Functional Concept
Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
CBER, Peter Marks, FDA, public health, healthcare innovation, regulatory affairs, biologics, vaccines, medical devices, preventive measures.
Revolutionizing Biology: AlphaFold 3 by Isomorphic and DeepMind Expands Beyond Protein Predictions
AlphaFold 3, Isomorphic, DeepMind, protein predictions, biology revolution, artificial intelligence, machine learning, structural biology, drug discovery, disease research.
Lykos Therapeutics’ MDMA-Assisted Therapy for PTSD: Awaiting FDA Advisory Committee Review
Lykos Therapeutics, MDMA-assisted therapy, PTSD treatment, FDA Advisory Committee, clinical trials, drug approval process.
FDA to Review Lilly’s Alzheimer’s Drug Donanemab in June Advisory Committee Meeting
FDA, Lilly, Alzheimer’s, donanemab, June, AdCom, review, approval, treatment, neurodegenerative disease.
FDA Panel to Evaluate Lykos’ Innovative Psychedelic Treatment for Post-Traumatic Stress Disorder
FDA, Lykos, psychedelic therapy, PTSD, mental health, clinical trials, review panel, innovative treatment, mental health breakthrough.
Novo, Gates, and Wellcome Join Forces with $300 Million Initiative to Tackle Global Infectious Diseases
Novo Holdings, Bill & Melinda Gates Foundation, Wellcome Trust, infectious diseases, global health, pandemic preparedness, antimicrobial resistance, research and development, funding, collaboration.
AstraZeneca Strengthens Partnership with Cellectis in Cell and Gene Therapy Advancement
AstraZeneca, Cellectis, cell therapy, gene therapy, partnership, stake, discovery, pact, biotechnology, healthcare, investment, innovation, medical research, therapeutic development.
Johnson & Johnson Presents Updated Findings on Balversa Treatment for Bladder Cancer
Johnson & Johnson, Balversa, bladder cancer, clinical data, FGFR inhibitor, targeted therapy, urothelial carcinoma.
Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
FDA, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), gene therapy, accelerated approval, controversy, clinical trials, efficacy, safety, patient advocacy, regulatory process.
Pharmaceutical Industry’s Public Image Deteriorates Post-Pandemic Era
Pharmaceutical industry, reputation, pandemic, public opinion, COVID-19, vaccine development, drug pricing, transparency.