Pharmacologic Substance
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.
MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)
MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies
FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
Overall Survival, Combined, cisplatin, Opdivo
BeiGene Scores Two Major FDA Approvals – Trivimbra for Esophageal Cancer and Brukinsa for Follicular Lymphoma
BeiGene, Trivimbra (tislelizumab), Esophageal Cancer, Brukinsa (zanubrutinib), Follicular Lymphoma, FDA Approval, Accelerated Approval, Obinutuzumab
Merck KGaA Abandons Evobrutinib Development, Emphasizes Deal-Focused Pipeline Strategy
Merck KGaA, Evobrutinib, BTK Inhibitor, Deal-driven Pipeline Strategy, Discontinuation of Development, Failed Phase 3 Trials, Multiple Sclerosis (MS) Treatment
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
Biden Proposes Expansion of Medicare Drug Price Negotiation Program
Biden, Medicare, Drug Prices, Negotiation, Increased Scrutiny, More Drugs, Health Care Policy
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