July 1, 2024 – Talk Bio

Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority

10 months ago talkbio0Tagged Administrative action, Agencies, Chevron doctrine, court, Interpretation Process, regulatory, statutory ambiguity, Supreme, United States Food and Drug Administration

Chevron doctrine, FDA, regulatory authority, Supreme Court, administrative law, agency interpretations, statutory ambiguity

Merck and Daiichi Sankyo’s ADC Pact Hits Regulatory Setback in FDA Rejection

10 months ago talkbio0Tagged Antibody-Drug Conjugates, Daiichi, Deruxtecan, HER3 protein, Merck, Non-Small Cell Lung Carcinoma, patritumab, Regulatory Setback, Rejection (Psychology), Sankyo, United States Food and Drug Administration

Merck, Daiichi Sankyo, Antibody-Drug Conjugate (ADC), Patritumab Deruxtecan, FDA Rejection, Regulatory Setback, HER3 Protein, Non-Small Cell Lung Cancer (NSCLC)

FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease, Requests Additional Manufacturing Information

10 months ago talkbio0Tagged Complete, control act - information, deficiency-I, gene therapy, LAD-I, leukocyte cell-cell adhesion, Manufacture, Response process, Rocket, United States Food and Drug Administration

FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Information, Complete Response Letter

Savara Raises $100 Million Following Lung Disease Treatment Breakthrough

10 months ago talkbio0Tagged Autoimmune Pulmonary, Lung diseases, PULMONARY ALVEOLAR PROTEINOSIS, ACQUIRED, Raise, Savara

Savara, Lung Disease, $100 Million Raise, Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Treatment

Alumis Completes IPO, Raising $250 Million for Inflammation and Immunology Research

10 months ago talkbio0Tagged Alumis, biotech, Dental Plaque, Immunology, Inflammation, Inhibitor, IPO, Psoriasis, TYK2 gene, Uveitis

Alumis, IPO, Inflammation, Immunology, Biotech, TYK2 Inhibitor, Plaque Psoriasis, Uveitis, Lupus