5 FDA Decisions to Watch in the First Quarter of 2026
Eli Lilly’s oral GLP‑1 candidate orforglipron received a national‑priority voucher, accelerating its FDA review and threatening Novo Nordisk’s recent oral Wegovy launch. Disc Medicine’s repurposed schizophrenia drug bitopertin is on the brink of approval for the rare disease erythropoietic protoporphyria, also under the fast‑track program. Ascendis Pharma expects a decision on its weekly injection TransCon CNP, which could erode BioMarin’s Voxzogo monopoly in achondroplasia, while Rhythm Pharmaceuticals seeks clearance for Imcivree in hypothalamic obesity and Rocket Pharma aims to secure approval for the gene‑therapy Kresladi for severe leukocyte adhesion deficiency‑I. Collectively, these five decisions illustrate how expedited FDA pathways are reshaping market dynamics across obesity, rare diseases, and gene therapy.
GSK, Ionis Achieve Functional Cure in Hepatitis B Studies, Clearing Path for FDA Run
GSK and Ionis reported that their antisense oligonucleotide bepirovirsen achieved a functional cure in the Phase III B‑Well 1 and B‑Well 2 chronic hepatitis B trials. The drug met its primary efficacy endpoint and all ranked secondary endpoints, showing statistically significant cure rates without...
Jazz’s Ziihera Shows ‘Practice-Changing’ Efficacy in Stomach Cancer
Jazz Pharmaceuticals reported Phase III HERIZON‑GEA‑01 data showing its bispecific HER2 antibody Ziihera dramatically improves outcomes in first‑line HER2‑positive gastroesophageal adenocarcinoma. In a trial of more than 900 patients, Ziihera combined with chemotherapy cut the risk of progression or death by...
Pfizer Searches for Novel Tumor-Selective Antigens With $865M+ Cartography Pact
Pfizer has signed a multi‑year agreement with Cartography Biosciences to discover novel tumor‑selective antigens. The deal provides up to $65 million in upfront and near‑term milestones, with potential total payments exceeding $800 million if all options are exercised. Cartography will employ its...
Europe Pharma R&D Lags, Companies Flee to U.S.
1/🚨Here is another great article - by FT excellent global Pharma correspondent @aanuadeoye, which wonderfully describes the rapid decline of the European 🇪🇺 and British 🇬🇧 Biotech and Pharma ecosystem and the growing gap between them and the American 🇺🇸...
Drone Monitoring Helps Dolphins
A Flinders University team demonstrated that drones equipped with infrared thermal cameras can accurately measure surface temperature and respiration rates of bottlenose dolphins. Analyzing more than 40,000 thermal images, researchers found optimal accuracy at 10‑15 m altitude directly overhead. The method...
Exosomes in Aging and Age-Related Conditions
Exosomes, nanoscale extracellular vesicles, are increasingly recognized as key mediators of aging and age‑related diseases through their cargo of proteins, lipids, and RNAs. Recent research shows that stem‑cell‑derived exosomes can reproduce the therapeutic signals of cell transplantation, prompting early clinical...
Evidence for Tau and Amyloid Pathology to Drive White Matter Damage in the Brain
A recent PET imaging study of older adults finds that amyloid‑β and tau protein deposits drive the progression of white matter hyperintensities (WMHs) rather than the reverse. Baseline analyses showed bidirectional links, but longitudinal data revealed that higher amyloid levels...
Novo Launches Oral Obesity Pill, Lilly Targets Lofty Revenue, FDA and M&A in Focus
Novo Nordisk introduced its first oral GLP‑1 obesity treatment, Wegovy pill, priced at $149 per month for lower doses. Eli Lilly is eyeing a March approval for its oral weight‑loss candidate orforglipron, positioning it as a catalyst to more than double...
Bayer and Cradle Enter Collaboration to Enhance AI-Enabled Antibody Discovery and Optimization
Pharma giant Bayer has signed a three‑year strategic collaboration with AI‑driven protein‑engineering firm Cradle to embed its generative platform into Bayer’s antibody R&D. The integration aims to accelerate lead generation, improve potency, safety and manufacturability, and reduce the number of...
BIO Warns of Risks From Change to CDC’s Vaccine Recommendations
The U.S. Centers for Disease Control and Prevention announced it will now recommend only 11 of the 17 childhood vaccines it previously endorsed, moving six vaccines to a high‑risk or provider‑consultation model. The Biotechnology Innovation Organization (BIO) condemned the shift...
Biotech Investors Bet on a 2026 Rebound as Deal Activity Accelerates
Biotech investors anticipate a rebound in 2026, driven by a wave of M&A activity and larger private financing rounds observed in late 2025. High‑profile deals such as Pfizer’s $10 billion acquisition of Metsera and AbbVie’s $10.1 billion purchase of ImmunoGen signal renewed...
Project Updates: Prototype Chassis Needed, Sucrose Transformation Progress
So first thing will be to recap the progress of both projects and make a gameplan. I have a draft prototype of the 24well reader but needs chassis work to fit the plate just right, hinge, magnetic assembly, etc. Sucrose needs...
Sequencing Depth Introduces Predictable Artifacts Affecting DE Analysis
1/ Different sequencing depths don't just change detection. They create specific, predictable artifacts that propagate into your DE calls and any downstream modeling. https://t.co/u0U7E5yq6J
The New Subcutaneous (SC) Landscape: Adapting Drug Delivery for Biologics Administration at Home
The pharmaceutical sector is rapidly transitioning high‑value biologics from clinic‑based IV infusions to at‑home subcutaneous (SC) self‑administration. Datwyler’s upcoming event will dissect market forces behind this shift, emphasizing challenges such as drug viscosity, volume limits, and component compatibility. Speakers will...
BioSpace’s NextGen Class of 2026 Attracts Big Bucks From Tight Wallets
BioSpace’s 2026 NextGen list spotlights 15 early‑stage life‑science startups that secured seed or Series A financing despite a 2025 capital crunch. The cohort includes rare‑disease pioneers and innovators tackling cardiovascular, oncology, and genetic therapies. Notable deals feature Light Horse’s $62 million Series A...
Recreate Any Bioinformatics Figure Easily with One Trick
The Secret to Recreating Any Bioinformatics Figure (It’s easier than You Think). The other day, I was on Bioinformatics subReddit and saw someone ask how to generate the figure below https://t.co/5oOU8As3T3
Arrowhead siRNA Data in Obesity Mark POC for Adipose Delivery
Arrowhead Pharmaceuticals announced proof‑of‑concept data showing its siRNA platform can be delivered directly to adipose tissue, producing notable weight loss in preclinical obesity models. The study demonstrated strong knockdown of the ALK7 target, yielding improved metabolic markers, while parallel INHBE...
Biosecure Is in the Trump Administration’s Hands
The Trump administration has taken direct control of Biosecure, a leading biotech firm specializing in pathogen detection and vaccine platforms. New designations and implementation policies are being drafted to align the company’s operations with the administration’s bio‑security agenda. Stakeholders anticipate...
Comparative Efficacy and Safety of Different Surgical Strategies for Refractory Obsessive-Compulsive Disorder: Evidence From Network Meta-Analysis
A recent network meta‑analysis evaluated the comparative efficacy and safety of surgical interventions for treatment‑refractory obsessive‑compulsive disorder (OCD), focusing on ablative procedures such as gamma ventral capsulotomy and lesion‑based capsulotomy versus deep brain stimulation (DBS) targeting regions like the ventral...
Correction: GRIN2A Null Variants Confer a High Risk for Early-Onset Schizophrenia and Other Mental Disorders and Potentially Enable Precision Therapy
Researchers led by Lemke et al. report that loss‑of‑function (null) variants in the GRIN2A gene markedly increase the risk of early‑onset schizophrenia and related psychotic disorders. By integrating genome‑wide data from more than 10,000 individuals with detailed functional assays, the study...
At Least Six PDUFA Dates on FDA’s January Calendar
The FDA has posted at least six PDUFA action dates for January 2026, marking a busy decision window for pending drug applications. Among the slated reviews is the first sublingual epinephrine formulation intended for rapid treatment of allergic reactions. These...
Amgen Acquires UK Biotech Dark Blue Therapeutics
Amgen announced a $840 million acquisition of UK‑based Dark Blue Therapeutics, adding an investigational small‑molecule that degrades MLLT1/3 proteins implicated in acute myeloid leukemia (AML). The deal expands Amgen’s targeted‑protein‑degradation platform and strengthens its oncology pipeline with a novel mechanism to overcome...
The Saturating-Removal Model of Damage Accumulation and Effects of Lifestyle on Aging
The Saturating-Removal (SR) model links stochastic damage accumulation to human mortality, showing that variations in damage production or removal rates are tightly constrained across individuals. Analyses of NHANES cohorts, centenarian siblings, and progeria cases support the model’s prediction that maximal...
Industry Outlook 2026: Trends Transitioning From 2025 Into 2026
Pharma firms widely adopted AI, IoT and digitalization in 2025, and those tools will dominate 2026. Real‑time process monitoring and predictive analytics have become competitive necessities, according to Ecolab Bioprocessing’s Laine Mello. The surge in complex biologics, cell and gene...
Deep Dive: Huntington’s at a Crossroads
The neuro‑degenerative field has gained momentum with recent disease‑modifying approvals, and uniQure’s September data showed its gene therapy could slow Huntington’s progression by 75%. However, the FDA signaled that the Phase I/II results may not satisfy the evidentiary standards for...
New Tools Turn Grain Crops Into Living Biosensors
Researchers at the Donald Danforth Plant Science Center, the University of Florida and the University of Iowa have engineered grasses, including a C4 model and major grain crops, to produce a visible purple anthocyanin pigment when exposed to specific chemicals....
Dentin Inside Wolffish Teeth Is a Rare Material: When Compressed Along Its Length—It Also Shrinks in Width
Researchers led by Prof. Ron Shahar have identified a rare auxetic material, osteodentin, inside Atlantic wolffish teeth that contracts laterally when compressed along its length. Using phase‑contrast X‑ray tomography and digital volume correlation, they measured negative Poisson’s ratios between –1...
Alumis Soars as TYK2 Drug Hits Mark in Psoriasis Trials
Alumis announced that its TYK2 inhibitor envudeucitinib met primary endpoints in two Phase 3 psoriasis trials, delivering 74% of patients achieving PASI‑75 after four months. The data suggest efficacy comparable to leading oral candidates and injectable biologics, prompting the stock to...
'Stomata In-Sight' System Allows Scientists to Watch Plants 'Breathe' In Real-Time
Researchers have unveiled the “Stomata in‑Sight” platform, a real‑time imaging system that visualizes stomatal opening and closing on living leaves. By combining high‑speed microscopy with machine‑learning algorithms, the tool records pore dynamics at sub‑second intervals. Early trials demonstrate precise measurements...
Genetic Medicines Project Gets Funding From UKRI Innovate UK and Canadian NRC IRAP
Chromatin Bioscience, Mediphage Bioceuticals, and Entos Pharmaceuticals announced a joint genetic‑medicine project funded by UKRI Innovate UK and Canada’s NRC IRAP. The partnership merges Chromatin Bioscience’s chromatinLENS synthetic‑promoter platform, Mediphage’s msDNA linear DNA technology, and Entos’s Fusogenix PLV fusion‑based delivery system....
Arrowhead Enters Obesity Chat by Doubling Tirzepatide’s Weight Loss in Combo Study
Arrowhead Pharma reported that its RNAi drug ARO‑INHBE, combined with Eli Lilly’s tirzepatide, produced roughly double the weight loss seen with tirzepatide alone in a small Phase I/IIa study. In the interim analysis, patients receiving the combo lost 9.4% of body weight...
Lilly Doubles Down With Nimbus, Paying $55M for Preclinical Obesity Drug
Eli Lilly has struck a new multi‑year collaboration with Nimbus Therapeutics, paying $55 million upfront for a preclinical oral obesity drug program that could generate up to $1.3 billion in milestones. The partnership leverages Nimbus’s AI‑driven, structure‑based design to discover small‑molecule treatments for...
From Pint to Plate, Scientists Brew up a New Way to Grow Meat
Scientists at University College London have demonstrated that spent yeast from beer brewing can be converted into bacterial cellulose scaffolds suitable for cultivated meat production. The yeast‑derived cellulose matches or exceeds the texture of conventional scaffolds while being edible and...
Top 10 Most Popular Drug Hunter Reviews of 2025
2025 drug discovery emphasized rigorous target selection, with genetics‑driven programs outpacing unvalidated approaches. Immunology saw a breakthrough as small‑molecule degraders and inhibitors of transcription factors IRF5 and STAT6 demonstrated oral activity, challenging the dominance of biologics. Emerging modalities such as...
Researchers Sustainably Produce Triacetic Acid Lactone From Sugarcane
Researchers at the University of Illinois’s Center for Advanced Bioenergy and Bioproducts Innovation demonstrated a sustainable route to produce triacetic acid lactone (TAL) from sugarcane using fermentation followed by crystallization. By coupling experimental solubility data with the BioSTEAM simulation platform,...
Nanoparticles Show Unexpected Ability to Activate Immune System Against Melanoma
Cornell researchers have shown that ultrasmall core‑shell silica nanoparticles, dubbed "prime dots," can reprogram the tumor microenvironment of melanoma, activating innate immunity and converting immunologically "cold" tumors into "hot" ones. The study published in Nature Nanotechnology documents multiple mechanisms—including pattern‑recognition...
MICOS in the Age-Related Decline of Mitochondrial Function
Recent 3‑D reconstructions reveal that the mitochondrial contact site and cristae organizing system (MICOS) becomes progressively disordered in aging neurons, especially those exposed to Alzheimer’s disease (AD) pathology. The study documents age‑dependent cristae fragmentation, reduced inter‑mitochondrial connectivity, and altered mitochondrial...
Modest Reversal of Proteomic Aging via a Structured Program of Exercise
A recent study using a 12‑week supervised exercise program showed a modest reversal of proteomic aging, shrinking the predicted biological age by roughly ten months in 26 male participants. The research linked higher ProtAgeGap scores to lower physical activity and...
Inhalable Therapy Aims for One-Two Punch Against Advanced Melanoma
Columbia engineers have created BEAT, an inhalable nanotherapy that uses engineered exosomes to co‑deliver PD‑1/PD‑L1 and Wnt/β‑catenin inhibitors directly to lung metastases of melanoma. In mouse models resistant to checkpoint inhibitors, inhaled BEAT achieved superior lung retention, dramatically suppressed tumor...
Argenx Names New CEO; Van Hauwermeiren to Become Chair
Swiss biotech Argenx announced that Dr. Anneliese Klein will assume the chief executive officer role on July 1, 2026, while founder Peter Van Hauwermeiren transitions to board chair. Klein, formerly head of commercial operations at Roche’s antibody division, brings deep market expertise. Van’s move...
2026 Biotech Kickoff — a BioCentury Podcast
The BioCentury podcast kicked off 2026 by evaluating biotech trends across the United States, Europe and Asia. Funding streams are reviving, with venture capital and IPO activity picking up, while innovation in gene‑editing and mRNA remains robust. At the same...
ENA Respiratory: Boosting Prophylactic Immunity with a Pan-Viral Nasal Spray
Australian biotech ENA Respiratory has unveiled a pan‑viral nasal spray that primes the host’s innate immune system to block a broad range of upper‑respiratory viruses. Early‑stage trials reported up to a 70% drop in laboratory‑confirmed infections across influenza, RSV and...
Gene Editing in Indonesia: Can New Biotechnology Solve Old Agricultural Problems?
Indonesia faces mounting food‑security pressures as climate stress and import dependence strain its staple‑centric agriculture. Gene‑editing technologies, touted for precise, non‑transgenic trait improvements, are being positioned to boost rice, cassava and sorghum yields. Yet stakeholder interviews reveal deep skepticism, especially...
Synaptic Potentiation Requires PARP1 Activation: Prevailing Concepts Are Revisited
A recent Mol Psychiatry study reveals that poly‑ADP‑ribose polymerase 1 (PARP1) activation is indispensable for long‑term synaptic potentiation (LTP) and memory formation. The authors demonstrate a DNA‑independent activation pathway where phosphorylated Erk2 binds PARP1, exposing its NAD⁺ site and triggering poly‑ADP‑ribosylation...
Suppressor tRNAs: Giving Genetic Medicines a Broader Reach
Suppressor tRNAs are emerging as a versatile platform to overcome premature stop codons that limit many gene‑editing and RNA‑based therapies. Recent preclinical studies demonstrate that engineered tRNAs can restore full‑length protein production across diverse disease models, from muscular dystrophy to...
China Clears Mepolizumab for COPD
China’s National Medical Products Administration approved GSK’s mepolizumab (Nucala) as an add‑on maintenance therapy for adults with eosinophilic COPD, making it the first monthly biologic for the disease in the country. The decision rests on Phase III MATINEE and METREX trials...
Restoration of Lymphatic Vessel Contractility in Aged Mice
Researchers identified the voltage‑gated sodium channel NaV1.3 as a selective, drug‑gable target in adult lymphatic smooth muscle. Using the scorpion‑venom‑derived activator Tf2, they fully restored lymphatic vessel contractility in aged mice and partially rescued radiation‑induced deficits. NaV1.3 is absent from...
Blocking the IgG Highway: FcRn Biology, Approved Agents, and the Small Molecule Horizon
The article reviews the role of the neonatal Fc receptor (FcRn) in extending IgG half‑life and outlines how therapeutic blockade of this pathway can reduce pathogenic antibodies in autoimmune diseases. It surveys the currently approved FcRn‑targeting biologics, such as efgartigimod...
High-Throughput Platform Enables Aptamer Discovery and Kinetic Profiling
Researchers at the Chinese Academy of Sciences unveiled SPARK‑seq, a high‑throughput platform that merges CRISPR perturbations, single‑cell multi‑omics and aptamer sequencing to map aptamer‑target interactions in native cellular contexts. In a proof‑of‑concept study, the system screened over 8,000 single cells,...