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FDA Faces Scrutiny Over KalVista Drug Review and Regulatory Uncertainty
FDA Commissioner Marty Makary reportedly attempted to intervene to block approval of KalVista Pharmaceuticals' rare disease therapy, raising concerns about agency independence under new...
Alphabet's Calico Seals $596M Deal for Mabwell’s Anti-Aging Therapeutics
Alphabet’s Calico Life Sciences has secured exclusive global rights, excluding greater China, to develop and commercialize Mabwell Bioscience’s investigational IL-11 targeted monoclonal antibody,...
Incyte Names Bill Meury CEO as Hoppenot Steps Down
Incyte has appointed Bill Meury as its new Chief Executive Officer, succeeding Hervé Hoppenot after an 11-year tenure. Meury brings leadership experience from Anthos Therapeutics and Karuna...
FDA Eases Restrictions on CAR-T Therapies to Boost Access
The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) requirements for CAR-T therapies targeting BCMA and CD19 proteins, easing safety monitoring and expanding treatment...
AI Models Aim to Revolutionize Virtual Cell Prediction in Biology
The Arc Institute has launched the Virtual Cell Challenge, a competition incentivizing development of AI models that predict gene expression responses to genetic perturbations across diverse...
Breakthrough in Spinal Cord Injury Recovery Using Electric Field Therapy
A novel study demonstrates that daily application of controlled electric fields significantly improves functional recovery after spinal cord injury in rats. The therapy, initiated within hours of...
Novel RNA Codon Expansion Platform Enables Precise Protein Engineering in Mammalian Cells
Researchers at Peking University have developed a new platform leveraging programmable pseudouridine modifications to expand the genetic code without disrupting natural stop codon functions. By...
Wholomics Develops Metabolomic Platform for Multi-Cancer and Single Tumor Detection
Wholomics, a startup formed by researchers from Dana Farber and University College London, unveiled early data on its nuclear magnetic resonance–based assay detecting metabolic signatures in serum...
Breakthrough Genetic ‘Dimmer Switch’ Regulates Mammalian Embryo Development Timing
Scientists at the MRC London Institute of Medical Sciences identified a dual enhancer-attenuator element controlling the transient expression of the critical developmental gene Cdx2 during early...
Novartis and ProFound Therapeutics Partner to Unlock Cardiovascular Targets
Novartis entered a strategic four-year collaboration with ProFound Therapeutics to leverage the latter’s ProFoundry platform for multi-layered proteomic data integration, aiming to discover novel...
Russian judiciary rules against CVS in $95M false claims case
A federal court in Pennsylvania ruled that CVS Caremark must pay $95 million for allegedly causing Medicare to overpay for prescription drugs through improper conduct. The case centers on...
FDA Streamlines CAR-T Therapy Access – Safety Monitoring Eliminated
The U.S. Food and Drug Administration has moved to ease restrictions on CAR-T cell therapies by removing the Risk Evaluation and Mitigation Strategies (REMS) requirements. This regulatory shift...
Altimmune’s GLP-1/Glucagon Agonist Shows Mixed Results in MASH Trial
Altimmune Inc. disclosed top-line phase IIb results for pemvidutide, a peptide-based dual GLP-1/glucagon receptor agonist targeting metabolic dysfunction-associated steatohepatitis (MASH). The...
Incyte Names Bill Meury CEO as Hervé Hoppenot Retires
Incyte Corporation announced a leadership transition with Bill Meury appointed as new CEO, succeeding Hervé Hoppenot after 11 years at the helm. Meury brings extensive experience from previous CEO...
Breakthrough Study Maps B-Cell Development Impact on Leukemia Treatment
A pivotal study led by St. Jude Children’s Research Hospital and Princess Margaret Cancer Centre reveals that the developmental stage of B cells at leukemia onset influences treatment outcomes in...
New Genetic 'Dimmer Switch' Controls Key Developmental Gene Timing
Scientists at the MRC London Institute of Medical Sciences have identified a DNA element acting as a 'dimmer switch' that precisely controls the temporal expression of the critical developmental...
Novel Electric Field Therapy Accelerates Spinal Cord Injury Recovery
In preclinical models, daily application of controlled electric fields significantly enhanced functional recovery following spinal cord injury. Researchers demonstrated improved neural tissue...
Wholomics Advances Multi-Cancer Detection via Metabolomic Profiling
Wholomics, a startup founded by researchers from Dana Farber and University College London, unveiled promising data on its metabolomic platform's ability to detect diverse tumor types from serum...
Vetter Breaks Ground on $285M Clinical Manufacturing Facility in Illinois
Contract development and manufacturing organization Vetter commenced construction of a 160,000-square-foot clinical manufacture site for aseptic processing in Des Plaines, IL, investing...
Supreme Court Upholds ACA Preventive Care Coverage Mandate
The U.S. Supreme Court affirmed the constitutionality of the Affordable Care Act provision requiring insurance coverage of specified preventive healthcare services without patient cost sharing....