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.
STAT+: Novo Nordisk’s High-Dose Wegovy Approved in the U.S.
Novo Nordisk announced FDA approval of a high-dose formulation of its obesity injectable Wegovy in the United States. The approval was granted through a new FDA priority review voucher program, which Novo earned via a price‑cut deal with the Trump administration. The move is intended to help Novo regain ground after losing market share to Eli Lilly’s competing weight‑loss drugs. Analysts remain uncertain how much the higher dose will boost Novo’s sales.
Iran-US Conflict Triggers Surge in Medicine Costs Across India and Nigeria
India’s wholesale pharmaceutical market is seeing 10‑15% price increases as the Iran‑US war disrupts key raw‑material imports, while Nigeria’s manufacturers caution that prolonged supply‑chain shocks could trigger shortages of essential medicines. Industry bodies in both countries have appealed to governments...
Studies Show Increased Risk of Heart Rhythm Problems with Seizure and Mental Health Medicine Lamotrigine (Lamictal) in Patients with Heart...
The FDA has issued a safety communication indicating that lamotrigine (Lamictal) may increase the risk of serious arrhythmias in patients with existing heart disease. The agency ordered in‑vitro studies after reports of abnormal ECGs, chest pain, loss of consciousness, and...
Thermal Stability Assays as Tools to De-Risk Discovery
Thermal stability assays, especially differential scanning fluorimetry, are gaining traction as early‑stage de‑risking tools in drug discovery. By measuring protein melting temperatures, these assays reveal ligand‑induced stabilization, enabling rapid hit validation and prioritization. The article outlines best‑practice workflows, data‑interpretation guidelines,...
FDA’s New Program Injects Politics Into Drug Approval
The FDA has introduced the Commissioner’s National Priority Voucher (CNPV) pilot, offering ultra‑fast approval pathways for drugs that align with the current White House policy agenda. The program could slash review times for qualifying products, giving participating companies a market...
FDA Approves Linerixibat for Cholestatic Pruritus in Primary Biliary Cholangitis
The U.S. Food and Drug Administration has granted approval to GSK’s linerixibat (Lynavoy) for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC). The decision rests on the GLISTEN phase‑3 trial, which demonstrated a statistically and clinically significant reduction...
Biosimilar CT-P43 Matches Ustekinumab in Treating Moderate to Severe Plaque Psoriasis
A phase‑3, double‑blind trial of over 500 patients showed the ustekinumab biosimilar CT‑P43 achieved equivalent PASI75 response at week 12 and maintained comparable PASI50/75/90 rates through week 52. Safety, adverse‑event profiles, and antidrug‑antibody incidence mirrored those of reference ustekinumab. Patients who switched...
Sarepta Plans FDA Run for Duchenne Exon Skippers Despite Confirmatory Trial Failure
Sarepta Therapeutics will submit a supplemental NDA to the FDA seeking to convert the accelerated approvals of its Duchenne exon‑skippers Amondys 45 and Vyondys 53 into traditional approvals, despite the confirmatory ESSENCE trial failing to improve motor function. The company bolsters its...
Tracking Leishmaniasis with New PCR Test
A team at the Hebrew University of Jerusalem has unveiled a high‑resolution melting (HRM) PCR assay that simultaneously identifies sand‑fly species, detects Leishmania parasites, and determines the insect's blood‑meal source from a single specimen. The method was applied to nearly...
Glaukos Announces Commercial Availability of Epioxa™, a Transformative Innovation in Interventional Keratoconus Care
Glaukos announced that Epioxa™ HD/Epioxa™ is now commercially available, marking the first FDA‑approved, incision‑free topical drug for keratoconus. The therapy uses a riboflavin solution with the O₂n™ System and Boost Goggles, eliminating the need to remove the corneal epithelium. By...
TALZENNA Plus XTANDI Significantly Improves Radiographic Progression-Free Survival in Metastatic Prostate Cancer
Pfizer announced that the Phase 3 TALAPRO‑3 trial met its primary endpoint, showing that TALZENNA (talazoparib) combined with XTANDI (enzalutamide) significantly improved radiographic progression‑free survival (rPFS) in patients with HRR gene‑mutated metastatic hormone‑sensitive prostate cancer. The combination achieved a hazard ratio...
STAT+: Pharmalittle: We’re Reading About a Lilly Weight Loss Trial, TrumpRx Shortcomings, and More
Eli Lilly’s late‑stage trial of the injectable retatrutide showed a 1.9% drop in HbA1c and a 15.3% weight loss after 40 weeks, outperforming placebo and matching its blockbuster Mounjaro. The drug targets the roughly 60% of type‑2 diabetics who are also...
Embecta to Acquire Owen Mumford for Up to £150 Million, Expanding Drug‑Delivery Portfolio
Embecta Corp. announced a definitive agreement to purchase UK‑based Owen Mumford Holdings Limited for up to £150 million, with £100 million paid at closing and up to £50 million in performance‑based earn‑out. The deal, slated to close in Embecta’s fiscal Q3 2026, adds...
FDA Lets Sarepta Push Failed Drugs, Blocks UniQure
Let's look at how the FDA is treating $SRPT and $QURE differently. The FDA grants accelerated approval to Amondys and Vyondys to treat Duchenne muscular dystrophy. Sarepta conducts a post-marketing confirmatory study that fails to show a benefit for either...
Oral Ozempic Trials Fail to Show Alzheimer's Benefit
The negative oral Ozempic randomized trials (EVOKE, EVOKE+) for Alzheimer's disease have now been published @TheLancet https://t.co/Xx0YknTSC2
Building Agent Studio: How Medable Is Using Agentic AI to Accelerate Clinical Trials
Medable has launched Agent Studio, a no-code/low-code platform that lets pharmaceutical companies configure and deploy AI agents across the clinical trial lifecycle. The platform currently powers two agents—a document‑classification ETMF agent that processes over 80,000 records a year, and a...
GLP‑1 Drugs May Protect Heart, Vessels, Kidneys in Type 1 Diabetes
GLP-1 drugs have established benefit for Type 2 diabetes. New data suggests that extends to Type 1 diabetes, with heart, vascular, and kidney protection https://t.co/nZDKHoFIRm https://t.co/lTHIgoj4ir
Prioritize Affinity, Specificity, Then Stability in Nanobody Design
Okay here's a game - you're making nanobody therapeutics. AI can help you optimise them, but you need to prioritise order of feature importance. What is your order? Affinity Specificity Expressibility Clinical toxicity In vivo stability Purified stability Patentability Other?
Excalipoint Closes $68.7M Seed Round for Cancer T-Cell Engagers
Excalipoint, a biotech focused on cancer T‑cell engagers, announced the close of a $68.7 million seed financing round. The capital, raised from leading venture firms and strategic investors, will fund the development of its bispecific antibody platform targeting solid tumors. The...
Congruence Launches First Drug, Secures $40M Funding
Exclusive: Clarissa Desjardins' newest biotech has put its first drug in the clinic + raised $40M more. Congruence also expects to put 2 more molecules into clinic in early 2027, seeing its platform driving its R&D efficiency: https://t.co/pzxcnmKFBj
Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss
The U.S. Food and Drug Administration granted Breakthrough Device Designation to Nia Therapeutics’ Smart Neurostimulation System (SNS) for treating episodic memory loss in adults with moderate to severe traumatic brain injury. The fully implantable, closed‑loop system records neural activity from...
International Business Briefs | Novo Nordisk Weight-Loss Drugs’ Patent Expiry to Benefit India
This week’s corporate round‑up highlighted several pivotal moves: Novo Nordisk’s semaglutide patent lapses in India, prompting more than 40 firms to launch over 50 generic weight‑loss brands; BP agreed to sell its Gelsenkirchen refinery, targeting roughly $1 bn of operating‑cost savings;...
Quintessence Debuts First ‘Living’ Artificial Cell for CGT Bio-Separation
Quintessence Biotech introduced DACS, the first "living" artificial cell designed to streamline bio‑separation in cell and gene therapy (CGT) manufacturing. The lipid‑particle platform mimics cell size, deformability and antigen presentation, enabling a gravity‑based flotation method that replaces magnetic‑bead workflows. DACS...
STAT+: Eli Lilly’s ‘Triple-G’ Drug Leads to Significant Blood Sugar, Weight Reductions in Diabetes Trial
Eli Lilly’s investigational injectable retatrutide achieved a 1.9‑point HbA1c reduction versus 0.8 points for placebo after 40 weeks, while participants on the highest dose shed 15.3% of body weight compared with 2.6% on placebo. The weight loss was still progressing at...
Overcoming Drug Development Obstacles for Some of the Most Challenging Ischemic Conditions
DiaMedica Therapeutics is advancing a recombinant tissue kallikrein (KLK1) to treat ischemic stroke and preeclampsia, leveraging the kallikrein‑kinin pathway to restore microvascular flow. Early trials show maternal blood‑pressure reductions, improved uterine‑artery Doppler indices, and no detectable drug in fetal circulation,...
AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)
AL‑S Pharma released Phase II (AP‑101‑02) data evaluating intravenous AP‑101 every three weeks in 73 ALS patients, including 52 with sporadic disease and 21 with SOD1 mutations. The trial met its primary safety and tolerability endpoint and demonstrated disease modification,...
Reviva Pharma Prices $10 Million Offering as Shares Plunge 33%
Reviva Pharmaceuticals priced a $10 million public offering of 6.66 million shares and accompanying warrants at $1.50 each, with closing expected around March 20, 2026. The cash will fund the RECOVER‑2 Phase 3 trial of brilaroxazine for schizophrenia. The news sent the stock down more...
Molecule in Python Blood Could Pave Way for New Obesity Drugs, Scientists Say
Scientists have isolated a gut‑bacterial metabolite, pTOS, that spikes in Burmese python blood after feeding and dramatically reduces appetite in obese mice. When administered to mice, pTOS caused a 9% body‑weight loss over 28 days without affecting energy expenditure. The...
Pharma Pulse: FDA Approval of Icotyde for Plaque Psoriasis and CCT’s MedAssure Debut
The FDA has approved Icotyde, the first targeted oral peptide therapy for moderate‑to‑severe plaque psoriasis, offering a once‑daily pill that blocks the IL‑23 receptor. In pivotal trials, roughly 70% of patients achieved clear or almost clear skin by week 16,...
Europe’s Last Chance to Revive Its Pharmaceutical Innovation Power
Europe’s pharmaceutical sector is losing its historic lead in R&D, with its share of global private research dropping from roughly half in 1990 to a third in 2025, while the United States now commands 55% and China is rapidly closing...
CANCER RESEARCH - TOCOTRIENOLS - 2025 Review - Therapeutic Potential of Tocotrienols as Chemosensitizers in Cancer Therapy (Why They Are...
The 2025 review examines tocotrienols, a subset of vitamin E, as chemosensitizers that boost the effectiveness of conventional cancer drugs. Pre‑clinical studies show that combining tocotrienols with antiparasitic agents such as fenbendazole or mebendazole markedly increases tumor cell death. The analysis...
BioCina Launches Manufacturing Program for Patrys’ Injectable Delirium Therapy
BioCina has launched a comprehensive Chemistry, Manufacturing and Controls (CMC) program for Patrys Ltd’s injectable formulation RLS-2201, a proprietary quetiapine product aimed at treating acute delirium in intensive‑care patients. The manufacturing effort is based in BioCina’s sterile facility in Perth...
Metformin Reduces Weight Gain in Young People Taking Antipsychotics
A large pragmatic trial involving 1,565 overweight or obese youths with bipolar spectrum disorders found that adding metformin to a brief lifestyle program significantly blunted weight gain associated with second‑generation antipsychotics. Over six months, the metformin group’s BMI rose only...
Is the Tide Turning for Pharmaceutical Patent Preliminary Injunctions in Australia?
After eight years of denying pharmaceutical preliminary injunctions, Australia’s Federal Court granted two rare orders in 2025‑26, favoring originators Janssen and AstraZeneca. The court applied the traditional two‑factor test—prima facie infringement and balance of convenience—but placed greater weight on the...
India Opens Anti‑Dumping Probe on Chinese Ethyl Chloroformate Imports
India’s Directorate General of Trade Remedies has launched an anti‑dumping investigation into ethyl chloroformate imports from China following a complaint by domestic producer Paushak. The probe, covering Oct 2024‑Sept 2025, could lead to duties that raise costs for drugmakers and agrochemical firms...
FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) From Merck Animal Health to Treat and Control Asian Longhorned Tick...
Merck Animal Health announced that the FDA has approved an expanded label for its once‑yearly injectable parasite control, Bravecto Quantum, adding treatment and control of Asian longhorned tick (Haemaphysalis longicornis) and Gulf Coast tick (Amblyomma maculatum) for 12 months. The product...
Implant vs Meds: Randomized Trial Questions LAA Closure Benefit
Questioning the benefit of an implant to close the left atrial appendage vs medical therapy in a randomized trial @NEJM https://t.co/N0hpdIfmLe https://t.co/8bkk8FzLuY
FDA’s Draft Guidance on Alternatives to Animal Testing in Drug Development
The FDA issued draft guidance to help drug developers validate new approach methodologies (NAMs) as alternatives to animal testing. The guidance outlines four validation principles—context of use, human biological relevance, technical characterization, and fit‑for‑purpose—to ensure NAM data are reliable for...
What Does Next-Generation Copay Assistance Look Like?
Matthew Turner, President of Patient Affordability at Paysign, says next‑generation copay assistance relies on ecosystem partnerships rather than a single‑vendor model, combining best‑in‑class services such as messaging, hub operations, and nursing education. He highlights financial threats like accumulator and maximizer...
After Buying HUB and Partnering with Promega, MilliporeSigma Charts Growth Path in Organoids
MilliporeSigma, the life‑science arm of Merck KGaA, completed its €104 million acquisition of HUB Organoids and has since integrated the business into its Discovery Solutions unit. The company launched a partnership with Promega to develop real‑time reporter assays for organoids, while...
Stopping GLP‑1 Therapy Quickly Erodes Cardiovascular Protection
A new finding after stopping GLP-1 drugs in a large cohort with Type 2 diabetes: rapid erosion of CV benefit/protection New @bmj_latest by @zalaly @Biostayan https://t.co/JG6yB8wTJJ See thread: https://t.co/6JvfIIjVBw https://t.co/wUgWhvs9Yy
FDA Investigating: US Patient Dies After Use of Placental Extract Laennec, Russian Med Student Also Died
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously...
CBER Updates SOPs, Enables RMAT for Held Therapies
CBER changes its standard operating procedures to open the door to RMAT designations for therapies on clinical hold - https://t.co/bZmhga8xxC
STAT+: A Maryland Legislator Wants Pharma and Patient Groups to Disclose Ties to Disease Awareness Campaigns
A Maryland bill would force pharmaceutical companies and patient advocacy groups to disclose any financial ties when they run disease‑awareness advertisements. The legislation requires drugmakers to state whether they sell or are developing a treatment for the condition featured, and...
In‑body Genome Editing Promises Cheaper, Practical CAR‑T Therapies
What if we could engineer T cells in the body, making CAR T vs cancer, autoimmune diseases, and other applications far more practical, much less expensive? A step forward today via genome editing T cells https://t.co/FjgQA8NUlu https://t.co/XXk43WL1ac https://t.co/rpC7eCAlJH
Boosting the Blood-Brain Barrier Could Avert Brain Damage in Athletes
Repeated head impacts in contact sports have been linked to lasting damage of the blood‑brain barrier (BBB), a finding that may underlie chronic traumatic encephalopathy (CTE). Researchers scanned 47 retired athletes using an MRI contrast agent that only enters brain...
Science's AI Model Explosion Is Just
We're about to see an explosion of AI models for Science like Andre's LigandForge and I'm here for it!
FDA Seeks to Encourage Fewer Animal Studies with New Draft Guidance
The FDA released a draft guidance that details how biopharma firms can validate non‑animal approaches for early‑phase toxicology and safety studies. The document encourages the use of in‑vitro assays, computational modeling, and other modern methods to replace traditional animal testing....
Repeated Psilocybin Doses Yield 73% OCD Response
A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive–compulsive disorder 73.3% were responders (⩾35% reduction in YBOCS scores), with 40% in remission. These effects diminished but remained substantial at 6 months. https://t.co/tp2SPIKDrB
Pharmaceutical Executive Daily: Federal Judge Halts Vaccine Advisory Council Appointments
A federal district court judge issued a preliminary injunction halting the Trump administration’s overhaul of the Advisory Committee on Immunization Practices, finding violations of the Federal Advisory Committee Act and gaps in vaccine expertise. The order pauses pending recommendations on...