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.
Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
The FDA is revising the boxed warning for every benzodiazepine product to explicitly list risks of abuse, misuse, addiction, physical dependence, and withdrawal. Updated patient Medication Guides will mirror these warnings, and prescribing information sections such as Warnings, Precautions, and Drug Abuse will be amended. Health‑care professionals are urged to assess individual risk, prescribe the lowest effective dose, limit treatment duration, and employ gradual tapering, especially when combined with opioid therapies. Patients and caregivers are instructed to disclose all substances, follow taper plans, and report adverse events through MedWatch.
Sleep Disorder (Sedative-Hypnotic) Drug Information
The FDA has issued a series of safety communications and label updates for sedative‑hypnotic drugs, including a 2019 boxed warning for sleepwalking injuries and stricter dosing guidance for zolpidem products. Recent alerts also highlight the lethal risk of combining benzodiazepines...
FDA Drug Safety Communication: Updated Drug Labels for Pioglitazone-Containing Medicines
The FDA has approved updated labeling for all pioglitazone‑containing medicines, adding a warning that use longer than one year may increase bladder cancer risk. Healthcare professionals are instructed not to prescribe pioglitazone to patients with active bladder cancer and to...
FDA Drug Safety Communication: FDA Approves Label Changes for Use of General Anesthetic and Sedation Drugs in Young Children
The FDA has approved label changes for general anesthetic and sedation drugs used in children under three, adding a warning that prolonged exposure—more than three hours or multiple procedures—may harm brain development. The revisions incorporate animal study data showing neuronal...
BREAKING: Federal Bill Introduced to Strip COVID-19 “Vaccine” Manufacturers of Liability Protection
Representative Chip Roy introduced the Let Injured Americans Be Legally Empowered (LIABLE) Act, which would strip COVID‑19 vaccine manufacturers of the federal immunity granted under the PREP Act. The bill would permit civil lawsuits against Pfizer, Moderna and others, even...
Ultrasound-Activated Nanoparticles Breach Bacterial Biofilms
Scientists have engineered silica‑based nanoparticles that encapsulate rifampicin and release it only when exposed to low‑frequency ultrasound. The ultrasound both propels the particles through the protective matrix of bacterial biofilms and triggers cavitation that opens the particles, delivering the antibiotic...
STAT+: Asthma Patients Suffered as GSK Pursued ‘Egregious’ Price Hikes, Senator Says
GlaxoSmithKline replaced its Flovent HFA and Flovent Diskus inhalers with an identical authorized‑generic version priced substantially higher. The move was designed to sidestep Medicaid rebate requirements, prompting health plans and pharmacy benefit managers to erect new access hurdles. Senator Maggie...
VIS-101 Shows Safety, Rapid Efficacy in Wet AMD
NovaBridge’s VIS‑101, a dual VEGF‑A and angiopoietin‑2 inhibitor, delivered rapid and durable efficacy in a phase 2a trial of 38 wet AMD patients in China. Participants receiving 3 mg or 6 mg doses achieved mean visual gains exceeding 10 ETDRS letters and central...
Structure Therapeutics Inc. (GPCR) Discusses Positive Topline Results From ACCESS II and Related Studies of Aleniglipron Oral GLP-1 Transcript
Structure Therapeutics announced positive topline data from its ACCESS II trial of aleniglipron, an oral small‑molecule GLP‑1 receptor agonist. The study demonstrated statistically significant reductions in HbA1c and weight loss comparable to injectable GLP‑1 therapies. Safety signals were mild, with few...
CytomX Surges on Positive Data for ‘Masked’ ADC in Colorectal Cancer
CytomX Therapeutics’ shares surged 66% after the company released expansion data from its Phase 1 study of Varseta‑M, a masked antibody‑drug conjugate targeting EpCAM in late‑stage colorectal cancer. The trial evaluated three dose levels, with the two highest doses achieving response...
Maker of Ozempic Failed to Report Strokes, Suicidal Ideation and Deaths
The FDA issued a formal warning letter to Novo Nordisk, citing serious violations for failing to report adverse events such as strokes, suicidal ideation, and patient deaths linked to its GLP‑1 drugs Ozempic, Wegovy and Saxenda. Inspectors found the company...
Sun Pharma's Tildrakizumab Advances Into Psoriatic Arthritis as FDA Accepts sBLA
Sun Pharmaceutical's tildrakizumab (Ilumya) received FDA acceptance for a supplemental biologics license application to treat active psoriatic arthritis. The sBLA is backed by two Phase III INSPIRE studies involving more than 800 patients, which met primary endpoints with significant ACR20 improvements...
This Hidden Immune Signal Could Change Cancer Therapy
Researchers have identified that a surface‑defensive molecule on cancer cells not only sends a “don’t‑eat‑me” signal but also conceals an “eat‑me” cue that would normally trigger immune clearance. A newly engineered antibody can disrupt this masking interaction, making tumors visible...
Bimekizumab Does Not Increase Depression, Suicide Risk Vs. Other Psoriasis Biologics
A retrospective TriNetX analysis of 1,691 psoriasis patients compared bimekizumab with IL‑23 inhibitors and found no greater incidence of new‑onset depression, suicidal ideation, or related medication use. Over a two‑year follow‑up, the combined psychiatric event rate was 4.9% for bimekizumab...
Off-Prescription Adderall Increases Blood Pressure, Heart Rate
A randomized, double‑blind study published in Mayo Clinic Proceedings found that a single 25 mg dose of off‑prescription Adderall caused significant acute increases in blood pressure and heart rate among healthy young adults. Systolic pressure rose by roughly 10 mm Hg, diastolic by...
Sentynl Therapeutics Enters Licensing Agreement with PRG S&T to Advance Progerinin
Sentynl Therapeutics, a Zydus Lifesciences subsidiary, has licensed Progerinin, an oral small‑molecule candidate for Hutchinson‑Gilford Progeria Syndrome, from PRG S&T. The agreement grants Sentynl full development rights, making Progerinin its second HGPS therapy and giving it orphan‑drug status from the FDA....
Six Biotech Companies Advancing the Next Generation of Prostate Cancer Therapies
Six biotech firms are pushing next‑generation prostate‑cancer therapies through late‑stage trials and financing milestones. Candel Therapeutics secured a $100 million royalty deal to fund aglatimagene’s launch, while Coherus Oncology closed a $50.1 million offering and partnered with J&J for a CCR8 antibody...
Lebrikizumab Delivered Significant Skin Clearance and Improved Disease Severity in Children With Moderate-to-Severe Atopic Dermatitis
Almirall reported that lebrikizumab met both co‑primary endpoints in the Phase 3 ADorable‑1 trial, with 63% of pediatric participants achieving EASI‑75 and 44% attaining clear or almost clear skin (IGA 0/1) after 16 weeks. Key secondary outcomes showed significant itch reduction, higher...
What Determines Success in Complex MASH Clinical Research Today?
Recent FDA approvals of resmetirom and semaglutide have shifted MASH care from a treatment‑void to a therapeutic reality, prompting sponsors to redesign trial endpoints and enrollment strategies. Non‑invasive diagnostic tools are emerging as potential primary endpoints, reducing reliance on liver...
Malicious Metals Muddy Fragment-to-Lead Optimization
Researchers at the Cleveland Clinic pursued fragment‑based inhibitors of SARS‑CoV‑2 NSP14, a viral exonuclease essential for replication and immune evasion. Initial crystal‑guided merges appeared active in a biochemical assay, prompting optimism about fragment linking. Subsequent resynthesis and rigorous purification revealed...
Module 2 Quiz
Drug Hunter’s online curriculum includes a Module 2 Quiz that tests learners on target identification and validation concepts. The quiz is part of a broader course designed for drug discovery professionals and requires full platform access via subscription or sign‑in. It...
Elevara Begins Phase 2b Trial of ELV001 in Rheumatoid Arthritis
Elevara Medicines has dosed the first patient in its phase 2b START‑SYNERGY trial, testing the oral CDK4/6 inhibitor ELV001 in rheumatoid arthritis patients who have failed methotrexate and TNF inhibitors. The randomized, placebo‑controlled study will enroll about 180 participants across nine...
Psychedelic Medicine Shifts From Stigma to Scientific Momentum
1/6 Excited to join @START_Global this week in Switzerland for a fireside chat on the psychedelic medicine opportunity. As co-founder and former CEO of one of the first psychedelics-focused biotechs, I’ve had a front-row seat to this field’s move from stigma...
China Startup CirCode Gets Clearance for Trial of Circular RNA Therapy
Cir‑Code Bio‑med, a Chinese biotech focused on circular RNA medicines, has secured an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration to commence its first human trial. The therapy targets a rare genetic disorder using a...
STAT+: Structure Therapeutics Reports Significant Weight Loss From Mid-Stage GLP-1 Pill
Structure Therapeutics announced that its daily oral GLP‑1 obesity pill produced an average 16% body‑weight reduction versus placebo after 44 weeks in a Phase 2 trial. The result outperforms Eli Lilly’s orforglipron, which showed about 11% loss over 72 weeks, and rivals...
Structure Therapeutics Reports More Phase 2 Data for Oral GLP-1
Structure Therapeutics released Phase 2 data for its oral GLP‑1 agonist, positioning the candidate as a next‑generation alternative to injectable therapies from Eli Lilly and Novo Nordisk. The trial demonstrated a mean 30% reduction in HbA1c and 70% of participants achieving target...
The Peptide Boom Is Getting Out of Hand
The Atlantic outlines a surge in off‑label and experimental peptide use, noting that Vyleesi—approved for women’s hypoactive sexual desire disorder—is being bought by men through “research use only” listings and online pharmacies. Compounding pharmacies and telehealth firms now market customized...
Widespread US Shift From Prescription to OTC Lies in Pharma’s Hands
The FDA is accelerating the shift of prescription medicines to over‑the‑counter status, highlighted by Commissioner Marty Makary’s call for broader OTC availability and the introduction of the Additional Condition for Non‑Prescription Use (ACNU) framework. Former FDA counsel Heidi Gertner stresses...
The Antibacterials of Tomorrow
The blog recaps the 2026 New Antibacterial Discovery and Development conference in Tuscany, where researchers presented emerging strategies against antimicrobial resistance (AMR). Dr. Quave highlighted her lab’s plant‑derived natural products targeting Gardnerella vaginalis, a key cause of bacterial vaginosis. The...
Pete Pharma Partners with Atrium24 on Pharmacy 3D Printing
Pete Pharma has entered a strategic partnership with Atrium24 Technologies, designating Pete Pharma as the primary 3D‑printing provider within Atrium24’s group‑ purchasing organization. The deal gives Atrium24‑member independent pharmacies preferred pricing on Pete Pharma’s FABRx 3D‑printing platform, enabling on‑site production...
RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa
RevnaBio received triple accreditation from the American Association for Laboratory Accreditation (A2LA) for ISO 15189, ISO 20387 and ISO/IEC 17043, validating its medical laboratory, biobanking and proficiency‑testing operations. The certifications boost diagnostic quality, enable local molecular testing, and provide a trusted platform for...
Biophytis and LynxKite Expand Alliance to Boost AI-Driven Drug Discovery
Biophytis has broadened its alliance with AI specialist LynxKite to fast‑track longevity drug discovery, launching the MASSIVE project that seeks Mas receptor activators for sarcopenia. Backed by Enterprise Singapore, the partnership will augment Biophytis’ computational platform with LynxKite’s chemoinformatics, advanced...
Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease
Bayer disclosed results from the pivotal Phase III FIND‑CKD trial evaluating Kerendia (finerenone) in more than 1,500 adults with non‑diabetic chronic kidney disease. Patients received 10 mg or 20 mg of Kerendia alongside standard of care and were compared with placebo. The study...
KERENDIA® (Finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease
Bayer announced that Kerendia® (finerenone) met its primary endpoint in the Phase III FIND‑CKD trial, showing a statistically significant slowing of eGFR decline versus placebo in non‑diabetic chronic kidney disease patients. The study enrolled over 1,500 participants and represents the fifth...
J&J Reports Positive Data for Erda-iDRS in Bladder Cancer
Johnson & Johnson announced encouraging Phase I data for its intravesical drug‑releasing system Erda‑iDRS in non‑muscle‑invasive bladder cancer (NMIBC) with FGFR alterations. The trial met its primary safety endpoint and delivered an 89% complete response rate in intermediate‑risk patients, with responses...
Roche Receives CE Mark for Its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing
Roche has secured CE Mark approval for its Elecsys ApoE4 in‑vitro diagnostic immunoassay, a blood‑based test that detects the ApoE4 gene variant linked to Alzheimer’s disease. In a validation study of 607 patients with cognitive complaints, the assay achieved 100%...
Cell Painting Images Predict Cellular Age Without Methylation
A model that predicts cellular age from Cell Painting microscopy images alone. No DNA methylation needed. The model captures morphological aging hallmarks across nuclear and cytoplasmic compartments, correlates with chronological age AND epigenetic clocks. The promise: screen for rejuvenation compounds...
Judge Stalls Kennedy Childhood Vaccine Overhaul Meeting
Kennedy childhood vaccine overhaul stalled by judge The next meeting of the Advisory Committee on Immunization Practices was scheduled for this week, but has been postponed due to the ruling https://t.co/0cUIXEVgyV
Viatris Settles Lawsuit Over Use of Woman’s ‘Immortal’ Cells to Power Drug Research
Viatris agreed to dismiss the Henrietta Lacks estate lawsuit with prejudice, ending claims that the company used HeLa cells without permission in its herpes drug Denavir and depression treatment Mylan‑Mirtazapine. The settlement details were kept confidential. This resolution follows similar...
Semaglutide Boosts Metabolism, Reduces Anxiety in Obese Mice
Beyond the Weight Loss: The Effects of Semaglutide on Standard and Diet-Induced Obese Mice 🤔"..semaglutide improved glucose metabolic health inboth diet groups..while chronic semaglutide treatment appeared to exertanxiolytic effects in obese mice, opposit[e] effects were observed in lean animals.." https://t.co/doU6EkwT7z
FDA Urges IRB Overhaul to Match China's 60‑day Trials
FDA commissioner Makary at a CMS conference today in Baltimore calls for “big and different” IRB reforms to catch China's speedy trial starts - pre-IND phase can run 380 days in the US, he said, while China is pushing for...
CytomX Jumps 66% on Promising Colorectal ADC Data
CytomX surges on positive data for ‘masked’ ADC in colorectal cancer https://t.co/PxQMISvyri by @Lilah_Alvarado $CTMX + 66%
Structure's GLP-1 Pill Shows Best-in-Class Obesity Results
Structure’s GLP-1 pill shows ‘best-in-class’ potential in obesity trial https://t.co/j0fzAg6GRV @ByJonGardner $GPCR $LLY $NVO $AZN $MRK #obesity
Multi-Ancestry Polygenic Score Predicts T2D, Obesity, GLP‑1 Need
A polygenic risk score that predicts Type 2 diabetes, obesity, and likelihood for requiring a GLP-1 drug. Across 6 ancestries. https://t.co/5hTVv8kqlK https://t.co/IgXhx8vFA6
Biotech IPOs Falter as Companies Pull Planned Listings
16March: Which companies recently withdrew their planned IPOs? And how much have the stocks of this year's #biotech IPOs risen or fallen this year? Read about the IPO market plus updates on $BNTX, $IXHL, and $INKT in my latest StockWatch...
AI-Driven Digital Biology Delivers Custom Cancer Vaccine for Dog
The era of digital biology, exemplified by making a bespoke and effective vaccine for cancer in a dog, is taking off. Access to the AI-Coscientist. A new feature @NatureMedicine https://t.co/AR9lqne7E1
P > 0.05 Means Inconclusive, Not Proof of No Effect
Correct interpretation of p > 0.05: The current sample size did not yield sufficient evidence to reject, at the incredibly arbitrary 0.05 level, the supposition that the treatment does nothing, assuming data model M (describe M ...) which forgot to...
Sarepta Tests Elevidys Safety, Sana
Sarepta tests new Elevidys safeguards; Sana advances diabetes cell therapy https://t.co/hkixuANCCV $SRPT $SANA $INO $BAYRY #biotech
Structure's Obesity Pill Shows Phase 2 Weight‑Loss Promise
Pretty impressive data from $gpcr, which remains my favorite ticker. Structure's obesity pill shows weight loss promise in Phase 2 trial https://t.co/T0JU2UuftY
EU Approves Imfinzi‑chemo Combo for Gastric Cancers
#AZN Imfinzi (durvalumab) combined with 'standard-of-care' Chemotherapy has been approved in the EU for treating Adults with forms of Gastric and Gastroesophageal Junction Cancers, following the MATTERHORN Phase III trial.