ExCellThera Secures German NUB Status 1 Listing for Zemcelpro
ExCellThera and its subsidiary Cordex Biologics have secured a Status 1 listing under Germany’s NUB programme for their cell therapy Zemcelpro (dorocubicel). The therapy, which received conditional marketing authorisation from the European Commission, targets adults with haematological malignancies lacking suitable donor cells for allogeneic stem cell transplantation. Over 120 patients participated in trials across North America and Europe, and 220 German hospitals have expressed interest in adopting the treatment from 2026. Cordex will pursue individual NUB applications, post‑market registries, and further regulatory submissions in the US, Canada, Switzerland and the UK.
STAT+: As China’s Drug Industry Races Ahead, Its GLP-1 Race Is Accelerating Too
China’s pharmaceutical sector is rapidly expanding, now generating its own GLP‑1 drugs alongside imported treatments. Novo Nordisk reported a 5% decline in Ozempic sales in China last year, the first dip since its 2021 launch, while sales grew elsewhere. The...
Biopharma Must Cope With The Fetal Bovine Serum Squeeze
Biopharma faces a tightening fetal bovine serum (FBS) market as U.S. cattle inventories hit record lows and European disease outbreaks curb supply. Prices have surged more than 300% over five years and release timelines have lengthened from weeks to months...
Red Light Therapy Shows Promise for Treating Brain Injuries
A University of Utah Health study examined red‑light photobiomodulation (PBM) as a preventive therapy for repetitive head acceleration events in collegiate football. Twenty‑six Division I athletes were randomized to active or sham transcranial and intranasal PBM over 16 weeks, receiving three...
Exploring the Impact of Cognitive Profiles on the Response to Magnetic Seizure Therapy and Electroconvulsive Therapy
An open‑label, non‑randomized trial compared magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in 398 patients with major depressive disorder (MDD) or schizophrenia (SCZ). Both modalities produced comparable symptom reductions, but MST yielded faster re‑orientation and less decline in processing...
Protective Mutations Associated with APOE in Alzheimer’s Disease
Recent research has identified several rare APOE mutations that confer protection against Alzheimer’s disease, including the R136S variant, the APOE3‑Christchurch (R136S) allele, loss‑of‑function CASP7, and missense changes V236E and R251G. These variants mitigate tau pathology, improve amyloid clearance, and dampen...
FDA Approval of Sibeprenlimab Signals New Era in IgA Nephropathy: Jackson Peter Kim, MD
The FDA granted accelerated approval to sibeprenlimab‑szsi (Voyxact) for primary IgA nephropathy, marking the first APRIL‑inhibiting monoclonal antibody for this condition. Interim results from the phase 3 VISIONARY trial showed a 50 % reduction in proteinuria at nine months versus 2 % with...
FM Nirmala Sitharaman to Push Biopharma, Semiconductor Missions in Norway
Finance Minister Nirmala Sitharaman arrived in Oslo to promote India’s Biopharma SHAKTI programme and Semiconductor Missions 2.0, seeking long‑term capital from Norwegian partners. She will meet Prime Minister Jonas Gahr Store, Finance Minister Jens Stoltenberg, and startup leaders at Oslo Science Park to showcase a ₹10,000‑crore,...
Vaccine Makers Curtail Research and Cut Jobs
Federal policies driven by Health Secretary Robert F. Kennedy Jr. are creating a hostile environment for vaccine developers, prompting companies like Moderna to scale back late‑stage studies. A Texas startup canceled a new manufacturing plant, and a San Diego firm...
2025 Q4 Job Market Report: Positive Signs Emerge for Job Seekers
The fourth quarter of 2025 marked the first quarter‑over‑quarter rise in biopharma job postings, with a 10% increase and a 4% uptick in average listings, despite a 14% year‑over‑year decline. Science/research and development roles grew 14% while clinical positions surged...
Why some Extracellular Vesicles Work Better: A Safer Path for Protein and Gene Delivery
Researchers compared two major extracellular vesicle (EV) biogenesis pathways and found that vesicles generated from cell‑surface protrusions via the I‑BAR protein MIM deliver functional proteins and genome‑editing enzymes far more efficiently than conventional endosome‑derived, CD63‑associated EVs. Using live‑cell imaging, they...
ML‑Predicted Insulin Resistance Identified as Risk Factor in 12 Cancers
Researchers at the University of Tokyo applied a machine‑learning tool, AI‑IR, to estimate insulin resistance in half a million UK Biobank participants. The analysis revealed insulin resistance as a significant risk factor for twelve distinct cancer types, providing the first...
Roche Trial Offers Hope to Patients with Rare Kidney Disease
Roche announced that its anti‑CD20 antibody Gazyva (obinutuzumab) met the primary endpoint in the phase 3 MAJESTY trial for primary membranous nephropathy (pMN). The study showed significantly higher complete remission rates at two years compared with the immunosuppressant tacrolimus, while maintaining...
‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements
Richard Pazdur, longtime FDA oncology leader, resigned after being pressured to endorse a controversial policy that would reduce required drug approval trials from two to one. He said Commissioner Marty Makary breached the traditional independence between the commissioner’s office and...
The Scientist Using AI to Hunt for Antibiotics Just About Everywhere
César de la Fuente’s Penn team is using artificial intelligence to scour genomes for antimicrobial peptides, creating a library of over one million candidate sequences. The AI has uncovered promising molecules hidden in archaea, venomous species, and even extinct organisms...
Novartis Reports Final Data of ALIGN Trial in IgAN
Novartis released final Phase III ALIGN data showing its oral endothelin‑A antagonist Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy. The double‑blind, placebo‑controlled trial enrolled 340 biopsy‑confirmed patients who continued optimized RAS inhibition, delivering a 2.39 ml/min/1.73 m² advantage in...
Systematic Discovery of Molecular Glues Targets Protein Degradation in Leukemia
Researchers at the AITHYRA Institute introduced a high‑throughput chemical diversification platform that systematically creates molecular‑glue candidates and screens them directly in living cells. Applying the workflow to the leukemia‑associated protein ENL, they identified a small molecule that selectively induces ENL...
Spatiotemporal Co‐Delivery of Hydrogen and Magnesium via Microneedle Patches for Neuroinflammation Modulation After Spinal Cord Injury: A Multi‐Modal In Vivo...
Researchers introduced a microneedle patch (MN‑Mg) that simultaneously delivers hydrogen gas and magnesium ions directly into the injured spinal cord. The hydrogen component rapidly scavenges reactive oxygen species, cutting oxidative stress by roughly 55%, while the magnesium release sustains microglial...
Mitochondrial RNA Links Aging to Cognitive Decline
A new Cell Research study reveals that the ER‑mitochondria channel protein SEC61A1 controls mitochondrial double‑stranded RNA (mt‑dsRNA) production, which activates MAVS‑dependent innate immunity and drives age‑related cognitive decline. Experiments in aged mice, Alzheimer’s patient tissue, and 5×FAD models show that...
New Broad-Spectrum Infection Prevention Method Successfully Blocks Drug-Resistant Bacteria and Influenza
Researchers at KRIBB demonstrated that the pharmaceutical excipient n‑dodecyl‑β‑D‑maltoside (DDM) can pre‑activate innate immunity, delivering complete survival in mice challenged with multidrug‑resistant bacteria and lethal influenza. The protection stems from selective neutrophil mobilization that activates only upon pathogen detection, avoiding...
2026 Could Mark a Turning Point for American Innovation
The United States faces a potential decline in biotech leadership as recent Supreme Court decisions blur patent eligibility and congressional price‑control measures under the Inflation Reduction Act force program cancellations. Proposals to seize university licensing revenue further strain tech‑transfer offices,...
How DIA Is Helping Regulators Turn AI Principles Into Everyday Review Practice
At the 2026 DIA Global Annual Meeting, the DIA AI Consortium will showcase how regulators such as the FDA are embedding artificial intelligence into medical product review workflows. The FDA’s 2025‑2026 roadmap uses AI to automate routine tasks, accelerate timelines,...
Microbes Harvest Metals From Meteorites Aboard Space Station
Researchers from Cornell and the University of Edinburgh demonstrated that microbes can biomine platinum‑group metals from a meteorite in microgravity aboard the ISS. The fungal species Penicillium simplicissimum showed especially high palladium extraction, while bacterial Sphingomonas desiccabilis also contributed to...
Handgrip Strength Forecasts Depression in Chinese Elders
A new BMC Geriatrics cohort study of Chinese seniors finds handgrip strength inversely predicts incident depression. Participants with lower baseline grip were significantly more likely to develop depressive symptoms over several years, even after controlling for age, gender, socioeconomic status...
Ultrasound Enables In Vivo Acoustoelectric Neural Recording
Researchers have demonstrated in‑vivo acoustoelectric neural recording in mice using ultrasound‑induced frequency mixing, achieving high‑fidelity, non‑invasive monitoring of brain activity. The technique converts neuronal electrical fields into detectable frequency shifts, delivering millimeter‑scale spatial resolution and millisecond‑level temporal precision. By calibrating...
Fujifilm Biotechnologies Opens Largest Single-Use CDMO Facility in the UK
Fujifilm Biotechnologies has opened an expanded UK site in Teesside, marking the launch of the country’s largest single‑use biopharmaceutical CDMO facility. The £400 million investment adds 2,000 L and 5,000 L single‑use bioreactors, delivering up to 19,000 L of small‑ and mid‑scale antibody manufacturing...
How AI Innovations Like DeepSeek Are Revolutionizing Emotional and Mental Health Support for Chinese Youth
DeepSeek, a Chinese AI startup, has launched a conversational platform that delivers real‑time emotional and mental‑health support to teenagers. Leveraging large‑language models tuned with culturally specific data, the service offers 24/7 chat‑based counseling, crisis detection, and personalized coping strategies. Within...
A Large-Scale DNA Methylation Study of Alcohol Use Identified Robust Associations and Cell-Type Specific Insights
Researchers conducted the largest DNA‑methylation study of alcohol consumption to date, analyzing blood samples from 13,970 participants and deconvoluting epigenetic signals across 12 distinct blood cell types. The methylome‑wide association study identified 1,266 CpG sites reaching genome‑wide significance in whole...
When AI Meets Physics: Unlocking Complex Protein Structures to Accelerate Biomedical Breakthroughs
Researchers at the National University of Singapore unveiled D‑I‑TASSER, a new AI‑driven software that predicts three‑dimensional protein structures with 13% higher accuracy than leading methods. The tool fragments complex proteins, models each segment with deep learning, then reassembles them using...
Freire Named Biogen Chair; Immunic Seeking New CEO
Biogen has appointed Maria Freire as its new chair, succeeding retiring chair Caroline Dorsa. Freire, a board member since 2021, previously led the Foundation for the National Institutes of Health and serves on multiple industry boards. The change becomes effective after...
Front Row with BioCentury: Competition in the Obesity Market
Obesity has shifted from a behavioral label to a high‑growth biopharma arena, driven by breakthrough GLP‑1 drugs and emerging oral formulations. Stephen Hansen of BioCentury highlights how these agents mirror Type II diabetes treatments, creating a lucrative market and reshaping clinical...
Nektar, Evommune Capitalize on Positive Phase II Readouts in Atopic Dermatitis: Public Equity Report
Nektar Therapeutics announced robust Phase II results for its IL‑2R modulator rezpegaldesleukin in atopic dermatitis, propelling its stock 51% higher. Leveraging the momentum, the company closed an upsized $400 million PIPE financing consisting of common stock and pre‑funded warrants. Evommune also secured...
A Fresh Energy Supply May Shield Nerves From Diabetic or Chemo-Induced Neuropathy
Researchers funded by the NIH discovered that satellite glial cells (SGCs) deliver mitochondria to sensory neurons through tunneling nanotubes, a process essential for neuronal energy supply. In mouse models of diabetes and chemotherapy‑induced neuropathy, this mitochondrial transfer is impaired, leading...
NIH Halts Arm of Clinical Trial Evaluating a Potential Stroke Treatment
The National Institutes of Health halted the low‑dose rivaroxaban arm of the CAPTIVA trial after the Data Safety and Monitoring Board identified a rise in adverse events and concluded the treatment was unlikely to be beneficial. CAPTIVA, a double‑blind, three‑arm...
NIH Scientists Develop "Digital Twin" Of Eye Cells to Understand and Treat Age-Related Macular Degeneration
NIH researchers have built the first subcellular‑resolution digital twin of human retinal pigment epithelial (RPE) cells, using 3‑D imaging of 1.3 million cells and an AI algorithm called POLARIS. The model maps polarity, organelle size and volume across developmental stages, creating...
NIH Proposes Embryonic Stem Cell Research Shift to Put Patients First
The National Institutes of Health announced a Request for Information aimed at identifying biotechnologies that can replace human embryonic stem cells (hESCs) in research. NIH is temporarily pausing the review and approval of new hESC lines, leaving the existing 503...
STAT+: FDA Rejects Rare Disease Therapy From Disc Medicine, Early Recipient of Commissioner’s Voucher
The FDA rejected bitopertin, Disc Medicine’s experimental therapy for acute hepatic porphyria, marking the first drug reviewed under Commissioner Marty Makary’s fast‑track voucher program. The agency cited uncertainties about the link between the trial’s blood‑based biomarker and actual clinical benefit....
Pod-Based, On-Demand Media and Buffer Manufacturing System
Nucleus Biologics introduced the Krakatoa K500, the first bioreactor‑scale, pod‑based system that manufactures sterile cell‑culture media and buffers on‑demand at point‑of‑use. The solution combines pre‑filled powder pods, a closed single‑use workflow and automated mixing, delivering up to 500 L in under three...
Pentagon Adds, Then Withdraws, WuXi AppTec to Chinese Military List
The Pentagon briefly placed WuXi AppTec, a major Chinese contract research organization, on its list of firms that support the People’s Liberation Army, then withdrew the designation hours later without explanation. The move occurred amid intensified U.S. scrutiny of Chinese...
Lilly Appeals Retatrutide Classification Ruling in Case that Could Impact Compounders
Eli Lilly has filed a notice of appeal challenging the FDA’s classification of its experimental obesity injection, retatrutide. The agency labeled the product as a new molecular entity, granting it a 12‑year data exclusivity period. Lilly argues the classification is incorrect...
Biopharma Money Raised: Jan. 1-Feb. 12, 2026
BioWorld’s latest brief highlights three emerging biotech advances. Researchers pinpointed the SCAN network as a central circuit disrupted in Parkinson’s disease, offering a new therapeutic target. Astellas presented promising preclinical data on ASP-2246, an mRNA‑encoded NeuroD1 candidate aimed at neural...
Generic Drug User Fee Amendments
On September 30, 2022 the FDA User Fee Reauthorization Act of 2022 re‑authorized the Generic Drug User Fee Amendments (GDUFA) through September 2027, marking the start of GDUFA III. The legislation sets new user‑fee rates for FY 2025 and FY 2026, including a...
What's New Related to Drugs
Between January and February 2026 the FDA issued a cascade of regulatory updates covering new drug approvals, safety‑label revisions, draft guidances, and consumer alerts. The agency granted approval for pembrolizumab combined with paclitaxel to treat platinum‑resistant ovarian, fallopian tube, or...
3 Trends Shaping the GLP-1 Landscape
GLP‑1 therapies are entering a new regulatory phase as the FDA stripped suicide‑ideation warnings from Saxenda, Wegovy and Zepbound and signaled tighter controls on compounded pills. At the same time, Novo Nordisk’s oral Wegovy has become the fastest drug launch...
Women in Science, Robotics, Automation, SLAS, and Lilly Updates
The GEN podcast highlighted Women in Science Day, noting the term “scientist” was originally coined for a woman, and featured Medra CEO Michelle Lee discussing the integration of AI‑driven robotics into biological research. It also covered automation advances presented at...
Vertex, CRISPR Set Lofty Goal for Casgevy Gene Therapy as Patient Starts Ramp
Vertex Pharmaceuticals and CRISPR Therapeutics forecast combined Casgevy gene‑therapy and Journavx pain‑drug sales of $500 million in 2026, a 185 % jump from 2025. The therapy generated $115.8 million in 2025, with Q4 revenue of $54.8 million, and treated 111 patients that year, up...
Epigenetic Editing Startup Moonwalk Shifts Focus to siRNA for Obesity
Moonwalk Biosciences, founded by CRISPR pioneer Feng Zhang and former Illumina CTO Alex Aravanis, announced a strategic pivot from epigenetic editing to siRNA‑based obesity therapies. The company secured a $120 million Series A round to fund the new platform, which targets liver‑expressed...
Moderna's Flu Shot Dilemma Muddies 2028 Break-Even Guidance
Moderna’s chief financial officer indicated that the company cannot yet confirm whether its 2028 cash‑flow break‑even goal will hold, as the outlook for its seasonal flu vaccine remains uncertain. The flu shot, once expected to be a steady revenue stream,...
Novel Drug Approvals for 2026
The FDA’s 2026 novel drug approvals catalogue highlights all new molecular entities receiving first‑time U.S. marketing authorization. A novel drug is defined as a product never previously approved or sold in the United States, and each entry links to the...
AAPS National Biotechnology Conference
The AAPS National Biotechnology Conference will take place May 11‑14, 2026 in San Diego, gathering leading pharmaceutical scientists to discuss the latest advances in biologics, biotechnology products, and advanced therapies. The four‑day event offers sessions on new modalities, technologies, and novel strategies...
