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FDA Drops Safety Monitoring for CAR-T Therapies to Expand Patient Access
The U.S. Food and Drug Administration (FDA) has eliminated the Risk Evaluation and Mitigation Strategies (REMS) safety monitoring requirements for all approved CAR-T cell therapies. This...
Alphabet’s Calico Signs $596M Deal for Mabwell’s IL-11 Therapeutic Program
Calico Life Sciences, backed by Alphabet, has secured exclusive global rights (outside China) to Mabwell Bioscience’s IL-11 targeting monoclonal antibody 9MW3811 in a deal worth up to $596 million...
St. Jude's ColdBrew Algorithm Illuminates Water's Role in Drug Design
Researchers at St. Jude Children’s Research Hospital have developed ColdBrew, a novel computational algorithm that more accurately models the presence and behavior of water molecules within...
New Genetic Dimmer Switch Discovered Regulating Embryonic Development Gene Cdx2
Scientists at the MRC London Institute of Medical Sciences have identified a novel DNA element functioning as a temporal 'dimmer switch' that precisely attenuates expression of the critical...
Plus Therapeutics Set to Relaunch CNSide Test for Central Nervous System Cancer
Plus Therapeutics plans to relaunch the CNSide cerebrospinal fluid assay, a diagnostic test for leptomeningeal metastases in the central nervous system (CNS), which detects circulating tumor cells...
FDA Regulatory Changes Signal Shift for Rare Disease and CAR-T Development
The FDA is undergoing significant regulatory evolution with landmark reviews illuminating policies for rare disease therapies, including biomarker-based accelerated approvals for orphan drugs....
Wholomics Advances Multi-Cancer Detection Through Metabolomic Signatures
Wholomics, a biotech startup founded by researchers from Dana Farber and University College London, revealed early data demonstrating its nuclear magnetic resonance-based metabolomic platform's...
Molecular Findings Link Citrate Transporter Mutations to Severe Epilepsy
Researchers at CeMM Research Center for Molecular Medicine have comprehensively characterized the function and structure of the citrate transporter SLC13A5, elucidating how mutations result in a...
Emerging Technologies in Biotech: Single Nanoparticle Analysis Enhances CAR-T Development
NanoFCM's single-molecule NanoAnalyzer technology is advancing in vivo CAR-T therapy development by enabling detailed characterization of lipid nanoparticles (LNPs) used for targeted delivery. The...
Qiagen Expands Clinical Digital PCR Menu through Partnership Program
Qiagen has launched a digital PCR partnership program to accelerate the development of innovative assays for its QiAcuityDx clinical platform. After registering its first partner, Gencurix, Qiagen...
FDA Eases CAR-T Therapy Restrictions to Expand Access
The U.S. Food and Drug Administration (FDA) has significantly relaxed regulatory requirements for CAR-T cell therapies, eliminating the mandated Risk Evaluation and Mitigation Strategies (REMS)...
Alphabet’s Calico Seals $596M Deal for Anti-Aging Candidate
Calico Life Sciences, backed by Alphabet, has entered into a deal valued up to $596 million with Mabwell Bioscience to acquire exclusive rights to investigational IL-11 targeting therapeutics,...
Breakthrough Genetic Regulation Mechanism Discovered in Embryo Development
Researchers at the MRC London Institute of Medical Sciences have identified a unique DNA element that functions as a 'dimmer switch' to finely control the temporal expression of the critical gene...
New Computational Tool Illuminates Water’s Role in Drug Discovery
Scientists at St. Jude Children’s Research Hospital have unveiled ColdBrew, a novel computational algorithm that models protein-bound water molecules under physiological conditions. This method...
Multi-Cancer Early Detection via Metabolomic Profiling Gains Momentum
Startup Wholomics has introduced a metabolomic platform employing nuclear magnetic resonance technology to detect cancer signatures across a broad spectrum of tumor types in serum samples. Unlike...
Pioneering Organoid Model Simulates Chemotherapy Response in Esophageal Cancer
Researchers led by Donald Ingber and Lorenzo Ferri have developed an advanced organ chip platform that integrates patient-derived organoids with elements of the tumor microenvironment to predict...
FDA Policy Shifts Spur Debate over Rare Disease Drug Approvals
Upcoming landmark decisions and reviews of the FDA’s rare disease policies will test the agency’s stance on biomarker-based accelerated approvals for orphan drugs. Regulatory unpredictability...
Unveiling the Role of PTGIR Immune Checkpoint in Cancer Immunotherapy
A collaborative study from Van Andel Institute uncovers PTGIR, a prostacyclin receptor, as a novel immune checkpoint regulating CD8+ T cell exhaustion in cancer. PTGIR engagement by prostacyclin...
Insights into Childhood Overweight Trends in China Signal Rising Health Crisis
A comprehensive longitudinal study published in the International Journal of Obesity documents a persistent increase in childhood overweight and obesity rates across all Chinese provinces from...
Major Biopharma Executive Moves and Industry Investments Highlighted
Recent appointments include Martin Stumpe named as Danaher’s Chief Technology and AI Officer, and Marjorie Green joining NeoGenomics’ board with a strong oncology development background. Qiagen’s...