Know What's Happening in BioTech
Know What's Happening in BioTech
BioTech Pulse
EMAIL DIGESTS
Daily
Every morning
Weekly
Tuesday recap
EMAIL DIGESTS
Daily
Every morning
Weekly
Tuesday recap
The FDA has approved a higher-dose regimen of nusinersen (Spinraza) for spinal muscular atrophy, aiming to boost drug exposure and improve long‑term motor function. The approval underscores a broader industry shift toward lifecycle optimization of RNA‑targeted therapies. Simultaneously, biopharma firms are channeling strategic investment into AI‑driven development, advanced biologics, and next‑generation manufacturing. Leaders also stress that heightened collaboration and stricter regulatory standards are becoming critical for sustainable growth.
The National Institutes of Health has launched a new five‑year, $3 billion Professional Scientific and Technical Support Services (PSTSS) recompete to back intramural and vaccine research. The solicitation, due by 3 p.m. ET on April 27, seeks multiple awardees with expertise in microbiology,...
Precision medicine is shifting pharma from a volume‑driven model to one focused on early patient identification and diagnostic certainty. Real‑world studies show genomic profiling yields actionable insights in about 61% of advanced solid‑tumor cases, yet only a fraction of patients...
Within3 unveiled Dataverse, a unified real‑world data ecosystem that merges electronic health records, claims, and specialty analytics to sharpen pharmaceutical launch decisions. Avalere Health released a global framework to broaden genomic profiling in cancer care, while Emota’s report highlighted rising...
University of York scientists have identified the ESB2 protein that enables the African trypanosome to edit its own surface coat, resolving a four‑decade‑old mystery in sleeping‑sickness biology. The discovery reveals a precise genetic‑editing mechanism and points to novel drug targets.
Researchers at the National University of Singapore have launched a skin‑conforming hydrogel wearable that delivers clinical‑grade ECG and blood‑pressure data while users move, classifying fatigue with 92% accuracy. The breakthrough could give biohackers and employers a continuous, objective view of...
Inventiva posted 2025 revenues of €4.5 million (≈ $4.9 million) and ended the year with €99.3 million ($108 million) in cash and €131.6 million ($143 million) in short‑term deposits. The company raised $172.5 million (≈ €149 million) in a U.S. public offering and expects its cash runway to last until...
New York‑based Mantis Biotech unveiled an AI platform that builds physics‑based digital twins of humans, producing synthetic biomedical datasets for drug discovery and other high‑risk biomedical research. The startup says the technology can fill data gaps in rare diseases and...
HHS Secretary Robert F. Kennedy Jr announced on a podcast that the federal government will lift restrictions on 14 injectable peptides, allowing compounding pharmacies to produce and sell them without the usual FDA review. The move bypasses the scientific advisory...
BullFrog AI Holdings saw its Nasdaq‑listed shares climb 126.24% to $1.15 after announcing a commercial agreement with a leading global pharmaceutical company. The deal gives the pharma partner exclusive access to a novel target candidate for major depressive disorder and...
The phase III SCOUT‑HCM trial showed that mavacamten (Camzyos) significantly reduced left ventricular outflow tract (LVOT) gradients in adolescents with obstructive hypertrophic cardiomyopathy (HCM) compared with placebo. Forty‑four patients aged 12‑17 were randomized to weight‑based doses of 2 or 5 mg daily, achieving a...
Scientists have long identified autism risk genes mainly in European‑ancestry cohorts, leaving gaps for other populations. The GALA Consortium sequenced over 15,000 Latin American individuals, including 4,700 with autism, and found 35 genome‑wide significant risk genes. These genes show substantial...
University at Buffalo researchers discovered that impairment of the ceramide transfer protein (CERT) blocks ER‑to‑Golgi ceramide transport, causing ceramide buildup in the endoplasmic reticulum and triggering ER stress that drives replicative senescence. Pharmacological inhibition of CERT reproduced the senescent phenotype...
Eli Lilly’s oral selective estrogen receptor degrader INLURIYO (imlunestrant) received FDA approval on September 25 2025 for adults with advanced ER‑positive, HER2‑negative breast cancer harboring an ESR1 mutation after endocrine therapy failure. The decision rests on the EMBER‑3 trial, which enrolled 874...
Kevin Tang, newly installed CEO of Aurinia Pharmaceuticals, has revived his bid for Kezar Life Sciences with a $50 million offer of $6.95 per share, roughly matching Kezar’s $47 million market cap. The proposal follows Tang’s earlier, unsuccessful $1.10‑per‑share attempt made through...
Merck reported that its experimental oral PCSK9 inhibitor, enlici‑tide, outperformed a range of commonly prescribed cholesterol‑lowering medicines in a head‑to‑head comparator trial. The data bring the drug a step closer to becoming the first oral PCSK9 therapy on the market....
At the American Academy of Dermatology (AAD) meeting in Denver, Takeda, Alumis, Priovant and Incyte each unveiled late‑stage dermatology data, ranging from novel biologics to targeted small molecules. Sanofi and Biogen also presented, highlighting mixed results in eczema and lupus...
Eli Lilly is pressuring the U.K. government to raise NHS drug prices and eliminate the VPAG rebate scheme before it resumes new investment in Britain. The company is also exploring outcome‑based pricing for its anti‑obesity medicines. In parallel, Lilly struck a...
The Microbiota Vault Initiative (MVI), launched in 2023 at the University of Zurich, aims to preserve global microbial diversity by storing fecal, fermented‑food, soil, water and air samples. Its pilot phase collected 1,200 stool and 190 fermented‑food specimens from seven...
Researchers at Liverpool School of Tropical Medicine have discovered a previously undescribed Treponema species strongly associated with noma, a fatal disease affecting impoverished children. Using metagenomic sequencing and machine learning on saliva samples, they identified the bacterium early in disease...
Researchers at Washington University in St. Louis examined how single versus repeated alcohol exposures affect gene‑regulatory mechanisms in mouse brains. They found that brief exposure altered epigenetic markers in select regions, while prolonged exposure produced changes across all examined areas,...
Ocugen’s phase‑2 ArMaDa trial of the modifier gene therapy OCU410 showed a 31% reduction in geographic atrophy lesion growth and a 27% slower rate of ellipsoid zone loss at the medium dose, with 55% of treated eyes achieving at least...
The $UTHR news today is great for IPF patients. But it is also very good news for $LQDA given they have better delivery of the same drug. UTHR has 7-year orphan protection in IPF, but that can be overcome by...
A phase‑2b trial of inhaled mebufotenin (GH001) in 81 adults with treatment‑resistant depression showed rapid symptom relief, with 57.5% of the active‑treatment group achieving remission by day 8 versus none on placebo. The mean MADRS score fell by 15.2 points compared...
Researchers reported that administering the metabolic hormone FGF21 boosts SIRT1 expression, which in turn activates the PINK1‑Parkin mitophagy pathway and reduces cellular senescence in intervertebral disc cells. In a rat model of puncture‑induced disc degeneration, FGF21 treatment partially restored nucleus...
The U.S. Patent Trial and Appeal Board affirmed 23 claims of Seer Inc.'s U.S. Patent No. 11,435,360 B2, preserving the core of its nano‑ and micro‑particle protein enrichment technology. The decision thwarts a challenge by Bruker subsidiaries PreOmics GmbH and...
Everyone complains that clinical trial recruitment is hard. Fair. 📍 But here is a question not enough people ask: Have you looked closely at your 𝘁𝗿𝗶𝗮𝗹 𝗿𝗲𝗰𝗿𝘂𝗶𝘁𝗺𝗲𝗻𝘁 𝘀𝗶𝘁𝗲? I ran one through https://t.co/f9IW600hsB. The science was solid. The 𝗺𝗲𝘀𝘀𝗮𝗴𝗶𝗻𝗴 𝘄𝗮𝘀 𝗻𝗼𝘁. 📉 That is the disconnect. Too...
β-Nicotinamide mononucleotide prevents senescence and lipid accumulation in hepatic stellate cells by restoring SIRT1 function https://t.co/wyVHZ13QNK
Viridian Therapeutics’ shares tumbled 34% to $18.66 after its late‑stage trial of elegrobart for thyroid eye disease (TED) fell short of investor efficacy expectations, despite meeting the primary endpoint of reducing eye bulging. The four‑week regimen showed a 54% improvement...
Glia-to-Axon Transfer of Ribosomes and miRNAs: A Novel Paradigm in Neural Repair "Schwann cell-derived exosomes thus represent both a novel mode of glia–neuron communication and a promising avenue for next-generation therapies for nerve regeneration." https://t.co/xU3zmkA5OA https://t.co/kK3FrVuN7T
Accurately predicting success and failure rate of late stage trials for new drugs could legitimately accelerate pharma. The late stages are where most of the time and money go, and are a bottleneck on bringing drugs to market today.
The FDA granted accelerated approval to the oral co‑pack Avutometinib and Defactinib for adults with KRAS‑mutated, recurrent low‑grade serous ovarian cancer (LGSOC) after prior therapy. The regimen pairs a RAF/MEK inhibitor with a FAK inhibitor, marking a rare “novel‑novel” combination...
Really interesting. One of their predictions is 100% success chance for $MLTX in psoriatic arthritis.
Elegant in theory, unproven in practice: setidegrasib and the case (or not) for KRAS degradation in NSCLC and pancreatic cancer: https://t.co/NuaOJ2amgn https://t.co/i9FpK4W19W
Fujifilm faced a 60% revenue collapse in 2006 as digital cameras displaced film, prompting a strategic pivot toward healthcare. The company launched a contract development and manufacturing organization (CDMO) in 2011, acquiring Biogen’s large‑scale site and expanding its biotech capabilities....
30March: How did @EliLillyandCo and @InSilicoMeds begin and expand their collaboration into the up-to-$2.75B partnership announced Sunday? Read about $LLY and $3696 in the latest for @GENbio from me and colleague @xiaofei_lin: https://t.co/KtXOWFjGdq
The SURViV randomized trial compared transcatheter mitral valve‑in‑valve (ViV) with redo surgical replacement in 150 patients with failed bioprosthetic mitral valves, many of whom had rheumatic disease. At one year, ViV showed a markedly lower all‑cause mortality (5.3% vs 20.8%)...
New: 5 FDA decisions to watch in the second quarter of 2026 https://t.co/AVvu8i9kgh $REPL $LLY $AXSM $PFE $ARVN $IONS $ARWR #biotech
InvestorNews announced an InvestorTalk on March 31, 2026 at 9 AM EST featuring Brent Willis, President and CEO of Voyageur Pharmaceuticals Ltd. (TSXV:VM). Voyageur is advancing a vertically integrated strategy to produce barium and iodine contrast agents, highlighted by a 132,000‑tonne, 98.8% pure barium...
GlycanAge is translating two decades of glycan research into clinical tools that measure inflammaging, the chronic low‑grade inflammation linked to age‑related disease. By profiling complex sugar structures on proteins, the company offers a long‑term biomarker that differs from short‑term markers...
Abbott has partnered with Flatiron Health to embed its Precision Oncology testing suite directly into Flatiron’s cloud‑based OncoEMR platform. The integration lets oncologists order tests such as Oncotype DX, OncoExTra, Oncodetect and Riskguard from within the patient chart, with results automatically...
Herbicide resistance is driving a search for new weed‑control tools, and Quercus Biosolutions is pioneering AI‑designed mini proteins that act like chemicals while offering biological benefits. Using protein‑structure prediction technology from drug discovery, the startup creates proteins that can enter...
Prilenia Therapeutics and Ferrer have enrolled the first participant in PREVAiLS, a pivotal Phase 3, 500‑patient, randomized, placebo‑controlled trial of the sigma‑1 receptor agonist pridopidine for rapidly progressive ALS. The study, launched at Mass General Brigham, will span 48 weeks with...
Meiji Seika Pharma announced a strategic investment in U.S. biotech Centivax to accelerate its universal influenza vaccine, Centi‑Flu 01, currently in Phase 1 trials. The partnership leverages Meiji’s pharmaceutical expertise and Centivax’s computational immune‑engineering platform to target conserved viral regions, aiming for...
Biocytogen has licensed its RenNano® fully human heavy‑chain‑only antibody discovery platform to Japan’s Taisho Pharmaceutical, granting access to RenNano mice for in‑vivo generation and screening of VHH candidates. The agreement, whose financial terms remain undisclosed, adds to Biocytogen’s expanding portfolio...
Kardigan reported that its experimental hypertension drug tonlamarsen achieved a 67% average reduction in the angiotensinogen biomarker after five monthly doses, confirming target engagement. However, the Phase 2 trial showed no statistically significant difference in office systolic blood pressure between the...
The iFAB accelerator in central Illinois secured a $51 million federal grant and $30 million state contribution to build a precision‑fermentation hub. Partnering with corn giants ADM and Primient, iFAB creates contract‑manufacturing pathways that let startups use large‑scale facilities instead of building...
