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.
Pfizer Inc. Announces Milestone as FDA Approves Pfizer’s Ibrance Regimen for Advanced Breast Cancer Frontline Maintenance
Pfizer Inc. announced the landmark FDA expansion of IBRANCE (palbociclib) in combination with anti-HER2 and endocrine therapies for HR+, HER2+ metastatic breast cancer frontline maintenance following successful Phase 3 PATINA trial results.
Eli Lilly Completes Acquisition of Centessa Pharmaceuticals to Advance Orexin Receptor 2 Agonist Therapies
Eli Lilly and Company has announced the successful completion of its acquisition of Centessa Pharmaceuticals plc, integrating a clinical-stage portfolio of orexin receptor 2 agonists to address severe sleep-wake disorders.
Gilead Trodelvy European Commission Approval Marks Historic First-Line Breast Cancer Advance
Gilead Sciences announced that the European Commission has approved Trodelvy as a first-line monotherapy for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors, based on the landmark Phase 3 ASCENT-03 study.
Pfizer Sigvotatug Vedotin Phase 3 Topline Results Released for Lung Cancer
Pfizer has announced topline Phase 3 results from its SigVie-002 study evaluating the investigational antibody-drug conjugate sigvotatug vedotin in previously treated metastatic non-squamous non-small cell lung cancer.