March 2024
Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal
Amylyx, Relyvrio, ALS, Failure, Phase III PHOENIX Study, Market Withdrawal, Clinical Trial, Placebo, No Statistical Significance
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
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
FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
Overall Survival, Combined, cisplatin, Opdivo
Biden Ramps Up Fight Against High Drug Prices in State of the Union Address
State of the Union Address, Biden Administration, Big Pharma, Drug Prices, Inflation Reduction Act, Medicare Drug Negotiations, Out-of-Pocket Cap Expansion, Private Insurance Protections, Generic Drug Cost-Sharing Limit, Cell & Gene Therapy Access Model, Commercial Drug Sales Rebates
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 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
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
Merck KGaA Abandons BTK Inhibitor Program, Emphasizes External Innovation
Merck KGaA, BTK inhibitor, Evobrutinib, External innovation strategy, Failed clinical trials
Boundless Bio, Oncology Startup Targeting Extrachromosomal DNA, Files for $100 Million IPO
Boundless Bio, Oncology Startup, Initial Public Offering (IPO), Extrachromosomal DNA (ecDNA), Small Molecule Drugs (ecDTx), Checkpoint Kinase 1 Inhibitors, Phase 1 Trials, Nasdaq Listing (Symbol: BOLD), Backed by Bayer and Arch Venture Partners, Preliminary Data Expected in Second Half of 2024