Portal Diabetes’ Insulin Pump Receives FDA Breakthrough Device Designation
Portal Diabetes has secured FDA breakthrough device designation for its implantable Portal Pump, an insulin delivery system that pairs an abdominal pump with continuous glucose monitoring and concentrated insulin. The company also launched a Phase I study of temperature‑stable Portal Insulin under an IND. The designation grants priority FDA engagement and eligibility for the Transitional Coverage for Emerging Technologies (TCET) pathway, potentially speeding Medicare reimbursement. Full combination‑system trials are projected to start in the fourth quarter of 2027.
Janux Commences Participant Dosing in Phase I JANX011 Trial
Janux Therapeutics has dosed the first participant in a Phase I, open‑label, dose‑escalation trial of JANX011, its inaugural candidate from the adaptive immune response modulator (ARM) platform. The bispecific antibody targets CD19‑expressing B cells to achieve a deep, lasting immune reset...
J&J’s Rybrevant Faspro Gains FDA Approval for New Dosing in NSCLC
Johnson & Johnson received FDA approval for a once‑monthly subcutaneous regimen of Rybrevant Faspro combined with Lazertinib for first‑line treatment of advanced EGFR‑mutated non‑small cell lung cancer. The new schedule delivers clinical outcomes comparable to the earlier bi‑weekly dosing while preserving...
Six Biotechs to Know in Barcelona
Barcelona is emerging as a premier European life‑sciences hub, contributing 7.6 % of Catalonia’s GDP and ranking sixth in scientific output. Six local biotech firms—Accure Therapeutics, Oryzon Genomics, SpliceBio, Peptomyc, Ona Therapeutics and Integra Therapeutics—are advancing diverse modalities from small‑molecule neuroprotectors...
Iron Deficiency Triggers Mature Pancreatic Β-Cell Loss
Researchers published in Nature Communications that iron deficiency triggers a selective loss of mature pancreatic β‑cells while sparing immature cells. Using lineage tracing and single‑cell transcriptomics, the team showed that iron scarcity impairs mitochondrial function, elevates ROS, and down‑regulates key...
AI and OCT Integration Highlights Promising Advances in Detecting Lipid-Rich Coronary Artery Plaques
Researchers at KAIST unveiled an AI‑driven method that extracts wavelength‑dependent information from standard optical coherence tomography (OCT) to automatically detect lipid‑rich coronary plaques. The weakly supervised deep‑learning model learns from frame‑level labels, eliminating the need for pixel‑wise annotations and works...
AI-Powered Liquid Biopsy Advances Pediatric Brain Tumor Classification
Researchers at St. Jude Children’s Research Hospital introduced M‑PACT, an AI‑driven liquid‑biopsy platform that classifies pediatric brain tumors from cerebrospinal fluid with 92% accuracy. The deep neural network was trained on over 5,000 DNA methylation profiles covering about 100 tumor...
Aging Podocytes: Unveiling Structural Adaptations
Scientists used array tomography to reconstruct podocytes in three dimensions, revealing how these non‑regenerative kidney cells adapt to aging. In rats, podocyte numbers fell while surviving cells expanded 4.6‑fold, forming autocellular junctions and exporting waste extracellularly. The study provides the...
When Senior Leaders Are Asked To Carry Too Much
Biopharma senior leaders are increasingly shouldering operational work left behind by downsizing, stretching their capacity beyond strategic duties. The overload fragments focus, slows decisions, and erodes communication, while burnout remains hidden behind continued presence. As pressure builds, the organization’s decision‑making...
Drug Discovery Platform Peptris Raises Rs 70 Cr in Series A Round
Peptris, a Bengaluru‑based AI drug‑discovery startup, closed a Rs 70 crore ($7.7 million) Series A round co‑led by IAN Alpha Fund and Speciale Invest. The capital will accelerate its pipeline, moving novel chemical entities and repurposing programs toward clinical readiness within 24 months. Peptris’ platform...
Early-Stage Biotechs Suffer in 2025 As VC Shuns Risk: PitchBook
Venture capital in biopharma rebounded in 2025, delivering $33.8 billion across 1,171 deals, but the capital is increasingly concentrated in late‑stage companies. Early‑stage startups received only 32% of the funding, down from over 40% during the pandemic surge, while median deal...
Ongoing Regulatory Uncertainty Means Innovation Is Now Higher Risk
Regulatory uncertainty is rising as the FDA shifts leadership, adopts a single‑trial approval pathway, and tightens its benefit‑risk framework. While the one‑trial standard promises faster, cheaper market entry, recent surprise complete response letters (CRLs) show that even successful Phase 3 results...
Ionis Paves Its Own Path as Initial Tryngolza Launch Defies Expectations
Ionis Therapeutics announced that its GSK‑partnered antisense drug bepirovirsen achieved a statistically significant functional cure rate of roughly 15‑20% in a Phase 3 trial, far surpassing the 1‑3% rate of existing hepatitis B therapies. The company also reported a strong first‑year launch...
Proliferating Patents, Lawsuits Stave Off Pharmas’ Generic Competitors
A new analysis in Health Affairs Scholar reveals that brand‑name drugmakers are exploiting the Hatch‑Waxman framework through serial patent litigation and continuation patents to extend market exclusivity. By filing multiple overlapping patents, companies can repeatedly sue generic challengers, triggering 30‑month...
ArgenTag, PacBio Partner on Long-Read Single-Cell Transcriptomics
ArgenTag, a Buenos Aires‑based startup, has entered PacBio’s Compatible Partner Program, confirming that its Single‑Cell RNA Library Kit works with PacBio’s Kinnex RNA kits for long‑read isoform sequencing. The partnership eliminates the need for expensive cell‑partitioning instruments by using ArgenTag’s...
Bausch + Lomb Corp (BLCO) Q4 2025 Earnings Call Transcript
Glaukos Corp reported record fourth‑quarter 2025 sales of $143.1 million, a 36% year‑over‑year increase, and annual net sales of $507.4 million, up 32%. The company reaffirmed its 2026 revenue outlook of $600‑$620 million, indicating more than 20% growth. Growth was powered by the...
Sex Differences in Placebo and Antidepressant Response to Intranasal Esketamine for Treatment-Resistant Depression
A pooled analysis of five double‑blind, placebo‑controlled intranasal esketamine trials (n≈1,016) confirms that esketamine significantly reduces Montgomery‑Åsberg Depression Rating Scale (MADRS) scores versus placebo. Female participants showed larger total MADRS improvements at later visits (days 22 and 28) and greater reductions in...
MiR126-Mediated Alteration of Vascular Integrity in Rett Syndrome
The study engineered 3D microvascular networks from Rett syndrome (RTT) patient‑derived iPS cells carrying MeCP2[R306C] or MeCP2[R168X] mutations and discovered markedly increased vascular permeability. Transcriptomic profiling linked this defect to up‑regulation of endothelial‑specific miR‑126‑3p, which suppresses tight‑junction regulators such as...
Ocular and Upstream Drop on Less-than-Wow Data; Compass Rallies on Second Phase III Win for Psilocybin
Ocular Therapeutix reported that its VEGF1/2/3 inhibitor Axpaxli outperformed aflibercept in the Phase III SOL‑1 trial, with 74.1% of patients maintaining visual acuity at 36 weeks versus 55.8% for the comparator. The study also met a 52‑week durability endpoint, showing 65.9%...
Oral SERD Spotlight. Plus: Setbacks at FDA— a BioCentury Podcast
The BioCentury This Week podcast highlighted the rapid expansion of oral selective estrogen receptor degraders (SERDs) as a leading application of targeted protein degradation, noting several candidates advancing toward late‑stage trials. Host Lauren Martz examined the competitive landscape and the therapeutic...
Rhododendron-Derived Drugs Now Made by Bacteria
Kobe University bioengineers have re‑programmed the gut bacterium Escherichia coli to synthesize orsellinic acid, the core of Rhododendron‑derived meroterpenoids, at 202 mg per liter—a 40‑fold increase over prior microbial attempts. This marks the first time the complex eukaryotic pathway has been...
Exploring Electron Microscopy and AI as Key Players for Identifying Pollen Grains
Researchers at IIT Gandhinagar have merged scanning electron microscopy (SEM) with artificial intelligence to automate pollen grain identification. Using a dataset of 28 medicinal plant species, they built a computer‑vision pipeline that segments pollen via YOLOv11n and classifies it with...
Projecting Light to Dispense Liquids: A New Route to Ultra-Precise Microdroplets
Researchers at Southern University of Science and Technology have unveiled an optoelectrowetting platform that uses programmable light patterns to dispense nanoliter droplets with unprecedented precision. By projecting dynamic illumination onto a microfluidic chip, the system creates virtual electrodes that guide...
Gilead-Genhouse Tie-Up Among Several Spanning Pacific: Deals Report
Gilead Sciences has agreed to pay $80 million upfront to Suzhou Genhouse Bio for worldwide rights to GH31, a clinic‑ready oncology molecule. GH31 employs synthetic lethality to inhibit the MAT2A enzyme, a target implicated in several cancers. The deal follows regulatory...
Kolchinsky: Policy Constraints Holding Back Biomedical Innovation
In a BioCentury interview, RA Capital Managing Partner Peter Kolchinsky warned that staffing cuts and a growing conservative stance at the FDA are adding at least a three‑month delay to even the most promising drug programs. He says sponsors are now...
Pancreatic Cancer Cells Sense ECM to Switch Between Growth and Autophagy
Researchers at NYU Langone Health discovered that pancreatic ductal adenocarcinoma cells sense extracellular matrix (ECM) components via the surface protein integrin α3, which determines whether they adopt a proliferative or autophagic state. Cells anchored to laminin‑rich ECM keep autophagy low and...
Resources for Biomarker Requestors
The FDA’s Biomarker Qualification Program (BQP) offers a three‑stage pathway—Letter of Intent, Qualification Plan, and Full Qualification Package—to secure regulatory endorsement of biomarkers as drug development tools. Under the 21st Century Cures Act, the process has been modernized, allowing qualified...
Enlil Launches Milestone View for Its Medtech Product Lifecycle Traceability Software
Enlil unveiled Milestone View, the industry’s first evidence‑based milestone interface for medical device product development. The new capability embeds directly within Enlil’s unified traceability platform, linking each milestone to underlying requirements, design outputs, risk controls, change histories and regulatory evidence....
Turning Microalgae-Derived Extracellular Vesicles Into a Next-Generation Drug Delivery Platform
Paris‑based AGS Therapeutics signed a strategic agreement with INITS SMO, a GMP‑qualified shared manufacturing organization, to transition its microalgae‑derived extracellular vesicle (MEV) platform to full GMP compliance. The partnership allows AGS to run its proprietary MEV manufacturing, loading, and analytics...
Longer Roots for Drought? How an Edited Protein Could Reshape Crop Resilience
Researchers at the University of Missouri have identified the protein SRFR1 as a key regulator of root depth in plants. By editing the SRFR1 gene, they induced significantly longer roots in test crops. The modified plants demonstrated enhanced water acquisition...
Completed BsUFA II Deliverables
The FDA has completed the BsUFA II deliverables, publishing a final assessment of the Biosimilar User Fee Act review program on February 21, 2022 and an interim assessment on January 27, 2021. Alongside these reports, the agency released annual updates...
More Shots on Goal: Boehringer’s Long-View Playbook From IPF to Obesity
Boehringer Ingelheim is expanding its cardio‑renal‑metabolic (CRM) platform beyond its recent idiopathic pulmonary fibrosis (IPF) successes to target obesity and related metabolic disorders. President Brian Hilberdink says the company is prioritizing partnerships rather than large‑scale M&A to broaden its pipeline...
Does Vaxart Hold the Key to the Elusive Norovirus Vaccine?
Vaxart is advancing an oral, bivalent norovirus vaccine pill (VXA‑G1.1‑NN) that demonstrated a 30% reduction in infection in a Phase 2b challenge study. The vaccine uses a non‑replicating adenovirus vector loaded with a dsRNA adjuvant to stimulate gut immunity, and a...
Prima Mente Unlocks Early-Stage Alzheimer’s Diagnostics with Epigenome Model
AI biology firm Prima Mente has launched Pleiades, a 7‑billion‑parameter epigenetic foundation model that reads DNA methylation in cell‑free DNA to diagnose early‑stage Alzheimer’s and Parkinson’s. In real‑world cohorts the model achieved 89% detection accuracy, rising to 97% when combined...
This Startup Developed a First-of-Its-Kind Brain Function Assessment Device
QuantalX secured FDA de novo clearance for Delphi‑MD, a first‑of‑its‑kind device that fuses transcranial magnetic stimulation (TMS) with electroencephalography (EEG) to deliver real‑time brain network function assessments. The system leverages proprietary algorithms and an age‑correlated normative database to generate actionable...
Can Treg Cell Therapy Really Target Autoimmunity?
Regulatory T‑cell (Treg) therapies are moving from discovery to clinic, with multiple biotech firms reporting early clinical data. Sonoma Biotherapeutics’ CAR‑Treg candidate SBT‑77‑7101 achieved a 67% reduction in rheumatoid‑arthritis swelling in a Phase 1 trial, while Coya Therapeutics secured IND approval...
Competitive Generic Therapy Approvals
The FDA’s Office of Generic Drugs has launched a public, bi‑weekly list of all approved abbreviated new drug applications (ANDAs) that carry a Competitive Generic Therapy (CGT) designation. The list details each product’s reference listed drug, NDA number, applicant, active...
Lung Cancer Rising Among Never-Smokers. Screening For This Group Lags.
Never‑smokers now account for 10‑20% of U.S. lung‑cancer cases, a share that is climbing despite overall declines. Current USPSTF guidelines limit low‑dose CT screening to heavy‑smoking adults, leaving most never‑smokers unscreened. Shira Boehler’s incidental finding on a whole‑body MRI prompted...
As FDA Moves Away From Animal Testing, AI and Organoids Can Shine
The FDA is actively phasing out animal‑testing requirements for certain therapies, a move echoed by the NIH and codified in the pending FDA Modernization Act. This regulatory shift opens the door for artificial intelligence and human‑derived organoid models to become...
Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
Cogent Biosciences announced that its lead drug bezuclastinib is on track for multiple FDA submissions in 2026, including NDAs for non‑advanced systemic mastocytosis (Non‑AdvSM), advanced SM (AdvSM) and second‑line GIST. The company reported $901 million in cash, sufficient to fund operations...
Sequential Optimization of Multivariate Metal–Organic Framework Based Biocatalysis
The study introduces a sequential Latin hypercube sampling‑coupled Bayesian optimization (LHS‑BO) workflow that simultaneously designs multivariate zirconium‑based enzyme‑@‑MOF (E‑MOF) biocomposites and tunes the downstream glucose oxidase–horseradish peroxidase (GOx‑HRP) cascade. Optimized E‑MOFs ZG67 and ZH16 deliver encapsulation efficiencies above 90%, retain...
Dual Wielding in I&I: A Pivotal Year Ahead
The article argues that the next breakthrough in immunology and inflammation (I&I) therapeutics will come from multi‑drug and multi‑target strategies rather than single‑target antibodies, which have hit an efficacy ceiling. It traces the evolution from early blockbuster biologics like Humira...
STAT+: Ocular’s Experimental Eye Drug Beats Low Dose of Regeneron’s Eylea in Late-Stage Trial
Ocular Therapeutix announced that its experimental drug Axpaxli met the primary endpoint in a Phase 3 trial for wet age‑related macular degeneration, maintaining vision in 74% of patients at nine months and 66% at one year after a single injection....
Size‐Transformable Supramolecular Nanoprodrugs Enable Redox Imbalance Amplification and Cholesterol Modulation to Boost Multidimensional Tumor Immunotherapy
Researchers have engineered a tumor‑targeting, tumor‑microenvironment‑responsive supramolecular nanoprodrug that switches size to enhance deep tumor penetration. The nanoprodrug simultaneously induces redox imbalance—accumulating reactive nitrogen species and depleting glutathione—to amplify ferroptosis, while depleting cholesterol to rejuvenate exhausted T cells. This multidimensional...
PH‐Responsive Nanoparticle‐Coated Calcium Phosphate Granules for Bone Cancer Therapy
Researchers have engineered β‑tricalcium phosphate (β‑TCP) granules coated with selenium‑doped mesoporous silica nanoparticles (SeMIA) linked via pH‑responsive imine–alendronate bonds. The imine linkers remain stable at physiological pH but cleave in the mildly acidic osteosarcoma microenvironment, releasing nanoparticles that selectively kill...
STAT+: Compass Says Its Psilocybin Drug Helped Patients with Severe Depression in Two Trials
Compass Pathways announced that its synthetic psilocybin therapy, COMP360, achieved statistically significant improvements in two identical Phase 3 trials for severe major depressive disorder. Both studies met primary endpoints, showing greater reduction in depression scores than placebo‑controlled psychotherapy. The data suggest...
Katerina Leftheris
Enhanced Genomics announced the appointment of Katerina Leftheris to its board of directors, tapping her extensive medicinal chemistry and machine‑learning drug‑discovery experience. Leftheris most recently served as Chief Scientific Officer at Vilya, a company focused on oral macrocycle therapeutics, and...
Haelixa Embeds DNA Authentication Into Products
Haelixa, a Swiss deep‑tech firm, introduced a DNA‑based Authenticity Service that embeds nano‑sized, brand‑unique DNA markers into luxury items such as watches, jewellery and leather accessories. The invisible marker survives resale, repair and returns, and can be verified on‑site with...
Selecting the Optimal Cell Therapy Manufacturing Platform
Developers of cell and gene therapies must choose between fully integrated turnkey platforms and modular, multi‑device systems. Integrated solutions deliver rapid time‑to‑value and simplified workflows, ideal for low‑volume autologous products, but they restrict reagent flexibility and scale. Modular platforms provide...
How to Evaluate Prospective Diagnostic Laboratory Partners for Your Patient Support Program
The pharmaceutical industry now invests over $5 billion annually in patient support programs (PSPs), which boost adherence by roughly 30 % and lower overall healthcare costs. Diagnostic laboratory testing is a cornerstone of these programs, delivering timely data that guides dosing, monitors...
