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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 approval from 2023. Approval was based on adult HS data, pharmacokinetic modeling, and pediatric trial evidence from related indications. The decision addresses a long‑standing therapeutic gap for a disease that often begins in teenage years.
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, 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 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...
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...
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...
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...
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...
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 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...
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...
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,...
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...
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 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, 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...
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, 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 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...
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...
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...
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 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...
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...
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 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...
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...
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 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 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...
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...
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...
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...
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...
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...
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...
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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...
When Erum Khan asked me why 80% of biotech companies fail at execution, I replied: "The majority of synthetic biology founders have become enamored with the tool, the technology that they developed and then they went out there with that hammer...
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
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
With FDA go ahead, a China #biotech notches a first in cell therapy testing https://t.co/QorwJmou8w by @realJacobBell $XENE $BHVN
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
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
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...
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
Links between gut microbiome proteins and pace of aging, metabolic diseases, and medications @Cell_Metabolism https://t.co/Vg6vMPjnXm https://t.co/3SKNH6IEhJ
Evotec, Vistagen lay off staff; Immutep shares collapse on study failure https://t.co/OikmCdJ6sg $EVO $VTGN $IMMP - 81% $RARE $ATRA
"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
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 Goes from Operating Room to Online Gaming in Hours by @cb_doge #EmergingTech #Innovation #Technology https://t.co/UaOCf4kTSC
