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.
Senators Grill RFK Jr. On Vaccines, Drug Prices and More at Hearing
Health Secretary Robert F. Kennedy Jr. faced intense questioning from Senate Finance and HELP committees, with Democrats probing his vaccine policies, promotional video costs, and the TrumpRx drug‑discount platform. Republicans highlighted his rural health initiatives and progress on food‑dye reductions, while Kennedy defended the measles vaccine and cited national‑security reasons for supporting a glyphosate production order. The hearings also revisited his past anti‑vaccine activism and his commitments to Senator Bill Cassidy. The episode underscores the political volatility surrounding the Trump administration’s health agenda.
Amazon Just Put the Biggest Trade of the Decade on the Wrong Side—And Big Pharma Is Paying for It
Amazon has launched a direct‑to‑patient pricing model for GLP‑1 drugs, offering cash‑pay rates of $25 per month for insured patients, $149 for oral pills and $299 for injectables such as Wegovy and Zepbound. The pricing, combined with same‑day delivery to...
Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD
Genentech presented Phase III METEOROID trial results for Enspryng (satralizumab) in patients aged 12 and older with myelin oligodendrocyte glycoprotein antibody‑associated disease (MOGAD). The study met its primary endpoint, showing 87% of participants remained relapse‑free at 48 weeks versus 67%...
PARP Inhibitors: A Proven Class Facing Limits
PARP inhibitors have reshaped treatment for BRCA‑mutated cancers by exploiting synthetic lethality, but their expansion beyond this niche faces hurdles. While ovarian, breast, pancreatic, and prostate indications now include PARP‑based maintenance or combination regimens, inconsistent benefits in HRD‑positive and broader...
The Definitive Infrastructure for Modern Drug Development
Paradigm Health has launched an AI‑powered clinical research platform that operates across a national network of more than 800 community and academic sites in the United States, Japan and Israel. The platform embeds trial design, patient identification and data capture...
Roche Reports Phase III METEOROID Study Results for MOGAD
Roche announced that its subcutaneous antibody satralizumab, marketed as Enspryng, achieved a 68% reduction in relapse risk in the Phase III METEOROID trial for myelin oligodendrocyte glycoprotein antibody‑associated disease (MOGAD). At 48 weeks, 87% of patients on Enspryng remained relapse‑free versus...
Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)
Sanofi’s monoclonal antibody Tzield (teplizumab‑mzwv) received U.S. FDA approval under priority review to delay the onset of stage 3 type 1 diabetes (T1D) in children as young as one year who are diagnosed with stage 2 disease. The decision was driven by one‑year...
Lentinan‐Enhanced Mn3O4 Nanoparticles for Neuroinflammation Relief and Parkinson's Disease Treatment
Researchers have engineered a lentinan‑coated manganese oxide (Mn3O4@LNT) nanoparticle that can circulate long‑term and cross the blood‑brain barrier (BBB). Proteomic analysis revealed that the LNT coating reshapes the particle’s protein corona, enhancing BBB traversal and brain accumulation. In cellular and...
Roche’s Fenebrutinib Cuts Relapses in MS Amid Safety Concerns
Roche’s investigational BTK inhibitor fenebrutinib achieved 51.1% and 58.5% reductions in annualised relapse rates versus teriflunomide in the Phase III FENhance 1 and 2 trials for relapsing multiple sclerosis, while also cutting MRI lesion activity. The drug showed encouraging trends in disability‑progression measures...
Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection
Merck’s Idvynso, a once‑daily tablet combining 100 mg doravirine with 0.25 mg islatravir, received FDA approval as a switch regimen for virologically suppressed HIV‑1 adults. The approval rests on two Phase III trials—Trial 052 (n=513) and Trial 051 (n=551)—which demonstrated comparable viral suppression to existing...
Lupin Launches Generic Diabetes Drug in US After USFDA Approval
Indian pharma Lupin Ltd received FDA approval for its generic dapagliflozin‑metformin extended‑release tablets and launched them in the United States. The product matches the brand Xigduo XR in bioequivalence and is offered in four strength combinations. The launch adds a lower‑cost...
Insilico Tops AI Drug Discovery, Drives Oncology Breakthroughs
I had to skip this year's #AACR2026 but I am watching it from the distance. Our posters and team did a very good job - it looks like our clinical-stage oncology assets are finally being better understood by the pharma...
FDA Expands Tzield to Toddlers, Boosting Sanofi's Valuation
FDA expands Sanofi’s Tzield💉 to age 1 — expands TAM, re-rates Sanofi; catalyst vs limited pediatric data and commercialization risk; watch earnings for uptake. Insight: accumulate on pullbacks. — Viktor Kopylov, PhD, CFA More insights: t.me/si14Kopylov
Two Drugs Stir Hope for Treatment of Deadly Pancreatic Cancer
Two experimental treatments presented at a San Diego cancer conference have shown early signs of efficacy against pancreatic cancer, a disease that kills more than 50,000 Americans each year. The data come from small, unpublished trials and the drugs have not...
Goodwin Guides Obsidian‑Galera Merger Backed by $350 Million Private Placement
Goodwin Procter LLP advised Obsidian Therapeutics on its all‑stock merger with Galera Therapeutics, a deal underpinned by an oversubscribed $350 million private placement. The financing is slated to close just before the merger, extending the combined company's runway into late 2028...
SynbioTech's L. Plantarum FS4722 Emerges as a Potential Preventive Approach for Hyperuricemia
SynbioTech announced that its probiotic Lactiplantibacillus plantarum FS4722 markedly lowers serum uric acid in mouse models, matching the efficacy of conventional uric‑lowering drugs while showing no kidney toxicity. The strain works through a multi‑mechanism gut‑liver‑kidney axis: it reduces intestinal purine...
Multi-Regional Trials Have yet to Become the Norm
BioCentury’s website outlines a comprehensive cookie policy that categorises cookies into strictly necessary, functional, marketing, advertising, and analytics types. Strictly necessary cookies are always active and essential for authentication and site navigation, while functional cookies enable enhanced personalization. Marketing and...
Anti-Amyloid Drugs May Not Work Against Alzheimer's but if so, What Will?
A Cochrane systematic review of 17 clinical trials involving over 20,000 patients with early Alzheimer’s found that anti‑amyloid drugs produce little to no clinically meaningful improvement in cognition or daily function. The analysis also highlighted an increased risk of brain...
Natural GLP-1 Discovery Hidden in Joints Could Revolutionize Arthritis Treatment
A study published in The Lancet Rheumatology found trace amounts of the body’s natural GLP‑1 hormone in the synovial fluid of patients with rheumatoid arthritis and spondyloarthritis. Researchers compared joint‑fluid and blood samples from the INART biobank and observed a...
Noxopharm SOF-SKN Data Shows Prolonged Skin Retention with Minimal Systemic Absorption
Australian biotech Noxopharm announced preclinical pharmacokinetic results for its SOF‑SKN candidate, showing a skin half‑life of roughly 3.5 days with negligible systemic exposure. The active moiety, SOF‑16, demonstrated consistent dermal concentrations across normal and disease‑like skin and remained confined to...
FDA Clears Merck's First Once‑Daily Oral HIV Pill
The U.S. Food and Drug Administration approved Merck's once‑daily oral HIV pill, the first daily regimen from a major pharmaceutical firm in recent years. The decision positions Merck to compete more directly in the HIV market and could reshape treatment...
FDA Issues Draft Guidance to Fast‑Track Ultra‑Rare, Individualized Therapies
The U.S. Food and Drug Administration released a draft guidance on Feb. 23, 2026 outlining a “plausible mechanism framework” for individualized therapies targeting ultra‑rare genetic diseases. The roadmap aims to replace traditional randomized trials with mechanistic data, accelerating approval pathways for treatments...
Biology’s Data Gap: Making Lab Results AI-Ready
Biology generates enormous amounts of data. Almost none of it is ready for AI. #SynBioBeta2026 is May 4-7th in San Jose, California, you can learn more about the conference and get your tickets here: https://t.co/8abYWJ1GbK Most experimental infrastructure was built for individual...
Weight‑loss Meds Hit 8% of U.S. Prescriptions.
wow. "... the weight-loss drugs accounted for nearly 8% of all U.S. prescriptions in March" -- Axios Vitals
Divalent siRNA Clinical Trial Is Now Recruiting
A first‑in‑human trial of a divalent PrP‑siRNA (2439‑s4) is now enrolling 15 symptomatic prion disease participants. The FDA‑cleared IND permits a single‑ascending‑dose study, testing 50 mg, 100 mg and 200 mg levels to assess safety and target engagement. The trial includes an optional...
Billionaires Drive Biotech's Race for Cancer Blockbusters
Just read "For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug" a good book about developing of a pair of cancer drugs. Great work by @nathanvardi https://t.co/rrTOe6GqIB
Blocking PGAM‑Chk1 Kills Senescent Cells, Eases Lung Fibrosis
Researchers found that senescent cells depend on a PGAM–Chk1 interaction to boost glycolysis and survive, and blocking this interaction selectively kills these cells and reduces disease effects like lung fibrosis. https://t.co/VTsHTkBcad
#AAN26: Roche’s Multiple Sclerosis Pill Delays Relapse, but Liver Toxicity Could Need Monitoring
Roche’s experimental multiple sclerosis pill fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, more than doubled the relapse‑free interval compared with Sanofi’s oral therapy Aubagio in a late‑stage trial. The Phase 3 data showed roughly 68% of patients remained relapse‑free at...
Durvalumab Plus FLOT Improves Resectable Gastric Cancer Outcomes
EFS in MATTERHORN: A Ph3 RCT of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin & docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC) - @YJanjigianMD et al. #ASCO25 LBA5 https://t.co/lW8KUtXdB3 #NCT04592913 #stcsm #esocsm
CtDNA‑guided Cam
Camizestrant + CDK4/6i for the Tx of emergent ESR1 mutations during 1L endocrine-based therapy & ahead of disease progression in Pts w/ HR+/HER2– advanced breast cancer (ABC): ...ctDNA-guided SERENA-6 trial - Turner et al. #ASCO25 LBA4 https://t.co/9jFfuGd1IS #NCT04964934 #bcsm
STAT+: With Successful Trials, Roche Takes Its MS Drug to Regulators, but Safety Questions Loom
Roche presented data on its experimental multiple‑sclerosis drug fenebrutinib, which showed efficacy in three late‑stage trials by cutting relapse rates and slowing disability progression. The Swiss firm is now seeking regulatory approval, but analysts highlight liver‑safety signals and two drug‑related...
Rusfertide Shows Efficacy in Phase 3 PV Trial
Results from VERIFY, a phase 3, double-blind, placebo (PBO)-controlled study of rusfertide for treatment of polycythemia vera (PV) - @KuykendallMd et al. #ASCO25 LBA3 https://t.co/XID3tkj6Sk #NCT05210790 #mpnsm
Adjuvant Nivolumab Boosts Outcomes in High‑Risk HNSCC
NIVOPOSTOP (GORTEC 2018-01): Ph3 RCT of adjuvant nivolumab added to radio-chemotherapy in Pts w/ resected head & neck squamous cell carcinoma at high risk of relapse - Bourhis et al. #ASCO25 LBA2 https://t.co/Uxh4JhZyDE #NCT03576417 #hncsm #ImmunoOnc
STAT+: From Revolution Medicines, More Strong Data on KRAS Drug and a Glimpse of a ‘Novel Class’ Beyond It
Revolution Medicines presented new clinical data on its next‑generation KRAS inhibitor daraxonrasib at the AACR meeting, highlighting strong first‑line activity and synergistic effects in combination regimens for advanced pancreatic cancer. The company also unveiled pre‑clinical results for RM‑055, a candidate...
Atezolizumab Boosts Adjuvant Therapy for dMMR Colon
RCT of standard chemotherapy +/- atezolizumab as adjuvant therapy for Pts w/ stage III deficient DNA mismatch repair (dMMR) colon cancer (@ALLIANCE_org A021502; ATOMIC) - @FASinicropeMD et al. #ASCO25 LBA1 https://t.co/cGalNPlxMe #NCT02912559 #crcsm
WGS Uncovers KMT2A PTD, Surpassing Old AML Tests
Detection of KMT2A partial tandem duplication (PTD) in AML by whole genome sequencing (WGS): Addressing limitations of traditional techniques in the era of revumenib approval - Huether et al. #ASCO25 Abst 6532 https://t.co/EEsXm7JGdv #AMLsm #leusm #PrecisionMedicine @TempusAI
STAT+: Kyverna Therapeutics Plans to Submit Cell Therapy for Stiff Person Syndrome for FDA Approval
Kyverna Therapeutics announced that its personalized CAR‑T cell therapy improved mobility and reduced disability in patients with stiff person syndrome, a rare autoimmune neurological disorder. The company plans to file an FDA submission by mid‑2026, which would make it the...
First Tumor NGS Usage Varies Across Top Five Cancers
Utilization and timing of first tumor next-generation sequencing testing (NGS) in Pts w/ 5 most common cancers in the USA - @chadihcmd et al. @huntsmancancer #ASCO25 Abstract 11014 https://t.co/lWefncnTb2 #PrecisionMedicine #hemonc #bcsm #crcsm #lcsm #pancsm #pcsm https://t.co/oIX8QTRD8x
The Great Ozempic Experiment
GLP‑1 medications such as Ozempic and Zepbound have moved beyond weight‑loss to treat a spectrum of conditions, from traumatic brain injury to long Covid and addiction. An interactive New York Times report highlights that roughly one in eight Americans have tried these...
Zymeworks Presents New Phase 1 Data for ZW191, a Folate Receptor Alpha-Targeting ADC at AACR Annual Meeting 2026
Zymeworks unveiled Phase 1 data for ZW191, a folate‑receptor‑α‑targeting antibody‑drug conjugate, at the AACR 2026 meeting. In platinum‑resistant ovarian cancer the drug showed a confirmed objective response rate of 61% at 6.4‑9.6 mg/kg, with a median progression‑free survival of 7.6 months and responses...
Aging Mechanisms Are Now Engineerable, Says SynBioBeta
Aging isn't just inevitable decline. It's a set of biological systems that are starting to look engineerable. #SynBioBeta2026 is May 4-7th in San Jose, California, you can learn more about the conference and get your tickets here: https://t.co/8abYWJ1GbK DNA damage accumulates. Protein...
A Natural Protein May Protect the GI Tract From Infection
MIT researchers have identified the natural lectin protein intelectin‑2 as a dual‑action defender of the gastrointestinal tract. The protein binds galactose on bacterial membranes, trapping and destabilizing pathogens while also reinforcing the mucus barrier by attaching to mucins. Laboratory tests...
World's First Longevity Board Launched to Accelerate Aging Therapies
I am very happy to report that we formed the world's first Longevity Board at the public biotechnology company. Our objective is to discover and develop longevity therapeutics with pipeline-in-a-product potential. GLP-1 therapeutics paved the way and demonstrated the path...
Nurix's NRX-0305 Shows
New degrader from Nurix looks interesting: NRX-0305 demonstrated antitumour activity across a wide range of Class 1 BRAF inhibitor-resistant and Class 2/3 mutant PDX models #aacr26 https://t.co/0UGF5Od2Cp
Medicare Indefinitely Delays Pilot Plan to Cover Weight Loss Drugs
Medicare’s Center for Medicare & Medicaid Services announced an indefinite postponement of its pilot program to cover prescription weight‑loss medications. The pilot, originally slated to test coverage for drugs such as Wegovy and Zepbound, was halted after participating insurers raised...
First Personalized CAR‑T Shows Mobility Gains in Stiff Person Syndrome
$KYTX Kyverna Therapeutics cell therapy improves mobility in patients with stiff person syndrome. If cleared, the medicine would be first personalized CAR-T therapy for an autoimmune disease https://t.co/B28Zp9IA2O
Daraxonrasib Monotherapy
Eileen O’Reilly’s daraxonrasib monoTx data in 1L PDAC - poster below to save y’all fighting through rows of people to get a view #aacr26 https://t.co/z4yW2apCBf
AI Tool Predicts How New Drug Molecules Move Before Costly Lab Tests
University of Oregon researchers unveiled an AI‑driven simulation tool that predicts how novel drug molecules move and bind inside the body, using only their chemical structure. By integrating physics‑based energy data with machine‑learning sampling, the model delivers coarse‑grained motion pathways...
Avacta Unveils FAP‑cleavable Dual TOPO‑Ii/DDR‑i Payload
Intriguing #AACR26 poster from Avacta w/ CSO Francis Wilson presenting on their dual payload tech. The idea is to release TOPO-Ii + DDRi via FAP cleavage https://t.co/UMeB8y8KaC
ARVN KRAS G12D Preclinical Shows Weak Tumor Inhibition
In the battle of the inhibitors vs glues vs degraders, this one (KRAS G12D preclinical) from ARVN doesn't look too encouraging with little TGI #aacr26 https://t.co/Ng9UWTQcsv