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
Proscia has been crowned the top‑performing digital pathology software vendor in the United States, receiving a 95.2 overall score in KLAS Research’s 2026 report and earning A+ or A grades across all six customer‑experience pillars. The company is also the most frequently considered platform by labs evaluating digital pathology solutions and the first to top KLAS rankings in multiple regions within a single year. Meanwhile, Porosome Therapeutics unveiled its Porosome.AI platform, which uses artificial intelligence to design small‑molecule, peptide, and biologic therapies that cross the blood‑brain barrier and target secretory dysfunctions such as Alzheimer’s disease and type II diabetes. Early organoid studies demonstrate rapid reversal of Alzheimer’s pathology, highlighting a novel mechanism‑of‑action beyond symptomatic treatment.
Omega‑3 supplementation trials produce mixed results due to differences in dose, population risk, and chosen endpoints. High‑dose EPA/DHA studies in secondary‑prevention cohorts with elevated triglycerides, such as REDUCE‑IT, show significant cardiovascular benefit, whereas lower‑dose primary‑prevention trials like VITAL and ASCEND...
After a wave of senior departures and a 3,500‑position cut, the FDA entered 2026 with a largely inexperienced workforce, raising uncertainty for drug developers. The agency’s new AI guidance, released in January, outlines best practices but emphasizes human oversight and...
"Treatable, not curable" should be a call to arms for any cancer biotech that isn't a grift to step up. Life is so cruel more often than not, but humans are tenacious and unstoppable.
SOPHiA GENETICS reported Q4 2025 revenue of $19.5 million, up 23% year‑over‑year, marking the third consecutive quarter of accelerating growth. The company added 31 new customers, bringing total 2025 signings to 94, and saw U.S. revenue rise 30%, highlighting strong market...
The FDA’s Center for Drug Evaluation and Research (CDER) has published its annual New Drug Application (NDA) and Biologics License Application (BLA) approval reports for calendar years 2015 through 2025, each linked in a consolidated list. These reports detail the...
Researchers from the Max Planck Institute of Biochemistry and the Technical University of Munich applied high‑throughput mass spectrometry to cerebrospinal fluid from more than 5,000 patients, measuring roughly 2,000 proteins per sample. They identified a 22‑protein panel that distinguishes multiple...
A head‑to‑head study of 55 post‑prostatectomy patients compared two FDA‑cleared PSMA PET agents, Posluma (flotufolastat F‑18) and Pylarify (piflufolastat F‑18). Posluma demonstrated markedly lower bladder radioactivity, with a median bladder SUV of 10.9 versus 29 for Pylarify. This reduction translated into higher...
Scientists have identified a molecular checkpoint that guides planarian stem cells during regeneration. The roundabout A receptor (RoboA) suppresses inappropriate pharyngeal differentiation by regulating the transcription factor FoxA, while the extracellular protein Anosmin1a partners with RoboA to fine‑tune cell identity...
Scientists at the University of Birmingham and Nottingham Trent University have created silica‑based nanoagents that encapsulate the hydrophobic antibiotic rifampicin and release it only when exposed to low‑frequency ultrasound. The ultrasound‑triggered particles penetrate deep into Staphylococcus aureus biofilms, achieving a...
The FDA has mandated electronic submissions to the FAERS database using the ICH‑endorsed E2B(R3) standard, beginning January 16 2024 for post‑marketing drug and biologic reports and April 1 2024 for pre‑marketing IND safety reports. Companies have until April 1 2026 to transition fully, after which only...
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone) to treat acute manic or mixed episodes of bipolar I disorder and schizophrenia in adults. The approval introduces a new chemical entity in the atypical antipsychotic class that is bioequivalent to Vanda’s...
A multicenter retrospective registry of 153 AChR‑positive generalized myasthenia gravis patients found that initiating add‑on immunotherapy within 24 months of diagnosis (early intensified treatment) produced faster and larger improvements in MG‑ADL, QMG, and quality‑of‑life scores than later escalation. Early patients...
Johnson & Johnson announced a more than $1 billion investment to build a next‑generation cell and gene therapy manufacturing complex on a 154‑acre site in Montgomery County, Pennsylvania. Construction is slated to start in the second half of 2026, creating over...
Idiopathic pulmonary fibrosis (IPF) continues to pose a severe, often late‑diagnosed respiratory challenge, with mortality exceeding many cancers. Boehringer Ingelheim’s Martin Beck highlighted the shift toward earlier detection using AI‑enhanced imaging and a broader view of IPF as a heterogeneous,...
Arizona State University researchers quantified how water interacts with biomolecule‑coated magnetite nanoparticles, revealing that surface coatings dramatically reshape hydration energetics, immune recognition, and drug‑delivery performance. Using a calorimetry‑gas adsorption system, they measured water adsorption on particles coated with bovine serum...
Generate Biomedicines priced its IPO at $16 per share, raising $400 million to fund pivotal trials of its lead candidate GB‑0895. The antibody blocks the TSLP pathway and is engineered for six‑month dosing, a potential advantage over existing asthma biologics that...
Cortical Labs in Australia has upgraded its biocomputer, built from lab‑grown human neurons, to play the first‑person shooter *Doom*. The new CL1 platform translates visual game data into electrical stimulation patterns that the neuronal network can interpret, achieving adaptive, real‑time...
Seattle Stem Cell Center was ordered to pay $24 million after a jury found the clinic liable for the 2019 death of Michael Trujillo, who suffered catastrophic bleeding following an undocumented epidural injection while on blood‑thinning medication. Evidence showed the procedure...
BioAtla announced it is slashing roughly 70% of its staff as it evaluates strategic alternatives, leaving only essential personnel for the review. The move follows a 30% reduction last year and leaves the company with about $7.1 million in cash, down...
Clonal hematopoiesis (CH) is the age‑related expansion of blood‑cell clones carrying somatic mutations acquired in hematopoietic stem cells. Detectable CH appears in roughly 10 % of individuals over 70, making it a common form of somatic mosaicism. While CH is a...
Researchers have built microbial community‑scale metabolic models that simulate how specific probiotic strains behave in an individual’s gut. Using baseline microbiome data, the models predicted engraftment with 75‑80% accuracy and linked bacterial growth to health outcomes such as improved post‑meal...
CollPlant has introduced BioFlex, a ready‑to‑print DLP bioprinting kit built on recombinant human collagen and a biodegradable polymer. The kit includes pre‑validated photo‑active agents and detailed formulation guidelines, aiming to cut bioink development time for tissue‑modeling and organ engineering. By...
Alnylam Canada received a positive recommendation from Canada’s Drug Agency to list AMVUTTRA® (vutrisiran) for public reimbursement in adult patients with cardiomyopathy caused by wild‑type or hereditary ATTR amyloidosis. The therapy, approved by Health Canada in December 2025, expands the...
The European Medicines Agency’s CHMP has issued a positive opinion on Moderna’s mCombriax, a combined COVID‑19 and influenza mRNA vaccine, after a Phase III trial showed stronger immune responses than a mixed regimen of Sanofi’s flu shot and Spikevax. EMA approval...
At CROI 2026, researchers spotlighted the growing neurodegenerative burden among aging people living with HIV, emphasizing heightened risks of depression and cognitive vulnerability despite long‑term antiretroviral therapy. Parallelly, the University of Southern California announced a novel series of MAPT aggregation...
BioWorld’s “In the Clinic for March 2, 2026” page functions as a centralized gateway to the latest biopharma, med‑tech, and scientific content. It aggregates data snapshots, special reports, infographics, and market scorecards covering everything from GLP‑1 trends in China to mRNA vaccine...
On March 2, 2026 BioWorld published a regulatory snapshot covering biopharma and med‑tech firms such as AS Software, Asieris, Boehringer Ingelheim, Deephealth, Eli Lilly, Ipsen, Moderna, Neurogene, Novartis, Optellum, Photocure, Regeneron, Sanofi, Sentynl, Synergy Spine Solutions and X4. The roundup highlights...
In this episode of Inside Biotech, host Karish Manchugani chats with Tim Dabrowski, a Berkeley‑trained patent attorney at Mintz, about his unconventional path from a physiology degree to biotech IP law. Tim explains how his scientific background informs his work...
The WHO’s INN proposed list 134, released in early 2026, reveals several late‑stage drug candidates that were previously hidden from public view. Notably, two NLRP3 inhibitors—abdenoflast and parunoflast—appear to map to Eli Lilly’s newly acquired Ventyx assets VTX2735 and VTX3232, both showing promising...
Researchers identified a previously unknown accessory mesenchymal cell (PDGFRα⁺/Sca1⁺/CD34⁺) that enables complete hair follicle formation in a dish. By integrating this cell type with epithelial stem cells and dermal papilla cells, they created a three‑cell organ germ that grew downward,...
Scientists at the Max Planck Institute have identified a novel RNA‑driven mechanism that pairs inactive ribosomes into disomes when animal cells, including neurons, face nutrient starvation or temperature stress. The pairing is mediated by a specific ribosomal RNA expansion segment,...
Researchers from the University of Liverpool and the University of Las Palmas de Gran Canaria have launched the world’s largest open‑source tumor database for dogs and cats, containing over one million records. The registry covers more than 200 breeds and...
I used to teach that osteoarthritis was "wear and tear" — lose weight, take painkillers, wait for a knee replacement. A study just published in Cell Metabolism proved that wrong. Semaglutide (Ozempic) didn't just reduce joint pain in osteoarthritis patients — it...
The breakthrough blood test p-tau 217 for risk and diagnosis of Alzheimer's disease is more accurate than total p-tau 217, in a head-to-head comparison using PET imaging https://t.co/faILpVr9Ua https://t.co/lzUgFnFUP5
Bioxytran announced positive phase 1b/2a data for its oral antiviral ProLectin‑M in a randomized, double‑blind, placebo‑controlled trial of 39 mild‑to‑moderate COVID‑19 patients in India. The highest dose (16,800 mg/day) achieved viral clearance in 90% of participants by day 5 versus 20% on placebo,...
A systematic RCT analysis of GLP-1 drugs show they are more effective in women than men for weight loss https://t.co/cycwi4nnN5 https://t.co/KOl0FgKaZD
Roche pill succeeds in another MS study, but approval questions linger https://t.co/JY8uZCI5iA @ByJonGardner $RHHBY $SNY
The Module 2, Section 2 lecture introduces the druggable interactome, compiling key resources that map the human druggable genome, protein expression, kinase families, transcription‑factor proteomics, GPCRs, and ion‑channel complexes. It highlights quantitative estimates—over 3,000 proteins deemed druggable and hundreds of actionable kinases—while...
UniQure says FDA wants another study of Huntington’s gene therapy https://t.co/1pgFDoE2V9 by @realJacobBell $QURE - 35% #GeneTherapy #Huntingtonsdisease
1/ AI won't replace you. But a biologist who uses AI will. Especially in bioinformatics, where the questions never stop coming. https://t.co/q2OHzntcoV
AI of whole slide images for cancer molecular markers is not ready for clinical use due to confounding and biases ("shortcut learning"), supported by multiple examples @natBME https://t.co/zG8uVIxrJf https://t.co/hQ0tjiapIJ
A new mechanism for improved cognitive function from exercise in the Alzheimer's disease model Skeletal muscle EC vesicles interact with the brain and rev up microglia function https://t.co/eZu14YVasY
Safety concerns spur Aardvark to halt key Prader-Willi drug trial https://t.co/PWkOuDMIvo $AARD - 52% $SLNO
Stanley Plotkin, known as the “godfather of vaccines,” in an interview with @HelenBranswell: “All I can say is that I’m beginning to regret having lived so long — because we’re going downhill.” https://t.co/A2zcoP2Ghd
New @NatureMedicine A randomized trial of antibody vs activin type II receptors with or without semaglutide (Ozempic). The antibody, bimagrumab, promotes muscle growth. Marked weight loss with the combination https://t.co/XUK93GTAmA
Stanley Plotkin had a major hand in the development of a number of vaccines in use today; he designed the rubella vaccine. He remembers the world before widespread use of vaccines & knows what's coming as vaccine policy is rewritten...
2March: How did @generate_biomed CEO @mike_nally describe his whirlwind of emotions as his company went public? Read what he and CFO Jason Silvers, MD, JD said about $GENB plus updates on $CASIF, $NVAX, $PMVP & $SRPT in my latest StockWatch...
Someday we'll be able to track our immune system like we do glucose Today @NatBME https://t.co/HFcFiUeyFg Previously @ScienceMagazine https://t.co/EcgBdwGxcd https://t.co/SpoZ5bLtjx
Who's heard of Flare Therapeutics? #GU26 late-breaker shows promise in hitting "undruggable" PPAR-γ target, with a few major caveats. Via @ApexOnco -> https://t.co/1GepvywtL0
