ENTITY
NICE Rejects Coverage for AstraZeneca and Daiichi Sankyo’s Breast Cancer Drug Enhertu Due to Cost-Effectiveness Concerns
NICE, Enhertu, AstraZeneca, Daiichi Sankyo, Breast cancer, Cost-effectiveness, Coverage rejection, Technology Appraisal, National Health Service (NHS)
Second Positive Phase 2 Trial Boosts Confidence in Alnylam’s RNAi Blood Pressure Med, Supporting Roche’s $2.8 Billion Biobucks Bet
Alnylam RNAi blood pressure medication, Zilebesiran, Phase 2 trial success, Systolic blood pressure reduction, Roche partnership, $2.8 billion milestone payments, Hypertension therapy, KARDIA-2 study
Novo Nordisk’s Ozempic Shows Promising Kidney Benefits for Diabetic Patients
Ozempic, Novo Nordisk, Chronic kidney disease, Cardiovascular events, Expanded use, Semaglutide, FLOW trial, Reduced risk, Type 2 diabetes
Merck KGaA Bolsters Protein Degradation Pipeline with $756M C4 Therapeutics Partnership
Merck KGaA, C4 Therapeutics, Targeted Protein Degradation, Collaboration, $756M Deal, Oncogenic Proteins, TORPEDO® Platform, Mid-Single to Low-Double Digit Tiered Royalties, Upfront Payment: $16 Million, Potential Milestone Payments: Up to $740 Million
Akero Reinforces Phase III FGF21 Analog Candidate with Enhanced Fibrosis Response Rates in MASH Data Update
Akero Therapeutics, FGF21 Analog, efruxifermin (EFX), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Phase IIb HARMONY Study, Fibrosis Response Rate, 96 Weeks, Statistically Significant Improvements
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.
“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”
ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy
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)
Gritstone Bio Implements Workforce Reduction Following Delay in COVID-19 Vaccine Trial
Gritstone Bio, COVID-19 vaccine trial delay, 40% workforce layoffs, Phase 2b CORAL trial, Manufacturing delay, Missed funding, Project NextGen, BARDA contract, Colorectal cancer vaccine