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Merck Secures FDA Approval for Subcutaneous Keytruda to Sustain Market Edge
Merck received FDA clearance for a new subcutaneous formulation of Keytruda, its blockbuster cancer immunotherapy. This novel delivery method aims to improve patient convenience and maintain...
Dualitas Raises $65 Million to Advance Bispecific Drugs for Autoimmune Diseases
San Francisco-based Dualitas Therapeutics has secured $65 million in a Series A funding round to develop bispecific antibodies that engage two targets on the same immune cell, enhancing...
Genomic Insights Link Oral Microbiome to Elevated Pancreatic Cancer Risk
A landmark prospective study analyzing oral microbiomes of over 122,000 participants identified 27 bacterial and fungal species associated with a 3.5-fold increased risk of pancreatic cancer. The...
Roche Acquires 89bio for $2.4 Billion, Expanding in Liver Disease Therapeutics
Roche announced a definitive agreement to acquire 89bio, securing pegozafermin, a late-stage FGF21 analogue in Phase III trials for moderate to severe metabolic dysfunction-associated...
Endpoints 11 Spotlights Biotech Innovators Driving Next-Gen Therapeutics
The prestigious Endpoints 11 recognizes eleven private biotech companies distinguished by rapid innovation across diverse modalities including AI-driven drug discovery, in vivo CAR-T therapies,...
CDC Vaccine Panel Alters COVID-19 and Childhood Vaccine Recommendations
The CDC’s Advisory Committee on Immunization Practices (ACIP), recently reshaped by Appointee RFK Jr., postponed a vote on delaying the newborn hepatitis B vaccine and voted to remove the...
AI Advances in Healthcare Enable Multi-Disease Prediction and Drug Discovery
Innovations in artificial intelligence are transforming healthcare with tools like Delphi-2M, an AI model predicting over 1,000 disease risks decades ahead using patient health records and...
Latest Regulatory Movements: FDA Rescinds LDT Rule, New Device Clearances
The FDA has officially rescinded the rule expanding its authority over laboratory-developed tests following a federal court decision, reverting oversight to prior regulations. Meanwhile, novel...
FDA Approves Subcutaneous Keytruda to Extend Blockbuster's Market Life
The US Food and Drug Administration granted approval for a new subcutaneous formulation of Merck's Keytruda cancer therapy, aiming to prolong the commercial competitiveness of the world's leading...
Roche Acquires 89bio for $3.5 Billion to Boost Metabolic Liver Disease Portfolio
Roche AG announced a $3.5 billion deal to acquire 89bio Inc., securing the rights to pegozafermin, a late-stage FGF21 analogue in Phase III development targeting metabolic dysfunction-associated...
Dualitas Therapeutics Raises $65 Million for Bispecific Immunology Drug Development
Bay Area startup Dualitas Therapeutics secured $65 million in Series A funding to advance its bispecific antibody platform designed to target two receptors on the same immune cell, aiming to...
CDC Vaccine Panel Postpones Vote on Delaying Newborn Hepatitis B Vaccine
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices deferred voting on a proposal to delay the first hepatitis B vaccine dose for infants born to mothers...
Oral Microbiome Species Linked to Elevated Pancreatic Cancer Risk
A large study led by NYU Langone Health identified a set of 27 bacterial and fungal oral species associated with a 3.5-fold increased risk of pancreatic cancer. Using metagenomic sequencing of...
Luxa Biotechnology Reports Vision Gains in Dry AMD Stem Cell Trial
Luxa Biotechnology published Phase 1/2a clinical trial data showing promising safety and efficacy of its adult retinal pigment epithelial stem cell (RPESC-RPE) transplantation in dry age-related...
Emerging AI Tool Forecasts Development of Over 1,200 Diseases Up to 20 Years Ahead
Researchers have developed Delphi-2M, an artificial intelligence model that integrates electronic health records and lifestyle data to predict individual risks for more than 1,200 diseases decades...
Advanced CRISPR Activation Restores Gene Expression in SCN2A Neurodevelopmental Disorder Model
Scientists at the University of California, San Francisco demonstrated that CRISPR activation technology can upregulate the functional SCN2A gene copy in mice with haploinsufficiency, a condition...
Cellares Unveils Automated Cell Therapy QC Platform with Strategic Partnerships
Cellares introduced the Cell Q, an automated quality control platform designed to match commercial-scale throughput demands in cell therapy manufacturing. The system integrates advanced...
Immunotherapy Advances in Hematology: Regeneron’s Lynozyfic Shows 100% Response in Smoldering Myeloma
Regeneron reported compelling early results for Lynozyfic, a T cell engager therapy, achieving complete response in all participants in a small study for smoldering multiple myeloma, a precursor...
FDA Approves Subcutaneous Keytruda: Merck's Bid to Extend Blockbuster Life
Merck secured FDA approval for a subcutaneous formulation of Keytruda, the company's leading cancer immunotherapy drug. This new delivery method is designed to improve patient convenience while...
Roche Acquires 89bio for $2.4 Billion to Target MASH Liver Disease
Roche announced the acquisition of biotech firm 89bio in a deal valued up to $3.5 billion, including upfront and milestone payments. The deal centers on 89bio's lead asset pegozafermin, an...