Organic Chemical – Page 13

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

4 months ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class

PureTech Spins Out Celea Therapeutics to Advance IPF Drug Candidate

4 months ago talkbio0Tagged Celea Therapeutics, Idiopathic Pulmonary Fibrosis, Lung diseases, LYT 100, Phase 3 trial, pirfenidone, Pulmonary Fibrosis, PureTech, spin-out

PureTech; Celea Therapeutics; spin-out; lung disease; idiopathic pulmonary fibrosis; IPF; deupirfenidone; LYT-100; Sven Dethlefs; phase 3 trial

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

4 months ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

4 months ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

4 months ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

CDC Launches ‘Free Mind’ Campaign Targeting Teen Substance Use and Mental Health

4 months ago talkbio0Tagged Adolescence, Alcohol or Other Drugs use, Centers for Disease Control and Prevention (U.S.), Drug Overdose, fentanyl, Free Mind ' Campaign, mental health, Strategy, teen suicide

CDC; Free Mind campaign; youth mental health; substance use; drug overdose; fentanyl; teen suicide; coping strategies

FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia

5 months ago talkbio0Tagged aceclidine, Approved, Eye Drops, LENZ, Myopia, presbyopia, United States Food and Drug Administration, VIZZ

FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision

Spine BioPharma’s Phase 3 Back Pain Drug Fails to Meet Primary Endpoint, Attributes Miss to High Sham Response

5 months ago talkbio0Tagged Chronic low back pain, Clinical Trials, Intervertebral Disc Degeneration, primary endpoint, Response process, salicylhydroxamic acid, SB-01, Spine BioPharma

Spine BioPharma; Phase 3 trial; chronic low back pain; degenerative disc disease; SB-01; primary endpoint; sham response; clinical trial results

Lilly’s Mounjaro Matches Cardiovascular Benefit of Trulicity in Landmark Trial, Paving Way for Expanded Approval

5 months ago talkbio0Tagged Cardiovascular system, Diabetes Mellitus, Non-Insulin-Dependent, dulaglutide, eli lilly, expansion, Hemoglobin A1c measurement, MACE-3, Mortality Vital Statistics, Mounjaro, non-inferiority, outcomes, SURPASS-CVOT, Trulicity, United States Food and Drug Administration, Weight Loss

Mounjaro; tirzepatide; Eli Lilly; cardiovascular outcomes; type 2 diabetes; SURPASS-CVOT; Trulicity; dulaglutide; major adverse cardiovascular events (MACE-3); non-inferiority; A1C reduction; weight loss; mortality; FDA expansion

Clinical Roundup: Cardiff, VYNE and NewAmsterdam Report Key Trial Results in Multiple Disease Areas

5 months ago talkbio0Tagged Alzheimer 's disease, BROADWAY trial, Cardiff Oncology, Clinical Trials, Metastasis from malignant neoplasm of colon and/or rectum, Neoplasms, NewAmsterdam Pharma, onvansertib, Statistical Significance, Vyne

Cardiff Oncology; VYNE; NewAmsterdam Pharma; clinical trial updates; onvansertib; metastatic colorectal cancer; Alzheimer’s disease; BROADWAY trial; oncology; statistically significant results