Pathologic Function
BridgeBio’s Infigratinib Demonstrates Sustained Efficacy in Phase 2 Trial for Achondroplasia Treatment
BridgeBio, Infigratinib, Achondroplasia, Hypochondroplasia, Phase 2 Trial, Growth Disorder Treatment
Blackstone Invests $300M in Uniquity Bio to Unleash Merck Drug’s Inflammation & Immunology Potential
Blackstone, Uniquity Bio, Merck, Inflammation & Immunology, Investment, Drug Development, Biotechnology
Chiesi Invests Heavily in Gossamer’s Promising Pulmonary Hypertension Treatment
Chiesi, Gossamer, pulmonary hypertension, drug development, investment, collaboration, GD-001, clinical trials, cardiovascular diseases.
Incyte Invests in Mast Cell Inhibitors with $750M Escient Acquisition
Incyte, Escient, mast cell inhibitors, acquisition, pharmaceutical, drug development, inflammatory diseases, cancer, fibrosis, $750 million
Enlivex Stock Plunges 50% Following Mixed Phase II Sepsis Results for Allocetra Cell Therapy
Enlivex Therapeutics, Allocetra Cell Therapy, Phase II Study, Sepsis Treatment, Stock Plummet, Mixed Results, Septic Shock, Urinary Tract Infection (UTI)
Verve Temporarily Halts Lead Base Editing Study Following Adverse Event, Prioritizes Alternative Therapy
Verve Therapeutics, Lead base editing program, Adverse event, VERVE-101, Serious adverse events (SAEs), Grade 3 ALT elevation, Thrombocytopenia, Pause enrollment in Heart-1 study, Alternative therapy focus: VERVE-102, Ionizable lipid delivery system, Phase Ib Heart-2 clinical trial, Q2 2024 initiation of Heart-2 clinical trial.
FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients
FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies
J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations
Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)