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.
Agenus to Host March 2026 Stakeholder Webcast Harnessing the Immune System to Advance BOT + BAL Across Tumor Types and...
Agenus announced a March 31, 2026 stakeholder webcast to detail progress on its botensilimab and balstilimab (BOT + BAL) immunotherapy program. The company highlighted clinical durability across multiple tumor types, with roughly 1,200 patients treated with botensilimab and over 900 with balstilimab in early‑stage trials. Executives will also discuss expanding global patient‑access pathways, including France’s AAC and Named Patient Programs. The webcast will outline Agenus’ strategic priorities for 2026 as it seeks broader adoption of its combination therapy.
Implications of the Rules of the Pharmaceutical Investment Promotion Committee in México.
Mexico published the Rules of the Pharmaceutical Investment Promotion Committee on February 23, 2026, implementing a 2025 decree aimed at boosting pharmaceutical investment and domestic health‑supply production. The rules tie participation in certain public procurement procedures, such as direct awards...
Clarity Secures Large-Scale Manufacturing Agreement for Copper-64
Clarity Pharmaceuticals has signed a manufacturing supply agreement with Theragenics to scale up production of copper‑64, a radiometal used in its investigational prostate‑cancer tracer 64Cu‑SAR‑bisPSMA. The deal leverages Theragenics’ Atlanta‑area facility, which houses 14 cyclotrons capable of producing roughly 100...
Beyond Lipid Nanoparticles: How Custom Polymers and AI May Reshape Gene Therapies
Researchers at Helmholtz‑Zentrum Hereon and partners propose a payload‑driven approach to nucleic‑acid delivery, designing polymeric carriers that are chemically tuned to each DNA, RNA or mRNA payload. The strategy contrasts with the one‑size‑fits‑all lipid nanoparticles that dominate current vaccines and...
LeonaBio Reports Full Year 2025 Financial Results and Provides Business Update
LeonaBio announced it has secured an exclusive global license for the Phase 3 lasofoxifene program, a novel selective estrogen receptor modulator aimed at ESR1‑mutated metastatic breast cancer, and raised $90 million in a private placement that could expand to $236 million with warrant...
Frank Harrell on Why and How to Do Bayes for Clinical Trials and the Recent FDA Draft Guidelines
Frank Harrell, a former FDA statistician, responded to recent JAMA commentary on the agency’s draft guidance promoting Bayesian methods for clinical trials. He highlighted that while the guidance is a step forward, FDA reviewers still rely on traditional frequentist approaches...
Hengrui Posts 13% Revenue Rise and Record $1.1B Net Profit in 2025
Jiangsu Hengrui Medicine announced 2025 results showing a 13% jump in revenue to RMB 31.63 billion ($4.4 billion) and a 21.8% rise in net profit to RMB 7.72 billion ($1.1 billion). The surge was powered by strong innovative‑drug sales and a landmark Hong Kong...
Egg-Based Biologics Drive Neion Bio Pharma Deal
Neion Bio, fresh from stealth mode, signed its first co‑development and supply agreement with a major global pharmaceutical company to produce recombinant biologics using its egg‑based Raptor™ platform. The deal provides upfront and milestone payments plus profit‑sharing after commercialization, delivering...
Bulk Drug Substances Used in Compounding
The FDA issued guidance clarifying how compounding pharmacies may use bulk drug substances, also known as active pharmaceutical ingredients. Under section 503A, state‑licensed physicians and pharmacists can compound with bulk substances that meet USP/NF monographs, are components of FDA‑approved drugs, or...
AI Simulates Patient Tumors, Transforming Oncology Research
@Ronalfa is speaking at @SynBioBeta in May and you probably already know who he is if you've been paying any attention to the AI x bio space. Ron spent years at @RecursionPharma as SVP of Research and acting CSO, helping build...
Agentic AI, Virtual Cell, LNP Vaccine Boosters, Engineered Organs, and Mergers
In this episode of Touching Base, the Gen editorial team discusses the latest advances in AI for life sciences, including NVIDIA’s GTC announcements on agentic AI, the deployment of 3,500 GPUs by Roche, and the emergence of open‑source autonomous agents...
Pharmaceutical Executive Daily: Trump Administration Misses Deadline to Nominate Permanent CDC Director
The Trump administration failed to meet the 210‑day deadline to nominate a permanent CDC director, leaving the agency without confirmed leadership for most of the second term. Meanwhile, the FDA granted accelerated approval to Denali Therapeutics’ Avlayah, the first enzyme...
Pinnacle Medicines Raises $89M Series B
Pinnacle Medicines announced the closing of an oversubscribed $89 million Series B financing, co‑led by LAV and Foresite Capital. The biotech firm leverages a proprietary platform that blends physics‑based molecular simulations, AI‑driven design, and advanced peptide chemistry to create oral peptide therapeutics....
New AI Platform Uncovers Hidden Cancer Targets, Raises $10M
Most cancer drugs go after the same targets: EGFR. PD-L1. HER2. Not because they’re the best targets. Because they’re the only ones we’ve been able to see. RyboDyn Inc. is going after what’s been invisible. The San Diego team, led by Imad Ajjawi, PhD,...
Biopharma Industry Pushes Back on FDA's 'America First' User Fee Proposals
The FDA’s upcoming user‑fee framework, dubbed "America First," seeks to tighten eligibility for the small‑business waiver, limiting it to U.S.‑based applicants. Industry groups argue the change politicizes fee policy and could disadvantage foreign‑owned biotech firms that rely on the waiver...
Pan-Cancer Variance Decomposition Nominates Translationally Actionable Therapeutic Antigen Candidates Across 33 Cancer Types
Researchers applied a genome‑wide variance decomposition across TCGA’s 60,656 genes and 33 cancer types to prioritize therapeutic antigens, moving beyond traditional mean‑expression screens. The analysis yielded 17 candidates that met functional dependency, safety, and immune‑cold criteria, with three highlighted: CRIPTO/TDGF1,...
Poll: U.S. Voters Want PBM and Insurance Reform—And Strong Biotech
A new Biotechnology Innovation Organization poll of 1,000 U.S. voters shows eight in ten would back leaders who lower drug costs by reforming pharmacy‑benefit managers, insurers, and the 340B program. Across party lines, 88% support passing PBM rebates directly to...
Valneva to Participate in Multiple Events at the 26th World Vaccine Congress in Washington DC
Valneva SE announced its participation in the 26th World Vaccine Congress in Washington, D.C., from March 31 to April 2, 2026. The company’s CEO, Thomas Lingelbach, and senior executives will present data on the chikungunya vaccine IXCHIQ® and join a...
Transgene to Deliver an Oral Presentation on Its Individualized Neoantigen Therapeutic Vaccine TG4050 at the World Vaccine Congress
Transgene (Euronext: TNG) will deliver a 30‑minute oral presentation on its individualized neoantigen therapeutic vaccine TG4050 at the World Vaccine Congress in Washington, D.C. on April 1, 2026. TG4050, built on the AI‑driven myvac® platform, targets patient‑specific tumor mutations. Phase 1 data in...
Editorial. Weighty Matter
The GLP‑1 drug semaglutide has entered the Indian market as generic versions after its patent expired last week, driving monthly prices down from roughly $144 to $36. The steep discount makes the medication affordable for a broader segment of diabetics...
Study Shows Metformin Acts in Brain, Prompting New Longevity Hacks
Scientists at Baylor College of Medicine identified a brain pathway that enables metformin to lower blood sugar, a discovery that could expand the drug’s use beyond diabetes and fuel new longevity protocols among biohackers.
Cellular Senescence and Senotherapeutics: The Expert Roundup
Cellular senescence has become a focal point for longevity medicine, prompting a surge of senolytic and senomorphic drug development. Pioneering studies showed that clearing senescent cells can extend healthspan, leading biotech firms like Rubedo, SENISCA, Deciduous Therapeutics, and Arda Therapeutics...
Magnetic Silk‑Iron Nanoparticles Offer Precise Steering of Drugs to Hard‑to‑Reach Disease Sites
A research team has created magnetic silk‑iron nanoparticles that can be steered with external magnetic fields to deliver therapeutics to otherwise inaccessible disease locations. The nanoplatform merges biocompatible silk fibroin with iron oxide, enabling magnetic control while maintaining safety, a...
WHO Issues New Guidance for Simpler Tuberculosis Tests
The World Health Organization announced new policy guidance aimed at simplifying tuberculosis detection tests, signaling a major push for more accessible diagnostics. While the guidance outlines a framework for low‑cost, point‑of‑care testing, specific technical details were not disclosed in the...
High‑Dose Psilocybin Outperforms Nicotine Patches Sixfold
One large psilocybin dose beat nicotine patches by 6x odds for smoking cessation. 82 otherwise-healthy cigarette smokers, 42 received a single high-dose 30mg/70kg psilocybin session, and 40 initiated an 8- to 10-week course of nicotine patch treatment. At 6 months; participants were 6x...
Kodiak’s Phase 3 Eye Drug Success; Innate Discontinues Anti-CD20 Program
Kodiak Sciences announced that its experimental eye drug Zenkuda (tarcocimab tedromer) achieved positive topline results in the GLow2 Phase 3 trial for diabetic retinopathy, outperforming sham treatment. The study met its primary endpoint, delivering a statistically significant gain in visual acuity...
Frozen Does Not Mean Stable: Rethinking Cryopreservation in Cell and Gene Therapy Manufacturing
Cryopreservation remains a linchpin for cell and gene therapy (CGT) manufacturing, yet frozen material is not inherently stable. Real‑world operations introduce transient warming events (TWEs) when products are moved, accessed, or shipped, silently degrading viability and potency. Traditional reliance on...
PharmaShots CXO Talks | Women’s History Month Special: A Conversation with Dr. Emanuela Offidani of Tris Pharma
Dr. Emanuela Offidani, Tris Pharma’s Medical Director of Digital Health Strategy, highlighted that ADHD is increasingly recognized as a lifelong condition that often goes undiagnosed in women because symptoms are less overt. She explained that Tris Pharma’s proprietary LiquiXR delivery...
Eggs as Cheap, Scalable Factories for New Medicines
I have a story today about the quest to turn eggs into low-cost factories for medicines. Gift link: https://nyti.ms/4bzSabB
Lancet Calls for Wider Access to GLP‑1 Drugs
This week's @TheLancet cover and editorial about getting GLP-1 drugs available for the people who need them the most https://t.co/BU9NZdmdGo https://t.co/TWOIKvfuth
Pistoia Alliance Publishes First Best-Practice Framework for Ethical Social Media Use in Drug Development
The Pistoia Alliance has published a peer‑reviewed best‑practice framework guiding ethical use of social‑media listening in drug development. The framework, co‑authored by experts from Bayer, Roche, Boehringer Ingelheim, Chiesi and Semalytix, outlines standards for data anonymization, bias mitigation, and AI‑driven...
MRD‑Negative Patients Can Stop Myeloma Maintenance Therapy
Discontinuation of maintenance therapy in multiple myeloma guided by multimodal measurable residual disease negativity (MRD2STOP) - @bdermanmd et al. @ajjakubowiak #ASCO24 Abstract 106 https://t.co/FBTY7SnCxK #NCT04108624 #mmsm #mmMRD
ODAC Backs MRD Testing as Early Myeloma Trial Endpoint
A Historic Turning Point: ODAC Unanimously Votes [4/12/24] in Favor of MRD Testing as an Early Endpoint in Myeloma Clinical Trials to Support Accelerated Approvals of New Treatments [Apr 18, 2024] @IMFmyeloma https://t.co/eDOgIrpVeR #mmMRD #mmsm #ctsm @FDAOncology https://t.co/ejA8KSoxOL
Corcept Therapeutics Shares Surge 20% on FDA Approval of Lifyorli
Corcept Therapeutics saw its shares climb almost 20% after the U.S. FDA approved its lead drug Lifyorli in combination with nab‑paclitaxel for platinum‑resistant ovarian, fallopian tube and primary peritoneal cancer. The approval, based on a 381‑patient trial, validates the company's...
Low‑cost, Patent‑free Vaccines Have Helped 100 Million
A “kazarian?” Is that like a Kardashian? What planet are these X trolls from? I develop low-cost often patent-free vaccines for global health and to help humanity. So far 100 million have benefited from access to our vaccine technologies developed...
Obesity Drug News Sinks Wave, Lifts Kodiak
Wave crashes on obesity drug update; Kodiak’s reboot pays dividends https://t.co/20H9OXVtIB $WVE - 54% $KOD + 58%
Precigen Posts 149% Revenue Surge, Forecasts $18M Q1 as Papzimius Gains Momentum
Precigen (PGEN) reported fiscal Q4 2025 revenue of $9.7 million, up 149% year‑over‑year, and projected first‑quarter 2026 sales to exceed $18 million. The surge stems from the rapid commercial rollout of its FDA‑approved gene‑therapy Papzimius and broader payer coverage across the United...
FDA Guidance Sparks Innovation Path for Inherited Disorders
My article in today's issue of the Journal of the American Medical Association Health Forum, on FDA's new rare disease guidance, and how the agency can build on these policy steps to promote innovation for inherited disorders, authored with Maarika...
FDA Approval Propels Denali, Boosts Rare Disease Biotech
FDA clears Denali drug in ‘clear step’ for rare disease biotechs https://t.co/x9yL4nyPaj by Kristin Jensen $DNLI #biotech
How to Turn a Chicken Egg Into a Drug Factory
Biotech start‑up Neion Bio is pioneering a method to turn chicken embryos into miniature drug factories. Scientists micro‑inject genetic constructs into three‑day‑old embryos, reprogramming the developing bird to synthesize pharmaceutical compounds within the egg. The approach promises faster, cheaper production...
IPHYF Falls Short of Promise, Future Uncertain
Of all the IO companies I've met and covered in the past ~15 years I'm struggling to think of one that's been more disappointing vs its initial promise than $IPHYF. Will it even last beyond Q3? Via @ByMadeleineA -> https://t.co/DepdZfDBdY
Allogene's Interim Data Hints at Off‑Shelf CAR‑T Breakthrough
This week's Biotech Scorecard: Allogene $ALLO: A preview of its April interim analysis. Very interesting (to me, at least) There just might be a path forward for off-the-shelf CAR-T therapy in B-cell lymphoma. Frontline consolidation. Read all about it: https://t.co/tcPFelUH3C
Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Novocure disclosed topline Phase‑2 PANOVA‑4 data showing that Tumor‑Treating Fields (TTFields) combined with Tecentriq and gemcitabine/nab‑paclitaxel achieved a 74.4% disease‑control rate in metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, enrolling 78 patients, outperformed the historical MPACT control arm’s 48% DCR. Secondary...
Oral Peptides Biotech Pinnacle Medicines Gets $89M From US, China Investors
Pinnacle Medicines, a two‑year‑old biotech focused on oral peptide therapeutics, secured $89 million from a mix of U.S. and Chinese investors. The financing will fund its platform that converts injectable peptides into pill form, building on the recent success of Novo...
DDW Highlights: 26 March 2026
In this episode, Bruno Quinney highlights three breakthrough studies: Edinburgh researchers engineered E. coli to convert PET plastic waste into the Parkinson's drug L‑DOPA, offering a sustainable route to a vital medication; scientists identified the enzyme DHX8 as a key...
Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)
Otsuka Pharmaceutical presented Phase III VISIONARY trial data for Voyxact (sibeprenlimab‑szsi) in IgA nephropathy patients at risk of progression. At 48 weeks, 82.5% of patients receiving 400 mg subcutaneous Voyxact achieved negative microscopic hematuria versus 52.6% on placebo, with median time to...
Anti‑TGFβ1 Antibody Shows Durable Efficacy, Low Toxicity
Scholar Rock's anti-TGFb1 antibody clinical study with early data in oncology indications... minimal AEs and signs of durable efficacy in checkpoint-refractory patients. $SRRK https://t.co/8xsN4wtbMV
Development of an Ultra-Sensitive Human Cardiac Troponin I Sandwich ELISA
Exazym®'s BOLD amplification technology boosts the sensitivity of a human cardiac troponin I sandwich ELISA by 180‑fold, lowering the detection limit to 0.07 pg/mL. The webinar presented by Cavidi’s Peter Stenlund shows how the method integrates into standard ELISA workflows with...