Bimatoprost Implant Reduces IOP, Improves Vision at 12 Months
SpyGlass Pharma’s Bimatoprost Drug Pad‑IOL System demonstrated significant intra‑ocular pressure (IOP) reductions and vision gains in a phase 1/2 trial of 104 patients with open‑angle glaucoma or ocular hypertension undergoing cataract surgery. At 12 months, the 78 µg dose lowered mean IOP 34% and the 39 µg dose 42% versus baseline, comparable to a control group using timolol drops. More than 95% of implant recipients eliminated the need for any topical IOP‑lowering drops, while achieving best‑corrected distance visual acuity of 20/32 or better. Safety was on par with standard cataract procedures, with no serious ocular events reported.
FDA Approves Cosentyx for Pediatric Hidradenitis Suppurativa
The U.S. Food and Drug Administration has approved Novartis' secukinumab, marketed as Cosentyx, for adolescents aged 12 and older with moderate‑to‑severe hidradenitis suppurativa (HS). This marks the first IL‑17A inhibitor cleared for a pediatric indication, extending the drug’s adult HS...
Ultrasound-Based Approach to Delivering Potent Drugs Into Cancer Cells Shows Promise in Benchtop Experiments
Duke engineers introduced SonoPIN, an ultrasound‑driven platform that bursts cancer‑targeted microbubbles to create temporary pores in cell membranes. The technique allowed large PROTAC drugs to enter tumor cells, killing 50% of them while sparing 99% of healthy cells in benchtop...
Kenai: Off-the-Shelf Parkinson’s Progenitors with Precision Transplant Tech
Kenai, a new allogeneic cell‑therapy company, is developing off‑the‑shelf iPSC‑derived progenitor cells for Parkinson’s disease, paired with a precision brain‑delivery platform that uses real‑time functional imaging. The approach builds on Japan’s recent approvals of iPSC‑based Parkinson’s treatments and aims to...
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...
Jeonbuk National University Researchers Develop DDINet for Drug-Drug Interaction Prediction
Researchers at Jeonbuk National University have unveiled DDINet, a lightweight neural network designed to predict drug‑drug interactions (DDIs) for previously unseen compounds. The model employs five fully‑connected layers and molecular fingerprints, with Morgan fingerprints delivering the best results. Using a...
Testing Parsley Promoter RUBY in Stable Petunia Transformation
Okee, two more cultivars to sterilize and transform and I'm done for the day. Let's rile up the agro and get this done. Also among the stuff I need to test for work, I'm going to see if this parsley...
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...
Money Raised by Biopharma
Researchers at INSERM uncovered hypothalamic tanycytes as a previously unknown tau‑clearing pathway, opening fresh therapeutic avenues for Alzheimer’s and related tauopathies. Merck Sharp & Dohme (MSD) announced the synthesis and pre‑clinical testing of novel PET tracers that bind α‑synuclein, aiming...
Shilpa Biologicals, mAbTree Program Targets Immune Pathway in Rare Blood Cancers
Shilpa Biologicals and mAbTree Biologics received FDA orphan drug designation for an investigational monoclonal antibody that targets an immune‑evasion pathway in essential thrombocythemia and polycythemia vera. The designation validates the novel mechanism and accelerates plans for IND‑enabling studies and first‑in‑human...
March 13 Policy Watch: FDA Streamlines Its Process for Approving Biosimilar Drugs
The FDA released draft guidance that lets biosimilar developers use foreign comparator data and, in some cases, replace clinical studies with chemical analysis, potentially cutting development costs by $20 million. Simultaneously, the agency launched the Adverse Event Monitoring System (AEMS), a...
Bacteria 4D Simulation, Safer Large Gene Insertion, uniQure Roller Coaster
The J. Craig Venter Institute unveiled a 4D, nanoscale simulation that tracks the entire life cycle of a minimal bacterial cell, marking a milestone for synthetic biology. A new gene‑editing platform designs DNA donors that dodge immune detection, enabling safer,...
Tahoe Therapeutics Builds Record Single-Cell Atlas Using Automated Pipetting Technology
San Francisco biotech Tahoe Therapeutics is building the world’s largest single‑cell atlas of cell‑chemical interactions, leveraging Integra Biosciences’ Assist Plus pipetting robot, Parse Biosciences’ Evercode scRNA‑seq kits, and its own AI analytics. Automation has increased single‑cell preparation throughput more than fivefold...
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...
Theriva Biologics Reports 2025 Results and Pipeline Progress
Theriva Biologics closed 2025 with $13.1 million in cash, rising to $15.2 million by February 2026, enough to fund operations into the first quarter of 2027. The company reported a net loss of $25.3 million, a modest improvement as R&D spend fell while...
Gubra Plots Roivant-Like Model as Partnered Obesity Drugs Take Flight
Gubra, a 300‑employee Danish biotech known for its obesity drug partnerships, announced plans to adopt a Roivant‑style incubation model. The strategy will spin out a series of focused biotech companies, each targeting niche therapeutic areas beyond obesity, such as metabolic...
Can A Single Shot Save Your Heart?
Researchers have developed a self‑amplifying RNA injection that directs skeletal muscle to produce the heart‑healing peptide Nppa, dramatically reducing scar formation in pig models of myocardial infarction. The lipid‑nanoparticle‑delivered RNA sustains protein expression for at least four weeks, far outlasting...
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...
Eurofins CDMO Alphora – Announces Development & Implementation of AI-Powered Salt and Co-Crystal Screening Software
Eurofins CDMO Alphora has launched an AI‑powered software that predicts salt and co‑crystal formation for APIs and intermediates, developed in partnership with a local university. The machine‑learning platform is now a core component of its solid‑state screening programs, delivering highly...
De Novo Enzymes Redefine Peptide Therapeutic Production
Peptide therapeutics are powerful. But making them has always been difficult. Traditional chemical synthesis can involve long routes, poor selectivity, and significant environmental impact, while biological production is often limited by the pathways evolution happened to provide. What if we could design...
Biotechs Report Regulatory Headaches, High-Stakes Catalysts During Q4 Earnings
Q4 earnings highlighted a mixed biotech landscape, with regulatory turbulence easing for some firms while high‑stakes catalysts loom. Capricor Therapeutics is preparing to resubmit its Duchenne cardiomyopathy cell therapy after the departure of FDA CBER director Vinay Prasad, and reported...
High Altitude Survival Gene Mutation Points to Strategy for Repairing Nerve Damage
Researchers identified a high‑altitude Retsat Q247R mutation that enhances myelin formation under hypoxic stress and accelerates remyelination in mouse models. The variant boosts neuronal production of the vitamin‑A‑derived metabolite ATDR, which activates the RXR‑γ pathway in oligodendrocyte progenitors. Administering ATDR...
Immutep's LAG-3 Drug Fails Phase 3 Lung Cancer Study
Immutep’s LAG‑3 fusion protein eftilagimod‑alpha failed to improve overall survival in a Phase 3 randomized study in non‑small cell lung cancer. The trial, enrolling roughly 600 patients, did not meet its primary endpoint and showed no statistically significant benefit versus standard...
A Newfound Blood Biomarker May One Day Predict Longevity
Researchers identified six circulating piwi‑interacting RNAs (piRNAs) that forecast two‑year survival in adults over 71 with up to 86% accuracy, surpassing conventional metrics such as age, cholesterol, and activity levels. The study of 1,200 participants linked lower piRNA concentrations to...
Patients Should Drive Aggressive Immunotherapy Post-Remission
Merkel cell carcinoma log, day #594. Yesterday, I was at Dana-Farber for my first infusion of avelumab in more than 3 months. Aside from two botched blood tests — the buzz is the blood tests are being done with recently...
Ultragenyx’s Gene Therapy Hits Key Endpoint in Phase 3 Trial for Blood Ammonia Disease
Ultragenyx announced that its investigational gene therapy for ornithine transcarbamylase (OTC) deficiency met a primary endpoint in a Phase 3 trial involving 37 patients. The study demonstrated a statistically significant reduction in blood ammonia levels, the key marker of disease...
How Colorectal Cancer Treatment Is Evolving in 2026
Colorectal cancer remains a major global health burden, with over 1.9 million new cases and 900,000 deaths in 2022, placing it high on biotech priorities. Treatment has shifted from surgery‑centric approaches to a blend of refined chemotherapy backbones and biomarker‑driven targeted...
Rare Disease Sales To Soar to $400B+ By 2032 as Small Molecules Resurgent: Evaluate
Orphan‑drug sales are projected to exceed $400 billion by 2032, more than double the 2025 level. Small‑molecule therapies dominate the pipeline, accounting for 45% of the 20 most valuable orphan candidates, signaling a resurgence after years of biologic focus. The Inflation...
Parkinson’s Research Reaches “Pivotal” Stage, but Barriers Remain
Parkinson’s research has entered a pivotal phase, driven by deeper disease insights and advanced models such as patient‑derived iPSCs. Despite a pipeline of potential disease‑modifying therapies, funding shortfalls and outdated trial endpoints continue to impede progress. Parkinson’s UK’s Virtual Biotech...
LabConnect Expands Global Central Laboratory Infra with Wuxi, China Facility
LabConnect announced the grand opening of a new central laboratory in Wuxi, China, expanding its global network to eight sites. The facility, built with Teddy Laboratory (now Frontage Laboratories), integrates LabConnect’s technology‑driven logistics and data oversight with local expertise. It...
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...
FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The U.S. Food and Drug Administration issued final guidance titled “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” The document outlines recommended non‑clinical testing and clinical study designs for devices aimed at weight loss, obesity treatment, or...
CBD and CBG Reverse Fatty Liver in Mice
I teach medical students that fatty liver disease (MASLD) affects 1 in 3 adults and has limited approved drug treatments. That may be changing. Hebrew University researchers found CBD and CBG -- two non-psychoactive cannabis compounds -- reversed fatty liver in mice...
Epigenetic Therapy Marks New Era in Glaucoma Treatment
Great to see ophthlamologists adopting epigenetic modifications and resets to treat eye diseases like glaucoma. A paradigm shift in medicine https://t.co/g2gr3WVpkf https://t.co/6gbBVHJuXI
Immutep Investors Spooked by LAG-3 Failure in Lung Cancer
Australian biotech Immutep saw its ASX shares tumble more than 88% after the independent data monitoring committee recommended halting its pivotal phase‑3 TACTI‑004 trial of the LAG‑3 inhibitor eftilagimod alfa (efti) in first‑line non‑small cell lung cancer. The trial, which...
Parsley Uniquitin Promoter Matches 35S at 72
Great signal at the 72hr mark which is peak RUBY accumulation. Parsley uniquitin promoter as reliable as 35s for my projects. Glory be. Here's the expired patent: https://t.co/njN84BkHho https://t.co/kDfx1RoenJ
China Biotech Receives FDA Approval for First Cell Therapy Trial
With FDA go ahead, a China #biotech notches a first in cell therapy testing https://t.co/QorwJmou8w by @realJacobBell $XENE $BHVN
Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria
Otsuka Pharmaceutical disclosed early open‑label extension (OLE) data for repinatrabit (JNT‑517) in adolescents with phenylketonuria (PKU). A 75 mg twice‑daily regimen achieved a 67% mean reduction in blood phenylalanine by day 56, with responses observed across prior sapropterin responders, non‑responders, and a...
Cancer Vaccines Show Promise for Hard-to-Treat Tumors
Cancer vaccines are showing marked efficacy vs refractory cancers and are going to be part of the future Rx armamentarium. Beyond that, ultimately, for prevention in high-risk individuals. A new stellar review @NatureMedicine https://t.co/PhtdZDtSBl https://t.co/okmwCD8AyB
Amyloid Antibody Therapy Triggers 100 Microhemorrhages in APOE4 Patient
100 brain microhemorrhages in a patient with cerebral amyloid angiopathy and 2 copies of APOE4 after amyloid antibody therapy https://t.co/ASpVuijFNW https://t.co/hdtwtv1usq
Eliquis Proves Safer than Xarelto for Patients with Deep Blood Clots
A head‑to‑head trial published in the New England Journal of Medicine compared Eliquis (apixaban) and Xarelto (rivaroxaban) in patients with deep‑vein thrombosis. The study found Eliquis significantly reduced major bleeding risk while maintaining equal efficacy in preventing clot recurrence. This...
LAG‑3 Checkpoint Suffers Another Trial Setback, Focus Shifts
NEW: Another failure in the clinic in the world of LAG-3, a target once seen as possibly the next major checkpoint inhibitor after PD-1 and CTLA-4. My latest on Immutep's Phase 3 disappointment, as LAG-3 focus now shifts to a...
HSV-1 Reactivation Linked to Faster Aging, Dementia
The reactivation of herpes simplex virus (HSV-1, not only herpes zoster) may be tied to accelerated aging and dementia, and account in part for the mechanism of Shingrix vaccine''s protection @WIRED https://t.co/iKF1JcYSu0
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HEALTH INEQUITY: Red Cross Children’s Hospital Doctor Using Donated ‘Miracle’ Cystic Fibrosis Drug to Save Lives
South Africa’s Red Cross Children’s Hospital is using donated Trikafta, a $300,000‑a‑year cystic fibrosis therapy, to keep seven‑year‑old Jaylin Leitjies alive after his lungs were severely damaged in infancy. The drug, produced by Vertex Pharmaceuticals, is not registered with SAHPRA...
Gut Microbiome Proteins Influence Aging Speed, Metabolic Disease
Links between gut microbiome proteins and pace of aging, metabolic diseases, and medications @Cell_Metabolism https://t.co/Vg6vMPjnXm https://t.co/3SKNH6IEhJ
Biotech Layoffs Hit Evotec, Vistagen; Immutep Shares Plunge
Evotec, Vistagen lay off staff; Immutep shares collapse on study failure https://t.co/OikmCdJ6sg $EVO $VTGN $IMMP - 81% $RARE $ATRA
Key Challenges and Strategies for Conducting Ex‑US Trials
"Ex-US Clinical Trials: Tribulations, Preparations, and Expectations" - new From The Trenches blog from @ArthurTzianabos, CEO of Lifordi and seasoned drug developer, on the considerations for ex-US clinical trials... https://t.co/IZ6RUVKrZj
Correct Lung Target, Yet IMMP’s
Lung (not head & neck) was the right choice for $IMMP to pursue in phase 3, but it still failed. Stock -89%. Sory via @APEXONCO -> https://t.co/Y1ilGP5Aqq
Neuralink Patient Plays Online Games Hours After Surgery
Neuralink Patient Goes from Operating Room to Online Gaming in Hours by @cb_doge #EmergingTech #Innovation #Technology https://t.co/UaOCf4kTSC