FDA Merges Adverse Event Trackers Into One Database
The FDA announced a unified adverse‑event database that will eventually incorporate all of its existing reporting systems, including the vaccine‑side‑effect tracker jointly operated with the CDC. The new platform, called the Adverse Event Monitoring System, centralizes data from drugs, biologics, and medical devices. By consolidating these silos, the agency aims to improve signal detection speed and analytical consistency. The rollout is phased, with full integration expected over the next few years.
FDA Clears New Large-Bore Catheter for Challenging Stroke Cases
Toro Neurovascular has obtained FDA clearance for its Toro 88 Superbore Catheter, a large‑bore device engineered for challenging stroke interventions. The catheter promises enhanced support, trackability, and stability, addressing the time‑sensitive nature of neurovascular procedures. UCLA interventional neuroradiologist Dr. Satoshi Tateshima...
Tailored Training Can Address Biopharma Skills Shortage
Ireland’s National Institute for Bioprocess Research and Training (NIBRT) reports a persistent global shortage of biopharma manufacturing talent, especially engineers skilled in digital bioprocessing, automation and AI. The gap spans cell culture, downstream processing, aseptic manufacturing and quality functions, with...
New Chromatography Resin Developed for Secretory Antibodies
Researchers at BOKU University in Vienna have engineered a novel chromatography resin designed to capture secretory immunoglobulin A (IgA) at titers suitable for commercial manufacturing. The resin employs a reengineered bacterial surface ligand, analogous to Protein A, within a macropore...
Giovanni Traverso
Giovanni Traverso, M.D., Ph.D., is a physician‑scientist who bridges gastroenterology and engineering as an associate member of the Broad Institute, director of the Laboratory for Translational Engineering, MIT associate professor, and Harvard gastroenterologist. His lab creates ingestible electronics, robotic capsules,...
Trouble Swallowing? A Nanogel Tweak May Keep Therapeutic Stem Cells Alive Longer
Researchers at Kyoto University and McGill University created hybrid stem‑cell spheroids incorporating biodegradable nanogel microfibers. The nanogel‑enhanced spheroids improved oxygen diffusion, increasing cell viability more than fivefold and boosting secretion of regenerative factors. In a rat model of swallowing‑muscle injury,...
Safer Large DNA Insertion Moves Genetic Medicine Toward Scalability
Researchers at Massachusetts General Hospital, in partnership with Full Circles Therapeutics, have introduced a circular single‑stranded DNA donor platform called INSTALL that enables kilobase‑scale gene insertion without triggering the cGAS immune sensor. The method combines a short double‑stranded DNA segment...
Simple 'Cocktail' Of Amino Acids Dramatically Boosts Power of mRNA Therapies and CRISPR Gene Editing
Researchers at Biohub identified a three‑amino‑acid cocktail—methionine, arginine and serine—that dramatically improves lipid nanoparticle (LNP) delivery of therapeutic mRNA and CRISPR components. Co‑administering the supplement boosted protein expression up to 20‑fold and raised gene‑editing rates from roughly 25% to nearly...
Biodegradable Nanoparticles Can Seek and Destroy Diseased Immune Cells
Johns Hopkins researchers have engineered a streamlined biodegradable polymeric nanoparticle that delivers mRNA to T cells, prompting them to generate CD19‑CAR receptors that target disease‑causing B cells. In mice, a single intravenous dose eliminated 95% of circulating B cells within...
A New AI Model Could Help Scientists Design New Forms of Life
Researchers at the Arc Institute unveiled Evo2, an AI model trained on trillions of DNA bases from diverse organisms. By treating DNA as language, Evo2 can generate genome‑scale sequences millions of letters long, demonstrated with Mycoplasma genitalium‑inspired designs. The model...
VIDO – Six Years Later: How VIDO Helped Respond to the COVID-19 Pandemic
VIDO swiftly responded to COVID‑19 by designing a subunit vaccine candidate within days of the SARS‑CoV‑2 genome release, isolating the virus, and establishing animal models that enabled a Phase 1 human trial by early 2021, making it the first Canadian university...
The Gut Microbiome May Influence Brain Aging, Mouse Study Suggests
A University of Pennsylvania study published in Nature shows that gut bacteria from aged mice can impair memory in young mice, effectively accelerating brain aging. The researchers identified the bacterium *Parabacteroides goldsteinii* as the key agent, linking it to inflammation...
Endometriosis Study Aims for Safer Diagnosis
A Worcestershire Acute NHS Trust‑led clinical trial is testing a non‑invasive electrode‑based method to diagnose endometriosis, marking the first such study within the NHS. The technique records small‑intestine muscle activity, which researchers claim shows a pattern unique to patients with...
Biogen Phase Ib Data Positions Salanersen for SMA Treatment Sequencing
Biogen reported Phase Ib data for its antisense oligonucleotide salanersen, showing substantial neurofilament light chain reductions and new motor milestones in children with spinal muscular atrophy (SMA) who had previously received onasemnogene abeparvovec. The study of 24 participants demonstrated a roughly...
Lonza Expands Agreement to Manufacture Gene Therapy for Transfusion-Dependent Beta-Thalassemia
Lonza has broadened its agreement with Genetix Biotherapeutics to increase manufacturing capacity for ZYNTEGLO, the sole FDA‑approved gene therapy for transfusion‑dependent beta‑thalassemia. Production will continue at Lonza’s Houston, Texas, dedicated cell‑and‑gene therapy site, with provisions to scale up for future...
The FDA Approves Leucovorin for Rare Genetic Condition and Not for Autism
The U.S. Food and Drug Administration approved leucovorin, a synthetic vitamin B9, solely for cerebral folate deficiency, a rare genetic disorder. Earlier this year, President Trump and HHS Secretary Robert Kennedy Jr. promoted the drug as an autism cure, prompting a surge in...
A New Antibody Approach To Preventive Treatment For HIV
Researchers have engineered an antibody‑drug conjugate that simultaneously triggers HIV’s entry‑facilitating conformational shift and binds the newly exposed epitopes. In vitro tests showed the dual‑action molecule achieved seven‑ to ten‑fold greater neutralization than the antibody alone and outperformed separate mixtures...
6 Companies Hiring in Cambridge
Cambridge, Massachusetts remains a premier life‑sciences hub, anchored by giants like Intellia Therapeutics and Moderna and supported by the MassBio trade group. While BioSpace job postings fell 4% year‑over‑year in February, they surged 17% month‑over‑month, reflecting renewed hiring momentum. Six...
Cell Rejuvenation Therapy to Hit Clinic
Life Biosciences has secured FDA IND approval for ER-100, the first partial epigenetic reprogramming therapy to enter human trials. The gene‑therapy delivers OCT‑4, SOX‑2 and KLF‑4 to retinal ganglion cells via a single intravitreal injection, aiming to reset age‑related epigenetic...
STAT+: Pharmalittle: We’re Reading About the FDA Warning Novo Nordisk, Lilly Investing in China, and More
Astellas Pharma leveraged the Trump administration’s push for lower U.S. drug prices to argue for higher reimbursement for its eye drug Izervay in Japan, winning a more generous price level. Meanwhile, a review of FDA adverse event reports found that...
FDA Adverse Event Monitoring System (AEMS) Electronic Submissions
The FDA is rolling out the Adverse Event Monitoring System (AEMS), replacing the legacy FAERS platform and consolidating reporting across drugs, biologics, devices, cosmetics, food, tobacco, and veterinary products. AEMS introduces standardized electronic submissions, AI‑driven redaction and analytics, and a...
Boron Chemistry Breaks Protein Synthesis Barrier, May Aid Cancer Therapies
Researchers at ETH Zurich have introduced a boron‑based ligation strategy that overcomes the concentration barrier in chemical protein synthesis. By masking potassium acyltrifluoroborates (KATs) with chiral zwitterionic complexes, the team achieved efficient peptide coupling at micromolar levels, far lower than...
Scientists Found This Organism Can Survive Some of the Harshest Conditions in the Universe
Researchers at Johns Hopkins University demonstrated that the extremophile bacterium Deinococcus radiodurans can survive simulated asteroid‑impact pressures up to 2.4 gigapascals, with roughly 60% of cells remaining viable. The study identified the bacterium’s crystalline membrane protein arrangement and robust DNA‑repair...
Biomarker for Differentiating MS From NMOSD Identified in Study
Researchers published in JAMA Neurology identified high‑level EBNA‑1 peptide antibody titers as a robust biomarker that distinguishes relapsing‑remitting multiple sclerosis from MOGAD and seronegative NMOSD. In a cohort of over 1,300 neuroinflammatory patients, persistent EBNA‑1 positivity in at least two...
UCB Reports P-III (BE BOLD) Trial Results on Bimzelx (Bimekizumab) in Active Psoriatic Arthritis
UCB announced results from its Phase III BE BOLD trial comparing Bimzelx (bimekizumab) to risankizumab in 553 adults with active psoriatic arthritis. The study met its primary endpoint, showing Bimzelx superior in achieving ACR50 responses at week 16. Bimzelx is...
Zinereo Pharma Set to Rollout New Probiotic Solution for Childhood Ear Infections
Zinereo Pharma is preparing to launch Otibiome, a clinically evaluated probiotic derived from *Ligilactobacillus salivarius* PS7, aimed at preventing recurrent acute otitis media (AOM) in children. A pilot study of 61 kids showed an 84% drop in AOM episodes over...
Playing Sound Waves to Cells Decreases Laryngeal Cancer Aggressiveness
An international team led by the Turku Bioscience Centre discovered that applying sound‑wave vibration to vocal‑fold cancer cells restores cellular movement and markedly reduces tumor aggressiveness. The mechanical stimulation lowered levels of the oncogenic protein YAP, both in cultured cells...
Scientists Are Trying to Train Lab-Grown Brains. The Brains Have Started to Solve Problems.
Scientists at UC Santa Cruz trained a mouse‑derived brain organoid to solve the classic cart‑pole balancing problem, boosting success from 4.5% with random stimulation to over 46% using adaptive electrical cues guided by an AI algorithm. The tiny, pepper‑corn‑sized tissue,...
Keytruda and Padcev Could Become Cancer’s Power Couple
Oncology is moving toward combination regimens, and Merck's Keytruda paired with Pfizer/Astellas' Padcev has emerged as a leading duo. A phase 3 trial in muscle‑invasive bladder cancer showed the combo cut the risk of recurrence, progression and death roughly in half,...
Mortality Risk Similar with Tocilizumab, Rituximab in RA-ILD
An emulated target trial using the TriNetX database compared tocilizumab and rituximab in 1,194 rheumatoid arthritis‑associated interstitial lung disease (RA‑ILD) patients each over a five‑year follow‑up. The analysis found no statistically significant difference in all‑cause mortality (15.9% vs 17.7%) or...
Capricor Shares Rise as FDA Sets August Decision Date for Rejected Duchenne Therapy
Capricor Therapeutics announced that the FDA has scheduled an August 22 decision on its investigational Duchenne muscular dystrophy cell therapy, deramiocel, after lifting a prior complete response letter. The biotech resubmitted an enhanced package that includes robust Phase III HOPE‑3 data showing...
ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1
ARTHEx Biotech announced that its RNA‑based drug ATX‑01 has received U.S. FDA Fast Track designation for treating Myotonic Dystrophy Type 1 (DM1). The therapy works by inhibiting miR‑23b, thereby increasing free MBNL protein, correcting splicing errors and reducing toxic DMPK mRNA...
UK Health Authorities Join Forces to Champion Foreign Infectious Disease Trials
UK health agencies and the Wellcome charity have launched a joint initiative to fund high‑quality infectious‑disease clinical trials in Africa, South Asia and Southeast Asia. The program, co‑led by the NIHR, the Foreign Commonwealth Development Office and Wellcome, will prioritize...
RA Capital, Forbion and Canaan Appear to Back Harbour's CTLA-4 Partner Solstice
RA Capital, Forbion, and Canaan have collectively invested in Solstice Therapeutics, the CTLA-4 antibody partner of Harbour Therapeutics. The funding round, reportedly a multi‑million dollar Series B, will support Solstice's pre‑clinical and early clinical programs. By backing Solstice, the investors...
Viagra Compound May Hold Promise for Treating Fatal Genetic Disease
Researchers have identified the erectile‑dysfunction drug sildenafil as a potential therapy for Leigh syndrome, a fatal mitochondrial disorder affecting roughly one in 40,000 births. In cell models, the compound corrected mitochondrial membrane potential and normalized gene expression, while treated mice...
Early Data Show Benefits of GLP-1s in Breast Cancer
Early data presented at the San Antonio Breast Cancer Symposium indicate that GLP‑1 receptor agonists, long used for diabetes and obesity, are linked to markedly lower breast cancer recurrence and mortality. Retrospective analyses of thousands of patients showed up to...
NHS to Offer Fezolinetant for Menopause‑related Hot Flushes and Night‑sweats
NICE has issued final draft guidance recommending fezolinetant 45 mg once daily for moderate to severe menopause‑related vasomotor symptoms when hormone replacement therapy is unsuitable. The recommendation enables the drug to be supplied through the NHS, providing a new non‑hormonal option...
DNA Barcoding Reveals Which Gene-Therapy Nanoparticles Reach Targets in Vivo
Researchers at Oregon State University have developed a DNA‑based barcoding assay that measures, in living mice, which lipid nanoparticles successfully deliver gene‑editing cargo to target cellular compartments. The technique identified that many particles are degraded in lysosomes, while a newly...
Spinal Stimulation Above and Below Injury Restores Leg Movement and Sensory Feedback in Clinical Trial
Researchers at Brown University, Rhode Island Hospital, and VA Providence demonstrated that simultaneous electrical stimulation above and below a spinal cord lesion can restore both leg movement and spatial sensory feedback in people with complete spinal cord injuries. In a...
Antibiotics Can Affect the Gut Microbiome for Several Years, Study Shows
A new study published in Nature Medicine shows that a single course of antibiotics can alter the gut microbiome for up to eight years. Researchers linked Sweden’s national drug‑dispensing register with microbiome data from 14,979 adults, revealing lasting changes in...
Kainova Reports Positive Top Line Results From Phase I EPRAD Trial
Canada‑based Kainova Therapeutics announced positive top‑line results from its Phase I EPRAD study of DT‑9081, an oral EP4 receptor antagonist, in patients with advanced, recurrent and metastatic solid tumours. The trial, conducted at four sites in Belgium and France, met all...
ICEEL 2026: What Does It Mean to Be Human in the Age of Gene Editing?
The 3rd International Conference on the Ethics of Engineering Life (ICEEL 2026) will be held online March 23‑24, 2026, and is free to attend. Organized by the University of Basel, ETH Zurich, the Pontifical Academy for Life and Bambino Gesù Hospital,...
Intra‐Articular Injectable Hydrogel Microsphere‐Based Drug Delivery System for Osteoarthritis Treatment
Osteoarthritis incidence is climbing as populations age and obesity spreads, intensifying health and economic pressures. Conventional treatments merely decelerate disease progression and often entail systemic side effects or surgical risks. Emerging hydrogel microsphere platforms create a biomimetic joint microenvironment, offering...
GELITA and Black Drop Collaborate on GelMA Bioinks for 3D Bioprinting Research
GELITA and Black Drop have signed an R&D agreement to develop methacrylated gelatin (GelMA) bioinks for 3D bioprinting applications. The partnership will leverage GELITA’s ultra‑low endotoxin gelatin (MEDELLAPRO) and Black Drop’s custom bioprinting platforms to create clinically usable, scalable bioinks....
Grand Avenue Report Examines 2026 Life Sciences Readiness
Grand Avenue Software has published its 2026 Life Sciences Quality, Compliance & Operations Benchmark Report, drawing on hundreds of responses from QA, regulatory affairs and manufacturing professionals. The study reveals wide variation in FDA QMSR readiness, persistent quality improvement hurdles,...
Melt&Marble Cleared to Sell Animal-Free ‘Designer Fats’ for Food & Personal Care
Swedish precision‑fermentation startup Melt&Marble has obtained regulatory clearance to commercialise its animal‑free “designer fats.” The MeltyMarble fat received US Generally Recognized as Safe status, while its Marble7 lipid earned an INCI name for worldwide personal‑care use. Backed by an $8.5 million...
Russia to Expand National Genetics Database to Ensure Treatment for Various Ethnic Groups
Russia is expanding its national genetics database by adding data from 80,000 additional individuals, focusing on patients with socially significant diseases. The first phase (2020‑2024) already catalogued over 200,000 genomes from healthy volunteers, creating one of the world’s largest variant...
Pharma Is Ravenous for M&A Action but Late-Stage Supply Dwindles
Big pharma is intensifying its M&A hunt as the pool of late‑stage biopharma assets shrinks, turning deal processes into competitive auctions. Sellers are leveraging multiple inquiries to secure higher upfront cash and better terms, while unsolicited public bids—exemplified by the...
Codexis Inc (CDXS) Q4 2025 Earnings Call Transcript
CareDx reported fourth‑quarter 2025 revenue of $108.4 million, a 25% year‑over‑year increase, driven by strong testing services and rapid growth in patient‑digital solutions. Adjusted EBITDA fell 34% to $6.5 million, reflecting a one‑time $6.7 million non‑executive cash bonus, while cash balances topped $200 million...
Elutia Inc (ELUT) Q4 2025 Earnings Call Transcript
Elutia Inc. reported a 49% sequential revenue surge for its LU Pro bio‑envelope, driven by new hospital contracts and seven national GPO agreements, pushing the product toward a $20 million run‑rate by year‑end. The company settled the bulk of legacy litigation, resolving...