% technical success rate, with most complications being mild and transient. Serum liver...
Join Final FDA Advisory Committee on Flu Shot Access
If you are curious about seeing what may be the last competent FDA advisory committee left standing in action as they contribute to determining access to flu shots next fall, join me, @jessicamalaty, & @SaveAmericaMvm at 12:30 pm ET on...
Ancient Mushroom, Modern Medicine: Paul Stamets Says Agarikon Mycelium May Be Key to Fighting Viral Pandemics
Mushroom mycologist Paul Stamets presented data indicating that Agarikon (Fomitopsis officinalis) mycelium possesses broad antiviral properties. In two placebo‑controlled trials, a combined Agarikon‑turkey‑tail extract reduced COVID‑19 vaccine side effects, sustained antibody titers, and accelerated recovery in hospitalized patients. The research,...
Probiotic L. Paracasei DG I1572 Combats Vascular Inflammaging
Gut Microbiota Manipulation by Probiotic Lacticaseibacillus paracasei DG I1572 as New Therapeutical Strategy to Counteract Vascular Inflammaging https://t.co/91dumlTNgU https://t.co/tkL0m8P6nd
FDA Signals Potential Updates to SUPAC Guidances—Comments Due June 1, 2026
The FDA has opened a public docket to solicit comments on its long‑standing Scale‑Up and Post‑Approval Changes (SUPAC) guidances for immediate‑release solid oral, non‑sterile semisolid, modified‑release solid oral dosage forms and the manufacturing equipment addendum. The agency seeks feedback on...
New Tissue Models Accelerate Liver Disease Drug Development
New tissue models could help researchers develop drugs for liver disease by Anne Trafton @MIT Learn more: https://t.co/hkeRZ0W47B #HealthTech #EmergingTech #TechForGood #Innovation https://t.co/LNvft8iX9M
Niclosamide Combats Frailty by Dampening mTORC1 Hyperactivation
Niclosamide extends health span and reduces frailty by ameliorating mTORC1 hyperactivation in aging models https://t.co/U8LALaiz9D https://t.co/67rsM0g0pP
Nektar Therapeutics (NKTR) Q4 2025 Earnings Call Transcript
Nektar Therapeutics reported strong Q4 2020 results, highlighting robust progress on its cytokine platform. The IL‑2 agonist BEMPEG demonstrated a median progression‑free survival of 30.9 months in melanoma and is now enrolled in six registrational trials across melanoma, renal, bladder,...
Daily Briefing: Vaccine-Carrying Mosquitoes Could Inoculate Bats Against Rabies
Researchers have engineered Aedes aegypti mosquitoes to carry vaccine antigens in their saliva, successfully inoculating bats against rabies and Nipah viruses in laboratory experiments. The mosquitoes were fed vaccine‑laden blood, then transmitted the immunogen when they fed on or were...
DNA Origami Vaccine Rivals mRNA Shots While Being Easier to Store and Manufacture
Researchers at Harvard’s Wyss Institute and Dana‑Farber unveiled DoriVac, a DNA origami‑based vaccine platform that delivers antigens and adjuvants on a self‑folding nanostructure. In pre‑clinical mouse studies and a human lymph‑node‑on‑a‑chip model, DoriVac generated antibody and T‑cell responses comparable to...
Researchers Use AI to Develop RNA-Based Synthetic NAND Switch in Living Cells
Researchers at TU Darmstadt have engineered the first RNA‑based synthetic NAND gate by linking two riboswitches that respond to distinct ligands. Using high‑throughput screening combined with a deep‑learning‑driven Bayesian optimization loop, they evaluated only 82 variants to isolate sequences that exhibit...
Startup Vima Adds Parkinson’s to Movement Disorder Scope, Expanding Series A Round to $100M
Vima Therapeutics announced an additional $40 million raise, taking its Series A funding to $100 million. The capital will support parallel Phase 2 trials of its lead candidate VIM0423 in isolated dystonia and Parkinson’s disease, expanding the startup’s focus beyond the rare movement disorder....
Gut‑brain Signaling Fixes Age‑related Memory Loss
Intestinal interoceptive dysfunction drives age-associated cognitive decline "We leverage this pathway to define interventions that enhance memory in aged mice, such as phage targeting of Parabacteroides, GPR84 inhibition and restoration of vagal activity. These findings indicate a key role for interoceptive dysfunction...
Can FDA Tolerate Cancer Risk for Rare Pediatric Disease Gene Therapies?
The FDA placed a clinical hold on Regenxbio’s RGX‑111 and RGX‑121 gene‑therapy trials after a pediatric MPS I patient developed a tumor four years post‑treatment. The case marks the first documented long‑latency cancer linked to an adeno‑associated virus (AAV) vector in...
Phase 2 Trial Compares Dara‑Bor
EAA241 - Ph 2 RCT Dara-Bor-Dex vs Cy-Bor-Dex in the treatment of Newly Diagnosed Multiple Myeloma with Light Chain Cast Nephropathy (LCCN) [Study activated 8/11/25] @keruakous https://t.co/1NgvVZ3fTA #NCT07085728 #mmsm @eaonc https://t.co/IvK3UNeem9
Phase 3
#EAOnc EQUATE EAA181 Effective Quadruplet Utilization After Tx Evaluation: Ph3 RCT NDMM Not Intended for Early ASCT [Activated: 10/27/20] PI= @myelomaMD https://t.co/qD26HMx3J8 #NCT04566328 #mmMRD #mmsm @eaonc @mweissmdphd @VincentRK @LynneWagnerPhD Wei Snyder Kostakoglu @mtmdphd https://t.co/FLK0sJ0N1w
Science Spotlight: New Ways to Attack Β-Amyloid Plaques in Alzheimer’s
Two pre‑clinical studies propose active clearance of β‑amyloid as a new Alzheimer’s strategy. Researchers at Washington University engineered astrocytes with chimeric antigen receptors (CARs) that engulf plaques, while another team designed bispecific peptides that ferry amyloid into cells for lysosomal...
Daratumumab Boosts Revlimid Efficacy in Smoldering Myeloma
#EAonc EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) - PI: @nsc_natalie https://t.co/VtBMJUjI5X Activated: Apr 30, 2019 #mmsm @eaonc #NCT03937635 @VincentRK @mweissmdphd https://t.co/ikQKjHjscU
Phase 3 Trial Tests
.@SWOG S2213 Ph3 RCT Dara-VC Induction Followed by ASCT or Dara-VCD Consolidation & Daratumumab Maintenance in Pts w/ Newly Diagnosed AL Amyloidosis [Activated: 12/1/23] https://t.co/OizUfJCc2c #mmsm #bmtsm https://t.co/FoT3i0xGcL
Artificial Kinetochores Take the Pressure Off Aging Chromosomes During Meiosis
Researchers at RIKEN have engineered protein‑based artificial kinetochores that compete with natural chromosome kinetochores for microtubule attachment during meiosis. By lowering the overall pulling force, these constructs keep weakened chromosome pairs together in aged mouse oocytes, restoring accurate DNA segregation....
Mapping Genomic Alterations in Multiple Myeloma Precursors
Genomic landscape of multiple myeloma and its precursor conditions [May 21, 2025] Jean-Baptiste Alberge et al. @IrenemGhobrial @NatureGenet https://t.co/DDWGRrpI4Y #mmsm #PrecisionMedicine #cagenome https://t.co/LY1MzFXSBN
Multiple Myeloma Evades GPRC5D T‑Cell Engagers via Multim
Multimodal antigenic escape to GPRC5D-targeted T cell engagers in multiple myeloma [Jan 15, 2026] @hollyleeYJ et al. @NBahlis @NatureMedicine https://t.co/mz393mPMAq #mmsm #PrecisionMedicine #tcellrx THREAD: https://t.co/lNX9b7LsnR HT @AuclairDan https://t.co/2qih7LwP1c
Hawley Unveils Bill to Ban Abortion Pill, Strip FDA Approval
Senator Josh Hawley introduced a bill to immediately withdraw the FDA's safety approval for mifepristone, the primary abortion medication. The legislation follows recent Supreme Court and Trump‑era reviews of the drug and cites a controversial conservative study alleging serious adverse...
AGENT IDE Midterm Results Still Give DCB an Edge for In-Stent Restenosis
Three‑year follow‑up of the AGENT IDE trial shows the Agent paclitaxel‑coated balloon (DCB) outperforms uncoated balloon angioplasty in treating in‑stent restenosis (ISR), with target‑lesion failure (TLF) rates of 32.7% versus 40.9% (hazard ratio 0.72). The advantage is driven mainly by...
Foghorn Therapeutics Provides Financial Update for 2025 and 2026 Strategic Outlook
Foghorn Therapeutics announced a financial update highlighting progress on its lead oncology candidate FHD-909, which remains on schedule in Phase 1 dose‑escalation for SMARCA4‑mutant NSCLC. The company also confirmed that its selective CBP and EP300 degrader programs are slated for...
Elutia Reports Fourth Quarter and Full Year 2025 Financial Results; Initiates NXT-41 Regulatory Process
Elutia Inc. reported its Q4 and full‑year 2025 results, highlighting the $88 million sale of its BioEnvelope business to Boston Scientific and a cash position of $36.4 million plus $8 million in escrow. The company submitted a 510(k) for the base biologic matrix...
NanoTess Lands Embecta Deal to Put Its Tech in 14,000 Canadian Pharmacies
Calgary‑based NanoTess has signed a distribution agreement with diabetes‑care company Embecta to place its NanoSALV Catalytic gel in more than 14,000 Canadian pharmacies. NanoSALV, authorized by Health Canada in 2022, uses micron‑scale catalytic particles to speed cellular reactions, reduce inflammation...
First In‑Utero Stem Cell Surgery Cures Spina Bifida
In a First, Researchers Use Stem Cells and Surgery to Treat Spina Bifida in the Womb by @ShellyFan https://t.co/4xO4I0iLJL https://t.co/HV1CGzlMXU
FDA Merges Adverse Event Trackers Into One Database
The FDA announced a unified adverse‑event database that will eventually incorporate all of its existing reporting systems, including the vaccine‑side‑effect tracker jointly operated with the CDC. The new platform, called the Adverse Event Monitoring System, centralizes data from drugs, biologics,...
FDA Clears New Large-Bore Catheter for Challenging Stroke Cases
Toro Neurovascular has obtained FDA clearance for its Toro 88 Superbore Catheter, a large‑bore device engineered for challenging stroke interventions. The catheter promises enhanced support, trackability, and stability, addressing the time‑sensitive nature of neurovascular procedures. UCLA interventional neuroradiologist Dr. Satoshi Tateshima...