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.
SAGA Diagnostics to Present New Pathlight™ MRD Data for Ovarian and Metastatic Breast Cancer at AACR 2026
SAGA Diagnostics will present two abstracts at AACR 2026 showcasing its Pathlight™ structural‑variant‑based circulating tumor DNA (ctDNA) assay. In metastatic breast cancer, the test achieved a 77% detection rate, with ultrasensitive reads predicting therapeutic response and preceding radiologic progression. In high‑grade serous ovarian cancer, baseline detection was 94% and ctDNA clearance after chemotherapy correlated with a 50% reduction in recurrence risk. The data highlight Pathlight’s potential as a real‑time, tumor‑informed MRD biomarker across late‑stage cancers.
Zai Lab Presents New Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Rapid and Robust Intracranial Responses in Small Cell Lung Cancer...
Zai Lab reported that its DLL3‑targeting ADC zocilurtatug pelitecan (Zoci) generated a 53.7% confirmed intracranial objective response rate (iORR) in extensive‑stage small‑cell lung cancer (ES‑SCLC) patients with brain metastases, rising to 62.5% at the 1.6 mg/kg dose. In a separate cohort...
DTE Producer Hoping For FDA Leniency, BLA Approval
The FDA announced it will exercise enforcement discretion for animal‑derived desiccated thyroid extract (DTE), allowing the product to stay on the market even though it is classified as an unapproved biologic. Producers of DTE welcomed the move, noting it preserves...
STAT's Live AACR Coverage: Newsletter, Event, Recap
A heads up: starting Sunday, and through the beginning of next week, STAT is going to be taking the annual meeting of the American Association of Cancer Research by storm. This is one of the best venues for spotting new ideas...
The Real Drivers of GLP-1 Growth
In this episode, Terrence Flynn, Morgan Stanley’s Head of U.S. Pharma and Biotech Research, outlines the next phase of growth for GLP‑1 obesity medicines, estimating the market could peak at about $190 billion globally. He highlights five key drivers: the shift...
Co-Pay Models and AFPs Shift Costs but Raise Access Concerns: Patty Taddei-Allen, PharmD, MBA
Co‑pay accumulators, maximizers, and alternative funding programs (AFPs) are gaining traction as insurers and PBMs attempt to curb rising drug costs. While accumulators and maximizers keep the existing benefit design, they shift more out‑of‑pocket expenses onto patients. AFPs, by contrast,...
Nanobody Fixes CFTR Misfolding, Boosts Cystic Fibrosis Therapy
A cell-penetrating nanobody repairs misfolded CFTR proteins in cystic fibrosis cells, restoring chloride channel function and showing strong synergy with existing therapies, potentially advancing treatment for protein misfolding disorders. biotechnology
Nanobody Repairs Misfolded CFTR Inside Cells, Boosting Function in Cystic Fibrosis
Researchers at Charité‑Berlin and the Leibniz FMP have engineered a cell‑penetrating nanobody that binds the F508del mutant CFTR inside lung cells, restoring proper folding and chloride transport. In vitro, the nanobody remained bound for at least 24 hours and rescued channel...
Dubai Unveils ‘Hayat’ Initiative to Educate Public on Obesity with Eli Lilly and True Body USA
Dubai has launched the three‑month “Hayat” initiative, a government‑backed program supported by Eli Lilly and True Body USA, to deliver evidence‑based education on obesity. Led by Shahriar Shahir Barzegar of Elegant Hoopoe, the effort combines pharmaceutical research, body‑composition technology and...
Corcept Investors Can Lead $100K+ Securities Fraud Suit by April 21
Rosen Law Firm announced that shareholders who purchased Corcept Therapeutics (NASDAQ:CORT) between Oct. 31, 2024 and Dec. 30, 2025 and incurred losses exceeding $100,000 may serve as lead plaintiff in a securities‑fraud lawsuit. The firm set an April 21, 2026 deadline, urging qualified investors to step...
AHA Urges en Banc Review of 4th Circuit’s West Virginia 340B Contract Pharmacy Law Decision
The American Hospital Association (AHA) and allied groups filed an amicus brief on April 17 urging the 4th U.S. Circuit Court of Appeals to rehear en banc a panel ruling that struck down West Virginia’s law protecting 340B contract‑pharmacy arrangements....
Personalized Bioelectrodes Improve Brain Signal Monitoring and Compatibility
Penn State researchers have created 3D‑printed hydrogel bioelectrodes that are customized to an individual’s brain geometry using MRI‑derived models. The honeycomb‑inspired, stretchable design conforms to cortical gyri and sulci far better than conventional stiff, one‑size‑fits‑all probes, delivering higher‑quality electrical signals....
Exploring Untapped Natural Chemistry for Future Medicines
Generare, a Paris‑based tech‑bio startup, is tackling AI drug‑discovery limitations by feeding models with diverse, biologically validated natural compounds from microbes. CEO Guillaume Vandenesch argues that current AI systems rely on narrow synthetic datasets, which restrict therapeutic relevance. The company...
Sona Nanotech Adds Two Oncologists to Advisory Board for Hyperthermia Therapy
Sona Nanotech announced that Dr. Michael Smylie and Dr. Jonathan Trites have joined its Scientific Advisory Board, a move intended to speed up clinical trials for its Targeted Hyperthermia photothermal cancer platform. The hires bring deep expertise in melanoma immunotherapy...
FDA Shifts to Single Pivotal Trial as Default Standard for All Drug Approvals
The U.S. Food and Drug Administration announced that a single adequate and well‑controlled trial will become the default evidentiary standard for all new drug approvals, replacing the long‑standing two‑trial requirement. The change, unveiled by Commissioner Martin Makary and CBER director...
Iris Long, Scientific Mentor to AIDS Activists, Dies at 92
Iris Long, a retired organic chemist, died at 92. She became a scientific mentor for ACT UP in 1987, guiding activists through FDA drug‑approval processes and clinical trial design. Her expertise helped accelerate access to experimental AIDS treatments, earning praise from...
Targeted Gene Delivery Calms Lung Inflammation in Respiratory Infection Mouse Models
Scientists at the University of Cambridge have engineered an adeno‑associated virus (AAV6.2‑CC10) to deliver anti‑inflammatory cytokines directly to mouse lung tissue. The platform achieved sustained, localized expression of IL‑1RA and IL‑10, markedly reducing lung damage and weight loss in influenza...
Bringing AI-Driven Protein-Design Tools to Biologists Everywhere
OpenProtein.AI has launched a no‑code, web‑based platform that gives biologists instant access to powerful protein‑language models and design tools. The suite includes the PoET transformer and its newer PoET‑2 version, which delivers higher accuracy while using a fraction of the...
AMPLIFY Redefines CLL Care: Adam Kittai, MD
The FDA has cleared acalabrutinib (Calquence) combined with venetoclax (Venclexta) as the first all‑oral, fixed‑duration regimen for chronic lymphocytic leukemia. The approval follows the phase 3 AMPLIFY trial, which demonstrated superior progression‑free and overall survival compared with traditional chemoimmunotherapy. The study...
Anti-Amyloid Alzheimer’s Drugs Show Limited Benefit in Cochrane Review
A Cochrane review of 17 randomized trials involving 20,342 participants found that anti‑amyloid antibodies deliver little to no clinically meaningful improvement in memory, cognition, or dementia severity after roughly 18 months of treatment. The analysis also identified a markedly higher...
Soley Therapeutics Presents Preclinical Data Demonstrating Selective Anti-Tumor Activity of STX-6398, a First-in-Class CKAP2 Modulator, at AACR 2026
Soley Therapeutics unveiled preclinical data on STX-6398, a first‑in‑class oral small‑molecule that modulates the previously undruggable CKAP2 pathway, at the AAC 2026 meeting. The compound demonstrated selective anti‑tumor activity in a 300‑cell line panel, with efficacy correlating to CKAP2 protein levels...
Initiation of the Interchangeable Biosimilar Insulin Glargine-Yfgn Among Older Adults
A Pennsylvania study of adults 65 and older found that only 3.7% initiated the interchangeable biosimilar insulin glargine‑yfgn (Semglee or unbranded version) between 2022 and mid‑2023. Initiators were disproportionately rural residents, long‑term‑care (LTC) patients, and those with three or more...
Merck’s Enflonsia Approved in EU for RSV Prevention in Infants Without Weight-Based Dosing
Merck’s long‑acting monoclonal antibody Enflonsia (clesrovimab) received European Commission approval for preventing respiratory syncytial virus (RSV) lower‑respiratory‑tract disease in neonates and infants during their first RSV season. The product is administered as a single fixed 105 mg intramuscular dose, removing the...
Mark Cuban Wants to Bring Drug Manufacturing to Hospitals’ Doorsteps — Literally
Mark Cuban’s Cost Plus Drugs is rolling out modular drug‑manufacturing pods that fit into tractor‑trailers, allowing hospitals to produce injectables and specialty medicines on‑site. The Dallas‑based facility already makes epinephrine, norepinephrine, Pitocin and pediatric cancer drugs, and claims rare‑disease therapies...
Industry Report: Advanced Therapy Market May Triple by 2030
Cardinal Health’s 2026 Advanced Therapy Report projects that the U.S. advanced therapy market will nearly triple, rising from 61 approved cell and gene treatments today to around 180 by 2030. The study, based on input from 160 physicians and administrators,...
Medicine's Next Leap: Delivering Gene Therapies Exactly Where They're Needed
Researchers at the University of Ottawa have shown that small extracellular vesicles (sEVs) can be selected based on their cell of origin to deliver siRNA therapeutics precisely to kidneys and the brain. In mouse models of chronic kidney disease, sEV‑mediated...
FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
The FDA’s Prescription Drug User Fee Act entered its seventh iteration, PDUFA VII, authorizing the agency to collect user fees from October 2023 through September 2027. The fees are earmarked to accelerate pre‑market drug application reviews and post‑market safety monitoring for both drugs...
Mal-Predict: Machine Learning-Guided Rapid Virtual Screening of Compounds Against Selected Targets of Plasmodium Falciparum Validated Using Molecular Dynamics Simulation
The researchers launched Mal‑Predict, a machine‑learning workflow that used a Random Forest classifier (AUC 0.912) to screen 1.9 million compounds from DrugBank, natural‑product, and Enamine‑Real databases for activity against Plasmodium falciparum targets. Predicted actives were docked and subjected to molecular dynamics simulations,...
Precision Biologics Highlights New AML Target for CAR-NK Therapies
Precision Biologics announced preclinical identification of truncated Core 1 O‑glycans as a novel antigen for acute myeloid leukemia (AML). The glycan‑based target is recognized by the company’s investigational antibody NEO‑201 and was presented as a poster at the AACR 2026 meeting....
Why Annex 21 Is an Important Commercial Risk Point in EU Market Entry
Charley Maxwell highlights that Annex 21, the EU GMP annex governing medicinal product imports, is more than a paperwork hurdle—it is a commercial risk point that can delay market entry. The annex requires the holder of a Manufacturing Import Authorisation and...
Scientists Find Unexpected Immune Pathways for mRNA Cancer Vaccines
Scientists at Washington University demonstrated that mRNA cancer vaccines can elicit potent anti‑tumor T‑cell responses even when the classic cDC1 dendritic cell subset is absent. Using mouse models lacking cDC1, cDC2, or both, they showed that cDC2 cells also prime...
Scaling Bio‑Products: Funding, Forecasting, and Partnerships
Getting from pilot plant to commercial scale is where most bio-based products die. The science works. The economics don't. Or the capital isn't there. Or the supply chain can't handle the volume. This session at @SynBioBeta 2026 brings together people who've actually...
ANDA Litigation Settlements - First Quarter 2026
During Q1 2026, U.S. district courts issued a wave of ANDA litigation settlements covering dozens of branded drugs, from ophthalmic gels to diabetes tablets. Most disputes were dismissed, many with prejudice, while several parties entered license agreements that preserve patent exclusivity....
Chinese Pharma Leads Speed, Insilico Wins on Novelty
Very insightful article in China Daily. There is a big delta between the AI CRO model and AI Biotech model. At Insilico, we do not compete with Xtalpi or other local companies. The most hardcore competitors now are the large...
Kennedy Misstates Danish Tylenol Data, Ignoring Prescription Surge
This appears to be a case of Secretary Kennedy speaking without having full command of the facts. He calls the Danish study that "garbage" because it tracked whether women got Tylenol by whether they were prescribed it -- but he...
Vertex’s CF Stronghold Tested by Emerging Gene Therapies
Vertex Pharmaceuticals, long the dominant player in cystic fibrosis (CF) treatment, is confronting new competition from gene‑therapy candidates such as Krystal Biotech’s KB407. While Vertex continues to expand its pipeline with mRNA‑based CF drugs and non‑CF indications, analysts warn that...
Sex Differences Crucial for Glucagon Obesity Drug Efficacy
Male and female bodies respond differently to glucagon-based obesity drugs, and FGF21 plays an important role—especially in females. This means future treatments need to account for sex differences to be effective and safe. https://t.co/Z9gllk02Dj
France Leads Approval of IV Ketamine for Suicidal Crises
Scientists test if ketamine has antidepressant effects under anesthesia; France is the first to approve IV ketamine for severe suicidal crisis https://t.co/s7W7YlAOMr
Marengo Reports Early Phase 2 Activity for Invikafusp Alfa Combination; Advances STAR Program at AACR 2026
Marengo Therapeutics announced early Phase 2 activity for its invikafusp alfa plus sacituzumab govitecan (Trodelvy) combo in metastatic breast cancer, reporting confirmed complete responses in heavily pretreated patients across both triple‑negative and hormone‑receptor‑positive/HER2‑negative cohorts. The interim safety data matched the known profiles...
UCB to Acquire Neurona for $1.2B, Targeting Seizure Cell Therapy
UCB, betting on seizure cell therapy, to buy Neurona for up to $1.2B https://t.co/LxI1Omodan by @realJacobBell $UCB
OpenAI and InSilicoMeds Partnership Promises Significant Growth
A collaboration between @OpenAI and @InSilicoMeds has great upward potential. Would you be open to exploring this @sama ?
Kailera IPO Interview: CEO Renaud Talks Biotech Market, China and Obesity Pipeline
Kailera Therapeutics closed a record‑setting $625 million Nasdaq IPO, the largest biotech debut of the year. The company, launched with Bain Capital Life Sciences backing, leverages a portfolio of obesity drug candidates originally sourced from China’s Hengrui Medicine. CEO Renaud highlighted...
Pancreatic Cancer Study May Usher New Treatment Era
A pancreatic cancer expert on why Revolution Medicines’ study could ‘open up a new era’ of treatment https://t.co/npSBO8iR7n via @statnews
Demanding 1,200 Benchmark Test Before Claiming SOTA
Until they test it in @InSilicoMeds benchmarks (1,200 benchmarks), I will not believe that this is anywhere close to SOTA. Let's benchmark it folks. Whoever has access and would like to benchmark - let's collaborate
Study Finds HPV Vaccine Cuts Male Cancer Risk by Half
Researchers analyzing data from about 1 million U.S. males found that a single dose of the nine‑valent HPV vaccine slashes the risk of HPV‑related head and neck cancers by roughly 50%. The findings bolster arguments for expanding routine HPV vaccination to...
JNJ's HLD-0117 Enters Phase 1, Target Unreve
Second $JNJ ex-Halda "riptac", HLD-0117, goes into phase 1. Previously only known as "breast cancer riptac", target still undisclosed https://t.co/aJRe55AgYH
China’s Drug Innovation Surge Defies Industrial Policy Narrative
China Is Now a Global Drug Innovation Powerhouse. Industrial Policy Had Little to Do with It. .....industrial policies like Made in China 2025 played a negligible role... https://t.co/MKyZ6auvAS
Inside Pharma's Revenue Engine: The Gross-to-Net Reckoning
Model N’s new podcast, Pricing & Policy with Model N, spotlights its annual state‑of‑revenue survey, revealing escalating gross‑to‑net (GTN) complexity across the pharmaceutical sector. Executives discuss how opaque PBM contracts, Medicaid program exits, and coordination‑of‑benefits failures erode net pricing. The conversation also...
AZD4956
Just disclosed in #AACR26 abstracts: $AZN AZD4956 = DNA pol theta inhibitor. My story from when it entered phase 1/2 Parthenon study +/-saruparib -> https://t.co/bHoOKqd7da
Minibinder Data for $149—Custom Assays Available
Get data on your minibinders for $149! Sequence in -> data out. Let us know other assays or protocols you'd like to see and we're happy to add to Ginkgo Cloud Lab.