BioTech News and Headlines

LifeVac Receives FDA De Novo Classification for Anti-Choking Device
NewsMar 9, 2026

LifeVac Receives FDA De Novo Classification for Anti-Choking Device

LifeVac has secured FDA De Novo classification, designating its suction anti‑choking device as a Class II medical device for second‑line treatment after failed basic life support protocols. The clearance confirms the device as a single‑use, non‑powered, non‑invasive tool suitable for adults and...

By Hospital Management
Aisa Pharma Reports Positive Results for AISA-021
NewsMar 9, 2026

Aisa Pharma Reports Positive Results for AISA-021

Aisa Pharma announced positive Phase II data for AISA‑021, a once‑daily calcium channel blocker, in systemic sclerosis‑associated Raynaud’s phenomenon (SSc RP). The double‑blind, placebo‑controlled RECONNOITER trial enrolled 64 patients and showed a 22.1% reduction in weekly Raynaud attacks and a 155% placebo‑adjusted...

By Hospital Management
Blood Test Using P-Tau217 Biomarker Predicts Alzheimer’s Symptom Onset Within 3–4 Years
NewsMar 9, 2026

Blood Test Using P-Tau217 Biomarker Predicts Alzheimer’s Symptom Onset Within 3–4 Years

Researchers at Washington University have created a blood‑test model using plasma p‑tau217 that can predict the onset of Alzheimer’s symptoms within three to four years. The model, validated on 603 participants, shows age‑dependent timelines, with younger individuals experiencing longer asymptomatic...

By Dark Daily
Health Care Interests Take Shape Ahead of State Budget Negotiations
NewsMar 9, 2026

Health Care Interests Take Shape Ahead of State Budget Negotiations

Health care stakeholders in New York are mobilizing as the state budget negotiations intensify, with the Associated Medical Schools of New York lobbying for an additional $100 million to bolster biomedical research and life‑science jobs. The state already receives over $3.5 billion...

By Crain’s New York Business
Safety Concerns Prompt Ipsen to Pull Tazverik From Market
NewsMar 9, 2026

Safety Concerns Prompt Ipsen to Pull Tazverik From Market

Ipsen is voluntarily withdrawing its EZH2 inhibitor Tazverik worldwide after an interim safety analysis in the phase 1b/3 SYMPHONY‑1 trial linked the drug to secondary hematologic malignancies. The pull‑back includes terminating all ongoing Tazverik studies and recalling the product in markets...

By pharmaphorum
Navigating the PPQ Process: Proven Strategies to Safeguard Quality for Cell and Gene Therapies
NewsMar 9, 2026

Navigating the PPQ Process: Proven Strategies to Safeguard Quality for Cell and Gene Therapies

Process Performance Qualification (PPQ) is the final validation step before commercial manufacturing of cell and gene therapies, but its complexity often triggers delays and compliance risks. The article highlights three proven strategies—early master‑plan development, continuous quality improvement, and data‑driven analytics—to...

By BioPharma Dive
Roche’s Big-Hope Breast Cancer Drug Fails in Crucial First-Line Trial
NewsMar 9, 2026

Roche’s Big-Hope Breast Cancer Drug Fails in Crucial First-Line Trial

Roche’s oral breast‑cancer therapy, touted as a potential blockbuster, missed its primary endpoint in the pivotal Phase 3 persevERA trial. The study evaluated the drug as a first‑line treatment for hormone‑receptor‑positive, HER2‑negative metastatic breast cancer and enrolled more than 1,200 patients...

By Endpoints News
kyron.bio Announces Strategic Partnership with Servier to Advance Precision Glycosylation in Antibody Therapeutics
NewsMar 9, 2026

kyron.bio Announces Strategic Partnership with Servier to Advance Precision Glycosylation in Antibody Therapeutics

Kyron.bio announced a strategic partnership with Servier to glycoengineer a Servier‑selected antibody using its precision glycosylation platform. Servier will fund the research and retain an option to pursue further development based on the results. The collaboration builds on Kyron.bio’s 2024...

By The Manila Times – Business
Under Trump, mRNA Skepticism Threatens a Promising Technology
NewsMar 9, 2026

Under Trump, mRNA Skepticism Threatens a Promising Technology

Under the Trump administration, the U.S. government slashed nearly $500 million in mRNA research funding, canceling 22 projects and a $766 million Moderna contract. The FDA’s initial refusal then reversal to review Moderna’s flu vaccine highlighted regulatory skepticism toward the platform. Private‑sector...

By Undark
A Coding Guide to Build a Complete Single Cell RNA Sequencing Analysis Pipeline Using Scanpy for Clustering Visualization and Cell...
NewsMar 9, 2026

A Coding Guide to Build a Complete Single Cell RNA Sequencing Analysis Pipeline Using Scanpy for Clustering Visualization and Cell...

The article presents a step‑by‑step Python tutorial that builds a full single‑cell RNA‑sequencing (scRNA‑seq) analysis pipeline using Scanpy. It walks through data loading, quality‑control filtering, normalization, highly variable gene selection, PCA, neighbor‑graph construction, UMAP embedding, Leiden clustering, and marker‑gene based...

By MarkTechPost
Arq Inc (ARQ) Q4 2025 Earnings Call Transcript
NewsMar 9, 2026

Arq Inc (ARQ) Q4 2025 Earnings Call Transcript

Arcutis Biotherapeutics reported record Q4 2025 results, with net product revenue of $127.5 million, an 84% year‑over‑year increase, and full‑year revenue up 123% to $372.1 million. Management raised its 2026 net product revenue guidance to $480‑$495 million, citing strong prescription growth, expanded Medicare...

By Motley Fool – Earnings Transcripts
Logic‑gated Nanomedicine Activates STING to Boost Metastatic Tumour Immunotherapy
NewsMar 9, 2026

Logic‑gated Nanomedicine Activates STING to Boost Metastatic Tumour Immunotherapy

Researchers at the University of Massachusetts Amherst have engineered a logic‑gated nanoparticle that releases a STING agonist only under acidic pH and hypoxic conditions typical of metastatic tumor sites. The dual‑stimuli‑responsive system triggers robust innate immune activation while sparing healthy...

By Nature Nanotechnology
How Fast Does a Protein Fold? Real-Time Technique Captures the Moment
NewsMar 9, 2026

How Fast Does a Protein Fold? Real-Time Technique Captures the Moment

Scientists have directly measured the transition‑path time of protein folding using an enhanced single‑molecule fluorescence technique. By attaching donor and acceptor dyes to opposite ends of a protein chain and amplifying the signal with nanoscale wells, they captured folding events...

By Nature – Health Policy
Zevra Therapeutics Inc (ZVRA) Q4 2025 Earnings Call Transcript
NewsMar 9, 2026

Zevra Therapeutics Inc (ZVRA) Q4 2025 Earnings Call Transcript

Zevra Therapeutics reported Q3 2025 net revenue of $26.1 million, driven primarily by $22.4 million from its FDA‑approved NPC therapy MyPlayFa. The company narrowed its net loss to $0.5 million, a dramatic improvement from a $33.2 million loss a year earlier, while cash and...

By Motley Fool – Earnings Transcripts
Editas Medicine Inc (EDIT) Q4 2025 Earnings Call Transcript
NewsMar 9, 2026

Editas Medicine Inc (EDIT) Q4 2025 Earnings Call Transcript

Editas Medicine reported Q2 2024 progress on its gene‑edited cell therapy reni‑cel, presenting interim data from the RUBY sickle‑cell and EdiTHAL beta‑thalassemia trials. All 18 RUBY patients were free of vaso‑occlusive events, with hemoglobin levels above 14 g/dL and fetal hemoglobin exceeding...

By Motley Fool – Earnings Transcripts
AND Logic Nanoparticle for Precision Immunotherapy of Metastatic Cancers
NewsMar 9, 2026

AND Logic Nanoparticle for Precision Immunotherapy of Metastatic Cancers

Researchers have engineered a dual‑stimuli‑responsive nanoparticle that activates the STING pathway only when both acidic pH and hypoxic NQO1 activity are present, creating an AND‑logic release of the agonist MSA‑2. In preclinical models of lung carcinoma, triple‑negative breast cancer and...

By Nature Nanotechnology
Anixa Biosciences Inc (ANIX) Q1 2026 Earnings Call Transcript
NewsMar 9, 2026

Anixa Biosciences Inc (ANIX) Q1 2026 Earnings Call Transcript

Anixa Biosciences reported $131.7 million in cash, no debt, and a cash burn of $7.1 million in Q1 2026, extending its runway to over three years. Operating expenses fell sharply, with R&D down 55% YoY and G&A reduced by 32%, reflecting the end...

By Motley Fool – Earnings Transcripts
MacroGenics Inc (MGNX) Q4 2025 Earnings Call Transcript
NewsMar 9, 2026

MacroGenics Inc (MGNX) Q4 2025 Earnings Call Transcript

MacroGenics reported 2024 revenue of $150 million, up from $58.7 million, largely fueled by $85 million in milestone payments from its Incyte partnership. The company posted a net loss of $67 million versus $9.1 million a year earlier, while cash and marketable securities fell to...

By Motley Fool – Earnings Transcripts
Deciphering the Causal Influence of BMI and Related Metabolic, Inflammatory, and Cardiovascular Factors on Brain Structure: A Mendelian Randomization Study
NewsMar 9, 2026

Deciphering the Causal Influence of BMI and Related Metabolic, Inflammatory, and Cardiovascular Factors on Brain Structure: A Mendelian Randomization Study

The study applied univariate and multivariate Mendelian randomization to test whether body mass index (BMI) causally influences brain structure. Results indicate that genetically higher BMI leads to reduced cortical thickness, especially in the precentral and fusiform gyri. Visceral adipose tissue...

By Nature (Biotechnology)
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
NewsMar 8, 2026

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

The FDA has issued a final guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” The document outlines the agency’s scientific framework for establishing biosimilarity of therapeutic proteins submitted via the abbreviated licensure pathway. It details expectations for...

By FDA
A Single Dose of DMT Reverses Depression-Like Symptoms in Mice by Repairing Brain Circuitry
NewsMar 8, 2026

A Single Dose of DMT Reverses Depression-Like Symptoms in Mice by Repairing Brain Circuitry

Researchers at Uppsala University reported that a single 30 mg/kg injection of the psychedelic N,N‑dimethyltryptamine (DMT) reversed depression‑like behaviors in mice subjected to chronic stress. The treated animals recovered their preference for sweetened water, displayed improved working‑memory performance, and showed reduced...

By PsyPost
High-Throughput Hidden Antibiotic Resistance Detection Unveiled
NewsMar 7, 2026

High-Throughput Hidden Antibiotic Resistance Detection Unveiled

A study by Ma and Kim in Nature Communications unveils the dilution‑and‑delay (DnD) susceptibility assay, a high‑resolution, high‑throughput method that combines antibiotic dilution gradients with timed incubation delays. Leveraging microfluidic chips and real‑time imaging, the assay can screen thousands of...

By Bioengineer.org
Chocolate Company Announces Plans to Produce Lab-Grown Cocoa
NewsMar 7, 2026

Chocolate Company Announces Plans to Produce Lab-Grown Cocoa

Puratos and California Cultured announced a partnership to develop commercially viable lab‑grown cocoa, aiming for a market‑ready product by the end of 2026. The process cultivates cocoa cells from elite flavor samples, shrinking growth time to days once scale is...

By Futurism BioTech
'It Could Revolutionize, Completely, the Way We Treat Depression': Researchers Are Exploring Promising Immune Therapy for Treating Psychiatric Symptoms
NewsMar 7, 2026

'It Could Revolutionize, Completely, the Way We Treat Depression': Researchers Are Exploring Promising Immune Therapy for Treating Psychiatric Symptoms

Researchers led by Dr. James Murrough and Dr. Emma Guttman‑Yassky identified the Th2 immune pathway as a contributor to major depressive disorder. Using proteomic profiling and computer modeling, they repurposed dupilumab—an IL‑4 receptor antibody approved for eczema—to target this pathway....

By Live Science
HIV-Seq Tool Finds Active Reservoir Cells During Therapy
NewsMar 7, 2026

HIV-Seq Tool Finds Active Reservoir Cells During Therapy

A team at Gladstone Institutes and the San Francisco VA has launched HIV‑seq, a virus‑specific single‑cell RNA‑sequencing platform that isolates active HIV reservoir cells from patients on antiretroviral therapy (ART). The method captured 25 treated‑patient cells and over 1,000 cells from...

By Medical Xpress
Machine Learning Links DEHP and Sjögren’s Immune Signatures
NewsMar 7, 2026

Machine Learning Links DEHP and Sjögren’s Immune Signatures

Researchers combined network toxicology, machine‑learning models and SHAP interpretability to show that exposure to the plasticizer Di(2‑ethylhexyl) phthalate (DEHP) generates immune signatures overlapping with Sjögren’s syndrome. By mapping thousands of DEHP‑associated genes, proteins and metabolites, they identified shared pathways involving...

By Bioengineer.org
The Age of Animal Experiments May Be Waning
NewsMar 7, 2026

The Age of Animal Experiments May Be Waning

Governments in the UK, US and EU are committing to phase out animal testing, starting with skin‑irritation assays and targeting broader reductions by 2030. Rapid advances in new‑approach methodologies—organs‑on‑chips, organoids and AI‑driven computational models—have driven a fourfold rise in NAM‑only...

By Scientific American – Mind
Lysophosphatidylcholine Acyltransferase 1 Drives Cancer via COX17
NewsMar 7, 2026

Lysophosphatidylcholine Acyltransferase 1 Drives Cancer via COX17

Researchers have identified lysophosphatidylcholine acyltransferase 1 (LPCAT1) as a driver of head and neck squamous cell carcinoma (HNSCC) by amplifying mitochondrial oxidative phosphorylation through the COX17 chaperone. Overexpression of LPCAT1 reshapes mitochondrial membrane lipids, stabilizing COX17 and boosting cytochrome c oxidase activity,...

By Bioengineer.org
ITK-Targeting Boosts Anti-CD19 CAR-T Therapy
NewsMar 7, 2026

ITK-Targeting Boosts Anti-CD19 CAR-T Therapy

A recent preclinical study shows that inhibiting interleukin‑2‑inducible T‑cell kinase (ITK) markedly improves the efficacy of anti‑CD19 CAR‑T cells. Researchers combined an ITK‑selective inhibitor with a second‑generation CD19‑CAR construct, observing enhanced cytotoxicity, reduced exhaustion markers, and prolonged persistence in mouse...

By Bioengineer.org
[Comment] Aldosterone Synthase Inhibition in Resistant Hypertension: Promises and Unknowns
NewsMar 7, 2026

[Comment] Aldosterone Synthase Inhibition in Resistant Hypertension: Promises and Unknowns

Resistant hypertension affects up to 20 % of hypertensive patients and carries heightened cardiovascular risk. Recent phase‑3 studies of aldosterone synthase inhibitors such as baxdrostat and lorundrostat have demonstrated significant ambulatory blood‑pressure reductions, positioning them as potential fourth‑line agents beyond traditional...

By The Lancet (Current)
Prasad Out At FDA, Turning Critics’ Focus Back To Makary
NewsMar 6, 2026

Prasad Out At FDA, Turning Critics’ Focus Back To Makary

Vinay Prasad, the FDA’s controversial biologics chief, has announced his departure, marking his second exit within a year. His resignation follows a public dispute over the agency’s handling of rare disease drug approvals, intensifying scrutiny of FDA decision‑making. Critics are...

By Inside Health Policy
High Fat, Low- Carb Diet Lowers Blood Sugar, Improves Exercise Response in Mice
NewsMar 6, 2026

High Fat, Low- Carb Diet Lowers Blood Sugar, Improves Exercise Response in Mice

A mouse study found that a high‑fat, low‑carb ketogenic diet normalized blood‑sugar levels in hyperglycemic mice and, when combined with aerobic training, restored their peak oxygen consumption (VO2max). The diet shifted metabolism toward fatty‑acid oxidation and ketone utilization, eliminating muscle‑remodeling...

By Medical News Today
EBay Is Selling a Cornucopia of Russian Peptides
NewsMar 6, 2026

EBay Is Selling a Cornucopia of Russian Peptides

A quick search on eBay reveals a flood of Russian‑origin peptide products, from injectable ampoules to dubious oral supplements. The items, marketed by Vita Stream Inc. – a firm linked to former footballer Roman Eremenko – claim bioregulation benefits but...

By Futurism BioTech
As Peptides Go Mainstream, USP  and  Matter More Than Ever
NewsMar 6, 2026

As Peptides Go Mainstream, USP and Matter More Than Ever

Peptide therapies have moved from niche compounding to mainstream outpatient care, driven by telehealth platforms and rapid market growth. This expansion has attracted regulatory attention, with state boards and courts increasingly referencing USP  and as compliance benchmarks. Non‑sterile peptide...

By Pharmacy Times
Simultaneously Decoding the Transcriptome, Epigenome and 3D Genome Within a Single Cell
NewsMar 6, 2026

Simultaneously Decoding the Transcriptome, Epigenome and 3D Genome Within a Single Cell

The team led by Inkyung Jung and Yarui Diao introduced scHiCAR, a trimodal single‑cell technology that simultaneously captures transcriptome, epigenome, and 3D genome architecture. By integrating AI, the method achieves ultra‑high throughput at roughly $0.04 per cell and was used...

By Phys.org – Biotechnology
5 FDA Developments From February: Kinase Inhibitors, GLP-1s, and a New Approval Pathway
NewsMar 6, 2026

5 FDA Developments From February: Kinase Inhibitors, GLP-1s, and a New Approval Pathway

In February 2026 the FDA approved a suite of targeted therapies, including the HER2‑mutant NSCLC kinase inhibitor zognertinib and the first all‑oral acalabrutinib‑venetoclax combo for CLL/SLL, as well as a BRAF‑targeted encorafenib regimen for metastatic colorectal cancer. A portable tumor‑treating‑fields...

By AJMC (The American Journal of Managed Care)
EpiciphAI: Reading Disease States From Blood’s Epigenetic Fingerprints
NewsMar 6, 2026

EpiciphAI: Reading Disease States From Blood’s Epigenetic Fingerprints

EpiciphAI, a Chinese pre‑seed biotech, is building a liquid biopsy that reads histone modifications on cell‑free chromatin to pinpoint a fragment’s tissue of origin and its disease state. Unlike most epigenetic tests that focus on DNA methylation, this platform targets...

By BioCentury
Methanol-Tolerant Microbial Strain Could Make Sustainable Biomanufacturing More Economically Viable
NewsMar 6, 2026

Methanol-Tolerant Microbial Strain Could Make Sustainable Biomanufacturing More Economically Viable

A UNIST research team engineered a methanol‑tolerant *Methylobacterium extorquens* strain that grows 1.7 times faster than conventional microbes at 2.5 % methanol. Using adaptive laboratory evolution, they identified recurring mutations in the metY and kefB genes that boost detoxification and energy...

By Phys.org – Biotechnology
Fat Composition Affects T Cell-Mediated Immunity
NewsMar 6, 2026

Fat Composition Affects T Cell-Mediated Immunity

Scientists discovered that the ratio of polyunsaturated to monounsaturated fatty acids in the diet determines T‑cell susceptibility to ferroptosis, a form of iron‑dependent cell death. Mice fed diets with low PUFA/MUFA ratios showed higher ferroptosis resistance, leading to stronger humoral...

By Lifespan.io
Canada and CSL Seqirus – a Global Leader in Influenza Vaccines, Agree on New Pandemic Preparedness Contract
NewsMar 6, 2026

Canada and CSL Seqirus – a Global Leader in Influenza Vaccines, Agree on New Pandemic Preparedness Contract

Canada’s Public Health Agency has signed a new agreement with CSL Seqirus to provide millions of doses of adjuvanted cell‑based influenza vaccine in the event of a WHO‑declared pandemic. The contract replaces a previous egg‑based arrangement and builds on the...

By BIOTECanada
Sleep Rhythms and Dementia Risk Link Emerges
NewsMar 6, 2026

Sleep Rhythms and Dementia Risk Link Emerges

Alzheimer’s disease now affects 55 million people worldwide, with 10 million new cases each year, prompting researchers to explore upstream triggers beyond genetics. Texas A&M scientists have shown that chronic circadian disruption in animal models drives microglia into a stress‑primed, inflammatory state,...

By Longevity.Technology
STAT+: The FDA, Urged to Avoid Controversy, Creates a New Headache with Attack Against UniQure
NewsMar 6, 2026

STAT+: The FDA, Urged to Avoid Controversy, Creates a New Headache with Attack Against UniQure

The FDA staged a media call where an anonymous senior official publicly criticized UniQure’s experimental Huntington’s disease gene therapy. The official, identified only as a practicing hematology‑oncology professor, framed his comments as serving the public interest while hinting at personal...

By STAT (Biotech)
Recapping AAAAI 2026: Updates on Remibrutinib and Innovative Treatments for Food Allergy, Atopic Disease, Asthma
NewsMar 6, 2026

Recapping AAAAI 2026: Updates on Remibrutinib and Innovative Treatments for Food Allergy, Atopic Disease, Asthma

At AAAAI 2026, Novartis presented data confirming remibrutinib’s rapid and sustained efficacy in chronic spontaneous urticaria, with a 25 mg BID dose delivering significant UAS7 reductions. Phase 2 trials also demonstrated the BTK inhibitor’s potential in peanut allergy, achieving 86.7% tolerance at...

By Pharmacy Times
Cognito Raises $105M to Bring Alzheimer’s Treatment Device to Market
NewsMar 6, 2026

Cognito Raises $105M to Bring Alzheimer’s Treatment Device to Market

Cognito Therapeutics secured $105 million in Series C financing to advance its Spectris device, a non‑invasive light and sound system targeting Alzheimer’s disease. Early trials showed modest cognitive benefits despite no amyloid reduction, prompting a larger pivotal study with about...

By MedTech Dive
Building an AI-Driven 'ChatGPT of Human DNA'
NewsMar 6, 2026

Building an AI-Driven 'ChatGPT of Human DNA'

Mount Sinai, the ARC Innovation Center, and Nvidia have announced a joint effort to develop AI models capable of decoding the human genome. Leveraging Nvidia’s GPU platforms and large‑scale machine‑learning frameworks, the partnership will create tools that translate raw DNA...

By Healthcare Finance News (HIMSS Media)
Upping the Profiling of Chemical Exposures in the Omics Sciences
NewsMar 6, 2026

Upping the Profiling of Chemical Exposures in the Omics Sciences

Panome Bio, a multi‑omics contract research organization, unveiled an exposomics service platform that pairs untargeted Discovery Exposomics with targeted quantification of priority chemicals. The Discovery workflow leverages the MassID™ engine and a 32,000‑compound database to profile environmental exposures without prior...

By GEN (Genetic Engineering & Biotechnology News)
STAT+: Servier to Acquire Day One, Maker of Pediatric Cancer Drug, for $2.5B
NewsMar 6, 2026

STAT+: Servier to Acquire Day One, Maker of Pediatric Cancer Drug, for $2.5B

Servier announced a $2.5 billion cash deal to acquire Day One Biopharmaceuticals, paying $21.50 per share—a 68% premium to the biotech’s closing price. The acquisition centers on Day One’s Ojemda, the first FDA‑approved therapy for pediatric low‑grade glioma, the most common...

By STAT (Biotech)
J&J Wins Third National Priority Approval for Multiple Myeloma Combo
NewsMar 6, 2026

J&J Wins Third National Priority Approval for Multiple Myeloma Combo

Johnson & Johnson’s Tecvayli and Darzalex combination received FDA approval for second‑line multiple myeloma treatment, marking the third drug cleared under the Commissioner’s National Priority Voucher (CNPV) program. The decision was rendered in just 55 days after J&J’s filing, thanks...

By BioSpace
Arginine Polymerization Boosts Anti‐Inflammatory Effects and DNA Nanostructure‐Assisted siRNA Delivery in Acute Respiratory Distress Syndrome
NewsMar 6, 2026

Arginine Polymerization Boosts Anti‐Inflammatory Effects and DNA Nanostructure‐Assisted siRNA Delivery in Acute Respiratory Distress Syndrome

Researchers discovered that polymerizing arginine amplifies its anti‑inflammatory activity, with longer polyarginine chains upregulating IL‑4 expression. An arginine trimer (3R) can self‑assemble DNA nanotubes without magnesium, serving both as a cell‑penetrating prodrug and a delivery scaffold for p65 siRNA. The...

By Small (Wiley)