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.
FUJIFILM Biosciences and NextCell Launch New Commercial Platform Comprised of RUO Stromal Cells and Cell Culture Media
FUJIFILM Biosciences and NextCell Pharma have launched a global commercial platform that pairs FUJIFILM’s PRIME‑XV MSC Expansion XSFM medium with NextCell’s research‑use‑only umbilical‑cord mesenchymal stromal cell product, NextCell‑Cord RUO. The bundle offers a standardized, scalable solution for MSC research, addressing heterogeneity and manufacturing inefficiencies. The products are now available worldwide through FUJIFILM’s distribution network, either standalone or as a media‑cell combo. The partnership leverages FUJIFILM’s life‑science reach and NextCell’s clinical‑stage MSC expertise.
Novo Hands Over Parkinson’s Therapy to Zuckerberg-Backed Startup
Novo Nordisk agreed to transfer its experimental Parkinson’s disease therapy to Cellular Intelligence, an AI startup backed by Mark Zuckerberg, to accelerate development. Cellular Intelligence will assume responsibility for clinical‑trial execution, while Novo retains rights to milestone payments and royalties...
GSK Enlists Local Aid for Chinese Rollout of Hep B Drug
GlaxoSmithKline (GSK) has signed a five‑and‑a‑half‑year agreement with Sino Biopharm’s subsidiary Chia Tai Tianqing Pharma (CTTQ) to import, distribute and promote its investigational hepatitis B antisense drug bepirovirsen across more than 5,000 Chinese medical centres, pending NMPA approval. The partnership gives...
New Patent Covers Short-Acting Monoamine Releasers
Short-acting monoamine releasers D Nutt, A Borthwick, R Tyacke - US Patent 12,590,077, 2026 https://t.co/P99hvyXiil
Makary’s Reported FDA Removal Could Be ‘Broad Positive’ for Biopharma
Industry sources report that President Donald Trump has approved a plan to remove FDA Commissioner Marty Makary, following the recent departure of CBER head Vinay Prasad. Makary’s tenure has been marked by calls for greater transparency but also criticism over...
Makary’s Reported FDA Removal Could Be 'Broad Positive' For Biopharma
President Donald Trump reportedly agreed to remove FDA Commissioner Marty Makary, a move confirmed by the Wall Street Journal and echoed by anonymous sources. The announcement follows the recent departure of CBER director Vinay Prasad and adds to a pattern of...
PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy
PulseSight Therapeutics presented Phase I (PST-611-CT1) trial data for PST-611 in dry age‑related macular degeneration (geographic atrophy) at ARVO 2026. The study enrolled six patients across two dose cohorts and demonstrated favorable safety, tolerability, stable best‑corrected visual acuity, and no...
Deal Finally Unlocks NHS Access to ITF's Duchenne Drug
ITF Pharma’s oral HDAC inhibitor Duvyzat has secured NICE endorsement for ambulatory Duchenne muscular dystrophy patients, unlocking access for more than 500 NHS England cases. The drug will be funded immediately through the Innovative Medicines Fund while NHS England arranges...
European Regulators Greenlight Fractyl Health's Clinical Test of GLP-1 Gene Therapy
European regulators have granted Fractyl Health permission to begin the first human trial of a GLP‑1 gene‑therapy candidate. The Phase 1 study will test a single‑dose AAV‑based vector designed to produce continuous GLP‑1, aiming to replace daily injections for type 2 diabetes...
Quality CDMO, Inc. - 665961 - 05/01/2026
The U.S. Food and Drug Administration issued a closeout letter to Quality CDMO, Inc., confirming that the firm’s corrective actions have addressed the violations cited in the September 11, 2024 warning letter. While the FDA acknowledges the remediation, it emphasizes that compliance...
CRISPRi Screening Identifies Fungal-Specific Drug Targets
Researchers adapted a pooled CRISPR interference (CRISPRi) platform for Candida albicans, allowing high‑throughput repression of 130 essential, fungal‑specific genes. The screen revealed dosage‑sensitive vulnerabilities across ten infection‑relevant stress conditions. Testing two drug‑resistant clinical isolates showed most hits are conserved, indicating...
Duke Study Shows Six Blood piRNAs Predict Two‑Year Longevity with 86% Accuracy
Researchers at Duke Health announced a blood test that measures six circulating piRNAs and predicts two‑year survival in adults over 71 with up to 86% accuracy. The finding, published in Aging Cell, could give clinicians and biohackers a precise, minimally...
Kissei Pharmaceutical Posts 15% Profit Rise on 10% Revenue Surge
Kissei Pharmaceutical Co., Ltd. announced full‑year earnings of ¥13.78 billion, a 15% increase from the prior year, while revenue rose 10.3% to ¥97.41 billion. The results highlight robust demand for its portfolio and signal broader momentum in Japan’s pharmaceutical market.
FDA Locks Down Post-Approval Pregnancy Safety Data Framework
The FDA issued final guidance on post‑marketing safety data collection for drugs and biologics used in pregnancy. The framework details best practices for pregnancy registries, case‑control, electronic health record‑based and population‑level studies, stressing early enrollment and multi‑pronged recruitment. It requires...
Daiichi Sankyo Forecasts $1.7B Net Income on Surge in Enhertu, Datroway Sales
Japanese drugmaker Daiichi Sankyo said it expects a net income of about ¥260 billion ($1.7 billion) for the year ending March 2027, driven by higher sales of its oncology drugs Enhertu and Datroway. The outlook reflects a broader shift in cancer‑treatment markets, where...
A Single Infusion Could Suppress H.I.V. for Years, Study Suggests
Scientists presented early data showing that a single infusion of genetically engineered immune cells can drive HIV to undetectable levels in patients. In a small study, two participants received the therapy, with one maintaining viral suppression for almost two years....
FDA Cliffhanger: Will Marty Makary Stay or Go?
The FDA’s leadership is in flux as reports suggest President Trump may fire Commissioner Marty Makary, though the president has so far remained noncommittal. Makary, a Johns Hopkins physician, has overseen controversial moves on abortion pills, flavored vapes, and accelerated...
Precision in Motion: Decoding the Critical Operations Behind the Logistics of Next-Generation Cell and Gene Therapies
Cell and gene therapies (CGTs) are transforming personalized medicine but demand ultra‑precise logistics because they are patient‑specific, highly sensitive, and often viable for only minutes to hours. Traditional freight cannot meet the sub‑30‑minute delivery windows, cryogenic temperature requirements, and real‑time...
The Capacity Crunch in Biopharma Is a Location Problem
Biopharma manufacturers are hitting a capacity crunch as demand for cell and gene therapies outpaces the construction of new GMP‑ready plants, which can take years. Companies are therefore prioritizing locations where compliant facilities, utilities and cold‑chain logistics already exist. Middlesex...
Day One Concludes Patient Enrolment for Tovorafenib’s FIREFLY-2 Trial
Day One Biopharmaceuticals announced that the Phase III FIREFLY‑2 trial of tovorafenib has finished enrolling roughly 400 pediatric low‑grade glioma patients across 140 sites worldwide. The open‑label, randomized study pits oral tovorafenib against four standard chemotherapy regimens as a first‑line option...
STAT+: Medicare Is Spending Far Less than Expected on New Alzheimer’s Drugs
Medicare’s uptake of the newly approved Alzheimer’s therapies Leqembi and Kisunla is far lower than projected, prompting the agency to forecast minimal spending through 2026‑2027. Earlier estimates had anticipated billions in annual costs, but real‑world adoption has stalled. The drugs...
Henlius Receives US FDA IND Clearance for HLX05-N (Biosimilar, Erbitux)
Henlius announced that the U.S. Food and Drug Administration granted Investigational New Drug (IND) clearance for HLX05‑N, its biosimilar version of Erbitux (cetuximab), aimed at treating metastatic colorectal cancer. The IND follows extensive analytical and non‑clinical studies that demonstrated high...
Nuclera Launches Antibody Triage Service to Advance AI-Driven Antibody Discovery
Nuclera, a biotech firm specializing in protein production, announced a new antibody‑screening service designed to accelerate AI‑driven antibody discovery. The offering uses a 96‑plex cell‑free expression platform and surface plasmon resonance to triage large in‑silico‑generated libraries, delivering early binding data...
Bologna’s Cellply Secures €7.15 Million to Develop Tools for Faster Immunotherapy and Cell Therapy Development
Italian deep‑tech startup Cellply has closed a €7.15 million ($7.8 million) funding round led by ENEA Tech e Biomedical. The capital will fund global rollout of its VivaCyte® single‑cell analysis platform and development of next‑generation ATMP quality‑control tools. The round also saw...
BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)
The European Commission has approved Bristol‑Myers‑Squibb’s oral drug Sotyktu (deucravacitinib) for adults with active psoriatic arthritis, either alone or with methotrexate. The decision follows positive Phase III data from the POETYK PsA‑1 and POETYK PsA‑2 trials, which enrolled over 1,200 patients and met...
Patient Perspectives on Gene Therapies and Gene Editing for Familial Cardiomyopathies
Early‑phase trials are testing gene replacement and editing for hypertrophic and dilated cardiomyopathies, yet patient viewpoints remain understudied. Interviews with 21 adults (average age 57, 57% female) revealed four decision drivers: perceived disease severity, quality‑of‑life impact, treatment safety and delivery,...
CEAS Collective: Bridging Biotech Innovation and Consumer Wellness Through Direct-to-Patient Delivery
CEAS Collective is positioning itself at the intersection of biotech and consumer wellness by offering science‑driven products through a direct‑to‑patient delivery model. The company emphasizes rigorous quality control, sourcing botanicals with verified purity, and a digital logistics platform that bypasses...
Advances in RSV Vaccine Research and Development
Respiratory syncytial virus (RSV) remains a leading cause of acute lower‑respiratory infections, accounting for roughly 33 million cases and over 3 million hospitalizations each year, especially in children under five and older adults. Recent advances focus on stabilizing the prefusion F (preF)...
Hong Kong Outlines Strategy to Strengthen Global Health Innovation and Clinical Trials
Hong Kong announced a comprehensive strategy to become a regional hub for health innovation, focusing on expanding clinical trial capacity, regulatory reform, and research commercialization. The government unveiled the Greater Bay Area International Clinical Trial Institute, a “one institute, one...
Merck, Amgen Double Down on Bad Cholesterol to Vanquish Number 1 Killer
Merck’s oral PCSK9 inhibitor enlicitide cut LDL‑C by 64.6% in an eight‑week Phase III trial, outperforming other oral non‑statin drugs. Updated ACC/AHA lipid guidelines now require LDL‑C < 55 mg/dL for ASCVD patients, leaving roughly 70% of statin users above target. The tighter goals...
Overmedicalization? RFK Jr.’s Antidepressant Crackdown Raises Conflict Questions over His Fee Stake in Wisner Baum, the Tort Firm Built on...
Robert F. Kennedy Jr., now heading the U.S. Health and Human Services Agency, unveiled a "MAHA Action Plan" to curb psychiatric overprescribing, especially among children, and to promote non‑drug therapies. The initiative follows his controversial statements linking antidepressants to mass...
When Superbugs Threaten Vulnerable Children: Can AI Help Solve Antibiotic Resistance?
A wave of drug‑resistant bloodstream infections is killing newborns in Southeast Asia, highlighting the accelerating global antibiotic resistance crisis. The World Health Organization warns that the pipeline for new antibiotics is dangerously thin, leaving clinicians with few treatment options. MIT...
BeOne Medicines Recognized as "Outstanding Global Oncology Company of the Year" At HKCT Business Awards 2026
BeOne Medicines was named "Outstanding Global Oncology Company of the Year" at the 2026 HKCT Business Awards, recognizing its rapid R&D progress and manufacturing capabilities. The Swiss‑based firm now operates in more than 45 markets, employs over 1,200 oncology R&D...
Hong Kong Highlights Innovation and Greater Bay Area Collaboration at Hospital Authority Convention 2026
Hong Kong officials used the Hospital Authority Convention 2026 to unveil a suite of health‑innovation policies, including faster drug approvals, a new regulatory centre, and expanded AI use in hospitals. A Greater Bay Area Clinical Trial Collaboration Platform will allow...
FDA Says No Estrogen Patch Shortage Amid Widespread Pharmacy Reports
The FDA, led by Dr. Marty Makary, asserted Tuesday that estrogen patches are not officially in shortage, even as the American Society of Health‑System Pharmacists and clinicians report difficulty filling prescriptions. The disagreement underscores tension between regulatory data and on‑the‑ground...
StockWatch: EnGene Shares Crater on Declines in Complete Response Rates to Bladder Cancer Therapy
enGene (ENGN) shares plunged 83% after Phase II LEGEND trial data showed its gene therapy detalimogene achieved a 43% complete response at six months, far below the 62% benchmark previously reported. The updated data also revealed a 13.3% twelve‑month response and...
FDA Approves Johnson & Johnson's Caplyta for Schizophrenia Relapse Prevention
The U.S. Food and Drug Administration approved Johnson & Johnson’s supplemental New Drug Application for Caplyta, extending its label to include relapse prevention in schizophrenia. The decision rests on a Phase III trial that showed a statistically significant delay in relapse...
Roche to Pay $750 Million Upfront for AI Diagnostics Pioneer PathAI
Swiss drugmaker Roche agreed to acquire Boston‑based PathAI for $750 million in cash, plus up to $300 million in milestone payments. The deal, slated to close in the second half of 2026, aims to embed AI into Roche’s global diagnostic platform and...
Cryo‑EM CRO Baiaode Secures ¥200 Million Series B to Scale Drug Discovery Platform
Baiaode, a China‑based cryo‑EM structural CRO, closed a ¥200 million ($28 million) Series B financing led by Kangjun Capital and Junlian Capital. The funds will boost its cryo‑EM infrastructure and fast‑track the three‑year “千靶万苗®” target‑and‑lead‑compound program, positioning the firm for deeper global...
Colossal Biosciences' Dire Wolves Reach Breeding Age, Paving Way for De‑Extinction Market
Colossal Biosciences said its three de‑extinct dire wolves—Romulus, Remus and Khaleesi—have reached breeding age in a 2,000‑acre Texas preserve. The firm plans to add two to four more pups through assisted reproduction before allowing natural breeding, marking the first step...
CRISPR Therapeutics Shows 82% Triglyceride Cut in First In‑Vivo Heart‑Disease Gene Therapy
CRISPR Therapeutics announced that a single dose of its in‑vivo gene therapy CTX310 reduced triglycerides by up to 82% and LDL cholesterol by up to 81% in an early‑stage study. The data marks the first human evidence of functional CRISPR...
Certara Inc (CERT) Q1 2026 Earnings Call Transcript
Certara reported a record Q1 2021 with revenue of $66.7 million, up 16% year‑over‑year, and adjusted EBITDA rising 20% to $23.9 million. Bookings surged 34% YoY, driven by strong demand for both software and services, while services bookings jumped 39%. The company...
MOA Limits Animal Testing at Poorly Rated Institutions
Taiwan's Ministry of Agriculture announced stricter animal‑testing rules that will bar laboratories with poor welfare ratings from initiating new experiments until they pass a re‑inspection. Effective as early as July, all research animals must be sourced from accredited providers and...
Pooled Analysis Reveals Semaglutide Shows Good Efficacy in Older Adults Aged over 65 Years
A pooled analysis of Novo Nordisk's STEP trials examined semaglutide 2.4 mg in adults over 65 with obesity. The senior subgroup (n=358) lost an average of 15.4% of body weight over 68 weeks, compared with 5.1% on placebo, and showed marked...
Underpowered Trial Misleads: Non‑significant Trend, Not Failure
One of my pet peeves is a headline saying "This trial showed drug X doesn't work in condition Y" when in actuality what was demonstrated was a non-significant trend to efficacy in a severely underpowered trial.
MANE Secures Patent, Launches Trials to Address Minoxidil
Turns out I was dead wrong in this thread from some four years back. $MANE managed to get a patent (US 12,268,688 ) and is conducting full-scale trials to assuage the obvious safety concerns with the approved Minoxidil oral dose.
FDA Clears Genentech’s Ocrevus for Pediatric Relapsing‑Remitting MS
The U.S. FDA has approved Genentech’s ocrelizumab (Ocrevus) for relapsing‑remitting multiple sclerosis in children and adolescents aged 10 and older who weigh at least 55 lb. The decision, driven by the OPERETTA II trial, gives clinicians a high‑efficacy, FDA‑backed option that previously...
Vertex Secures German Reimbursement Deal for CASGEVY Gene Therapy
Vertex Pharmaceuticals has clinched a national reimbursement agreement with Germany’s GKV‑Spitzenverband for its CASGEVY gene therapy targeting sickle cell disease and beta‑thalassemia. The deal adds Germany to a growing list of markets where the therapy is covered, bolstering Vertex’s goal...
Gallium‐Containing Agents for Tumor Diagnosis and Therapy: Current Status and Future Prospects
Gallium-based agents are emerging as powerful tools in tumor theranostics, combining diagnostic precision with therapeutic action. 68Ga-labeled PET probes have become routine for detecting prostate, neuroendocrine and other cancers, while gallium therapeutics target DNA metabolism, tumor immunity and angiogenesis. The...
Field‑Programmable Biofunctional Films: From Assisted Fabrication to Integrated Diagnostic‐Therapeutic Devices
Field‑programmable biofunctional films (FPBFs) are thin‑film platforms that can be programmed to react to a range of physical fields—thermal, mechanical, electrical, optical, magnetic and acoustic. Recent advances in single‑ and multi‑field‑assisted fabrication have expanded their structural tunability and functional density,...