No Evidence of Health Risks From Genetically Modified Crops Found
South Korean researchers from Seoul National University and Chosun University published a paper showing no scientific link between genetically modified (GM) crops and chronic diseases, confirming earlier findings from the 2016 National Academies report. Their analysis of PubMed literature and epidemiological data across countries with and without GM cultivation found no increase in cancer, preterm birth, allergies, or other health issues. Despite this consensus, public skepticism remains high, driven by media amplification, social‑media echo chambers, and lingering concerns about glyphosate. The study underscores a persistent gap between scientific evidence and consumer perception.
Low‑dose Rapamycin Eases Fatigue and PEM in ME/CFS
Low-dose rapamycin alleviates clinical symptoms of fatigue and PEM in ME/CFS patients via improvement of autophagy: a pilot study Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem disorder characterized by profound fatigue… 👉 “Low-dose rapamycin effectively reduced PEM and other key...
The Many Dangers of 7-Ketocholesterol
Researchers led by Matthew O’Connor have published a comprehensive review of 7‑ketocholesterol (7KC), an oxidized cholesterol formed by reactive oxygen species. The paper details how 7KC accumulates in atherosclerotic plaques, transforms macrophages into inflammatory foam cells, and exerts neurotoxic effects...
Pfizer to Close Ignite, Its R&D Services Unit for Small Biotechs
Pfizer announced the shutdown of its Ignite unit, a dedicated R&D services platform that partnered with early‑stage biotech companies. Ignite offered fee‑based scientific, regulatory, and strategic support, helping dozens of startups advance drug candidates. The closure aligns with Pfizer’s cost‑discipline...
Propanc Advances PRP Toward Clinical Trials for Pancreatic Cancer
Propanc Biopharma announced that its proenzyme therapy PRP is moving toward a Phase Ib first‑in‑human study for advanced pancreatic cancer. The company highlighted preclinical data showing more than 85 % tumor‑growth inhibition and secured FDA orphan‑drug designation. A validated pharmacokinetic assay developed...
Can High-Dose Vitamin D Prevent Long-COVID Cognitive Decline?
Researchers in the VIVID trial, one of the largest randomized studies on vitamin D and COVID‑19, found that a high‑dose vitamin D3 regimen (3,200 IU/day after a loading dose) did not lower acute disease severity, hospitalizations, or death. However, among participants...
In the Clinic for March 12, 2026
BioWorld’s March 12, 2026 clinic roundup aggregates a suite of data snapshots and special reports spanning biopharma, medical technology, and emerging therapeutic areas. The collection links to analyses on mRNA vaccine research, China’s GLP‑1 market, CAR‑T developments, and the med‑tech outlook for...
‘Magic Mushroom’ Derivative Could Heal without Hallucinations, Sparking Hope for New Therapies
Scientists at the University of Padova synthesized fluorinated psilocin derivatives, identifying compound 4e as a lead that retains serotonergic activity while markedly reducing hallucinogenic effects in mice. In vitro assays showed 4e is a selective partial agonist at 5‑HT2A and...
Diatom-Based Microrobots Show Promise for Targeted Photodynamic Therapy of Glioblastoma
Researchers at China’s Shenyang Institute of Automation have created magnetically controlled microrobots from diatom frustules for glioblastoma photodynamic therapy. The robots retain natural chlorophyll, serving as a built‑in photosensitizer, and can be steered via external magnetic fields to tumor sites....
Stanley Family Foundation Renews Commitment to Accelerate Psychiatric Research at Broad Institute
The Stanley Family Foundation has renewed its support for the Stanley Center for Psychiatric Research at the Broad Institute, bringing its cumulative investment to over $1 billion, including a fresh $280 million pledge. The funding fuels large‑scale genetic studies aimed at uncovering...
LLNL-Led Study Uses Machine Learning, Veterans’ Health Records to Identify ALS Drug-Repurposing Candidate
Lawrence Livermore National Laboratory and partners applied causal‑inference machine learning to electronic health records of more than 11,000 U.S. veterans with amyotrophic lateral sclerosis. The analysis, published in The Lancet Digital Health, identified 27 existing medications that correlate with longer...
A Simpler Form of DNA May Be Key to Non-Viral Gene Therapy, Study Suggests
Researchers have identified a streamlined DNA construct that could replace viral carriers in gene‑therapy applications. The study demonstrates that this minimalist DNA format delivers therapeutic genes with efficiency comparable to adeno‑associated viruses while eliciting a weaker immune response. Production of...
FDA to Unify Agency’s ‘Fragmented’ Safety Surveillance System
The FDA launched the Adverse Event Monitoring System (AEMS), a unified dashboard that merges seven previously fragmented safety databases into a single platform. Four databases are already live, with the remaining three slated for integration by May, covering drugs, vaccines,...
FDA to Unify Agency’s ‘Fragmented’ Safety Surveillance System
The FDA has launched the Adverse Event Monitoring System (AEMS), a unified platform that merges seven previously fragmented safety‑surveillance databases. Four of those databases are live today, with the remaining three slated for integration by May 2026. The agency processes...
FDA Clears Intravascular Device Billed as ‘World’s Smallest Camera’ as Physicians Share New Data
Vena Medical secured FDA clearance for its Vena MicroAngioscope System, marketed as the world’s smallest intravascular camera, for peripheral artery imaging. The device provides real‑time color images without X‑ray fluoroscopy by pairing a balloon distal access catheter with a saline...
Navigating Complexity in Emerging Biotech: Innovations, Integrations, and Initial Hurdles
Industry experts highlight three intersecting forces reshaping emerging biotech: the persistent funding and regulatory hurdles faced by early‑stage startups, the rapid migration of AI from a supportive tool to an operational backbone, and breakthrough computational methods—including quantum chemistry—that are redefining...
The Hepatitis B Birth Dose Trial That Triggered the WHO Alarm
The World Health Organization issued a formal warning on 13 February 2026 about a proposed randomized trial in Guinea‑Bissau that would withhold the hepatitis B birth‑dose vaccine from roughly half of 14,000 newborns. The study seeks to measure non‑specific effects...
RFK Jr Promotes Unproven Peptides, BPC‑157 Lacks Solid Data
RFK Jr is trying to get 14 peptides, without data on safety or efficacy, licensed and approved by FDA. His favorite is BPC-157. "Only three small human studies of BPC-157 exist, for instance, the largest of which is a telephone...
FDA Reform Essential for Real Longevity Breakthroughs
I love the longevity proponents on X But we WON'T get true longevity therapeutics if we don't reform the FDA or find a way around them. The FDA is still a quagmire of regulatory rot that has to be reformed to get...
Why African Striped Mice Can Be the Best of Dads — or the Worst
Researchers discovered that the Agouti gene acts as a molecular switch governing paternal behavior in African striped mice. Males housed together displayed aggression toward pups, while solitary males became attentive fathers, a shift linked to reduced Agouti activity in the...
Lilly Warns GLP‑1 Knockoffs Are Dangerous, Intensifies Compounder Battle
Lilly warns GLP-1 knockoffs may be ‘dangerous,’ escalating war with compounders https://t.co/XOKLqIzAES @ByJonGardner $LLY $NVO #obesity
Microbes in Tumors: Unraveling a Controversial Role
What is the significance of microbes in tumors, a field mired in controversy? https://t.co/D5sHkLLsrT https://t.co/ntGLlke4iC
Baseimmune Announces Strategic Expansion Into Fibrosis with Lead Program Targeting Idiopathic Pulmonary Fibrosis (IPF)
Baseimmune announced a new fibrosis‑focused pipeline leveraging its computational protein design platform to create multi‑pathway immunotherapies, starting with idiopathic pulmonary fibrosis (IPF). The company aims to deliver proof‑of‑concept efficacy data for its lead IPF program in 2026‑2027, addressing the limitations...
Top Resources for TF Binding, Enhancers, Histone Marks
8 Resources to study Transcription factor binding, enhancers and histone modification distribution 1. ENCODE https://t.co/N5hScyoAoP
Tropic Secures $105M to Mass‑produce Non‑browning Bananas
Tropic, a British gene-editing startup, has raised $105 million in new financing to expand production of bananas that don’t brown https://t.co/rHHAMO6mST
PharmaShots Magazine-March-2026 Edition
AI is reshaping clinical trial oversight by moving from periodic checks to continuous, real‑time intelligence. Advanced analytics and machine learning now power predictive, risk‑based monitoring that aggregates data from decentralized sites, wearables, ePROs and multiple clinical systems. This integration enables...
Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 2026
Compass Pathways plc announced that its senior management will attend the Stifel 2026 Virtual CNS Forum on March 17‑18, 2026, and will take part in a fireside chat on March 18 at 10:30 am ET. The session will be streamed live...
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Venomous Snakes Represent a Serious Public Health Problem. Scientists Are Biting Back With a Groundbreaking Antidote
Snakebite envenoming kills over 125,000 people each year and leaves three times as many disabled, while current horse‑derived antivenoms trigger severe allergic reactions in nearly half of patients. The high cost—up to $100,000 per course—and limited hospital access leave rural...
BridgeBio Builds Case for Early 2027 Launch of Dystrophy Drug
BridgeBio Pharma reported that its small‑molecule candidate BBP‑418 produced a 1.8‑fold increase in the α‑dystroglycan biomarker in a Phase 3 FORTIFY trial for limb‑girdle muscular dystrophy type 2I/R9, with effects sustained through 12 months. The trial enrolled 81 patients and also showed...
Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia
Aplagon Therapeutics has administered the first dose of its intravenous APAC candidate to a patient in a Phase 2a (HEALING) trial for peripheral arterial occlusive disease leading to chronic limb‑threatening ischemia in Finland. The study will enroll approximately 42 CLTI...
Pierre Fabre, ATRA to Meet FDA on Ebvallo CRL Soon
Pierre Fabre and $ATRA said FDA meeting to discuss the Ebvallo CRL has been scheduled. (Likely occuring within the next month.)
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...
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...