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.
Roche AXELIOS 1: A Transformative Step for Next-Generation Sequencing Platforms Launched
Roche has officially announced the launch of AXELIOS 1, a next-generation sequencing platform built on proprietary SBX technology, promising same-day whole-genome sequencing with unprecedented speed and accuracy.
AstraZeneca Datroway EU Approval: CHMP Recommends Novel ADC for Metastatic Triple-Negative Breast Cancer
AstraZeneca and Daiichi Sankyo’s Datroway has received a positive CHMP recommendation in the European Union for the first-line treatment of adult patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
Merck KGaA Acquires Bio-Techne to Advance ProteinSimple and RNAscope Workflows in $11.3 Billion Deal
Merck KGaA has entered into a definitive agreement to acquire Bio-Techne for US$73 per share in cash, representing an enterprise value of US$11.3 billion to strengthen its global leadership in high-growth life sciences markets.