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.
HCW Biologics Appeals Nasdaq Notice, Targets Phase 1 Data for HCW9302 in H1 2026
HCW Biologics Inc. filed an appeal to Nasdaq over a minimum bid‑price compliance notice and announced that Phase 1 results for its lead immunotherapy HCW9302 are slated for the first half of 2026. The appeal follows a 5.56% drop in the company’s shares to $0.34.
Text Mining Culture Conditions and Glycosylation Relationships
Researchers at the University of Delaware and Waters have created an automated text‑mining pipeline that extracts relationships between cell‑culture conditions and protein glycosylation with 88% accuracy. The extracted data are normalized and stored in a Bioprocess Knowledge Graph, enabling a...
Peptonics Solves Cell Culture Defoaming Debacle
Researchers have demonstrated that the peptide‑based surfactant Peptonic ih‑T1010 performs on par with the industry‑standard poloxamer 188 in CHO and HEK293 fed‑batch cultures for monoclonal antibodies and AAV vectors. The new surfactant dramatically reduces foam formation, allowing manufacturers to skip...
Under the Magnifying Glass: A Wave of Drug Price Transparency
In late January and early February 2026, three federal initiatives – a Department of Labor proposed rule, the Consolidated Appropriations Act of 2026, and an FTC settlement with Express Scripts – introduced mandatory transparency reporting for pharmacy benefit managers (PBMs)....
Pharmaceutical Executive Daily: Trump Administration Delays Appeal of Federal Ruling Blocking Vaccine Policy Overhaul
The Trump administration has postponed filing an appeal against a federal judge’s injunction on RFK Jr.’s vaccine policy overhaul, citing internal debates over election‑year politics. Meanwhile, Biogen announced a $5.6 billion cash acquisition of Apellis Pharmaceuticals, paying $41 per share—a premium of...
Teva Intensifies Biosimilar Competition with FDA Approval and Dual Filing Acceptance in US and Europe
Teva Pharmaceutical Industries received U.S. FDA approval for its denosumab‑adet biosimilar, covering all approved indications of Amgen’s Prolia, including osteoporosis and bone loss in cancer patients. The company also secured simultaneous acceptance of regulatory filings with the FDA and the...
Esketamine Nasal Spray Shows Rapid, Durable Effectiveness in Treatment-Resistant Depression
New real‑world evidence from the ECHO study confirms that esketamine nasal spray delivers rapid and durable symptom relief for adults with treatment‑resistant depression. In a European‑Israel cohort of 570 patients, average treatment lasted nine months, producing mean MADRS reductions of ‑10.3...
Being Specific About Being General: Vaccines Edition
Emerging platforms are converging on a universal influenza vaccine, aiming to replace strain‑specific shots that require yearly reformulation. Companies such as Versatope are leveraging engineered bacterial outer‑membrane vesicles to deliver precise antigens, while NIH’s FluMos‑v2 expands hemagglutinin coverage to six...
Amgen, Zai Lab Team up on DLL3; Janux Gets $35M Milestone Payment
Amgen and China‑based Zai Lab have announced a Phase 1b clinical study that combines Amgen’s T‑cell engager Imdelltra with Zai Lab’s experimental antibody‑drug conjugate zocilurtatug pelitecan, targeting the DLL3 protein in aggressive neuroendocrine cancers. The trial will evaluate safety and early...
DNA Testing Can Help Right Racial Imbalance in Breast Cancer
Routine genomic testing with Agendia’s MammaPrint and BluePrint can narrow the long‑standing survival gap between Black and white women with early‑stage, hormone‑receptor‑positive breast cancer. In a study of more than 1,000 matched patients, Black women were twice as likely to...
Atom Swapping Arrives for 5-Membered Cyclic Ethers
Researchers at the National University of Singapore have unveiled a skeletal‑editing method that replaces the oxygen atom in five‑membered saturated cyclic ethers with nitrogen, sulfur, carbon or selenium. The protocol uses triphenylphosphine and N‑bromosuccinimide to generate a dibromo intermediate, which...
Paragon Offshoot Korsana to Go Public in Reverse Merger for Alzheimer's Work
Paragon Therapeutics is spinning out its Alzheimer’s-focused unit, Korsana Biosciences, via a reverse merger that will list the company on a U.S. exchange. The deal, championed by Paragon co‑founder Jonathan Violin, merges Korsana with a publicly traded shell, providing immediate...
A Deep Dive Into INN Proposed List 134
The World Health Organization released its International Nonproprietary Names (INN) Proposed List 134, introducing 124 new drug names slated for future approval. The list features a notable influx of antiviral and oncology agents, as well as the first biosimilar designations...
How a 20-Year Old Asthma Drug Is Boosting Food Allergy Research
A 20‑year‑old asthma medication, Xolair (omalizumab), is now accelerating food‑allergy research, especially for peanut sensitivities. Recent clinical trials combined the drug with oral immunotherapy, cutting severe reaction rates by roughly 70 percent. The FDA has recently cleared the first oral...
IO Biotech Will File for Bankruptcy After Failure of Cancer Vaccine in Key Trial
Danish biotech IO Biotech announced it will file for Chapter 11 bankruptcy after its lead cancer vaccine failed to demonstrate efficacy in a pivotal trial. The vaccine, designed to treat aggressive solid tumors, showed no statistically significant benefit, prompting the...
Can AI Agents Automate Scientific Discovery?
Nvidia’s GTC keynote highlighted a new wave of agentic AI systems—OpenClaw, Kosmos, LabOS, Latent‑Y and Dyno Psi‑Phi—designed to automate and accelerate scientific discovery. These agents combine large‑language models, XR interfaces and robotic labs to compress months of research into days while...
Vertex Announces US FDA Approval for Label Extensions of ALYFTREK® and TRIKAFTA®, Expanding Availability of These Medicines to ~95% of...
Vertex Pharmaceuticals announced that the U.S. FDA has approved label expansions for its CFTR modulators ALYFTREK and TRIKAFTA. ALYFTREK is now indicated for patients six years and older whose CFTR gene produces any functional protein, while TRIKAFTA’s indication now includes...
Zai Lab Announces Global Clinical Trial Collaboration and Supply Agreement to Evaluate Novel DLL3 ADC, Zocilurtatug Pelitecan, in Combination with...
Zai Lab and Amgen have entered a global collaboration to test Zai Lab’s DLL3‑targeting antibody‑drug conjugate, zocilurtatug pelitecan (zoci), together with Amgen’s FDA‑approved bispecific T‑cell engager IMDELLTRA® in extensive‑stage small cell lung cancer (ES‑SCLC). Amgen will sponsor and lead a...
The New Infrastructure of Drug Commercialization
The pharmaceutical commercialization landscape is undergoing a rapid overhaul, driven by heightened government pricing controls, the rise of complex biologics, cell and gene therapies, and advanced data systems. Cold‑chain logistics have become a strategic priority as temperature‑sensitive products proliferate, while...
FDA Threatens Unprecedented Ban Lift on Untested Injectables
If FDA does this, which is highly likely succumbing to pressure from RFK Jr, it crosses a new red line and, as far as I know, is unprecedented. Lifting a ban on drugs that are injected into the bloodstream without...
STAT+: Insilico Medicine CEO on How Best to Use AI in Drug Development
Insilico Medicine, a veteran AI‑driven drug discovery firm, announced a partnership with Eli Lilly that includes a $115 million upfront payment and up to $2.75 billion in milestone‑based total consideration. The deal leverages Insilico’s generative‑AI platform to co‑develop novel therapeutics, primarily targeting metabolic...
Cyclerion Therapeutics and Korsana Biosciences Announce Merger Agreement
Cyclerion Therapeutics and privately‑held Korsana Biosciences have signed an all‑stock merger agreement, creating a combined company that will operate as Korsana Biosciences and trade on Nasdaq under the ticker KRSA. Korsana secured an oversubscribed $380 million private placement that will fund...
PharmaShots Quarterly Outlook: The Forces Reshaping Biopharma in Q1 2026
Q1 2026 biopharma saw a wave of mega‑size M&A, with deals like Boston Scientific’s $14.5 billion purchase of Penumbra and Eli Lilly’s $7.8 billion acquisition of Centessa, underscoring a strategic push for precision platforms. The quarter also delivered a string of rare‑disease approvals—Zycubo,...
Homoharringtonine Extends Mouse Lifespan and Cuts Obesity in New Preclinical Study
A team led by Kim et al. reported that homoharringtonine (HHT) acts as a senolytic, extending lifespan and reversing diet‑induced obesity in mice. The findings, published in Nature Communications, suggest a repurposed cancer drug could become a cornerstone of longevity...
Abbisko Therapeutics Secures EMA Orphan‑Drug Designation for FGFR4 Inhibitor Irpagratinib
Abbisko Therapeutics announced that the European Medicines Agency granted orphan‑drug designation to its oral FGFR4 inhibitor irpagratinib for hepatocellular carcinoma. The milestone adds to earlier U.S. designations and comes as the company also secures FDA IND clearance for its FGFR2/3...
RenovoRx FY25 Net Loss Expands to $11.2M as CFO Prepares for Mid‑2026 Phase III Enrollment
RenovoRx announced a widened FY25 net loss of $11.2 million, up from $8.8 million a year earlier, while posting its first full year of revenue from the FDA‑cleared RenovoCath device. The company also said it expects to complete enrollment for its Phase III...
NHS to Offer Wegovy to Over 1 Million Heart Patients to Cut Cardiovascular Risk
The NHS has secured a cost‑effective deal with Novo Nordisk to make the GLP‑1 drug Wegovy available to over 1 million English adults who have suffered a heart attack, stroke or peripheral arterial disease and have a BMI of 27 or...
Pfizer Shares Edge Higher on Strong Oncology Data Amid Flat 2026 Revenue Guidance
Pfizer's shares rose about 0.7% to $27.97 after the company reported positive Phase 3 data for its Talzenna‑Xtandi combo in metastatic prostate cancer and encouraging mid‑stage breast cancer results. The gains came despite a 2026 revenue outlook that is essentially...
Merck to Acquire Terns Pharmaceuticals for $6.7 B, Accelerating M&A Ahead of Keytruda Patent Expiry
Merck announced a definitive agreement to buy California‑based cancer biotech Terns Pharmaceuticals for an estimated equity value of $6.7 billion. The deal, slated to close in Q2 2026, expands Merck’s hematology pipeline and underscores a rapid M&A cadence designed to cushion the...
Portugal: Will the Life Science Sector See Upswing Amid Funding Worries?
Portugal’s life‑science sector generated €29.7 billion ($34.4 billion) in gross value added in 2024, employing over 268,000 people across 124,000 firms. The ecosystem gained visibility after hosting BIO‑Europe Spring, showcasing biotech startups, research parks like Biocant, and major deals such as BioNTech’s...
ACC 2026: Dulaglutide Promotes Coronary Plaque Stabilisation in Patients with T2D
At the American College of Cardiology 2026 meeting, researchers reported that dulaglutide, a weekly GLP‑1 receptor agonist, stabilised coronary plaques in patients with type‑2 diabetes. In a prospective randomised trial of 39 participants with intermediate coronary stenoses, dulaglutide led to...
Scientists Are Working on “Everything Vaccines”
Vaccines prove their worth when they fail, as recent flu and COVID‑19 seasons have shown. The COVID‑19 pandemic exposed how quickly a novel virus can outpace vaccine development, while the 2025 flu season suffered a mismatch when the H 3 N 2 strain...
Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes
Biopharma giants Biogen, Eli Lilly and Merck collectively spent over $20 billion in a single week to acquire biotech firms with approved products or promising pipelines, accounting for three of the year’s four largest deals. Merck bought Terns Pharmaceuticals for $6.7 billion, while...
Ambrosia Eyes Next-Generation Small Molecule GLP-1s With $100M Series B
Ambrosia Biosciences announced the completion of a $100 million Series B financing round to fund the development of next‑generation small‑molecule GLP‑1 oral therapies for obesity. The capital will support a Phase 1 trial of its lead GLP‑1 candidate, which leverages AI‑driven molecular design...
Rare Disease Advocacy Group Urges Trump Administration to Restore FDA Clarity
A coalition of nearly 100 rare‑disease patient groups, biotech executives and investors wrote to President Trump, Health Secretary Robert F. Kennedy Jr., Medicare administrator Mehmet Oz and FDA Commissioner Marty Makary urging the administration to restore regulatory clarity at the...
Axsome Therapeutics Acquires Global Rights to Balipodect From Takeda
Axsome Therapeutics has signed an asset purchase agreement with Takeda to acquire worldwide rights to the PDE10A inhibitor TAK‑063, branded as balipodect. The deal provides Axsome with the ability to develop, manufacture and commercialize the drug for schizophrenia and Tourette...
Protective Effects of Gypenosides on LDL-Induced Myocardial Injury Through the miR-223/NLRP3 Axis in Hyperlipidemia
A cross‑sectional analysis of 19,862 Chinese adults linked elevated LDL‑C to higher glucose, BMI, blood pressure, white‑blood‑cell count and triglycerides, especially among middle‑aged and older men. Parallel in‑vitro experiments showed native LDL directly impairs H9C2 cardiomyocyte viability, proliferation, migration and...
Estonian Validfor Raises $1.2 Mililion Pre-Seed to Cut Pharma Validation Timelines From Months to Weeks
Estonian compliance startup Validfor secured a $1.2 million pre‑seed round led by DOMiNO Ventures, with participation from Curiosity VC and angels. The company is building an AI‑native, agentic digital validation platform that promises to shrink pharma, biotech and medtech validation cycles...
IO Shuts Down Following Regulatory Roadblocks
Danish biotech IO Biotech announced it will wind down operations and file for Chapter 7 bankruptcy after regulatory setbacks. The FDA rejected its biologics license application for the cancer vaccine Cylembio in September, citing insufficient data. A Phase 3 trial combining Cylembio...
EMA Seeks Input on Virtual Alternative to Animal Test
The European Medicines Agency has released a draft qualification opinion that would allow virtual control groups (VCGs) to replace rats in dose‑range‑finding toxicology studies. The proposal, submitted by Synapse Research and five pharma partners under the VICT3R consortium, is open...
Metformin Undermines Exercise’s Insulin‑Sensitivity Gains
As a medical school professor, I've recommended metformin to countless patients. But a new double-blind trial just revealed something alarming. Metformin BLUNTED the insulin-sensitizing benefits of exercise in adults at risk for metabolic syndrome. The findings from a 16-week RCT: -> Exercise +...
Lilly's Obesity Drug Cleared, Heats up Novo Rivalry
Eli Lilly’s obesity pill approved by FDA, setting up fierce competition with Novo Nordisk https://t.co/8TyrKyyNYP
Medical Podcasts
Medical Design Briefs released a series of podcasts on April 1 2026 highlighting emerging trends in drug delivery. The episodes cover AI‑driven personalized medicine in oncology, sustainability challenges for insulin pens and other devices, intra‑arterial platforms that target solid tumors, and wearable...
Biotech Platforms Valuation: From mRNA to AI Explained
Mackenzie published a detailed quantitative analysis of biotech platforms. Good place to start to understand how platform companies from Moderna with mRNA to Isomorphic with AI reach patients and are valued in markets.
Medical Podcasts
Medical Design Briefs released a series of April 2026 podcasts spotlighting emerging drug‑delivery trends. Episodes feature First Ascent Biomedical’s AI‑driven platform that personalizes oncology therapy, MGS engineers discussing greener insulin‑pen designs, RenovoRx’s intra‑arterial delivery system that targets solid tumors, and...
Clinical Trial For Brain Cancer Treatment Has Promising Results
A novel glioblastoma treatment combining oral 5‑ALA with low‑intensity ultrasound has shown promising early results, extending median survival by over 14 months in a phase 1 trial for recurrent patients. The approach sensitizes tumor cells to ultrasound, allowing diffuse targeting of...
FDA, After Turbulent Year, Leaves Drugmakers Guessing on Its Direction
The FDA’s leadership turmoil has intensified under Commissioner Marty Makary, with the agency cycling through multiple heads of its CDER and CBER centers in just over a year. Public‑facing comments from senior officials have sparked sharp stock moves, most notably...
Will Pfizer’s Lyme Disease Gamble Pay Off or Set the Space Back?
Pfizer and French partner Valneva are seeking FDA approval for a 6‑valent OspA Lyme disease vaccine after a late‑stage trial showed more than 70% efficacy, though the study missed its primary statistical endpoint due to low infection rates. The candidate...
How Drug Discovery Is Tackling Global Health Challenges
In this DDW podcast episode, host Bruno Quinney discusses two recent DDW articles: one on the urgent need to combat antimicrobial resistance (AMR) with insights from Professor Janet Hemingway, and another on the rapid expansion of mRNA therapeutics. Hemingway highlights...
GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma
GlaxoSmithKline’s biologic Exdensur (depemokimab) received approval from China’s National Medical Products Administration as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The approval is based on Phase III SWIFT‑1 (382 participants) and SWIFT‑2 (380 participants)...