Know What's Happening in BioTech

China’s Rapid Dead-Virus Vaccines Match Severe-Case Protection
SocialMay 9, 2026

China’s Rapid Dead-Virus Vaccines Match Severe-Case Protection

small point, but the record time is a bit of exaggeration. China developed two old-fashioned dead virus vaccines in roughly the same time-frame. They were less effective in preventing the original strain, but comparably effective in preventing serious illness and...

By Dean Baker
New Combo Shows Promise for Unknown Primary Cancer
NewsMay 9, 2026

New Combo Shows Promise for Unknown Primary Cancer

Researchers reported phase II results of the Fudan CUP‑002 trial, which combines an anti‑PD‑1 checkpoint inhibitor, nab‑paclitaxel chemotherapy, and bevacizumab anti‑angiogenic therapy for cancer of unknown primary (CUP). The triplet achieved higher objective response rates and longer progression‑free survival than historical...

By Bioengineer.org
Engaging Older Adults in Pragmatic Trial Research
NewsMay 9, 2026

Engaging Older Adults in Pragmatic Trial Research

A 2026 multi‑methods study published in BMC Geriatrics examined how researchers involve older adults in pragmatic clinical trials. Using interviews, focus groups and surveys, the authors identified facilitators such as dedicated PPI coordinators and barriers like limited funding and absent...

By Bioengineer.org
StuffThatWorks Hires Veteran CRO Exec Caroline Redeker as Chief Commercial Officer
NewsMay 9, 2026

StuffThatWorks Hires Veteran CRO Exec Caroline Redeker as Chief Commercial Officer

StuffThatWorks announced the appointment of Caroline Redeker as Chief Commercial Officer. The veteran CRO leader will steer commercialization of the company’s AI‑native patient‑generated data platform, which now spans over 3 million patients and 1.3 billion data points, aiming to halve trial timelines.

By Pulse
Regeneron Secures FDA Accelerated Approval for First Neurosensory Gene Therapy
NewsMay 9, 2026

Regeneron Secures FDA Accelerated Approval for First Neurosensory Gene Therapy

Regeneron Pharmaceuticals has won FDA accelerated approval for Otarmeni, the first in‑vivo gene therapy aimed at restoring hearing in patients with OTOF‑related sensorineural loss. The decision, based on a Phase I/II CHORD trial of 20 children, makes the treatment free...

By Pulse
Asthma Medication Formoterol Shows Promise for Treating Fatty Liver Disease
NewsMay 9, 2026

Asthma Medication Formoterol Shows Promise for Treating Fatty Liver Disease

Researchers at the Medical University of South Carolina found that the asthma drug formoterol reverses fatty liver in mouse models of metabolic dysfunction‑associated steatohepatitis (MASH) and is linked to lower liver‑related complications in retrospective patient data. The β‑2 adrenergic agonist...

By News-Medical.Net
Beacon Biosignals Launches At-Home Sleep EEG Platform for Brain Health Diagnostics
NewsMay 9, 2026

Beacon Biosignals Launches At-Home Sleep EEG Platform for Brain Health Diagnostics

Boston‑based Beacon Biosignals introduced an at‑home sleep EEG platform that uses a lightweight headband to capture clinical‑grade brain activity while users sleep. The FDA‑cleared device is already deployed in more than 40 global clinical trials, positioning the company to reshape...

By Pulse
FDA Pushes Leqembi Subcutaneous Start‑Dose Review to Aug. 24, 2026
NewsMay 9, 2026

FDA Pushes Leqembi Subcutaneous Start‑Dose Review to Aug. 24, 2026

Eisai and Biogen announced that the U.S. FDA has extended the PDUFA deadline for Leqembi® Iqlik™ as a starting dose for early Alzheimer’s disease by three months, moving the decision date to Aug. 24, 2026. The agency cited a major amendment...

By Pulse
FDA Clears Fruit‑Flavored Vapes From Glas Inc., Citing Age‑Gate Technology
NewsMay 9, 2026

FDA Clears Fruit‑Flavored Vapes From Glas Inc., Citing Age‑Gate Technology

The U.S. Food and Drug Administration approved the marketing of fruit‑flavored e‑cigarette pods made by Los Angeles‑based Glas Inc., citing built‑in age‑verification technology as a safeguard. The decision, the first of its kind, follows reported pressure from the Trump administration and...

By Pulse
Reedley Lab Operator Convicted for $3.8 Million COVID Test Fraud
NewsMay 9, 2026

Reedley Lab Operator Convicted for $3.8 Million COVID Test Fraud

Jia Bei Zhu, the operator of a Reedley biolab, was convicted of a $3.8 million fraud scheme that sold mislabeled COVID‑19 test kits as U.S.-made. The verdict underscores weaknesses in oversight of small medical‑device firms and raises questions about future enforcement.

By Pulse
University of Michigan Unveils CRYSTAL Nanoassembly to Safely Activate STING in Cancer Therapy
NewsMay 9, 2026

University of Michigan Unveils CRYSTAL Nanoassembly to Safely Activate STING in Cancer Therapy

A joint team from the University of Michigan College of Pharmacy and MD Anderson Cancer Center announced CRYSTAL, a manganese‑based nanoassembly that activates the STING pathway at low doses while avoiding systemic inflammation. Preclinical tests in triple‑negative breast cancer showed...

By Pulse
IBM Quantum Simulates 12,635‑Atom Protein Complex, Claiming 210‑Fold Accuracy Boost
NewsMay 9, 2026

IBM Quantum Simulates 12,635‑Atom Protein Complex, Claiming 210‑Fold Accuracy Boost

IBM Research announced at the 2026 Think conference that its quantum hardware, together with classical supercomputers, simulated a 12,635‑atom protein complex, delivering a 210‑fold accuracy improvement over prior quantum‑centric methods. The breakthrough, demonstrated with partners Cleveland Clinic, RIKEN and Oak...

By Pulse
LSD Microdosing Linked to Acute Mood Improvements in Adults with Depression
NewsMay 9, 2026

LSD Microdosing Linked to Acute Mood Improvements in Adults with Depression

A small open‑label pilot gave 19 adults with major depressive disorder sublingual LSD microdoses (4‑20 µg) over eight weeks. Participants reported acute spikes in creativity, energy and social connectedness on dosing days, with a 60% average reduction in overall depression severity...

By PsyPost
Integrating Cell-Type-Specific Gene Expression and Genome-Wide Associations Identifies Risk Genes for Schizophrenia
NewsMay 9, 2026

Integrating Cell-Type-Specific Gene Expression and Genome-Wide Associations Identifies Risk Genes for Schizophrenia

A new multi‑omics study combines single‑cell expression quantitative trait loci (eQTL) from distinct brain cell types with the largest schizophrenia genome‑wide association studies to pinpoint dozens of candidate risk genes. By colocalizing cell‑type‑specific eQTL signals with GWAS loci, the researchers...

By Nature (Biotechnology)
The BioPharm Brief: Bispecifics, Biocatalysis, and Dual-Pathway Therapies
NewsMay 8, 2026

The BioPharm Brief: Bispecifics, Biocatalysis, and Dual-Pathway Therapies

Harbour BioMed has secured FDA clearance to start a Phase I trial of its B7H4×CD3 bispecific antibody, HBM7004, in patients with advanced solid tumors. Merck published a scalable biocatalytic process for its oral PCSK9 inhibitor, enlicitide decanoate, showcasing a new route...

By BioPharm International
The Gates Foundation Is Funding A Startup’s Plan To Fight Malnutrition With Bacteria
NewsMay 8, 2026

The Gates Foundation Is Funding A Startup’s Plan To Fight Malnutrition With Bacteria

The Bill & Melinda Gates Foundation has pledged new funding to Kanvas Biosciences to develop a synthetic microbiome pill aimed at treating environmental enteric dysfunction (EED), a gut‑inflammation disease that threatens roughly 150 million children worldwide. Kanvas uses machine‑learning‑driven microbiome mapping to...

By Forbes – Healthcare
Odyssey Completes Journey to NASDAQ: Public Equity Report
NewsMay 8, 2026

Odyssey Completes Journey to NASDAQ: Public Equity Report

Odyssey Therapeutics completed its long‑awaited IPO and debuted on Nasdaq, after withdrawing a previous filing in June 2025. The immunology‑focused company priced its shares in early May 2026, marking a successful market entry. At the same time, three biotech firms—Cytokinetics,...

By BioCentury
Tr1X: Inducing Long-Term Immune Tolerance with Allogeneic Tr1 Cells
NewsMay 8, 2026

Tr1X: Inducing Long-Term Immune Tolerance with Allogeneic Tr1 Cells

BioCentury has updated its website privacy framework, detailing the use of strict, functional, marketing, advertising, and analytics cookies. The policy explains that essential cookies enable authentication, registration, and navigation, while functional cookies enhance personalization. Marketing and advertising cookies are used...

By BioCentury
Brain Stimulation Boosts Willpower to Quit Smoking
NewsMay 8, 2026

Brain Stimulation Boosts Willpower to Quit Smoking

A double‑blind, fMRI‑guided trial found that high‑frequency rTMS targeting the left dorsolateral prefrontal cortex (DLPFC) cut smokers’ daily consumption by about 11 cigarettes, outperforming sham and orbitofrontal cortex stimulation. The 15‑session protocol boosted prefrontal activity while suppressing reward‑related regions, correlating...

By Neuroscience News
How to Build a Single-Cell RNA-Seq Analysis Pipeline with Scanpy for PBMC Clustering, Annotation, and Trajectory Discovery
NewsMay 8, 2026

How to Build a Single-Cell RNA-Seq Analysis Pipeline with Scanpy for PBMC Clustering, Annotation, and Trajectory Discovery

The tutorial walks through a full Scanpy pipeline applied to the PBMC‑3k benchmark, covering quality control, doublet removal, normalization, variable‑gene selection, dimensionality reduction, clustering, and cell‑type annotation. It then extends the analysis with PAGA‑based trajectory inference, diffusion pseudotime, and a...

By MarkTechPost
FDA Approves Ocrevus for Relapsing-Remitting MS in Children Aged 10 Years and Up
NewsMay 8, 2026

FDA Approves Ocrevus for Relapsing-Remitting MS in Children Aged 10 Years and Up

The U.S. Food and Drug Administration has approved Genentech's ocrelizumab (Ocrevus) for children aged 10 and older who weigh at least 55 lb, expanding its use beyond adult multiple sclerosis (MS) populations. The decision follows the OPERETTA II trial, which demonstrated superior...

By Healio
Addressing Manufacturing and Access Barriers in Advanced Therapeutics
NewsMay 8, 2026

Addressing Manufacturing and Access Barriers in Advanced Therapeutics

Advanced cell and gene therapies are moving from research to commercial markets, but their complex manufacturing creates variability that delays patient access. Industry leaders are deploying process analytical technologies (PAT) and artificial intelligence (AI) to gain real‑time insight and predictive...

By BioPharm International
Economic Assistance and Incentives for Drug Development
NewsMay 8, 2026

Economic Assistance and Incentives for Drug Development

The FDA and other federal agencies offer a suite of pre‑approval assistance and post‑approval incentives to lower the financial risk of drug development. Programs such as the Orphan Products Grant, SBIR/STTR funding, and PDUFA fee waivers help sponsors fund clinical...

By FDA
GlycanAge to Launch Inflammaging Conference in Dubrovnik, Targeting Clinical Use
NewsMay 8, 2026

GlycanAge to Launch Inflammaging Conference in Dubrovnik, Targeting Clinical Use

GlycanAge, together with the Mayo Clinic, announced a landmark conference in Dubrovnik, Croatia, opening June 19 with a dedicated clinical day on June 20. The event aims to turn 25 years of inflammaging research into actionable diagnostics for doctors and patients.

By Pulse
AstraZeneca and Daiichi Sankyo Secure Earlier‑Line Enhertu Approvals in South Korea
NewsMay 8, 2026

AstraZeneca and Daiichi Sankyo Secure Earlier‑Line Enhertu Approvals in South Korea

AstraZeneca and Daiichi Sankyo announced that South Korea’s Ministry of Food and Drug Safety approved Enhertu for first‑line metastatic HER2‑positive breast cancer and second‑line HER2‑positive gastric cancer. The decisions, based on DESTINY‑Breast09 and DESTINY‑Gastric04 trials, could broaden the drug’s Asian...

By Pulse
Odyssey’s IPO Brings In $304M for Quest to Develop Better Immunology Drugs
NewsMay 8, 2026

Odyssey’s IPO Brings In $304M for Quest to Develop Better Immunology Drugs

Odyssey Therapeutics priced 15.5 million shares at $18, raising $304 million including a $25.2 million private placement. The funds will finance Phase 2a/2b trials of OD‑001, an oral RIPK2 inhibitor for ulcerative colitis, and advance OD‑002, a SLC15A4 inhibitor, toward Phase 1/2a. Odyssey’s platform targets...

By MedCity News
Precision Neuroscience CEO on Medtronic Partnership, What's Next
NewsMay 8, 2026

Precision Neuroscience CEO on Medtronic Partnership, What's Next

Precision Neuroscience CEO Michael Mager announced a partnership with Medtronic to commercialize a reversible brain‑computer interface (BCI) that lets paralyzed users control digital devices with thought. The company has temporarily implanted 83 devices in volunteers under FDA clearance and is...

By Bloomberg – Markets
Entera Announces First Quarter 2026 Financial Results and Updates Across Its Oral Peptide Programs
NewsMay 8, 2026

Entera Announces First Quarter 2026 Financial Results and Updates Across Its Oral Peptide Programs

Entera Bio reported Q1 2026 results, highlighting a streamlined Phase 3 protocol for its lead osteoporosis candidate EB613 and a completed Phase 1 bridging study that positions a single‑tablet formulation for the upcoming trial. The company also advanced its partnership with OPKO, securing...

By GlobeNewswire – Earnings Releases
Family Offices Surge in April, Allocating One‑Third of Deals to Health‑Tech
NewsMay 8, 2026

Family Offices Surge in April, Allocating One‑Third of Deals to Health‑Tech

Family offices stepped up deal‑making in April, completing 55 direct investments—up from 39 in March—and earmarked almost a third of those for healthcare and life‑science firms. The rebound follows a slowdown triggered by the Iran conflict and reflects a growing...

By Pulse
FDA Grants National Priority Voucher to Partner Therapeutics' BIZENGRI for Rare Liver Cancer
NewsMay 8, 2026

FDA Grants National Priority Voucher to Partner Therapeutics' BIZENGRI for Rare Liver Cancer

Partner Therapeutics announced that the FDA awarded a Commissioner’s National Priority Voucher for its bispecific antibody BIZENGRI, targeting NRG1‑positive cholangiocarcinoma. The voucher could cut review time to as little as two months, accelerating a therapy for an ultra‑rare liver cancer...

By Pulse
Building New Tools Is Valid Even When Alternatives Exist
SocialMay 8, 2026

Building New Tools Is Valid Even When Alternatives Exist

I've never been a fan of the argument of "why build y if x already exists?" That's a silly stance to hold. "Why do people keep making new car brands? We got plenty of cars on the road already..." I'm gonna make...

By Sebastian Cocioba
The $1 Trillion Cardiovascular Reset
BlogMay 8, 2026

The $1 Trillion Cardiovascular Reset

The blog highlights Eli Lilly's $1.3 billion acquisition of Verve Therapeutics, targeting a one‑shot PCSK9 gene‑editing therapy that could replace daily statins. It underscores the massive adherence problem—up to 75% of statin users stop within two years—and the untapped 1.4 billion‑person market for...

By Macro Notes
[Comment] Could Enpatoran Add to Our Therapeutic Toolbox in SLE?
NewsMay 8, 2026

[Comment] Could Enpatoran Add to Our Therapeutic Toolbox in SLE?

Systemic lupus erythematosus (SLE) remains a heterogeneous disease with only two novel agents—BAFF and type‑1 interferon receptor inhibitors—approved since the 1950s. These drugs often fall short as stand‑alone treatments, are expensive, and are not uniformly accessible worldwide. Clinicians continue to...

By The Lancet (Current)
[Comment] RTS,S/AS01 Implementation Reduces Mortality in African Children
NewsMay 8, 2026

[Comment] RTS,S/AS01 Implementation Reduces Mortality in African Children

A recent Lancet analysis shows that the RTS,S/AS01 (Mosquirix) malaria vaccine rollout in Ghana, Kenya and Malawi cut child mortality by roughly 20% after three years of implementation. The program reached over five million children under five, integrating the vaccine...

By The Lancet (Current)
Electrospinning of Hydroxypropyl Chitosan Nanofibers for Bone Regeneration Application
NewsMay 8, 2026

Electrospinning of Hydroxypropyl Chitosan Nanofibers for Bone Regeneration Application

Researchers electrospun nanofiber mats using hydroxypropyl chitosan (HPCH) and poly(vinyl alcohol) (PVA) in varying ratios to assess osteoconductive potential in MC3T3 pre‑osteoblast cells. Characterization by SEM, FT‑IR and mechanical testing confirmed uniform fiber formation. Biological assays showed that a 50/50...

By Research Square – News/Updates
FDA Issues Most Serious Recall for Certain Pacemaker Devices by Boston Scientific
NewsMay 8, 2026

FDA Issues Most Serious Recall for Certain Pacemaker Devices by Boston Scientific

The FDA issued a Class I recall for Boston Scientific’s ACCOLADE pacemakers and cardiac resynchronization therapy models after detecting a software‑related battery flaw that can trigger Safety Mode and limit pacing. The agency advises clinicians to install a software upgrade during...

By AHA News – American Hospital Association
Glint of Light in Therapy for Deadly ALS After Decades of Struggle
NewsMay 8, 2026

Glint of Light in Therapy for Deadly ALS After Decades of Struggle

Researchers reported that tofersen, an antisense oligonucleotide targeting the SOD1 gene, dramatically slowed and even reversed disease progression in a subset of ALS patients with the rare SOD1 mutation. The phase‑III trial, published in JAMA Neurology, showed about a quarter...

By Harvard Gazette – Science & Health/Mind Brain Behavior
Pharma Company Planning $280M Denton Plant
NewsMay 8, 2026

Pharma Company Planning $280M Denton Plant

Novartis broke ground on a new 46,000‑square‑foot manufacturing facility in Denton, Texas, investing roughly $280 million. The plant will specialize in producing radioligand therapy drugs, a targeted radiation treatment for advanced cancers. Scheduled to open in 2028, it will be Novartis’s...

By Connect CRE
We’ve Launched the Most AI‑discovered Longevity Drugs
SocialMay 8, 2026

We’ve Launched the Most AI‑discovered Longevity Drugs

This is cool. Not sure why you need so much money if you are making drugs faster and cheaper. But it is great - maybe I should be thinking about raising more to scale. At the end of the day,...

By Alex Zhavoronkov, PhD
Smart Homes Integrated with Biotech Extend Lifespan
SocialMay 8, 2026

Smart Homes Integrated with Biotech Extend Lifespan

A bigger house is not going to give you significantly longer life. But a much smarter house integrated into the advanced biotechnology research and clinical ecosystem will. Very happy to see our chapter with CY Leung published in Springer Nature...

By Alex Zhavoronkov, PhD
Inclisiran Linked to Lower MACE, AMI Rates in High-Risk ASCVD Population
NewsMay 8, 2026

Inclisiran Linked to Lower MACE, AMI Rates in High-Risk ASCVD Population

Inclisiran, added to maximally tolerated statins, lowered 4‑point major adverse cardiovascular events (MACE) from 22.7% to 14.6% in a real‑world ASCVD cohort. The therapy also reduced acute myocardial infarction (5.0% vs 8.5%) and all‑cause hospitalizations (20.8% vs 28.8%) over one...

By AJMC (The American Journal of Managed Care)
Billion-Dollar Ideas Lurk in Free PubMed Data
SocialMay 8, 2026

Billion-Dollar Ideas Lurk in Free PubMed Data

Martin Shkreli came on MFM a while back and told Shaan and I something interesting: PubMed has 40M+ biomedical papers. It's the government database of every medical innovation ever logged. And it's 100% free. He told us if you sit there and read long...

By Sam Parr
Taking a Look at the Toxicity Trade-Offs of EPCORE FL-1
NewsMay 8, 2026

Taking a Look at the Toxicity Trade-Offs of EPCORE FL-1

The phase 3 EPCORE FL‑1 trial added AbbVie/Genmab’s bispecific antibody epcoritamab to the rituximab‑lenalidomide (R²) regimen for relapsed or refractory follicular lymphoma. The triplet produced a 79% reduction in progression‑or‑death risk and lifted 16‑month progression‑free survival to 85.5%, nearly doubling the complete...

By AJMC (The American Journal of Managed Care)
Multimodal Remote Digital Phenotyping for Detecting and Tracking Early Parkinsonian Change in LRRK2 Carriers
NewsMay 8, 2026

Multimodal Remote Digital Phenotyping for Detecting and Tracking Early Parkinsonian Change in LRRK2 Carriers

Researchers introduced a remote, multimodal video platform to phenotype Parkinson’s disease risk in LRRK2 gene carriers. The study analyzed 829 participants, including 158 carriers, and achieved 92.9% accuracy (AUROC 0.92, AUPRC 0.82) in distinguishing non‑manifest carriers from controls. A continuous “PD Weigh‑In” score...

By Research Square – News/Updates
Mabwell IPO Highlights China’s Rising Biologics Powerhouse
SocialMay 8, 2026

Mabwell IPO Highlights China’s Rising Biologics Powerhouse

Do you remember the company which sold their IL11 nanobody to Google Calico after it realized that after 13 years in the business they need a drug for aging? The company is called Mabwell and they just listed in Hong...

By Alex Zhavoronkov, PhD
Gene Therapy Restores Six-Year-Old's Sight Like Magic
SocialMay 8, 2026

Gene Therapy Restores Six-Year-Old's Sight Like Magic

The mother of a six-year-old girl who had life-changing eye gene therapy says it is "like someone waved a magic wand and restored her sight https://t.co/IU3YRMtJSG

By Liz Parrish
INBX to Release INBRX‑106 Phase 2 Data Monday
SocialMay 8, 2026

INBX to Release INBRX‑106 Phase 2 Data Monday

$INBX reporting INBRX-106 ph2 data on Monday. This is the ox40 cancer drug that reportedly drew interest from Merck and others?

By Adam Feuerstein
MRNA Nanoparticles Reprogram T Cells In Vivo, Show Promise
SocialMay 8, 2026

MRNA Nanoparticles Reprogram T Cells In Vivo, Show Promise

Impressive. In vivo reprogramming of killer T cells with mRNA-nanoparticle packaging in non-human primates. Multiple use cases in the clinic vs pathogens and cancer, no less an alternative version vs autoimmune diseases https://t.co/ddhebnxvkE @SciImmunology

By Eric Topol
Patents Aren't the Magic Key to Drug Development
SocialMay 8, 2026

Patents Aren't the Magic Key to Drug Development

The $3 billion number is hokey for a number of reasons, but the point is that there is not some magical sauce that allows for drugs to be developed when financed by patent monopolies, but not by upfront funding.

By Dean Baker