Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech rounds
Spanish biotech firm Ona announced an $86.6 million Series B financing, ranking among the largest venture rounds in Spain’s life‑science sector this year. The round was led by Seventure Partners with participation from existing backers and new strategic investors. The funding will be used to scale Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical programs.
Celldex Reports Quality of Life Gains in Urticaria Trials
Celldex Therapeutics reported Phase 2 data showing its KIT‑targeting antibody barzolvolimab dramatically improves quality‑of‑life scores for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). At Week 52, 94 % of CSU patients achieved a Dermatology Life Quality Index (DLQI) of 0‑1, and response durability persisted seven months post‑treatment. In CIndU, the drug raised the odds of no impact on life quality by up to 3.1‑fold in cold urticaria and 4.0‑fold in symptomatic dermographism. Celldex completed enrollment of 1,939 CSU patients early and analysts upgraded price targets, fueling a 59 % stock rise.
Blocking TIE2 Protein May Prevent Blood Vessel Defects in the Brain
Researchers at the University of Pennsylvania identified the endothelial receptor TIE2 as a pivotal link between the MEKK3‑KLF2/4 and PI3K signaling cascades that drive cerebral cavernous malformations (CCMs). In mouse models, oral inhibition of TIE2 with the tyrosine‑kinase inhibitor rebastinib...
FDA Approves Novo Nordisk's Once-Weekly Insulin
The U.S. Food and Drug Administration has approved Novo Nordisk’s once‑weekly insulin, the first longer‑acting basal therapy for type‑2 diabetes in the United States. The product, insulin icodec, demonstrated non‑inferior HbA1c reduction and comparable safety to daily basal insulins in...
In‑vivo CAR‑T Achieves 4/5 MRD‑Negative Remissions
Outstanding piece here from @leilei_wuu on AstraZeneca's in vivo CAR-T for multiple myeloma. There's data on 5 patients, which is pretty lean, but 4 come out MRD negative in two months, which is extraordinary. We're going to see a lot...
EU Regulator Backs Sanofi’s Injectable Version of Blood Cancer Drug
The European Medicines Agency has issued a positive opinion on Sanofi’s subcutaneous version of Sarclisa, a drug for multiple myeloma, citing late‑stage trials that proved non‑inferior efficacy to the intravenous formulation. If the European Commission follows the EMA’s recommendation, the...
Brightseed Launches Enterprise AI Solution to Streamline Formulation and Manufacturing Success
Brightseed unveiled the world’s first clinically validated enterprise AI platform, designed to unite discovery, development, and commercialization for health‑science products. The system targets the industry’s 75% early‑stage failure rate by eliminating fragmented workflows and late‑stage risk discovery. Powered by the...
Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises
A BioSpace webinar highlighted how biotech firms can close the expectation gap with the FDA to avoid last‑minute decision‑day setbacks. Speakers emphasized the FDA’s recent pledge—led by Commissioner Marty Makary and CBER Director Vinay Prasad—to provide regulatory navigation for small companies,...
Oral GLP‑1 Pill Orforglipron Beats Ozempic in Weight‑Loss Trial
Researchers reported that the oral GLP‑1 tablet orforglipron achieved greater weight loss and blood‑sugar reduction than injectable semaglutide (Ozempic) in a 52‑week phase‑3 study. The findings could shift prescribing patterns for obesity and type‑2 diabetes.
UT Health San Antonio Launches Precision Rapamycin Trial in 84 Seniors
UT Health San Antonio has started a National Institute on Aging‑funded, randomized trial of rapamycin and everolimus in roughly 84 adults 65 to 90 years old. The six‑week study will assess safety, optimal dosing and biological markers of healthy aging,...
WPI AI Model Predicts Alzheimer’s with 93% Accuracy From MRI Scans
Researchers at Worcester Polytechnic Institute unveiled an artificial‑intelligence model that identifies Alzheimer’s disease from MRI scans with 93% accuracy. The breakthrough could shift screening from symptom‑based to image‑based detection, accelerating treatment and trial enrollment.
GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B
GlaxoSmithKline announced that the European Medicines Agency has accepted the marketing authorization application for bepirovirsen, an antisense oligonucleotide targeting chronic hepatitis B. The acceptance follows positive Phase III data from the B‑Well 1 and B‑Well 2 trials, which enrolled patients...
Nordic Cold Chain Solutions Launches Lab to Meet GLP-1 Demand
Nordic Cold Chain Solutions (NCCS) has opened a GLP‑1 & Small‑Format Packaging Innovation Lab to help pharmaceutical manufacturers, specialty pharmacies and e‑commerce players manage temperature‑sensitive drugs. The lab provides end‑to‑end services from early‑stage design and pilot testing to high‑volume production,...
AstraZeneca’s in Vivo CAR-T Led to Early Responses, but One Death in China Trial
AstraZeneca’s in‑vivo CAR‑T platform, acquired last year, has entered a Phase I/II trial in China for relapsed/refractory multiple myeloma. Early data show a 33% overall response rate with several partial remissions, but the study also reported one death due to severe...
The Expanding Role of Checkpoint Inhibitors in CSCC Management
The NCCN has revised its guidelines to place checkpoint inhibitors at the forefront of cutaneous squamous cell carcinoma (CSCC) treatment, extending their use beyond metastatic disease to neoadjuvant and adjuvant settings. PD‑1/PD‑L1 agents such as cemiplimab, cosibelimab and pembrolizumab are...
Do GLP-1s Have a Future in Europe?
GLP‑1 receptor agonists are booming in the United States, where roughly 12 % of patients use them, but European uptake lags at about 2 % across the EU and UK. Consumer skepticism—especially in France, Italy and Spain—and the dominance of public‑health reimbursement...
Novartis to Spend up to $2B on Excellergy and Its Next-Gen Xolair Candidate
Novartis announced it will pay up to $2 billion upfront to acquire Excellergy Inc., securing the biotech’s next‑generation anti‑IgE candidate. The move comes as Xolair, Novartis’ blockbuster allergy drug, prepares for imminent biosimilar competition that could erode its market share. By...
Triple Pre-Surgery Therapy May Boost Immunity Against Soft Tissue Sarcoma
Researchers at UCLA Health and Stanford Medicine reported that a neoadjuvant regimen combining hypofractionated radiation, the experimental immunomodulator BO‑112, and anti‑PD‑1 therapy (nivolumab) can reshape the tumor microenvironment of soft‑tissue sarcoma. Preclinical mouse work and a Phase I trial in 14...
‘Milestone’ Research Method Measures Gene Activity Across Whole Mice
Researchers at the University of Chicago have unveiled a whole‑body spatial transcriptomics method that slices frozen mice and maps gene expression across millions of cells in a single cross‑section. Using a cryomacrotome and 600,000 spatial spots, the technique captured activity...
AstraZeneca’s COPD Antibody Gets Phase 3 Wins in Broader-than-Expected Population
AstraZeneca announced that its investigational COPD antibody achieved positive results in two Phase 3 trials, marking a turnaround after a previous mid‑stage failure. The studies demonstrated statistically significant improvements in lung function and exacerbation rates across a broader patient population...
Human Longevity, Inc. Teams with LEV Foundation to Study Centenarians
Human Longevity, Inc. and the LEV Foundation announced a strategic partnership to analyze blood samples from centenarians and supercentenarians. The collaboration will use HLI's AI‑driven precision longevity platform and LEV’s expertise in lifespan extension to uncover molecular drivers of exceptional...
FDA Approves Novo Nordisk's Awiqli, First Once‑Weekly Basal Insulin
Novo Nordisk announced that the U.S. Food and Drug Administration has approved Awiqli (insulin icodec-abae), the first and only once‑weekly basal insulin for adults with type 2 diabetes. The approval follows the ONWARDS phase 3a trial program involving roughly 2,680 patients and...
Microbiome-Activated Nanogel Successfully Delivers Butyrate in Mice
A preclinical study in Small describes an inulin‑butyrate nanogel that releases butyrate directly in the inflamed colon of mice, markedly improving colitis outcomes. The nanogel remains stable through the upper GI tract and is enzymatically activated by colonic microbes, delivering...
Job Opportunity: HPM Seeks Associate Drug Development Attorney
Hyman, Phelps & McNamara (HPM) announced a vacancy for a 3rd‑to‑6th year associate attorney on its drug development team. The role supports clients through the full FDA pre‑market lifecycle, from pre‑IND strategy to IND, NDA/BLA submissions and dispute resolution. Candidates...
Hims & Hers Shifts to Branded GLP‑1s and Telehealth After Novo Nordisk Deal
Hims & Hers announced it will stop actively marketing compounded GLP‑1 drugs and focus on a broader portfolio of FDA‑approved, branded GLP‑1s through a new partnership with Novo Nordisk. The pivot follows a 70% stock plunge and aims to sustain...
Asia Emerges as Testbed for Healthcare Innovation
It was a pleasure to participate in the Investment and Innovation Pathways to a Healthy Asia session at the Global Investors’ Symposium in Hong Kong. A timely discussion on where durable value is being created in healthcare across Asia, from prevention...
AI Empowers Chemists, Accelerating Novel Drug Discovery
The life of a chemist is about to change dramatically as we move away from tedious trial-and-error and deeper into the comfort of the prompt window. We don't need fewer medicinal chemists; we need more high-novelty drugs on the market...
Simulations Plus and Three Pharma Companies Collaborate on AI-Driven Drug Development
Simulations Plus has launched strategic partnership programmes with three pharmaceutical companies to embed AI‑driven modelling into the drug development lifecycle. The collaborations will integrate Simulations Plus platforms—ADMET Predictor, GastroPlus, Thales and MonolixSuite—into model‑informed drug development (MIDD) workflows, enabling natural‑language interaction and automated...
Zhongzhi Pharmaceutical Reports 82% Drop in Net Income, Revenue Falls 21%
Zhongzhi Pharmaceutical Holdings Limited announced a full‑year 2025 net profit of RMB17.29 million ($2.4 million), an 82% plunge from the previous year, while revenue dropped 21.5% to RMB1.737 billion ($243 million). The sharp contraction underscores growing pressure on Chinese drug makers amid a tightening...
Pharma Pulse: Commercial Risks of the NDC-12 Transition and FDA Approval of Avlayah for Hunter Syndrome
The pharmaceutical industry faces commercial risk as it prepares for the 2033 transition to a uniform 12‑digit NDC format, with experts warning that thousands of zero‑prefix collisions could trigger PBM claim rejections, disrupt patient‑hub enrollments, and corrupt market‑intelligence data. Simultaneously,...
How Anesthetics Destabilize the Brain: Scientists Stumble upon Common Mechanism
MIT researchers discovered that three widely used anesthetics—propofol, ketamine and dexmedetomidine—produce an identical destabilization of brain dynamics, measurable as a loss of dynamic stability. Using EEG‑based perturbation analysis, they showed that despite distinct molecular targets, each drug pushes the brain...
HaemaLogiX – Precision Immunotherapy for Multiple Myeloma
HaemaLogiX, an Australian clinical‑stage biotech, is developing precision immunotherapies for multiple myeloma by targeting novel antigens KMA and LMA that appear only on malignant plasma cells. Peer‑reviewed research validates these targets, allowing the company to spare healthy plasma cells and...
Novartis Agrees to Acquire Excellergy, Building on Allergy Leadership With Next-Generation Anti-Ige Innovation
Novartis announced a definitive agreement to acquire Excellergy, a private biotech developing next‑generation anti‑IgE therapies. The deal values Excellergy at up to $2 billion in upfront and milestone payments, with closing targeted for the second half of 2026. Exl‑111, Excellergy’s lead...
Insilico Medicine Expands AI-Driven CNS Collaboration with Tenacia in a ~$94.75M Deal
Insilico Medicine and Tenacia Biotechnology have expanded their AI‑driven partnership to create a second central‑nervous‑system (CNS) candidate, now advancing to the preclinical stage. The original March 2025 collaboration combined Insilico’s Pharma.AI platform with Tenacia’s expertise in blood‑brain‑barrier‑permeable small‑molecule inhibitors. Under...
Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026
Abcuro presented Phase II/III MUSCLE trial data for ulviprubart (ABC008) in inclusion body myositis (IBM) at the GCOM 2026 meeting. The study enrolled 272 patients who received either 0.5 mg/kg, 2 mg/kg, or placebo. Across the entire cohort the drug showed only...
AstraZeneca Drug Reduces Flare-Ups of Chronic Lung Disease in Late-Stage Trials
AstraZeneca’s experimental antibody tozorakimab cut moderate‑to‑severe COPD flare‑ups in two phase‑III trials, meeting its primary endpoint. The drug showed a statistically meaningful reduction across both current and former smokers, including those with varying lung damage. The positive data lifted AstraZeneca...
LLMs Enable DIY mRNA Vaccine for Pets
The coolest meeting I had this week with was Paul, who used ChatGPT and other LLMs to create an mRNA vaccine protocol to save his dog Rosie. It is amazing story. "The chat bots empowered me as an individual to act...
Top HHS Official Makes Impassioned Pitch to Take on China Biotech
Senior HHS official and Medicare administrator Chris Klomp warned that competition with China’s rapidly advancing biotech sector is “a war,” signaling heightened urgency in U.S. policy circles. He highlighted gaps in domestic research funding, manufacturing capacity, and talent pipelines that...
AI-Designed mRNA Vaccine Targets Cancer Precisely
Now imagine every cancer patient had access to this technology (they should) "A specifically designed mRNA vaccine - a precision-guided weapon to strike the cancer, developed with a pipeline designed by ChatGPT o1, implemented for candidate development by Gemini Pro 2,...
Aging Research Gains Momentum: Collaboration Fuels Therapeutic Breakthroughs
Now at 1M+ views. What struck me most here wasn’t the views. It was the engagement. People are ready to engage seriously with aging biology. Now the opportunity is to turn that energy into stronger collaboration, better translational science, and...
Innovent Shares Jump on First Profit, Obesity Drug Momentum
Innovent Biologics reported its first annual profit, propelled by strong demand for its weight‑loss medication. The Hong Kong‑listed company’s shares surged as much as 7.75%, the biggest jump since late October. The profit milestone underscores the rapid growth of China’s...
Tech Experts Overestimate Their Grasp of Cancer Biology
As someone who has covered cancer drug development for 25 years, one of the few things I am sure of is that the odds of technology folks thinking they understand biology are much higher than the odds they actually do.
FDA Commissioner Seeks Private Partnerships for Collaboration and Regulation
Couple interesting meetings for FDA Commissioner Makary: met with Arnold Ventures on Mar. 3 about "collaboration opportunities" https://t.co/vEyhDu5xaW and with $MNPR on "establishing a regulatory mechanism" on Mar. 13 https://t.co/DHaD6IlvCS
Vytrus Biotech SA Posts 183% Profit Jump as Revenue Climbs 66% to €8.37M
Vytrus Biotech SA announced full‑year earnings of €2.89 million, up 183% from the prior year, while revenue surged 66% to €8.37 million. The results highlight robust market demand for its pipeline and signal momentum for European biotech firms.
Pharma Rushes Into Psychedelics, M&A Activity Surges
Pharma’s appetite for psychedelic therapies is rapidly accelerating, with M&A interest heating up across the sector.
Decade-Long Quest to Break Blood-Brain Barrier Highlights Biotech Challenges
When we seeded Denali the idea was to break the curse of the blood/brain barrier. It took a decade and tons of faith and money. Biotech is hard. Curing diseases is hard. This is a good summary. ...
STAT+: FDA Approves Rocket Gene Therapy for Rare Immune Disorder
The FDA has granted approval to Rocket Pharma's gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD‑1), an ultra‑rare immune disorder. The therapy was previously rejected in 2024 due to manufacturing concerns, but the agency cleared it after the...
Alpha‑Lipoic Acid Shows Promise for Ischemic Heart Failure
Efficacy of Alpha-Lipoic Acid in Patients With Ischemic Heart Failure: A Double-Blind, Randomized, Placebo-Controlled Study | @JACCJournals https://t.co/nW9SbwEDfy https://t.co/qsemjmMb9k
GLP‑1 Therapies Show Promising Cardiovascular Benefits
GLP-1 and the cardiovascular system "This Review summarizes the effects of GLP-1 and GLP-1RAs in the CV system..." https://t.co/Sy7Jjb96WD https://t.co/v3T01fIcOs
GARM Adds Anti‑Aging Klotho to Gene‑Therapy Suite in Honduras
GARM, operating as Longevity Advanced, announced the addition of the anti‑aging protein Klotho to its gene‑therapy portfolio at its Roatán clinic. The move broadens a suite that already includes Follistatin and VEGF, positioning the center as a hub for high‑end...
Eye Drops Made From Pig Semen Deliver Cancer Treatment to Mice
Scientists at Shenyang Pharmaceutical University have engineered eye drops using exosomes derived from pig semen, loaded with a carbon‑dot nanozyme, to breach the retinal barrier in mice. The formulation halted retinoblastoma tumor growth and preserved normal vision over a 30‑day...