Functional Concept
Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy
Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR
Merck KGaA Abandons BTK Inhibitor Program, Emphasizes External Innovation
Merck KGaA, BTK inhibitor, Evobrutinib, External innovation strategy, Failed clinical trials
AstraZeneca Commits £650M Expansion for UK Vaccine Hub and Research Campus
AstraZeneca, £650 million investment, UK vaccine hub, Speke/ Liverpool, Renewable energy, Operationally net-zero facility, Research and Development (R&D) campus, Cambridge/ England, Job creation, Pandemic preparedness, Public health protection, Economic growth, Government support, Tax environment, Life sciences sector
Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy
Bayer, BridgeBio Pharma, Acoramidis, ATTR-CM, Exclusive License, European Rights, Royalties, Milestone Payments, Phase 3 Data, Potential Approval, Low-Thirties Percent Royalties, EMA Approval 2025, PDUFA Action Date November 2024, Vyndaqel Rival, Blockbuster Potential, Cardiovascular Infrastructure, Investor Hopes for Clarity on Split Strategy.
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)
Sarepta’s ELEVIDYS Gaining Ground Amidst Anticipation for Expanded Label Approval
ELEVIDYS, Age, Muscular Dystrophy, Duchenne, Sarepta, Labels (device), Child
Sandoz Pays $265 Million to Resolve Partial Antitrust Claims in Price Fixing Lawsuits
sandoz, Settlement and Resettlement, Litigation
Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA
United States Food and Drug Administration, MFSD1 gene, Symptoms aspect, Schizophrenia, New Drug Application