FDA Investigating: US Patient Dies After Use of Placental Extract Laennec, Russian Med Student Also Died
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously ill. Laennec, approved in Japan for liver support, is being used off‑label and often administered intravenously despite lacking U.S. approval. The deaths highlight illegal importation, counterfeit products, and the growing trend of unsupervised biologic use promoted by wellness influencers.
Valbenazine
Valbenazine (Ingrezza®), an oral selective VMAT2 inhibitor from Neurocrine Biosciences, received FDA approval for treating tardive dyskinesia and Huntington’s disease‑associated chorea. In the Phase 3 KINECT‑3 trial, a once‑daily 80 mg dose produced a statistically significant reduction in AIMS dyskinesia scores after...
Zalsupindole
Delix Therapeutics announced the results of a Phase 1b study of zalsupindole, a selective 5‑HT2A receptor partial agonist, in patients with major depressive disorder. The trial, published in the January 2026 issue of ACS Chemical Neuroscience, demonstrated favorable safety, tolerability, and early...
Blood Test Detects Brain Tumours with 90% Accuracy
Scientists at the University of Manchester have developed a blood test that detects brain tumours with 90% accuracy by measuring a pair of proteins. The test, validated in glioblastoma patients, is being evaluated in a multi‑site clinical trial across six...
Designing Clinical Trials to Address Asthma and COPD Flare-Ups
Acute asthma and COPD exacerbations remain a costly, life‑threatening gap despite advances in chronic therapies. Connect Biopharma, led by Barry Quart, is the first biotech targeting these flare‑ups with a biologic that blocks IL‑4Rα, aiming to curb upstream inflammation. The...
Huntington’s Disease Gene Therapy: FDA Reversal Delays AMT-130
A Phase I/II trial of AMT‑130, an AAV‑delivered microRNA gene therapy, showed a 75% reduction in Huntington's disease progression over three years in 12 patients. The FDA initially supported using external control data from the Enroll‑HD database for the Biologics...
Evidence for Microglia to Actively Promote Amyloid Aggregation in the Aging Brain
Researchers have discovered that microglia, the brain’s innate immune cells, can actively remodel soluble amyloid‑β (Aβ42) into extracellular fibrils with strong seeding activity, contrary to the prevailing view that they only clear plaques. Cell‑based assays showed that microglia‑generated amyloid closely...
ION717 Trial Re-Opens with 3rd Dosing Regimen
Ionis Pharmaceuticals announced that its Phase 1/2a PrProfile trial of ION717, the first PrP‑lowering antisense oligonucleotide for symptomatic prion disease, has reopened with a third dosing regimen. The study, which enrolled 56 patients in 2024, will now recruit at three...
Interfering in Induction of Bystander Senescence as an Approach to Senotherapy
Researchers have mapped how senescence spreads between human brain cell types via the senescence‑associated secretory phenotype (SASP). Using DNA‑damage‑induced cultures and conditioned‑media assays, they identified cell‑type‑specific SASP signatures that drive secondary senescence in neighboring astrocytes, endothelial cells, microglia, oligodendrocytes and...
NeoGenomics’ PanTracer LBx Receives Medicare Coverage, Expanding Access to Comprehensive Liquid Biopsy Profiling
NeoGenomics announced that its PanTracer™ LBx liquid biopsy test has received Medicare coverage under CMS’s MolDX program. The CLIA‑certified assay profiles more than 500 genes, including MSI and blood‑tumor mutational burden, with a seven‑day turnaround. Coverage allows Medicare beneficiaries to...
Sentynl Therapeutics Enters Licensing Agreement with PRG S&T to Advance Progerinin
Sentynl Therapeutics, a Zydus Lifesciences subsidiary, has licensed Progerinin, an oral small‑molecule candidate for Hutchinson‑Gilford Progeria Syndrome, from PRG S&T. The agreement grants Sentynl full development rights, making Progerinin its second HGPS therapy and giving it orphan‑drug status from the FDA....
Lebrikizumab Delivered Significant Skin Clearance and Improved Disease Severity in Children With Moderate-to-Severe Atopic Dermatitis
Almirall reported that lebrikizumab met both co‑primary endpoints in the Phase 3 ADorable‑1 trial, with 63% of pediatric participants achieving EASI‑75 and 44% attaining clear or almost clear skin (IGA 0/1) after 16 weeks. Key secondary outcomes showed significant itch reduction, higher...
What Determines Success in Complex MASH Clinical Research Today?
Recent FDA approvals of resmetirom and semaglutide have shifted MASH care from a treatment‑void to a therapeutic reality, prompting sponsors to redesign trial endpoints and enrollment strategies. Non‑invasive diagnostic tools are emerging as potential primary endpoints, reducing reliance on liver...
Malicious Metals Muddy Fragment-to-Lead Optimization
Researchers at the Cleveland Clinic pursued fragment‑based inhibitors of SARS‑CoV‑2 NSP14, a viral exonuclease essential for replication and immune evasion. Initial crystal‑guided merges appeared active in a biochemical assay, prompting optimism about fragment linking. Subsequent resynthesis and rigorous purification revealed...
Two Publications Highlight Clinical Utility of Signatera™ in Anal and Rectal Cancers
Natera announced two peer‑reviewed studies demonstrating the clinical utility of its personalized ctDNA assay, Signatera, in anal squamous cell carcinoma and locally advanced rectal cancer. In the ASCC cohort of 84 patients, baseline negativity or clearance of ctDNA during chemoradiotherapy...
Module 2 Quiz
Drug Hunter’s online curriculum includes a Module 2 Quiz that tests learners on target identification and validation concepts. The quiz is part of a broader course designed for drug discovery professionals and requires full platform access via subscription or sign‑in. It...
How Does Marburg Virus Enter Cells so Efficiently?
University of Minnesota scientists pinpointed structural features of the Marburg virus entry protein that make it up to 300 times more efficient at infiltrating human cells than Ebola’s. By creating a tightly controlled assay, they showed the protein binds the...
Silicon Nanotube Arrays Deliver mRNA Into Human Stem Cells While Preserving Pluripotency
A team from Monash and Deakin Universities demonstrated that silicon nanotube arrays can deliver functional mRNA into human induced pluripotent stem cells (hiPSCs) with transfection efficiencies between 55% and 64%. By redesigning nanotube geometry, using low‑molecular‑weight poly‑D‑lysine, and adjusting the...
Electron Microscopy Reveals How Mitochondrial Stress Proteins Remodel to Protect Cells
Researchers at University Medical Center Göttingen employed cryo‑electron tomography to capture near‑atomic structural remodeling of the mitochondrial heat‑shock protein 60 (mHsp60) under proteostatic stress. The protein reconfigures its barrel‑shaped complex, boosting folding activity and preserving mitochondrial function in stressed human...
The Antibacterials of Tomorrow
The blog recaps the 2026 New Antibacterial Discovery and Development conference in Tuscany, where researchers presented emerging strategies against antimicrobial resistance (AMR). Dr. Quave highlighted her lab’s plant‑derived natural products targeting Gardnerella vaginalis, a key cause of bacterial vaginosis. The...
RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa
RevnaBio received triple accreditation from the American Association for Laboratory Accreditation (A2LA) for ISO 15189, ISO 20387 and ISO/IEC 17043, validating its medical laboratory, biobanking and proficiency‑testing operations. The certifications boost diagnostic quality, enable local molecular testing, and provide a trusted platform for...
KERENDIA® (Finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease
Bayer announced that Kerendia® (finerenone) met its primary endpoint in the Phase III FIND‑CKD trial, showing a statistically significant slowing of eGFR decline versus placebo in non‑diabetic chronic kidney disease patients. The study enrolled over 1,500 participants and represents the fifth...
IGFBP7 Secreted by Senescent Cells Suppresses the Benefits of Exercise
Researchers identified insulin‑like growth factor binding protein‑7 (IGFBP7) as a circulating factor that limits exercise adaptation in older adults. Plasma proteomics from a year‑long high‑intensity interval training trial showed higher IGFBP7 levels predicted smaller fitness gains. In mice, genetic deletion...
#384 – Special Episode — Obicetrapib: The CETP Inhibitor with Cardiovascular Benefits and Potential Alzheimer’s Prevention
Obicetrapib, a next‑generation CETP inhibitor, has demonstrated potent LDL‑C, apoB, and Lp(a) reductions in a large phase III lipid trial. A pre‑specified biomarker sub‑study reported a marked attenuation of p‑tau217 progression, especially among APOE4/4 carriers, hinting at a potential Alzheimer’s‑related benefit....
Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-Acting Semaglutide
Samsung Bioepis and its sister firm Epis NexLab have signed a research collaboration and exclusive license agreement with G2GBIO to develop a long‑acting semaglutide formulation using G2GBIO’s proprietary microsphere technology. The deal grants Samsung Bioepis full rights to the semaglutide...
EGFR Vs. ALK: How Molecular Profiling Defines Lung Cancer Treatment
Comprehensive molecular profiling of two stage IV NSCLC patients revealed distinct driver alterations—an EGFR exon 19 deletion in one and an EML4‑ALK fusion in the other—prompting personalized first‑line therapy with osimertinib and alectinib respectively. Both patients experienced rapid symptomatic improvement and enhanced...
YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency...
YolTech Therapeutics announced FDA approval of its IND for YOLT-202, an in vivo adenine base‑editing therapy targeting Alpha‑1 Antitrypsin Deficiency. The clearance permits an open‑label, single‑dose Phase 2/3 expansion study across the U.S. and other regions. In the ongoing first‑in‑human trial,...
No Broad Autism Approval for Leucovorin, Despite FDA Commissioner’s Prior Suggestions
The FDA on March 10 expanded leucovorin’s label to cover a very rare genetic folate‑transport disorder, not autism. Earlier, Commissioner Marty Makary suggested the drug could help “hundreds of thousands of kids” with autism, creating expectations of a broad approval. FactCheck.org...
How Dompé Is Innovating in Neuro-Ophthalmology with the FDA’s CNPV Program
Dompe, a privately owned biopharma, is advancing an intranasal nerve growth factor (NGF) therapy to treat non‑arteritic anterior ischemic optic neuropathy (NAION), a leading cause of sudden vision loss affecting roughly 6,000 U.S. patients annually. The approach leverages NGF’s neuroprotective...
A Preprint Claiming Exceptional Extension of Life in Mice via a Telomere Transfer Mechanism
A recent preprint from biotech startup Sentcell claims that adoptive transfer of engineered CD4+ T cells can generate extracellular “telomere Rivers,” which purportedly extend median mouse lifespan by about 17 months, with some animals living nearly five years. The authors...
Pharmaceutical Executive Daily: FDA Expands Approval for Arexvy
A West Health‑Gallup survey reveals that over 82 million Americans have reduced daily spending to afford healthcare, highlighting deepening affordability pressures across income levels. The FDA has broadened GSK’s RSV vaccine Arexvy to cover high‑risk adults aged 18‑49, a group responsible...
Ketamine Therapy for Chronic Pain and Substance Misuse
Recent peer‑reviewed study of 20 adults with chronic pain and substance misuse found ketamine therapy improved pain, mood, and dependence scores. The integrated treatment was delivered within a coordinated pain program, highlighting benefits of interdisciplinary care. Findings suggest ketamine can...
Renal Cell Carcinoma Strategic Intelligence Report
The latest ASCO GU strategic intelligence report spotlights renal cell carcinoma (RCC) as a field entering a transformative phase. Analysts highlight emerging biomarkers, novel HIF‑2α inhibitors, and evolving immunotherapy combinations as potential high‑impact developments. While these advances promise to reshape...
Aditxt Acquires Ignite Proteomics to Address a Critical Challenge in Cancer Care: Optimizing Therapy Selection
Aditxt, Inc. announced the acquisition of Ignite Proteomics for $36 million in Series A‑2 convertible preferred stock, adding a CLIA‑certified functional proteomics platform to its oncology portfolio. Ignite’s Reverse Phase Protein Array (RPPA) assay quantifies 32 phospho‑ and total‑protein biomarkers, offering therapy‑selection...
Gold Nanoclusters Could Help in Identifying Diseases
Researchers at the University of Jyväskylä used GPU‑accelerated simulations on the LUMI supercomputer to explore how chiral gold nanoclusters bind small chiral biomolecules. Nearly 100 cluster‑biomolecule pairings and 300 simulation runs revealed that only specific combinations trigger a measurable change...
Pharma Pulse: SteinCares Partners to Expand Biosimilar Access in Latin America and Eli Lilly Issues Warning Over Compounded Tirzepatide Safety
SteinCares and Shilpa Biologicals have signed a licensing deal to commercialize biosimilars across Latin America, with SteinCares handling regional registration and distribution while Shilpa oversees product development and long‑term manufacturing. The partnership targets broader patient access to cost‑effective biologics in...
Functionalized Nanoparticles Could Open the Door to Swallowable Insulin Pills
Researchers have grafted the permeation enhancer 1‑phenylpiperazine onto safe silica nanoparticles, creating a hybrid that boosts intestinal insulin absorption while eliminating toxicity. In obese, insulin‑resistant mice, oral insulin delivered with these functionalized particles lowered blood glucose for 8‑10 hours, outperforming...
Closing the 9-Year Gap: A New Biomarker Targets the Diagnostic Delay in Axial Spondyloarthritis
Axial spondyloarthritis affects about 1.4% of adults but patients wait an average of nine years for diagnosis in North America, far longer than rheumatoid arthritis. Augurex has introduced SPINEstat, an anti‑14‑3‑η multiplex blood test that can distinguish inflammatory back pain...
Some Spiny Mouse Species Are Long-Lived in Addition to Displaying Exceptional Regeneration
Researchers found golden spiny mouse (Acomys russatus) lives longer and retains regenerative abilities compared to its sister species. In a non‑pathogen‑free setting, aged A. russatus showed minimal frailty, reduced inflammaging, and preserved thymic structure beyond four years. Transcriptomic analysis revealed youthful...
‘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...
Europa Biosite Acquires Stratech Scientific, Expanding Their Product Offering and Strengthening UK Customer Reach
Europa Biosite, the pan‑European life‑science distributor, announced that its UK arm Cambridge Bioscience has acquired Stratech Scientific, a 43‑year‑old UK reagent distributor. The deal merges two complementary product portfolios, creating a larger catalogue and broader national coverage across academia, biotech...
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...
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...
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...
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...
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...
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...
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,...
