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Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy
Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation
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