Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech financings
Spanish biotech Ona announced a $86.6 million Series B round, ranking among the largest venture financings 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 funds will expand Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical pipeline.
A New Standard for Copay Excellence: Q&A with Brian Laird
Pharmaceutical manufacturers are confronting escalating out‑of‑pocket costs, high‑deductible plans and fragmented payer rules, prompting a shift from static copay reimbursements to strategic, data‑driven solutions. EVERSANA, which already processes over 12 million claims for 1.5 million patients, launched its Intelligent Copay Solution to give manufacturers real‑time spend visibility, AI‑powered fraud detection and multi‑pathway claim routing. The platform moves copay programs from transactional services to integrated financial tools that protect access while controlling risk. Laird predicts the next five years will see copay models become increasingly adaptive, patient‑centric and analytics‑focused.
How Are Regulatory Factors Impacting Biosimilars
The FDA issued draft guidance in March that would drop certain pharmacokinetic (PK) studies for biosimilars, aiming to lower development costs. At the same time, the Inflation Reduction Act (IRA) and most‑favored‑nation (MFN) pricing provisions are reshaping how manufacturers price...
3H Labs Research: Steamed Ginger Extract Supports Weight Loss
A randomized, double‑blind, placebo‑controlled trial of 80 overweight adults found that daily 480 mg of 3H Labs' steamed ginger extract, Zinoact, significantly reduced body weight, body‑fat percentage, and waist circumference over 12 weeks. The extract, standardized to high levels of 1‑dehydro‑6‑gingerdione, also...
GlycoNex Secures Japan’s PMDA Approval for GNX1021 Phase I Trial
GlycoNex has secured approval from Japan’s Pharmaceuticals and Medical Devices Agency to launch a first‑in‑human Phase I study of its lead ADC, GNX1021, in advanced gastrointestinal cancers. The multi‑centre trial will begin patient enrollment in Japan by June 2026, with parallel IND...
A Molecular Movie Captures Cancer's Great Escape From Targeted Therapy
Researchers at the Institute for Systems Biology captured a "molecular movie" showing that melanoma cells enter a reversible, drug‑tolerant state within hours of BRAF‑targeted therapy. The study, published in Nature Communications, reveals an ordered two‑wave transcriptional program driven by NF‑κB‑mediated...
Can Europe Finance and Keep Its Biotech Winners?
The United States saw a surge of life‑sciences IPOs in early 2026, raising over $1 billion, while Europe continues to lose its biotech firms to foreign markets. Over the past six years, 66 of 67 EU biotech companies that went public...
Mending University and Venture Capital Relations: Is It Possible to See Eye-to-Eye?
European university spin‑outs in deep‑tech and life sciences now represent a $398 billion asset pool, but collaboration with venture capitalists remains fraught. Tech transfer offices are tasked with bridging divergent goals—academia’s focus on discovery and publications versus VCs’ demand for speed...
Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma
Partner Therapeutics has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Bizengri (zenocutuzumab‑zbco), a monoclonal antibody designed for adults with advanced unresectable or metastatic cholangiocarcinoma that carry an NRG1 gene fusion. The filing is supported by...
Lab Success Doesn't Guarantee Real Cancer Drug Efficacy
Just a reminder. Killing cancer cells in a lab is very easy. Almost anything will kill cells. Even water (because of osmotic damage). Inside our bodies killing cancer cells is extremely hard for many reasons so things that kill...
PreVenTB Trial: Considerations for Interpreting Extrapulmonary Tuberculosis Efficacy and Tuberculin Skin Test-Stratified Analyses
The PreVenTB phase‑3 trial evaluated the recombinant BCG vaccine VPM1002 and the subunit vaccine Immuvac in 12,700 Indian household contacts, but neither met the primary endpoint of preventing microbiologically confirmed tuberculosis. The authors noted a 23.1% versus 20.3% six‑month tuberculin...
Drug-Resistant Fungi Prompt a Five-Step Global Plan Ahead of WHO's 2026 Update
An international consortium of 50 researchers led by Radboudumc has issued a five‑step plan to curb the rise of drug‑resistant fungi. The strategy—covering awareness, surveillance, infection control, optimized drug use, and investment—aims to shape the World Health Organization’s 2026 Global...
Off the Shelf Cell Therapies for Bone Marrow Transplantation with Ossium Health’s Kevin Caldwell — Episode 251
In episode 251 of the Xtalks Life Science Podcast, Kevin Caldwell, CEO and co‑founder of Ossium Health, discusses the company’s pioneering off‑the‑shelf bone‑marrow therapy derived from deceased organ donors. The treatment aims to solve long‑standing clinical and logistical hurdles in...
Deep Dive: Checking in with the FDA
The FDA’s 2025 turmoil included a 3,500‑person workforce cut, multiple leadership turnovers, and a surge in guidance reversals that delayed drug reviews. In 2026, the agency declined to file Moderna’s mRNA‑1010 flu vaccine, contradicting earlier guidance, underscoring regulatory uncertainty. Despite...
Viewpoint: CRISPR and mRNA — Under Attack by Technology Skeptics — Poised to Save Millions of Children with Rare Diseases
Rare genetic diseases affect roughly 25 million Americans and generate about $400 billion in annual medical costs, yet fewer than five percent have FDA‑approved therapies. The scarcity of treatments stems from the economics of drug development for tiny patient pools. Recent breakthroughs...
Major Organoids Companies Plus Latest TechBio News
The latest TechBio briefing spotlights the fastest‑growing private organoid firms, highlighting recent Series A‑C rounds that collectively raised over $500 million. Leaders such as OrganoTech, CellSphere, and BioMimic are scaling production pipelines to meet demand from pharma, diagnostics, and personalized‑medicine partners. The...
FDA Requests Additional Safety Data on Eli Lilly's Newly Approved Obesity Pill Foundayo
The U.S. Food and Drug Administration has formally asked Eli Lilly to provide further safety information on its recently cleared oral GLP‑1 obesity medication Foundayo. The regulator’s letter, signed on April 1, flags liver‑injury signals and mandates post‑marketing studies on cardiovascular events,...
Eli Lilly’s Jaypirca Secures Fourth Phase III Win in CLL, Paving Way for Label Expansion
Eli Lilly announced that its BTK inhibitor pirtobrutinib (Jaypirca) achieved its fourth Phase III success in chronic lymphocytic leukemia, meeting the primary endpoint of improved progression‑free survival. The result clears a path for a U.S. label expansion and underpins a GlobalData...
Labcorp, AWS and Datavant Launch AI‑Powered Platform to Speed Alzheimer’s Research
Labcorp announced a partnership with Amazon Web Services and Datavant to roll out an AI‑driven real‑world data platform for Alzheimer’s research. The platform promises to compress data‑preparation cycles from months to minutes, leveraging Labcorp’s diagnostic data and privacy‑preserving tokenization. The...
Common Osteoporosis Drugs Could Slow or Halt Aneurysm Progression
Researchers at Nagoya University discovered that clonal hematopoiesis, found in about 60% of aortic aneurysm patients, accelerates aneurysm expansion. In mouse models, Tet2‑mutant macrophages promoted elastin loss and matrix degradation via the RANK/RANKL pathway. Treatment with FDA‑approved osteoporosis drugs—anti‑RANKL antibodies...
FDA Sends Letters to 2,200 Sponsors, Demanding Public Trial Results
The U.S. Food and Drug Administration has formally notified more than 2,200 drug developers that they must post pending clinical trial results on ClinicalTrials.gov, highlighting that nearly 30% of mandated studies remain unpublished. The agency warns of civil penalties and...
AWS Unveils Amazon Bio Discovery, Cutting Drug Design Time From Months to Weeks
Amazon Web Services launched Amazon Bio Discovery, an AI‑driven platform that lets researchers design and evaluate drug molecules without writing code. Early adopters such as Bayer, the Broad Institute and Memorial Sloan Kettering report that the tool can compress months‑long...
GLP-1 Goes For The Middle
Indian pharmaceutical firms are rapidly converting the GLP‑1 hype into scale after Novo Nordisk’s semaglutide patent expired in March. Generics from Sun Pharma, Torrent, Zydus and others have already captured more than 15% of the market, pushing Novo’s share down...
NTU Singapore, SUSTech, and Lipigon Advance Inhaled Nanocarrier Therapy for Severe Lung Infections
Nanyang Technological University in Singapore, Southern University of Science and Technology in China, and Sweden’s Lipigon Pharmaceuticals have pushed their inhaled nanocarrier drug targeting ANGPTL4 into non‑human primate testing. The move clears the path toward an IND filing and could...
Helical Secures $10 Million Seed Round to Launch Virtual AI Lab for Pharma
Helical Ltd., a biotech AI startup, closed a $10 million seed round led by Redalpine Venture Partners, with participation from Gradient, BoxGroup, Frst Capital and several AI CEOs. The funding will accelerate deployment of its virtual AI lab that turns foundation...
AI Models Map Worm Brain, Scale to Synthetic Biology
The C. elegans nervous system has exactly 302 neurons and 7,000 synaptic connections. Scientists have had the full wiring diagram since 1986. What they haven't had: a computational model that captures how those neurons actually develop and wire themselves up. Eric Wasiolek...
New Drug Boosts Survival for Platinum‑Resistant Ovarian Cancer
Combining a new drug with #chemotherapy extends the survival of platinum-resistant ovarian #cancer patients in #clinicaltrial https://t.co/JE4r8nISUq
Traws Pharma Inc (TRAW) Q4 2025 Earnings Call Transcript
Harrow Health reported Q4 2025 revenue of $89.1 million, a 33% year‑over‑year increase, and full‑year revenue of $272 million, up 36%. Management forecast 2026 revenue between $350 million and $365 million, with adjusted EBITDA of $80‑100 million, driven by sales‑force...
FDA Introduces Standardized Framework for Gene Therapy Safety
New FDA guidance on evaluating the safety of gene therapies will establish a more predictable development process as these measures are implemented They provide a standardized, layered framework for uncovering off-target effects and other safety issues https://t.co/D7lsBeZybT
Patent‑Free COVID Vaccine Reaches 100 Million at $2‑3
Except the opposite, I make low cost vaccines that actually bypass big pharma, our patent-free COVID vaccine reached 100 million people at $2-3 per dose. It’s sad to see so many give up their critical thinking skills for conspiracy sites,...
Consumers, Employers Make Joint Call For Price Transparency Reform
A coalition of consumer advocates, employers and health‑payer groups is urging Congress to pass a price‑transparency law that would require providers to disclose the true cost of treatments and prescription drugs at the point of care. The proposal also calls...
Grapefruit Compound Bergamottin Blocks STAT3, Triggers Tumor Cell Death
Bergamottin, a natural furanocoumarin obtained from grapefruit juice induces chemosensitization and apoptosis through the inhibition of STAT3 signaling pathway in tumor cells https://t.co/cLRxHMFBCJ
One Injection Restores Hearing via OTOF Gene Therapy
A single injection uses an engineered AAV virus to deliver a healthy OTOF gene into cochlear cells, enabling them to produce otoferlin and restore the ear’s ability to convert sound vibrations into signals the brain can interpret. https://t.co/Lk34jpnRBe
Sonodynamic Therapy with Ferrocene-Modified Frameworks Targets Breast Cancer Metastasis
Researchers at Beijing Institute of Technology have engineered ferrocene‑modified covalent organic frameworks (mCOFs) that act as ultrasound‑activated sonosensitizers. When combined with sonodynamic therapy, the nanoplatform reduces breast cancer cell viability to 24.3% and drives apoptosis above 84%, while simultaneously generating...
Psoriasis Paves the Way for Next-Generation TYK2 Inhibitors in Autoimmunity
Takeda and Alumis reported Phase III data for their next‑generation TYK2 inhibitors, zasocitinib and envudeucitinib, showing more than half of patients achieve PASI 90 in plaque psoriasis. The results close the efficacy gap between oral agents and injectable biologics, surpassing the 28%...
FDA's 27-Year Freeze Stalled Critical Strep A Vaccine
The FDA accidentally froze Strep A vaccine development for 27 years. @AsimovPress explains what happened and where things stand now, ft. @jacobtrefethen and @coeff_giving's research.
EU Launches PsyPal Project to Test Psychedelic Therapy for Palliative Care Distress
The European Union has inaugurated the PsyPal project, a research initiative that will evaluate psychedelic therapy for patients experiencing psychological distress in palliative care. The launch event took place on 13 April 2026 at the Directorate‑General for Health and Food Safety, signaling...
Seattle Children’s Hospital Cuts Infant Leukemia Diagnosis to One Day
Seattle Children’s Hospital’s Sarthy Lab has begun delivering infant acute lymphoblastic leukemia diagnostic results in a single day using Benchling’s AI platform. The breakthrough, highlighted by Mallory Carlson’s twins, promises faster treatment decisions and less anxiety for families.
Phospholipid Asymmetry Helps Explain Extracellular Vesicle Surface Charge and Therapeutic Quality
Researchers led by Naohiro Seo and Takanori Ichiki published a review in ACS Nano Medicine that links extracellular vesicle (EV) surface charge to phospholipid asymmetry, especially the distribution of phosphatidylserine (PS). They show exosomes retain PS on the inner leaflet,...
CAR T Cell Therapy Biomanufactured by Cellares Infused Into First Two Patients
Cellares has successfully infused the first two patients with rese‑cel, Cabaletta Bio’s investigational autologous CAR‑T therapy, using its automated Cell Shuttle manufacturing platform. The product met all GMP release criteria, demonstrating that a low‑cost, high‑capacity process can produce clinical‑grade cell...
When Political Speech Becomes a Clinical Exposure
The letter highlights chronic underfunding of women’s health research and warns that high‑profile political statements can act as a clinical exposure, rapidly altering prescribing patterns. Data from the United States show a 10% drop in acetaminophen orders for pregnant women...
Adcendo Raises $75M to Advance Cancer Drug Pipeline
Adcendo, a Copenhagen‑Boston biotech focused on antibody‑drug conjugates (ADCs), announced a $75 million Series C financing led by Jeito Capital. The capital will accelerate Phase 1 trials for three lead ADC candidates targeting tissue factor, uPARAP, and a preclinical asset. The round attracted...
Stanford Team Demonstrates Ultrasound‑Powered Nanophosphor Light Source Inside Living Tissue
Stanford scientists have shown that mechanoluminescent nanophosphors injected into the bloodstream can emit blue light when triggered by external ultrasound, creating a controllable, deep‑tissue light source in live mice. The breakthrough could replace invasive fiber optics for neuromodulation, gene editing...
FDA Grants First Gene‑Therapy Approval for Rare Pediatric Immune Disorder LAD‑I
The U.S. FDA has approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel) for children with leukocyte adhesion deficiency type I, marking the world’s first gene‑therapy option for the disease. Approval follows a single‑arm trial of nine patients that showed 100% survival and restored...
CDER SBIA Chronicles
The FDA’s CDER Small Business & Industry Assistance (SBIA) Chronicles newsletter delivers regulatory guidance to drug manufacturers through a series of podcasts and a searchable archive. The most recent episodes—released on Dec 13 2024, Nov 14 2024, and May 17 2024—cover centralized statistical monitoring for data...
Pharmacy's Rising Role in Cell and Gene Therapy: Zahra Mamoudjafari, PharmD, MBA
Cell and gene therapies (CGTs) are receiving approvals faster than health‑care institutions can operationalize them. Zahra Mahmoudjafari, a clinical pharmacy leader at the University of Kansas Health System, published a framework outlining eight interdependent domains needed for financially sustainable, patient‑accessible...
Helpful Webinars and Other Resources for Generic Drug Manufacturers
The FDA has compiled a suite of webinars, workshops and seminars aimed at helping generic drug manufacturers improve their abbreviated new drug application (ANDA) submissions. Topics span bioequivalence studies, inactive ingredient databases, sample retention, and product‑specific challenges for oral, inhalation,...
Hims & Hers Health, Inc. Dba Hers - 716825 - 09/09/2025
The FDA issued a warning letter to Hims & Hers Health, Inc., alleging that the company’s website falsely marketed its compounded semaglutide as equivalent to FDA‑approved products like Ozempic and Wegovy. The agency cites violations of FDCA sections 502(a), 502(bb)...
About the Quantitative Medicine Center of Excellence (QM CoE)
The FDA’s Center for Drug Evaluation and Research (CDER) has launched the Quantitative Medicine Center of Excellence (QM CoE) to centralize quantitative expertise across its offices. Governance includes senior leaders from the Offices of Generic Drugs, New Drugs, Pharmaceutical Quality,...
Cancer Dependency Map Consortium Launches Phase 3 to Accelerate Next-Generation Therapeutics
The Broad Institute’s Cancer Dependency Map Consortium (DMC) has entered Phase 3, expanding its mission beyond cataloguing tumor vulnerabilities to tackling drug resistance, surface‑protein targets, and high‑dimensional readouts. Backed by 23 pharma partners, the consortium builds on DMC 2.0’s expansion to over...
Elahere Combination Achieves 62.7% ORR in Phase 2 Trial for Platinum-Sensitive Ovarian Cancer at SGO 2026
AbbVie’s Elahere (mirvetuximab soravtansine) combined with carboplatin produced a confirmed objective response rate of 62.7% in patients with FRα‑positive, platinum‑sensitive ovarian cancer, meeting the primary endpoint of the Phase 2 IMGN853‑0420 trial presented at SGO 2026. The study enrolled 125 participants,...