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.
Waters Expands Cervical Cancer Screening Access with At-Home HPV Test Approval
The U.S. FDA has cleared the Onclarity HPV Self‑Collection Kit and approved the BD Onclarity HPV Assay for at‑home cervical cancer screening. The kit detects every high‑risk HPV genotype, delivering both individual and pooled results, and is processed on the automated BD COR System. Waters is partnering with the National Cancer Institute on the SHIP trial to validate self‑collection accuracy, and plans to roll out prescription‑based kits that insurers are expected to cover nationwide.
How to Use Real-World Data to Improve Drug Development, Starting with the Patient Journey
A new eBook from PurpleLab and MedCity News highlights how real‑world data (RWD) can expose hidden gaps in the non‑small cell lung cancer (NSCLC) patient journey, such as missed biomarker testing and transportation barriers. Recent state legislation now requires insurers...
Rapamycin Fails to Slow Epigenetic Aging, Sinclair Concedes
David Sinclair says rapamycin had no measurable effect on slowing or reversing epigenetic aging in humans. This was a drug most of the longevity community supported. He was even a believer of it. It was found to extend lifespan in: • Inbred lab animals •...
Vanda Pharmaceuticals Initiates Thetis Study of Nereus for GLP-1–Induced Vomiting Prevention
Vanda Pharmaceuticals has launched the Phase‑III Thetis trial to test Nereus (tradipitant) against placebo for preventing vomiting in patients on GLP‑1 receptor agonists. The study’s primary endpoint is the proportion of participants who remain vomiting‑free, with topline data slated for...
EU Launches PsyPal Project to Test Psychedelic Therapy for Palliative Care Distress
The European Commission announced the launch of the EU‑funded PsyPal project, a clinical research programme that will evaluate psychedelic therapy for psychological distress in palliative‑care patients. The initiative, unveiled on 13 April 2026 at the Directorate‑General for Health and Food Safety, signals...
Why Anti-Cancer Drugs Often Fall Short of Expectations
Recent analyses reveal that many anti‑cancer drugs underperform because they confront complex tumor biology that preclinical studies often oversimplify. Heterogeneous cell populations, rapid emergence of resistance pathways, and inadequate biomarker strategies limit clinical efficacy. Additionally, safety concerns restrict dose intensity,...
Eli Lilly's Foundayo Oral GLP‑1 Gets FDA Nod, Targets $2 B U.S. Sales in 2026
Eli Lilly announced that the FDA approved its once‑daily oral GLP‑1 pill Foundayo (orforglipron) for chronic weight management, ahead of the April 10 PDUFA deadline. The drug is priced from $25 to $349 a month and analysts project $1.2‑$2 billion in...
Smart Nanocarrier Promises Non‑Surgical Treatment for Blindness‑Causing Retinopathies
Wayne State University and Washington State University have engineered a trehalose‑based nanocarrier that delivers the anti‑angiogenic drug Axitinib via a simple IV, potentially eliminating the need for intravitreal injections in proliferative retinopathies. Published in Theranostics, the study shows the carrier...
Grail’s $824 Liquid Biopsy Test Sparks Debate Over Accuracy and Cost
A first‑hand account of a $824 Galleri liquid‑biopsy screening test from Grail has ignited a fresh debate over the technology’s clinical value and price point. The test, which claims to detect more than 50 cancers, delivered a 51.5% overall detection...
Granules India to Tighten Oversight After US FDA Warning, Exec Says
Granules India, a leading global paracetamol and API producer, is tightening oversight after the U.S. FDA cited GMP, equipment cleaning and record‑keeping violations at its Telangana plant. The company will digitise logbooks, batch records and badge cards, increase gemba walks,...
How to Make Cancer Therapies BETter: An Insight Into the Distinct Roles of BET Proteins
A new study from the Max Planck Institute reveals that BET proteins BRD2 and BRD4 play distinct, sequential roles in gene activation, explaining why broad‑spectrum BET inhibitors have shown limited clinical success. BRD4 drives the release of RNA polymerase II,...
Breathing New Life Into Tubercolosis Treatment with Iinhalable Nanomedicine
Scientists at the University of Witwatersrand’s Wits Advanced Drug Delivery Platform have created an inhalable nanocarrier that can encapsulate all four first‑line tuberculosis drugs and release them directly in the lungs. The system bypasses the liver and bloodstream, aiming to...
Octopus-Shaped Nanomachine Reprograms ATP Flow to Starve Cancer Cells
Researchers unveiled an octopus‑shaped nanomachine, HSA‑ABC, that anchors to cancer cell membranes and uses an ATP‑sensing aptamer to trigger photodynamic therapy and rapid doxorubicin delivery. The device creates a self‑amplifying cycle: ATP binding activates a photosensitizer, damaging the membrane, which...
FDA Seeks Permanent Future for Rare Pediatric Priority Review Vouchers
The FDA announced plans to permanently authorize the rare pediatric disease priority‑review voucher (PRV) program as part of its $7.2 billion FY 2027 budget request. The initiative ends the cycle of four‑year reauthorizations that left the program in limbo after its 2024...
Shionogi Secures $482m BARDA Contract to Tackle AMR Crisis
Japanese pharmaceutical firm Shionogi has secured a BARDA contract worth up to $482 million to build a U.S.-based manufacturing facility for its injectable antibiotic Fetroja (cefiderocol). The agreement provides $119 million upfront and up to $363 million over several years, enabling production aimed...
“I Don’t Need Those Pills”—Until the Second Heart Attack
At ACC 2026, researchers unveiled the Ez‑PAVE trial, a multicenter, randomized study of 3,048 South Korean patients with established atherosclerotic cardiovascular disease. The trial compared an ultra‑low LDL‑C target of <40 mg/dL against a conventional target of <70 mg/dL, using statin plus...
Pharma Pulse: Tariffs, a Ceasefire, and Patient Access
The U.S. Commerce Department announced a 100% base tariff on imported active pharmaceutical ingredients and patented drugs, urging manufacturers to shift production domestically. Companies can avoid the full rate by securing a most‑favored‑nation pricing agreement or by filing an onshoring...
BIO Coffee Chat: Price Controls Like MFN Harm Access, Increase Costs
BIO’s March Coffee Chat highlighted how recent U.S. drug‑price policies, including the Inflation Reduction Act’s out‑of‑pocket cap and proposed Most Favored Nation (MFN) pricing models, are unintentionally raising patient costs and tightening access. Evidence shows beneficiaries often pay more than...
Astellas Exercises Option to License Dyno’s AAV Capsid for AI-Designed Gene Delivery
Astellas has exercised its option to license an AI‑engineered adeno‑associated virus (AAV) capsid from Dyno Therapeutics for skeletal muscle gene delivery, marking the first licensed asset from their 2021 partnership. The capsid, created using Dyno’s large‑scale in‑vivo data‑driven AI models,...
STAT+: Biotech VCs, Used to a Winning Formula in Drug Development, Face Disruption
For decades, biotech venture capitalists have followed a formula—seed university science, add seasoned pharma executives, and invest tens of millions—to generate drugs and returns. That playbook is now under pressure as Chinese biotech firms deliver research faster and cheaper, and...
FDA Guidance May Move Goalposts For Form 483 Responses
The FDA released draft guidance that reshapes how drug manufacturers respond to Form 483 inspection observations. The guidance introduces a standardized framework for documenting, assessing and correcting systemic quality issues. While the clearer process aims to improve regulatory consistency, it...
Anumana Secures the US FDA 510(k) Clearance for Its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early
Anumana has received FDA 510(k) clearance for its ECG‑AI algorithm, a software‑as‑a‑medical‑device that screens for cardiac amyloidosis using routine 12‑lead electrocardiograms. The AI model, originally developed at the Mayo Clinic, identifies subtle waveform patterns invisible to clinicians, enabling early risk...
The FDA Has Released Draft Guidance for NAMs Validation – Now What?
On March 18, 2026 the FDA issued draft guidance for validating new approach methodologies (NAMs), including complex in‑vitro models (CIVMs). The guidance centers on four validation principles—context of use, human biological relevance, technical characterization, and fit‑for‑purpose. The 11th 3D Tissue Models Summit in Boston...
Virica Biotech and FUJIFILM Biosciences Collaborate Under the Canada-Japan Co-Innovation Program to Advance AAV Production Enhancers
Virica Biotech secured advisory services and funding from NRC IRAP under the Canada‑Japan Co‑Innovation Program to partner with FUJIFILM Biosciences. The joint effort will optimize Virica’s Viral Sensitizer (VSE) formulation for FUJIFILM’s BalanCD® HEK293 media, aiming to boost adeno‑associated virus (AAV)...
Molecular Hydrogen as a Treatment for Chronic Fatigue Syndrome
Molecular hydrogen is emerging as a potential therapy for chronic fatigue syndrome (ME/CFS) by protecting mitochondria from oxidative damage and restoring cellular energy production. Pre‑clinical and early‑stage human trials show hydrogen‑rich water and inhalation improve endurance, lower blood lactate, and...
Regenerative Medicine Needs Data Over Hype
I recently had the opportunity to sit down with Scott Carney for a wide-ranging conversation on regenerative medicine, stem cells, peptides, and the growing gap between scientific promise and clinical reality. In the conversation, we dig into: – Why stem cell therapies...
Bipartisan Push for FDA “Pre-Review” Of DTC Drug Ads
On March 31, 2026 Senators Dick Durbin and Roger Marshall sent a bipartisan letter urging the FDA to require pre‑submission of certain direct‑to‑consumer (DTC) prescription‑drug television ads. The request builds on earlier concerns about the FDA’s limited enforcement capacity despite...
Metformin Raises Exercise‑Mimic Molecule Lac‑Phe in Prostate Cancer Patients
Researchers at the University of Miami Miller School of Medicine reported that metformin increased blood levels of N‑lactoyl‑phenylalanine (Lac‑Phe) in 29 men with prostate cancer, a molecular signal normally triggered by intense exercise. The finding positions the inexpensive diabetes drug...
Joint‑on‑Chip Multi‑Sensor Platforms Enable Real‑Time Disease Monitoring
Researchers led by Mantegazza have integrated optical, electrical, mechanical and biochemical sensors into joint‑on‑chip (JoC) platforms, moving beyond endpoint analyses to continuous, real‑time monitoring of disease dynamics. The breakthrough promises more accurate models of osteoarthritis and rheumatoid arthritis and could...
GLP-1 Drugs Shown to Fight Arthritis Independent of Weight Loss
A Chinese study found that semaglutide, a GLP‑1 drug best known for diabetes and weight‑loss treatment, can halt cartilage degradation and even thicken cartilage in osteoarthritis patients, independent of weight loss. In mice, only the semaglutide‑treated group showed reduced joint...
Long-Term Follow-Up Results of Topical Imiquimod for High-Grade Cervical Intraepithelial Neoplasia in Young Women: An Original Research
A retrospective single‑arm cohort studied topical imiquimod in nulliparous women under 35 with CIN 2/3 to avoid cervical excision. After eight weekly applications, 96% of lesions regressed to at least CIN 1 and 47% cleared high‑risk HPV. Long‑term follow‑up showed 81.6% complete...
GLP‑1 Drugs Cut Heart Events 20% as Health Systems Scramble to Adapt
Researchers and clinics in the UAE and the UK report that GLP‑1 medicines such as Wegovy and semaglutide reduce serious cardiovascular events by roughly 20%, while U.S. endocrinologists warn that health systems are unprepared for the surge in demand and...
Engineered Bacteria Consume Tumor Core, Overcoming Drug Barriers
JUST IN: Scientists built bacteria that EATS cancer from the inside out. The future of cancer treatment isn't a drug. It's a living organism that devours tumors from the inside. Here's how it works: Solid tumors have a dead center. No oxygen. No...
Next-Gen Yellow Fever Vaccine Shows Promise in Mid
My comments and interview with @Medscape Next-Gen Yellow Fever Vaccine Hits the Mark in Mid-Stage Trial https://t.co/kFfGH4c5gt
Daily Briefing: A Treatment to Reverse Cellular Ageing Is About to Be Tested in People
Researchers are preparing the first human trial of a "partial reprogramming" therapy that uses targeted protein expression to reverse cellular ageing. The approach, derived from stem‑cell reprogramming techniques, has shown organ‑level rejuvenation in mice and could, if safe, reshape how...
View mRNA‑CRISPR as Molecular Surgery, Not Drugs
What if we started thinking of mRNA-CRISPR gene editing as molecular surgery, not as a pharmaceutical product? Excellent @nytimes guest essay ⤵️ https://t.co/S61XwNRVZF
Weight‑loss Drug Semaglutide Cuts Depression Risk by 42%
A 10-year study finds weight-loss drugs lower the risk of #depression and anxiety. Published in The Lancet Psychiatry, the #research revealed a 42% lower risk of #mentalhealth hospitalisation during periods of semaglutide use. https://t.co/CphnQl0Khx
One Woman, Three Autoimmune Diseases: CAR-T Therapy Vanquishes Ultra-Rare Disease Trio
German researchers used a single dose of engineered CAR‑T cells to treat a 47‑year‑old woman suffering from three ultra‑rare autoimmune diseases—autoimmune haemolytic anaemia, immune thrombocytopenia, and antiphospholipid syndrome. After previous failures with steroids and nine other therapies, her own T...
SIRT6 Gene Therapy Remains Safe, Effective in Aged Beagles
Genflow sees sustained safety and efficacy in SIRT6 beagle trial 🐶 “Genflow Biosciences reported that three-month follow-up data from its SLAB trial in aged beagles show sustained safety and efficacy of its SIRT6 centenarian gene therapy, with no adverse events and...
Nxera Pharma Achieves Second Development Milestone in Collaboration with Eli Lilly Targeting Metabolic Diseases
Nxera Pharma announced it has reached a second development milestone in its multi‑target collaboration with Eli Lilly, triggering an undisclosed payment. The achievement validates Nxera’s NxWave™ GPCR structure‑based platform for identifying small‑molecule binders. Under the 2022 agreement, Lilly will now lead...
Hong Kong: Leading the Way in Smart Biopharmaceutical Innovation
The University of Hong Kong has signed a strategic research agreement with a leading pharmaceutical company to fast‑track drug discovery in Hong Kong. The partnership centers on anti‑infective therapies, leveraging advanced synthetic chemistry and chemical biology to create novel candidates...
Organ-on-Chip Integrated Into Preclinical Glioblastoma Research
German biotech Dynamic42 and oncology firm EPO have formed a strategic partnership to embed organ‑on‑chip technology into preclinical glioblastoma research. The collaboration merges Dynamic42’s human‑based blood‑brain barrier‑on‑chip platform with EPO’s tumor models and translational expertise, targeting more predictive drug testing....
The BALANCE Model, GLP-1 Coverage, and the Peptide Regulatory Collision: What Every Health Tech Operator and Investor Needs to Know...
CMS launched the BALANCE Model, a voluntary 1115A demonstration that waives the Part D exclusion on weight‑loss drugs and negotiates a net price of $245 per month for GLP‑1s such as Zepbound, Ozempic and Wegovy. To trigger a Medicare rollout...
Malaysia, Australia Empower Women to Lead in Biotechnology Innovation
Malaysia and Australia launched an inaugural biotechnology session aimed at boosting women’s leadership in high‑growth sectors such as vaccine manufacturing and bioprocessing. The partnership aligns with Malaysia’s 2021‑2030 STI policy and Biotechnology Policy 2.0, leveraging Australia’s life‑science expertise and Malaysia’s strong...
Single Gene Therapy Dose Eradicates Brain Tumors in Mice
GENE THERAPY SAFELY ERADICATES BRAIN TUMOURS IN MICE A single dose of an innovative gene therapy could eliminate hard-to-treat brain tumours and prevent them from coming back, according to a pre-clinical trial in mice, reported in Nature. “More than 80 per cent...
New Trial Compares Dara‑Bor‑Dex vs Cy‑Bor
EAA241 - Ph 2 RCT Dara-Bor-Dex vs Cy-Bor-Dex in the treatment of Newly Diagnosed Multiple Myeloma with Light Chain Cast Nephropathy (LCCN) [Study activated 8/11/25] @keruakous https://t.co/1NgvVZ3fTA #NCT07085728 #mmsm @eaonc https://t.co/18HJ5kRuNj
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Blaine Labs, Inc. announced a voluntary nationwide recall of three lot numbers of its Revitaderm® and Tridergel™ wound‑care gels after detecting the environmental bacterium Lysinibacillus fusiformis. The affected products, 1‑oz and 3‑oz bottles containing 0.1% benzalkonium chloride, were distributed to...
Phase
#EAOnc EQUATE EAA181 Effective Quadruplet Utilization After Tx Evaluation: Ph3 RCT NDMM Not Intended for Early ASCT [Activated: 10/27/20] PI= @myelomaMD https://t.co/qD26HMx3J8 #NCT04566328 #mmMRD #mmsm @eaonc @mweissmdphd @VincentRK @LynneWagnerPhD Wei Snyder Kostakoglu @mtmdphd
Tackling Translation: The Parker Institute Model
The Parker Institute for Cancer Immunotherapy marks its tenth anniversary by spotlighting a deliberate approach to translating scientific discoveries into medicines. Founder Karen Knudsen notes that while U.S. discovery remains strong, the nation struggles with moving breakthroughs through development pipelines....
Dietary Amino Acid Restriction Shows Promise Against Pediatric Brain Cancer
Can rebooting the diet, eliminating 2 essential amino acids, help treat an aggressive brain cancer in children? mechanism and potential established from experimental model https://t.co/wmAFM2ErRB https://t.co/PAOr5SL30y