Pfizer and Astellas Win FDA Approval for PADCEV Plus Keytruda in Muscle-Invasive Bladder Cancer
The FDA has approved PADCEV plus Keytruda as the first platinum-free neoadjuvant and adjuvant regimen for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, backed by Phase 3 EV-304 data showing major reductions in recurrence and death risk.
Sanofi’s Sarclisa Escena Wins FDA Approval as First On-Body Injector Cancer Drug
Sanofi’s Sarclisa Escena has been approved by the FDA as the first anticancer treatment deliverable via an on-body injector, offering multiple myeloma patients a faster, needle-free-feeling alternative to IV infusions.
WuXi Biologics FDA PLI Approval Secured for MFG8 Facility to Accelerate Commercial Supply of Autoimmune Therapy
WuXi Biologics’ MFG8 facility in Hebei has successfully cleared a rigorous seven-day U.S. FDA Pre-License Inspection. This crucial WuXi Biologics FDA PLI Approval paves the way for the scaled commercial supply of a highly anticipated blockbuster autoimmune therapy, reinforcing the company’s unblemished 100% FDA PLI success rate and robust global quality standards.
Merck’s Enpatoran FDA Breakthrough Therapy Designation Granted for Cutaneous Lupus Treatment
Merck has secured an FDA Breakthrough Therapy designation for enpatoran, an investigational oral TLR7/8 inhibitor aiming to address the high unmet need in lupus patients suffering from active skin manifestations.
Vertex Acquires Crinetics Pharmaceuticals to Expand Rare Disease Portfolio with PALSONIFY
Vertex Acquires Crinetics Pharmaceuticals under a definitive merger agreement, where Vertex will purchase all outstanding shares of Crinetics common stock for $85.00 per share in [Read More…]
Novartis Acquires Myricx Bio to Advance Next-Generation NMTi Antibody-Drug Conjugate Pipeline
Novartis has announced a definitive agreement to acquire UK-based biotechnology firm Myricx Bio for USD 1.1 billion upfront plus USD 400 million in milestones, gaining a breakthrough NMTi payload platform targeting solid tumors.
Roche Divarasib KRAS G12C Inhibitor Demonstrates Superiority in Head-to-Head Phase III Lung Cancer Trial
Roche’s next-generation KRAS G12C inhibitor, divarasib, has achieved statistical significance in a global head-to-head Phase III trial against sotorasib and adagrasib for advanced non-small cell lung cancer.
Kyowa Kirin Infigratinib Phase 3 PROPEL 3 Trial Results Published in NEJM
BridgeBio Pharma and Kyowa Kirin announced the publication of positive data from the global Phase 3 PROPEL 3 study of oral infigratinib for pediatric achondroplasia in The New England Journal of Medicine (NEJM), demonstrating unparalleled improvements in annualized height velocity and body proportionality.
Novartis Receives European Commission Approval for Itvisma for Spinal Muscular Atrophy
Marking a major milestone, Novartis receives European Commission approval for Itvisma, introducing a fixed, one-time gene replacement therapy for a broad population of spinal muscular atrophy patients across Europe
Amgen Tavneos NEJM Retraction: Medical Journal Pulls Pivotal Clinical Trial Paper For Amgen’s Rare-Disease Drug Tavneos
The New England Journal of Medicine has retracted the pivotal 2021 clinical trial paper for Amgen’s rare-disease drug Tavneos (avacopan). The retraction follows an FDA investigation revealing undisclosed modifications to patient outcome data after the database was locked and unblinded.