AbbVie Submits FDA NDA for Upadacitinib (RINVOQ) to Treat Severe Alopecia Areata
AbbVie announced it has submitted a new drug application to the U.S. FDA for upadacitinib (RINVOQ) in severe alopecia areata, based on Phase 3 results showing significant scalp hair regrowth. The filing targets both adult and adolescent patients, a population with limited therapeutic options.
Ageing Forms Gene Network Linking Diseases via Two Pathways
Ageing isn't one disease, it's a network. Excited to share our latest study exploring the genetic links between ageing and age-related diseases 🧬 We show how shared pleiotropic genes connect disease clusters, revealing two distinct genetic architectures: one driven by ageing-related...
FDA to Pilot Real-Time Clinical Drug Trials Through Cloud and AI
The FDA announced a pilot that will stream clinical‑trial data to the agency in real time using cloud platforms and artificial‑intelligence analytics. Commissioner Marty Makary said the effort could shave up to 40% off the time between Phase 1 trials and...
FDA Launches Real‑Time Clinical Trial Tracking Pilot with AstraZeneca and Amgen
The FDA announced a pilot that will stream real‑time data from two pharmaceutical trials—AstraZeneca’s mantle‑cell lymphoma study and Amgen’s early‑stage lung cancer trial. The effort seeks to shrink the decades‑long lag between trial results and regulatory decisions, creating new IT...
MIT Team Unveils Magnetically‑controlled Soft Hydrogel Microrobots for Medical Use
Researchers from MIT, EPFL and the University of Cincinnati have 3D‑printed soft magnetic hydrogel structures that transform into microrobots controllable by external magnets. The “magno‑bots” can deform and grip at sub‑millimeter scales, opening pathways for biopsy retrieval and targeted drug...
Supply Chain Digital Twins: An Evolution, Not a Breakthrough
Researchers at NIST and EMD Millipore argue that digital twins can model the intricate biopharmaceutical supply chain, from demand shocks to distribution bottlenecks. By creating in‑silico replicas of cells, raw materials, and logistics flows, twins could identify alternative distribution centers and...
Milk Exosomes Transform Therapeutic Bioprocessing
Milk-derived extracellular vesicles, known as milk exosomes, are emerging as a biocompatible platform for therapeutic delivery. Researchers have loaded the JAK inhibitor tofacitinib into exosomes (mEXOs@TOF) for ulcerative colitis, achieving high drug‑loading efficiency, stability and strong anti‑inflammatory effects without toxicity....
Hopes Raised for More Sustainable Oligonucleotide Manufacturing
QurAlis CTO Hagen Cramer says enzymatic synthesis could make large‑scale oligonucleotide production far more sustainable than the solvent‑intensive solid‑phase method. While solid‑phase synthesis remains fast and automated, it generates high process mass intensity due to extensive solvent washes. Enzymatic, aqueous‑based...
Adaptive, Agent-Oriented Control for Biomanufacturing Systems
The Adaptive Agent‑Oriented System Control (AAOSC) framework, created by the Technical University of Denmark and SiC Systems, adds a decentralized layer of autonomous agent "hives" to biomanufacturing plants. By linking digital twins, IoT sensors and enterprise systems, AAOSC can reduce...
Sandoz Q1 Net Sales Rise 3% to $2.76 Bn, Biosimilars Up 18% and 2026 Guidance Reaffirmed
Sandoz reported first‑quarter net sales of $2.76 billion, a 3% increase at constant currency, and confirmed its 2026 financial guidance. The growth was driven by an 18% jump in biosimilar sales, while generic sales slipped modestly.
Prenatal Surgery for Spina Bifida May Get a Boost From Stem Cells
Researchers at UC Davis have performed the first in‑utero repair of spina bifida using a stem‑cell‑infused patch on six fetuses. The procedure appeared safe, with no infections, tumors, or delayed healing reported in the initial cohort. While early safety data...
Late‑Stage Drug Development Trends: Phase III, AI, Global Partnerships
LOOKING forward to tomorrow's webinar on late-stage drug development trends with Susan Galbraith (AstraZeneca), Levi Garraway (Roche) and Ken Getz (Tufts). We'll be discussing the fundamentals of Phase III, with thoughts on efficiencies, interplay with biotech partners, China, AI, and...
Astellas’s R&D Head Talks Strategy Ahead of Looming Patent Cliff
Astellas Pharma faces a looming patent cliff as its blockbuster prostate‑cancer drug Xtandi, which generated about $4.6 billion in the 2025 fiscal year, loses U.S. patent protection next year. To offset the expected revenue hit, chief R&D officer Tadaaki Taniguchi is accelerating...
Henlius and Organon Gain EC Approval for Pertuzumab Biosimilar
Henlius and Organon have received the first European marketing authorization for a pertuzumab biosimilar, Poherdy, targeting HER2‑positive breast cancer. The EC approval mirrors the product’s earlier U.S. clearance and covers all indications of Roche’s reference drug, Perjeta, including metastatic, neoadjuvant...
Pfizer Earns Positive Phase 3 in Multiple Myeloma; ICON Overstated Revenue
Pfizer announced that its antibody‑drug conjugate Elrexfio achieved a statistically significant and clinically meaningful improvement in progression‑free survival for patients with double‑class exposed relapsed or refractory multiple myeloma. The Phase 3 trial met its primary endpoint, positioning the drug as a...
Quintuple Receptor Agonist Outperforms Tirzepatide in Trials
New @Nature A quintuple [GLP-1 + 4 other] receptor agonist drug that exceeds effects of the dual receptor (GLP-1 and GIP, tirzepatide) in the experimental model vs diabetes and obesity (in case you thought a dual receptor was max effect, as...
After Apellis Deal, Biogen Looks to Fill Early-Stage Pipeline
Biogen announced a $5.6 billion acquisition of Apellis Pharmaceuticals, adding a complement‑inhibition platform to its portfolio. While the deal closes this month, the company emphasized that its growth engine will now hinge on early‑stage development and research rather than late‑stage launches....
Brenntag Pharma Unveiled BYPHAR, the New Regulated Biopharma Manufacturing Brand
Brenntag Pharma introduced BYPHAR, a new regulated biopharma manufacturing brand that consolidates high‑quality raw materials, advanced facilities, and value‑added services into a single, compliance‑ready portfolio. The brand groups materials into three tiers—Explore, Enhance, and Excel—covering non‑GMP to LBLE critical grades,...
With Growth Curve Trending up, Biogen Looks to Early-Stage Assets for ‘Next Generation’
Biogen, fresh from its $5.6 billion acquisition of Apellis, announced on its Q1 earnings call that it will pivot toward early‑stage assets to thicken a pipeline it described as “quite thin.” The shift comes as Alzheimer’s patients transition off Eli Lilly’s Kisunla,...
March 2026 Patent Highlights
The March 2026 Patent Highlights page aggregates the latest drug‑discovery milestones, from 38 first‑time small‑molecule approvals by Europe’s EMA, China’s NMPA and Japan’s PMDA to a deep dive on protein‑structure advances and machine‑learning tools. It spotlights a newly optimized HPK1 inhibitor...
Circio Partners with TraffikGene Project to Advance Non-Viral circVec Delivery
Circio, an Oslo‑based circular RNA company, has partnered with the Universidad de Santiago de Compostela’s TraffikGene project to explore non‑viral delivery of its circVec circular RNA expression vectors. The collaboration merges Circio’s circVec platform with TraffikGene’s peptide amphiphile carrier system...
SYRE Jumps to $8B After Breakthrough UC Trial
$SYRE pushing $8 billion cap currently on a major $XBI red day following their open label a4b7 data proving that a4b7 continues to work. Valuation was ~$3B at the start of the year. Must’ve been a massive surprise that their...
FDA Pilots Real-Time Trials as AbbVie Eyes KRAS Biotech
FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech https://t.co/diuieVTJ3g $ABBV $LLY $GSK $IONS $PFE #biotech
Infinite Epigenetics Acquires Tally Health in ‘Largest Epigenetic Testing Deal to Date’
Infinite Epigenetics announced the acquisition of Tally Health, creating the largest private‑sector DNA methylation database. The deal merges Infinite's TruDiagnostic biological‑age platform with Tally's at‑home epigenetic test and supplement program, forming a vertically integrated measurement‑to‑intervention stack. Executives say the combined...
FDA to Relax Peptide Rules After High‑profile Endorsement
FDA moves toward easing restrictions on certain peptides The agency’s decision to hold an advisory committee meeting on the topic comes after HHS Secretary Robert F. Kennedy Jr. told podcaster Joe Rogan he’s a “big fan” of peptides. https://t.co/wynhLuBUPE https://t.co/y9dgG0xWAq
Tomorrow's Dual AZN ODAC: Serena-6 AM, Truqap-281
Reminder that the dual $AZN ODAC takes place tomorrow. Camizestrant Serena-6 trial being debated in the morning, then Truqap Capitello-281 in the afternoon. Youtube link -> https://t.co/RDcvhRqVWR
FDA Knew of Better Method to Detect COVID Vaccine Safety Signals — But Refused to Use It
Senator Ron Johnson released a report showing that FDA officials during the Biden administration knew a superior empirical Bayesian data‑mining method existed for detecting COVID‑19 vaccine safety signals in VAERS but ordered staff to continue using the older, flawed tool....
Skin Nerve Fibers Slow Melanoma Growth, Challenging Cancer Neuroscience
A twist in cancer neuroscience with many studies showing hijacking of neurons to promote cancer—melanoma growth slowed by nerve fibers in skin https://t.co/9OWEAhJPOb https://t.co/XGSdYYPqk8
Thermo Fisher Scientific Launches Applied Biosystems PowerFlex Thermal Cycler
Thermo Fisher Scientific unveiled the Applied Biosystems PowerFlex Thermal Cycler, a next‑generation PCR instrument that emphasizes speed, precision, and flexibility. The system features a 10.1‑inch touchscreen, AI‑driven Smart Help, and two configuration options—a 96‑well plate and a 3 × 32‑well layout with...
Nanozymes Against Brain Tumors
Researchers at Empa and HOCH Health Ostschweiz are developing biocompatible nanozymes that can be applied directly during brain‑tumor surgery to attack astrocytoma cells. The nanozymes act like enzymes, generating reactive‑oxygen species and activating drug precursors, and they are triggered by...
Biogen Ready to Catch Alzheimer’s Patients Transitioning Off Lilly’s Kisunla
Biogen is positioning its Leqembi therapy to capture Alzheimer’s patients who will finish Eli Lilly’s 18‑month Kisunla regimen and need a maintenance option. Leqembi, approved in January 2023, saw a 74% year‑over‑year sales jump to $168 million in Q1 2026, beating expectations. Biogen is...
Inside Servier’s New €200M Venture Fund
Servier has unveiled a new corporate venture fund, committing roughly $216 million to back early‑stage biotech focused on oncology and neurology. The fund, Servier Ventures, will target late pre‑clinical and Series A assets where it can add capital and industrial expertise, especially...
Never Blindly Trust Data, Even From Trusted Sources
1/ Bioinformaticians, I’ll say it loud: Never blindly trust the data you're given. Not from collaborators. Not from vendors. Not even from “reliable” sources. Here’s why: https://t.co/zXhgzqyISi
US Firm Implants Brain Device in China, Rare Cooperation
"A US company has tested a brain implant in a Chinese patient in Shanghai, a rare sign of cooperation as the two countries compete to develop the most advanced neurotechnology." https://t.co/4xEs7DZTpk
Candel Therapeutics Announces Commercial Agreement with EVERSANA to Support U.S. Launch of Prostate Cancer Therapy
Candel Therapeutics announced a commercialization agreement with EVERSANA to support the potential U.S. launch of its gene‑therapy candidate aglatimagene besadenovec (CAN‑2409) for intermediate‑ to high‑risk localized prostate cancer. EVERSANA will deliver a full suite of services, including data analytics, medical...
Chiesi Signs $1.9B Deal to Acquire KalVista and Its Approved Drug
Italian pharmaceutical group Chiesi announced a $1.9 billion cash acquisition of U.S. biotech KalVista Pharmaceuticals, paying $27 per share. KalVista brings an FDA‑approved therapy for a rare disease into Chiesi’s portfolio, bolstering its specialty drug offerings. The deal is part of...
SRN‑901 Extends Mouse Lifespan by 33% in Preclinical Trial, Raising Longevity Hopes
SinoGen, Tsinghua University and China National Pharmaceutical announced that the oral anti‑aging candidate SRN‑901 extended median remaining lifespan by 33% in naturally aging mice. The study also cut tumor incidence by 30% and slowed visible aging signs, positioning the drug...
Paradigm Health Teams with FDA and Pharma Giants to Speed Trial Data Review
Paradigm Health announced a partnership with the U.S. Food and Drug Administration, Amgen and AstraZeneca to pilot an integrated technology platform that delivers real‑time trial data to regulators, promising to shrink review cycles from months to days. The model, already...
Chiesi Expands Rare Disease Portfolio, Acquires KalVista for $1.9 Billion
Chiesi Group announced a $1.9 billion cash acquisition of KalVista Pharmaceuticals, its largest deal to date. The purchase adds EKTERLY (sebetralstat), the first oral, on‑demand therapy for hereditary angioedema (HAE), to Chiesi’s rare‑disease pipeline. EKTERLY is already approved in major markets...
Insilico Medicine Secures IND for AI-Designed Rentosertib Inhalation, First Direct‑to‑Lung Trial
Insilico Medicine announced IND clearance from China's CDE for its AI‑designed Rentosertib inhalation solution, marking the 13th AI‑driven program to reach clinical testing and the first to use a direct‑to‑lung delivery route. The Phase I study will enroll about 80...
When ADCs Meet Targeted Protein Degraders: The Emerging Field of Degrader-Antibody Conjugates
The biotech sector is exploring degrader‑antibody conjugates (DACs), a hybrid that merges antibody‑drug conjugate targeting with catalytic protein‑degradation payloads. C4 Therapeutics has expanded its partnership with Roche to co‑develop two undisclosed oncology DAC programs, while Orum Therapeutics secured $100 million to...
Teva to Acquire Emalex Biosciences for ~$900M
Teva Pharmaceutical Industries has signed a definitive agreement to acquire Emalex Biosciences for an estimated $900 million, comprising $700 million upfront and up to $200 million in commercial milestones. The purchase brings Emalex’s lead asset, ecopipam—a selective dopamine D1 receptor antagonist—into Teva’s neuroscience...
FDA Halts Manual Trial Data Entry, AI Opportunity Ignored
The FDA Finally Stopped Re-Typing Clinical Trial Data. That's the AI Story Nobody Is Writing. https://t.co/hAH43sFSTg
Psychedelics Go Mainstream: Medicine, Mania Or Both?
Psychedelics are re‑emerging as a potential breakthrough in behavioral health, spurred by loosening regulations and a Trump‑issued executive order that accelerated research. Early clinical data suggest benefits for depression, PTSD and other conditions, prompting biotech stocks to rally after FDA...
Amgen, AZ Will Pilot FDA's Real-Time Clinical Trial Plan
The FDA unveiled a plan to receive clinical‑trial data in real time, aiming to accelerate drug development. AstraZeneca and Amgen have agreed to pilot the model with two studies that will stream endpoints and safety signals to regulators as they...
EPA Approves Soilcea’s CarriCea T1: The First CRISPR-Edited Rootstock to Offer Greening Tolerance for Florida Citrus
The U.S. Environmental Protection Agency has approved Soilcea’s CarriCea T1, the first CRISPR‑edited citrus rootstock engineered for tolerance to Huanglongbing (HLB) disease. Developed by University of Florida researchers and Soilcea, the rootstock blocks the bacterium’s interaction with the tree, limiting infection....
Robotics
Ekso Bionics' Ekso GT™ exoskeleton became the first FDA‑cleared wearable robot for stroke rehabilitation in May 2016. The device enables individuals with lower‑limb paralysis to stand and walk during therapy sessions. It also secured clearance for certain spinal‑cord‑injury patients, marking a...
Revolution’s on a Pancreatic Cancer Winning Streak. What Comes Next for the Biotech?
Revolution Medicines announced that its oral RAS(ON) inhibitor daraxonrasib nearly doubled overall survival in previously treated metastatic pancreatic cancer, while its second candidate zoldonrasib showed tumor shrinkage in over half of KRAS‑driven lung cancer patients. The breakthrough data sent the...
The 20 Enterprise AI Drug Discovery & Life Sciences CEOs You Need to Know in 2026
The AI Insider has compiled a roster of the 20 most influential CEOs steering enterprise AI drug discovery and life‑sciences firms in 2026. The list showcases companies that are compressing decade‑long development cycles into months through generative protein design, AI‑optimized...
Drug Trials Snapshot: DAXXIFY
Revance Therapeutics’ DAXXIFY, a daxibotulinumtoxin A formulation, received FDA approval on September 7 2022 for temporary reduction of moderate to severe glabellar lines. Approval was based on two randomized, double‑blind, placebo‑controlled trials (GL‑1 and GL‑2) that enrolled 609 adults across the United States...