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.
A Vaccine for Lyme Disease Could Be on the Horizon
Pfizer and Valneva reported that their Lyme disease vaccine candidate LB6V reduced cases by about 70% in a Phase 3 trial. The four‑dose regimen targets the OspA protein, preventing bacterial transmission from ticks to humans. If regulators approve it, the shot would be the first Lyme vaccine in the U.S. since LYMErix was withdrawn in 2002, addressing a disease that now affects an estimated 476,000 Americans annually.
Decoding Resistance to Targeted Therapy via New Cancer Models
ATCC and the Broad Institute have created a panel of isogenic non‑small cell lung cancer (NSCLC) cell lines that model resistance to osimertinib, the newest EGFR inhibitor. Using CRISPR editing and gene‑overexpression, the team introduced six clinically observed resistance mechanisms,...
Pheast Therapeutics Reports Early P-Ia Data for PHST001 at AACR 2026
Pheast Therapeutics presented initial Phase Ia data for its anti‑CD24 macrophage checkpoint inhibitor PHST001 at the AACR 2026 meeting. The study showed clear target engagement, activation of innate immunity and a favorable safety profile across dose‑escalation cohorts. Early clinical signals...
Boehringer Ingelheim Launches AI Center for Pharma Research in London
Boehringer Ingelheim announced the launch of a new artificial‑intelligence and machine‑learning centre in London, its fourth dedicated AI hub after sites in Austria, Germany and the United States. The company will invest £150 million (about $200 million) over the next ten years...
![[Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/e66ba866d739cb77f8cd3922f2eb37b8.webp)
[Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
Almac Clinical Services has launched a six‑part podcast series that walks listeners through the end‑to‑end clinical supply chain, from protocol translation to global regulatory release. The series targets biopharma sponsors, highlighting how early collaboration with supply partners can streamline planning,...
Who Is Dr. Houman Hemmati, Potentially CBER’s Next Leader?
Dr. Houman Hemmati, a board‑certified ophthalmologist and biotech entrepreneur, is the leading candidate to replace Dr. Vinay Prasad as director of the FDA’s Center for Biologics Evaluation and Research (CBER). Hemmati co‑founded Optigo Biotherapeutics, held senior roles at companies such as...
Update: Lilly Makes $7bn Bid for in Vivo CAR-T Firm Kelonia
Eli Lilly has confirmed a $3.25 billion upfront offer for Kelonia Therapeutics, with milestone payments that could lift the total value to $7 billion. Kelonia’s in vivo CAR‑T candidate KLN‑1010 demonstrated MRD‑negative responses in a four‑patient early‑stage study, highlighting the promise of off‑the‑shelf cell...
Merck’s Early PD-1/VEGF Data Competitive in Lung Cancer, but Summit ‘Looms Large’
Merck’s anti‑PD‑1/VEGF bispecific MK‑2010 posted a 55% overall response rate in treatment‑naïve non‑small cell lung cancer (NSCLC) and a 44% response in later‑line patients, figures that rival the current leader, Summit/Akeso’s ivonescimab. The data were presented at the AACR meeting,...
Nektar’s Long-Term Mid-Stage Alopecia Data Fuel Phase 3 Plans
Nektar Therapeutics reported that its IL-2 variant rezpegaldesleukin achieved modest efficacy and safety signals in the long‑term extension of a previously failed Phase 2b alopecia areata trial, barely meeting Wall Street expectations. The data revive confidence in the program and...
STAT+: Extended Use of Nektar Therapeutics Drug Shows Promise in Alopecia
Nektar Therapeutics announced that its experimental oral drug rezpeg produced significant hair regrowth in patients with severe alopecia areata. After a year of treatment, 27% of participants reached a SALT Score 20, meaning at least 80% of the scalp was covered...
Novo Nordisk Reports Positive P-III (HIBISCUS) Study Data for Etavopivat in Sickle Cell Disease
Novo Nordisk announced that its oral pyruvate kinase activator etavopivat met both primary endpoints in the Phase III HIBISCUS trial for sickle cell disease. In 385 patients aged 12 and older, the drug reduced vaso‑occlusive crisis (VOC) rates by 27% and...
AstraZeneca Reports Positive P-III (MIRANDA) Data for Tozorakimab in COPD
AstraZeneca announced that its anti‑IL‑33 antibody tozorakimab achieved its primary endpoint in the Phase III MIRANDA trial, delivering a statistically significant reduction in the annualised rate of moderate‑to‑severe COPD exacerbations. The double‑blind study enrolled 1,454 patients receiving standard inhaled therapy and...
Vaginal Drug Delivery Had A Funding Problem—Merck Changed That
Calla Lily Clinical Care’s tampon‑shaped vaginal drug delivery platform, Callavid, has secured a strategic collaboration with Merck to accelerate clinical development for IVF luteal‑phase support and miscarriage prevention. The device, cleared under FDA 510(k) and patented in 14 countries, promises...
AZ Is Three for Three with COPD Hope Tozorakimab
AstraZeneca’s anti‑IL‑33 antibody tozorakimab has succeeded in all three pivotal Phase 3 COPD trials, showing a statistically significant reduction in moderate‑to‑severe exacerbations. The MIRANDA study confirmed benefit with biweekly dosing, while OBERON and TITANIA validated once‑monthly regimens. These results place AZ...
Novo Nordisk’s Sickle Cell Therapy Hits in Phase 3, but Data Lag Expectations
Novo Nordisk announced that its oral sickle‑cell drug etavopivat met its primary endpoint in a Phase 3 trial, showing a statistically significant reduction in painful vaso‑occlusive crises. The study, however, fell short of the ambitious efficacy and safety benchmarks the...
Omada Health Study Shows 6% Weight Loss and Muscle Preservation on GLP-1 Program
Omada Health released a 12‑week study of 245 adults with obesity showing its GLP‑1 Care Track delivered 6.0% average weight loss, a 3.3‑point drop in body‑fat percentage and a threefold rise in muscle‑mass share compared with a control group. The...
Haryana Drugs Regulator Reports Fake Mounjaro Seizure in Gurugram: Eli Lilly
Eli Lilly disclosed that Haryana’s drug regulator seized roughly ₹70 lakh (about $85,000) of counterfeit Mounjaro injections in Gurugram. The company said it is actively supporting the investigation and praised the authorities’ enforcement action. Mounjaro, a GLP‑1 drug used for obesity, has...
UCB to Acquire Neurona Therapeutics for $650M, Adding Regenerative Epilepsy Asset
UCB announced a definitive agreement to acquire Neurona Therapeutics for $650 million upfront and up to $500 million in milestones, adding the regenerative cell therapy NRTX‑1001 to its epilepsy pipeline. The deal, expected to close by Q2 2026, expands UCB’s portfolio into advanced‑therapy...
Innate Pharma to Present P-II (MATISSE) Interim Data of IPH5201 in NSCLC at AACR 2026
Innate Pharma will present interim Phase‑II (MATISSE) data for its anti‑CD39 antibody IPH5201 in resectable non‑small cell lung cancer (NSCLC) at the AACR 2026 meeting. The analysis of 40 patients shows a pathological complete response (pCR) of 35.7% in tumors...
Certain Drugs Like SGLT2 Inhibitors Cut Mortality Risk
A 2024 study on half a million UK individuals analyzed the mortality effects of 406 medications 92% were seen to be associated with increased mortality risk because of the underlying diseases. However, 14 were surprisingly associated with reduced mortality. An overview by...
Mitrix Bio as an Example of the Trend Towards Alternative Paths to Initial Human Data
Mitrix Bio reported preliminary Phase 1 safety results for large‑dose mitochondrial infusions, showing no immediate adverse effects in two older participants. The company simultaneously opened Right‑to‑Try clinics in Dallas, Newport Beach and Palm Beach, offering the experimental therapy under a patient‑driven model. Its...
Eli Lilly in Advanced Talks to Buy Kelonia Therapeutics for over $2 Billion
Eli Lilly is in advanced talks to acquire Kelonia Therapeutics for over $2 billion, according to the Wall Street Journal. The deal, which may include milestone payments, could be announced as early as Monday and would bolster Lilly’s oncology pipeline. Shares...
Nanobiotix's Nanoprimer Boosts LNP‑DNA Immunotherapy Bioavailability, Cuts Toxicity
Nanobiotix unveiled preclinical results that its Nanoprimer platform, given before lipid‑nanoparticle DNA immunotherapies, markedly increases systemic exposure and reduces hepatic toxicity in mice. The data, presented at the 2026 AACR meeting, could unlock more effective LNP‑based cancer treatments.
Contributor: Focus on the Real Causes of the Shortage in Hormone Treatments
U.S. pharmacies have struggled to fill estradiol patch prescriptions, prompting media narratives that blame a surge in menopause hormone demand. In reality, usage of hormone therapy has hovered around 5% of menopausal women, far from unprecedented levels. The shortage is...
GLP-1 May Only Be the Beginning, Not the End of the Story
Researchers led by Richard DiMarchi and Matthias Tschöp published a paper in Molecular Metabolism showing that triple agonist retatrutide can drive weight loss even when GLP‑1 signaling is blocked. Their preclinical work demonstrates that co‑activating GIP and glucagon receptors produces...
Freudenberg Medical Launches ISO Class 5 Cleanroom for Biopharma
Freudenberg Medical announced CleanAssure, an ISO 5 controlled cleanroom that delivers washed, dried and gamma‑sterilized single‑use assemblies for biopharma customers. The service expands the company’s portfolio beyond component manufacturing to include validated cleaning and sterilization under cGMP conditions. By integrating this...
Magazine: Digital Twins Become the New Battleground for CDMOs
The latest issue of Pharmaceutical Technology highlights how knowledge‑graph digital twins are becoming a strategic weapon for contract development and manufacturing organisations (CDMOs) tackling complex biologics, gene therapies and advanced products. By creating a virtual replica of the entire manufacturing...
Georgetown Engineers Pectin-Based Bone Grafts to Replace Metal Implants
Georgetown University researchers have engineered a 3D‑printed bone graft that combines pectin—a food‑grade polysaccharide—with hydroxyapatite layers to mimic natural bone architecture. The pectin matrix can be printed at room temperature, creating a porous scaffold that promotes nutrient flow and cell...
Inclusive Clinical Trials: An Oxymoron?
The author argues that mandating the inclusion of pregnant and breastfeeding women in pivotal clinical trials is driven more by sentiment than scientific rigor. He highlights that strict eligibility criteria are essential for internal validity, and adding these populations would...
The Future of Quality in CDMOs: The Five-Stage Journey to an Advanced Pharmaceutical Quality System (PQS)
Sharp, a leading contract development and manufacturing organization (CDMO), outlined a five‑stage journey to an advanced Pharmaceutical Quality System (PQS) that shifts quality from basic compliance to a strategic, performance‑driven function. The roadmap progresses through foundational compliance, strategic direction, integrated...
Marty Makary: The FDA’s Quiet Blockade on Safer Nicotine
The article argues that FDA Commissioner Marty Makary is deliberately stalling approvals for low‑risk nicotine products such as vapes, heated tobacco and nicotine pouches, despite clear scientific consensus that they are far less harmful than smoking. Youth e‑cigarette use has...
Four Ways to Build a Secure and Scalable CGT Distribution Network
Cell and gene therapies (CGTs) are expanding rapidly, with 34 US products approved and a projected $80 bn global market by 2029, driven largely by oncology. Successful commercialization now hinges on building secure, scalable distribution networks that protect fragile, cryogenic products...
What Actually Drives Speed in Complex Drug Development Programs
Speed in complex drug development is less about pushing harder and more about early, cross‑functional coordination. Traditional sequential handoffs often create hidden delays, forcing teams to revisit decisions under pressure. Thermo Fisher Scientific’s Accelerator™ Drug Development model integrates CDMO and...
Potential Spillover Effects on Diagnostic Delay for Cancer During the NHS-Galleri Trial
A quasi‑experimental study examined whether England’s NHS‑Galleri trial, which tests a cell‑free DNA multi‑cancer early detection (MCED) assay, caused spillover effects on cancer diagnostic timelines. Using a difference‑in‑differences design across 21 cancer‑alliance regions, researchers found that participating regions experienced a...
Pulnovo Raises $100M Led by Medtronic to Advance PADN System for Pulmonary Hypertension
Pulnovo Medical announced an oversubscribed $100 million financing round led by Medtronic, bringing together existing backers such as EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed and Lilly Asia Ventures. The capital will accelerate clinical development, regulatory work and commercialization of Pulnovo’s...
STAT+: PBMs Warn Trump’s Proposal to Disclose Drug Prices Is Illegal
The U.S. Department of Labor has issued a proposed rule that would require pharmacy benefit managers (PBMs) to disclose detailed drug‑pricing information to employers and simplify audit processes. The rule, released in January, has sparked a flood of comments, with...
Fully Defined 3D Culture Substrate for Cancer Research
AMSBIO announced that its fully defined MatriMix 511 extracellular matrix enables patient‑derived colorectal cancer cells to form robust 3D organoids. In a Kyoto University study, the organoids preserved stage‑specific tumor biology and expressed metastatic markers, outperforming alternative matrices. MatriMix’s composition...
AlphaGen Therapeutics to Present Preclinical Studies of Two Next-Generation Alpha Therapies at AACR 2026
AlphaGen Therapeutics announced it will present preclinical data on two next‑generation alpha radiopharmaceuticals, AG1002 and AG1206, at the AAC 2026 meeting in San Diego. AG1002 is a non‑agonist SSTR2‑targeting agent that achieved a superior tumor‑to‑kidney ratio and robust tumor inhibition in multiple...
EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors
EpiBiologics has dosed the first patient in a global Phase‑1 trial of EPI‑326, a tissue‑selective bispecific antibody that targets EGFR in advanced solid tumors. The study will assess safety, tolerability, pharmacokinetics and early anti‑tumor activity in non‑small cell lung cancer...
From Product to Patient in Nuclear Medicine: Why Vertical Integration Is Essential for a Competitive Advantage
Nuclear medicine’s ultra‑short radiopharmaceutical half‑lives make delivery inseparable from production, forcing a single, time‑bound operational system. Curium has built a globally integrated model that combines isotope manufacturing, quality release, and distribution into one coordinated network. The approach proved its resilience...
Using AI to Advance Validated Real-World Evidence
The HealthVerity event highlighted how AI can turn early‑stage life‑science questions into reproducible real‑world evidence (RWE) within minutes. Speakers from HealthVerity, Chiesi USA, Argenx and Medeloop shared practical methods for building transparent, iterative analyses that support feasibility, patient‑journey, regulatory and...
Emyria Launches Empax Global Partnership Platform Targeting International Drug Sponsors
Emyria (ASX:EMD) has launched the Empax Global Partnership Platform, giving international drug sponsors and CROs direct access to its clinical delivery infrastructure for complex psychedelic‑assisted therapies. The service creates a dual‑revenue model that blends existing reimbursed treatment programs with high‑margin,...
Trump Cuts Crucial Health Research Funding, Fueling Crisis
This piece in the WaPo summarizes what I've been say. The feds under Trump are choking off research dollars -- particularly for women's health, cancer and mental health. Young researchers are particularly hard hit, steering scientists into other work. It's...
GSK's Blenrep Approved in China for Multiple Myeloma
#GSK Blenrep (belantamab mafodotin) approved in China with a Bortezomib and Dexamethasone combo for treating Adults with a form of multiple myeloma.
FDA Seeks More Cardiovascular Data on Eli Lilly’s Orforglipron After Safety Concerns
The U.S. FDA has asked Eli Lilly to provide further cardiovascular safety data on its newly approved oral GLP‑1 weight‑loss drug Orforglipron, after the agency’s approval letter flagged “unexpected serious risks.” Lilly says patient safety remains its top priority as it...
AI-Driven Drug Discovery: Current Landscape and Future Promise
Cool review and perspective on the current state and the future of AI-powered drug discovery https://t.co/AgwqOlt4RU
Alembic Pharma Secures US FDA Nod for Generic Methotrexate Injection, Boosting US Generics Portfolio
Alembic Pharmaceuticals announced US FDA approval for its generic methotrexate injection USP on April 16, 2026. The clearance covers 50 mg/2 mL multi‑dose and 1 g/40 mL single‑dose vials, bringing the Indian drugmaker’s total US ANDA approvals to 236. The move strengthens Alembic’s foothold...
Gene‑Therapy Pioneers Win $3 Million Breakthrough Prize for Vision and Sickle‑Cell Treatments
The Breakthrough Prize Foundation awarded a $3 million Life Sciences prize to three University of Pennsylvania scientists and two collaborators for pioneering gene‑therapy treatments that restore sight in Leber congenital amaurosis and target sickle‑cell disease. The honor spotlights Luxturna’s market entry...
FDA Approves Breakthrough Therapy for Critically Ill Children
FDA says ‘yes’ to transformative therapy for sick children — and more media coverage of UCLA https://t.co/N6AJsRwCyX
Eli Lilly to Spend $6.3 B on Centessa Buy, with up to $1.5 B in Milestone Payouts
Eli Lilly agreed to acquire UK‑based Centessa Pharmaceuticals for an upfront $6.3 billion, plus a contingent value right that could add $1.5 billion if the lead sleep‑wake disorder drug meets regulatory milestones. The deal, priced at a 40% premium, follows Lilly’s cash‑rich...