Know What's Happening in BioTech

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
NewsFeb 18, 2026

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

The FDA and UTMB are hosting a free, week‑long training course on data quality and integrity for BSL‑4 laboratories from July 28 to August 1, 2025, with in‑person seats in Manhattan, Kansas and a virtual option. The curriculum covers GLP requirements, Animal Rule...

By FDA
Reduced APOE Expression Improves Bone Regeneration in Aged Mice
BlogFeb 18, 2026

Reduced APOE Expression Improves Bone Regeneration in Aged Mice

Researchers discovered that elevated circulating APOE in older mice suppresses bone regeneration by inhibiting osteoblast differentiation. Liver‑specific knockout of APOE or a single dose of a neutralizing antibody lowered serum APOE, restored Wnt/β‑catenin signaling, and markedly improved fracture callus density...

By Fight Aging!
NewCo Boom Shows No Signs of Slowing
NewsFeb 18, 2026

NewCo Boom Shows No Signs of Slowing

The NewCo model, where Asian biotech assets are spun out into Western start‑ups backed by Western capital, surged in 2025 with 13 new companies—more than double the six disclosed in 2024. Early 2026 already sees three additional launches, including Kidswell...

By BioCentury
FDA to Review Moderna’s Flu Jab on Agency Pivot
NewsFeb 18, 2026

FDA to Review Moderna’s Flu Jab on Agency Pivot

The FDA has reversed its earlier refusal and will now evaluate Moderna’s mRNA‑1010 seasonal flu vaccine using a two‑track approach: a full Biologics License Application review for adults 50‑64 and an accelerated approval pathway for those 65 and older, contingent...

By Pharmaceutical Technology (GlobalData)
Nova-Institut Reports Global Bio-Based Polymer Market to Rise 11% Annually Until 2030
NewsFeb 18, 2026

Nova-Institut Reports Global Bio-Based Polymer Market to Rise 11% Annually Until 2030

The nova‑Institut report shows bio‑based polymers reached 4.5 million tonnes in 2025, representing about 1 % of total polymer output. Production is projected to grow at an 11 % compound annual growth rate through 2030, potentially doubling the market share to 2 %. Capacity...

By CompositesWorld
Aceclidine
BlogFeb 18, 2026

Aceclidine

Aceclidine (Vizz®) received FDA approval in 2025 as an ophthalmic solution for presbyopia, targeting age‑related near‑vision loss. The drug acts as a pupil‑selective muscarinic agonist, inducing miosis without significant ciliary muscle activity, thereby enhancing depth of focus through a pinhole...

By Drug Hunter
Global Conference to Tackle Longevity Clinical Translation
BlogFeb 18, 2026

Global Conference to Tackle Longevity Clinical Translation

The National University of Singapore Academy for Healthy Longevity is hosting the Geromedicine Conference on February 26-27, 2026, bringing together geroscience researchers, clinicians, and industry leaders. The event emphasizes clinical translation of molecules such as NAD+ precursors, urolithin A, and ergothioneine,...

By SENS Research Foundation – The SENSible Blog
Lilly to Pay CSL $100M to License Monoclonal Antibody Targeting IL-6
NewsFeb 18, 2026

Lilly to Pay CSL $100M to License Monoclonal Antibody Targeting IL-6

Eli Lilly has agreed to pay CSL Ltd. $100 million to license the monoclonal antibody clazakizumab, which targets interleukin‑6. Under the agreement, CSL will keep development rights for the drug’s use in preventing cardiovascular complications in end‑stage kidney disease patients, currently...

By BioPharma Dive
From DNA To Decision
NewsFeb 18, 2026

From DNA To Decision

Rapid functional testing is turning ambiguous genetic variants into actionable medical decisions. A zebrafish model proved a newborn‑identified SMN1 mutation benign, allowing clinicians to defer costly SMA therapy. This proof‑of‑concept shows whole‑genome sequencing can move from data to diagnosis within...

By Forbes – Healthcare
Pharmaceutical Quality Resources
NewsFeb 18, 2026

Pharmaceutical Quality Resources

The FDA’s Center for Drug Evaluation and Research created the Office of Pharmaceutical Quality (OPQ) to standardize drug quality oversight across all manufacturing sites, both domestic and foreign. OPQ’s mandate spans new drugs, biologics, generics, biosimilars, over‑the‑counter products, and certain...

By FDA
FDA Accepts BMS Protein Degrader for Review; Disc Rare Disease Drug Rejected
NewsFeb 18, 2026

FDA Accepts BMS Protein Degrader for Review; Disc Rare Disease Drug Rejected

The FDA has accepted Bristol Myers Squibb’s protein‑degrading multiple myeloma candidate iberdomide for review, with a decision expected by Aug. 17 after a Phase 3 trial showed higher minimal residual disease‑negative rates. In contrast, the agency rejected Disc Medicine’s accelerated‑approval bid for...

By BioPharma Dive
Addressing the 58% Launch Failure Rate: Accelerating Market Access Through Intelligent Decision-Making
NewsFeb 18, 2026

Addressing the 58% Launch Failure Rate: Accelerating Market Access Through Intelligent Decision-Making

Pharma launches are missing the mark 58% of the time, a failure rate driven by poor market insight and fragmented decision‑making. Accelerating market‑access planning from pre‑Phase 2 and integrating real‑world data can give companies a strategic north star. Purpose‑built AI tools...

By MedCity News
Does the Motion of DNA Influence Its Activity?
NewsFeb 18, 2026

Does the Motion of DNA Influence Its Activity?

Researchers at the Salk Institute demonstrated that the dynamic three‑dimensional folding of the genome directly influences gene expression and cell identity. By depleting the cohesin‑loader protein NIPBL in human iPSC‑derived neurons and cardiomyocytes, they observed region‑specific unfolding of chromatin loops....

By Phys.org – Biotechnology
STAT+: The FDA’s Moderna Pirouette Is One More Sign of Chaos at the Agency
NewsFeb 18, 2026

STAT+: The FDA’s Moderna Pirouette Is One More Sign of Chaos at the Agency

The FDA initially issued a refuse‑to‑file letter for Moderna’s mRNA influenza vaccine, then reversed course within a week and agreed to review the product. The agency will now consider two separate pathways: full approval for adults 50‑64 and accelerated approval...

By STAT (Biotech)
Innovation in Ophthalmology: How Biotechs Are Reshaping the Treatment of Eye Diseases
NewsFeb 18, 2026

Innovation in Ophthalmology: How Biotechs Are Reshaping the Treatment of Eye Diseases

Vision loss remains a leading disability, prompting biotech firms to shift from symptom‑management to disease‑modifying therapies. Gene‑replacement approaches using AAV vectors dominate the inherited retinal disease pipeline, highlighted by Luxturna’s success and multiple late‑stage candidates such as Beacon’s laru‑zova and...

By Labiotech.eu
A New Era For Blindness Treatment Is Within Sight
NewsFeb 18, 2026

A New Era For Blindness Treatment Is Within Sight

A wave of clinical trials is testing stem‑cell, gene‑editing and bionic‑eye technologies to treat blindness, especially retinitis pigmentosa and dry age‑related macular degeneration. Early‑stage studies from UC Davis, BlueRock Therapeutics and the University of Michigan report measurable vision gains, such as...

By Forbes – Healthcare
How Does Cholera Colonize the Gut? Unmasking Virulence Activation with Cryo-EM
BlogFeb 18, 2026

How Does Cholera Colonize the Gut? Unmasking Virulence Activation with Cryo-EM

Cryogenic electron microscopy enabled researchers to solve five structures of Vibrio cholerae transcription activation complexes, revealing how the bacterium initiates virulence in the human gut. The study shows ToxR and TcpP transcription factors bind the RNA polymerase α‑C‑terminal domain via...

By BioTechniques (independent journal site)
Global Genomics: Representative Research Is Key to Unlocking the Full Potential of Precision Medicine
BlogFeb 18, 2026

Global Genomics: Representative Research Is Key to Unlocking the Full Potential of Precision Medicine

Professor Segun Fatumo highlights the stark under‑representation of African genomes in global research, where over 86% of GWAS participants are of European ancestry despite Africa housing the greatest genetic diversity. He explains how this gap limits the accuracy of polygenic...

By BioTechniques (independent journal site)
IRF7 Expression Drives Instability in Atherosclerotic Plaques
BlogFeb 18, 2026

IRF7 Expression Drives Instability in Atherosclerotic Plaques

Researchers identified interferon regulatory factor 7 (IRF7) as a master transcriptional driver that pushes vascular smooth muscle cells (SMCs) into a pro‑inflammatory, macrophage‑like state, a key step in plaque destabilisation. Single‑cell RNA sequencing and trajectory analysis uncovered an intermediate stem‑endothelial‑monocyte...

By Fight Aging!
Novartis' Oral BTK Drug Moves the Needle in CINDU
NewsFeb 18, 2026

Novartis' Oral BTK Drug Moves the Needle in CINDU

Novartis announced that its oral BTK inhibitor Rhapsido (remibrutinib) achieved significantly higher complete response rates than placebo in the phase 3 RemIND trial for the three most common forms of chronic inducible urticaria (CINDU). The drug, already approved for chronic spontaneous...

By pharmaphorum
AI Transforms Unknown Genetic Variants Into Actionable Insights
SocialFeb 18, 2026

AI Transforms Unknown Genetic Variants Into Actionable Insights

A “Variant of Unknown Significance” is a genetic finding that can’t yet be interpreted, leaving families with uncertainty instead of answers. Now, AI agents can help connect sequencing data with scientific literature and biological context to turn VUS into traceable, evidence-backed...

By Catherine Adenle
FDA Chief: Most Drugs Belong Over‑the‑counter
SocialFeb 18, 2026

FDA Chief: Most Drugs Belong Over‑the‑counter

FDA chief Marty Makary says 'everything should be over the counter' unless drug is unsafe or addictive https://t.co/HiYBuxvyWC

By Matthew Herper
STAT+: Biotech Startup Raises $175 Million to Advance Alzheimer’s Antibody Therapy
NewsFeb 18, 2026

STAT+: Biotech Startup Raises $175 Million to Advance Alzheimer’s Antibody Therapy

Korsana Biosciences announced a $175 million financing round led by Fairmount, Venrock, Wellington Management and TCGX to develop its Alzheimer’s antibody candidate KRSA‑028. The startup positions KRSA‑028 as a next‑generation “brain shuttle” designed to clear amyloid plaques more efficiently than existing...

By STAT (Biotech)
Federal Vaccine Panel Meeting Delayed After HHS Missed Deadlines
SocialFeb 18, 2026

Federal Vaccine Panel Meeting Delayed After HHS Missed Deadlines

Upcoming meeting of federal vaccine panel may be postponed after HHS missed deadlines https://t.co/zfAl7owoQg via @statnews

By Matthew Herper
MRNA Vaccines Advance Triple‑negative Breast Cancer Therapy
SocialFeb 18, 2026

MRNA Vaccines Advance Triple‑negative Breast Cancer Therapy

The unfounded move by @HHSGov against mRNA vaccines will hurt our future potent immune therapy vs cancer. Another point of progress for triple-negative breast cancer with individualized neoantigen mRNA vaccines today @Nature Adds to successful pancreatic, renal cell, melanoma reports...

By Eric Topol
The Biotech Bi-Weekly: A 48-Channel SPR Platform, Robust RNA-Seq Libraries and Microgravitational Discoveries
BlogFeb 18, 2026

The Biotech Bi-Weekly: A 48-Channel SPR Platform, Robust RNA-Seq Libraries and Microgravitational Discoveries

Carterra unveiled Vega, the industry’s first 48‑channel high‑throughput SPR platform, delivering roughly 12‑fold higher screening capacity for small‑ and large‑molecule drug candidates. Covaris introduced the truCOVER® Total RNA Library Prep Kit, enabling robust RNA‑seq libraries from as little as 10 ng...

By BioTechniques (independent journal site)
Listen to Biology’s Early Whispers to Prevent Disease
SocialFeb 18, 2026

Listen to Biology’s Early Whispers to Prevent Disease

We could prevent diseases so much better but we haven't learned to listen to when biology whispers long (10 + years) in advance. A key theme in Super Agers, too. https://t.co/0pSap3f32N @NathanPriceSci @ @nrappapo @BuckInstitute example below for Type 2...

By Eric Topol
Agentic AI Enables Accurate Rare Disease Diagnosis via DeepRare
SocialFeb 18, 2026

Agentic AI Enables Accurate Rare Disease Diagnosis via DeepRare

Another good use case for agentic AI in medicine: diagnosis of rare diseases. Exemplified by DeepRare https://t.co/XBd68V3iDl https://t.co/rBl5yn95sI

By Eric Topol
NICE Backs First Disease-Modifying Drug for ARG1 Deficiency
NewsFeb 18, 2026

NICE Backs First Disease-Modifying Drug for ARG1 Deficiency

Immedica’s pegzilarginase (Loargys), the first enzyme replacement therapy for arginase‑1 (ARG1) deficiency, has received NICE endorsement for NHS use in the UK. The weekly IV or subcutaneous treatment cuts blood arginine levels by roughly 80% and is recommended for patients...

By pharmaphorum
Pharma Demands FDA Stability as Leadership Sparks Drama
SocialFeb 18, 2026

Pharma Demands FDA Stability as Leadership Sparks Drama

The pharmaceutical industry needs stability & clear guidance from #FDA as it attempts to bring through licensure new drugs & vaccines. Vinay Prasad, FDA's head of biologics, has brought drama to a setting where it's not welcome, @matthewherper.bsky.social writes. https://t.co/Qaw1QmYNpL

By Helen Branswell
FDA's Erratic, Unpredictable Decisions Undermine Drug Regulation
SocialFeb 18, 2026

FDA's Erratic, Unpredictable Decisions Undermine Drug Regulation

The FDA keeps spinning, spinning, spinning round and round. Just what you want from a drug regulator: Erratic decision-making and complete unpredictability. https://t.co/q5abiPwgkW

By John Carroll
£20M Fund Backs UK Addiction Treatment Tech
NewsFeb 18, 2026

£20M Fund Backs UK Addiction Treatment Tech

The UK government, via Innovate UK, has launched a £20 million funding programme to accelerate development of medicines, medical devices, wearables, virtual‑reality therapies and AI‑enabled tools for drug and alcohol addiction. Grants of up to £10 million for late‑stage projects and up to...

By Startups Magazine
V‑plot TF Binding May Be Artifact of Fragmentation
SocialFeb 18, 2026

V‑plot TF Binding May Be Artifact of Fragmentation

🧵 That V-plot showing transcription factor binding? It might be an artifact. New research shows chromatin fragmentation methods create patterns even on naked DNA. Here's what went wrong. https://t.co/79B5c0ulgD

By Ming Tang
Claude Code Fabricates Fake ENSEMBL IDs for Gene Plots
SocialFeb 18, 2026

Claude Code Fabricates Fake ENSEMBL IDs for Gene Plots

1/ Claude Code just hallucinated ENSEMBL IDs for my volcano plot. (it happened last week for real) I asked it to highlight specific genes. The data matrix uses ENSEMBL identifiers. Instead of flagging that it couldn't map the gene symbols, it invented...

By Ming Tang
Portal Diabetes’ Insulin Pump Receives FDA Breakthrough Device Designation
NewsFeb 18, 2026

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...

By Hospital Management
10 Free Bioinformatics Tools to Save Time & Money
SocialFeb 18, 2026

10 Free Bioinformatics Tools to Save Time & Money

🧵 10 free bioinformatics tools you should know in 2026. These will save you time, money, and headaches. https://t.co/t8amdLE4MX

By Ming Tang
FDA's Moderna U‑turn Highlights Agency Chaos
SocialFeb 18, 2026

FDA's Moderna U‑turn Highlights Agency Chaos

The FDA’s Moderna $MRNA pirouette is one more sign of chaos at the agency https://t.co/zThJqhT2BS via @matthewherper

By Adam Feuerstein
Janux Commences Participant Dosing in Phase I JANX011 Trial
NewsFeb 18, 2026

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...

By Hospital Management
FDA Relents, Agrees to Review Moderna's mRNA Flu Vaccine
SocialFeb 18, 2026

FDA Relents, Agrees to Review Moderna's mRNA Flu Vaccine

#FDA backs down on #Moderna: The agency had refused to review the company's licensure application for an mRNA flu vaccine, but after significant pushback has relented. https://t.co/omo7bEBQGW

By Helen Branswell
Moderna's Flu Vaccine Review Set for August 5
SocialFeb 18, 2026

Moderna's Flu Vaccine Review Set for August 5

$MRNA says FDA will now review its flu vaccine. PDUFA date is Aug. 5. https://t.co/npZzeEa5nk

By Adam Feuerstein
J&J’s Rybrevant Faspro Gains FDA Approval for New Dosing in NSCLC
NewsFeb 18, 2026

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...

By Hospital Management
FDA Splits Moderna Flu Vaccine Review by Age
SocialFeb 18, 2026

FDA Splits Moderna Flu Vaccine Review by Age

FDA agrees to review Moderna flu vaccine application, splitting review into standard approval for those under 65 and accelerated approval for those 65 and above. $mrna https://t.co/HMMlPm0PGh

By Matthew Herper
Six Biotechs to Know in Barcelona
NewsFeb 18, 2026

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...

By Labiotech.eu
Iron Deficiency Triggers Mature Pancreatic Β-Cell Loss
NewsFeb 18, 2026

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...

By Bioengineer.org
AI and OCT Integration Highlights Promising Advances in Detecting Lipid-Rich Coronary Artery Plaques
NewsFeb 18, 2026

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...

By Bioengineer.org
Nanoparticle-Based Gene Editing Could Expand Treatment Options for Cystic Fibrosis
BlogFeb 18, 2026

Nanoparticle-Based Gene Editing Could Expand Treatment Options for Cystic Fibrosis

UCLA researchers have engineered lipid nanoparticles to co‑deliver CRISPR/Cas9 components and a full‑length CFTR gene, achieving precise, mutation‑agnostic insertion in human airway cells. The non‑viral system corrected 3‑4% of cells yet restored up to 100% of normal chloride channel function,...

By Nanowerk
Injectable Nanocomposite Hemostat Speeds Blood Clotting for Trauma Care
BlogFeb 18, 2026

Injectable Nanocomposite Hemostat Speeds Blood Clotting for Trauma Care

Researchers at Texas A&M have created injectable nanocomposite hemostats that cut blood clotting time from six‑seven minutes to one‑two minutes, slashing bleeding duration by up to 70% in internal hemorrhage models. The devices combine clay‑derived nanosilicates with a shape‑memory foam...

By Nanowerk
AI-Powered Liquid Biopsy Advances Pediatric Brain Tumor Classification
NewsFeb 18, 2026

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...

By Bioengineer.org
Aging Podocytes: Unveiling Structural Adaptations
NewsFeb 18, 2026

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...

By Bioengineer.org