Merck’s Erbitux BRAF V600E mCRC Regimen Gets EU Approval for First-Line Treatment
The European Commission has approved Merck’s Erbitux BRAF V600E mCRC combination regimen cetuximab plus encorafenib and FOLFOX as first-line therapy for metastatic colorectal cancer with the BRAF V600E mutation, based on Phase 3 BREAKWATER data showing a 51% reduction in risk of death versus standard chemotherapy.
AstraZeneca Zegfrovy Deal: AstraZeneca Licenses Dizal’s Oral EGFR Inhibitor for Lung Cancer in Up to $1.5 Billion Agreement
AstraZeneca has secured exclusive worldwide rights to Zegfrovy (sunvozertinib), Dizal Pharmaceutical’s oral EGFR inhibitor for EGFR exon 20 insertion non-small cell lung cancer, in a deal worth up to $1.5 billion. The agreement strengthens AstraZeneca’s EGFR-mutated lung cancer portfolio ahead of potential first-line expansion.
Charles River NGS Services Power Arovella Therapeutics’ ALA-101 Cell Therapy Manufacturing
Charles River Laboratories will supply GMP-grade Next Generation Sequencing (NGS) and viral safety release testing to Arovella Therapeutics for its ALA-101 CAR-iNKT cell therapy. The tie-up follows FDA acceptance of NGS-based viral safety testing in Arovella’s IND for treating CD19+ B-cell lymphomas and leukemias.
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.