Functional Concept
Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs
Sanofi adds new inflammatory target to growing Nurix tie-up
Nurix, sanofi, Target, STAT6 protein, human, cellular targeting, Collaboration, Inflammation, Autoimmune Diseases, TRANSCRIPTION FACTOR, DEL-AI
Atsena reels in $150M to advance work on ocular gene therapies
Atsena, Retinoschisis, Juvenile, X-Linked, United States Food and Drug Administration, Dependovirus, Cloning Vectors, Hereditary, Retinal Diseases, Blindness, ATSN-201, ATSN-101
Patient suffers side effect in Cabaletta autoimmune CAR-T trial, but analysts unfazed
Systemic Scleroderma, Lupus Erythematosus, Systemic, Cabaletta, cell-associated neurotoxicity, Adverse effects, analysts, Autoimmune Diseases, CAR-T therapy, reSET (device), aspects of adverse effects, Cytokine Release Syndrome
Mass Firings at FDA Spark Concerns Over Agency’s Future
FDA, layoffs, leadership changes, public health, drug regulation, Trump administration
AIRNA nets $155M series B to launch clinical test of RNA editing tech
RNA Editing, Airna, AIR-001, RNA
AstraZeneca’s oral PCSK9 inhibitor halves cholesterol in phase 2 trial
AZD0780, LDL Cholesterol Lipoproteins, AstraZeneca ‘s, Oral cavity, PCSK9 inhibitor, Effectiveness
Isomorphic Labs raises $600M to push AI-designed drugs into clinic
Isomorphous, Laboratory test finding, development aspects, AI-designed
ACC25: Merck & Co.’s Winrevair reduces mortality in most severe PAH patients
Pulmonary arterial hypertension, Winrevair, Severe (severity modifier), Mortality Vital Statistics
Transcend’s neuroplastogen posts positive mid-stage results in PTSD
TSND-201, Post-Traumatic Stress Disorder, Placebos, Statistical Significance, CAPS-5