Health Care Related Organization
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
Overall Survival, Combined, cisplatin, Opdivo
Boehringer Ingelheim Caps Out-of-Pocket Costs for Asthma and COPD Inhalers in the U.S.
Boehringer Ingelheim, Out-of-pocket costs, Asthma, COPD, Inhalers, $35 cap, June 1/ 2024, Uninsured and under-insured patients, List price reduction
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
Roche and Alnylam’s Hypertension Hopeful Zilebesiran Shows Promising Results in Combination Therapy Trial
Roche, Alnylam, Zilebesiran, Hypertension, Combination Therapy, Phase 2 Trial, Blood Pressure Control, AngioTensinogen (AGT), RNA Interference (RNAi) Therapeutic, Significant Reductions in Systolic Blood Pressure, Encouraging Safety Profile
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
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)
Sandoz Pays $265 Million to Resolve Partial Antitrust Claims in Price Fixing Lawsuits
sandoz, Settlement and Resettlement, Litigation