Research Activity – Page 79

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

2 years ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

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.

Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal

2 years ago talkbio0Tagged Amylyx, Amyotrophic Lateral Sclerosis, Clinical Trials, Failure (biologic function), Market, Phase III PHOENIX Study, Placebos, Relyvrio, Statistical Significance, Withdraw (activity)

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

2 years ago talkbio0Tagged Accelerated, Antibodies, Bispecific, Approved, BeiGene, Brukinsa, Chimeric Antigen Receptor T-cells, Clinical Trials, Combined Modality Therapy, competition, Disease Progression, Gazyva, Lymphoma, Follicular, obinutuzumab, ORR, Overall response rate, Rosewood, Toxicity aspects, United States Food and Drug Administration, zanubrutinib

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

Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

2 years ago talkbio0Tagged Accelerated, Approved, broadest label, Brukinsa, BTK Inhibitor, CHMP, Chronic lymphoma, Combined Modality Therapy, Lymphoma, Follicular, obinutuzumab, Oregon (geographic location), Overall response rate, Phase 2 Clinical Trials, Phase II ROSEWOOD trial, Recommendation, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Relapsing course, Rosewood, United States Food and Drug Administration

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

2 years ago talkbio0Tagged BTK Inhibitor, Clinical Trials, evobrutinib, External innovation strategy, Failed, Merck KGaA

Merck KGaA, BTK inhibitor, Evobrutinib, External innovation strategy, Failed clinical trials

AstraZeneca Commits £650M Expansion for UK Vaccine Hub and Research Campus

2 years ago talkbio0Tagged AstraZeneca, Cambridge/, Economic Growth, England, Environment, Government support, Investments, Life sciences sector, Occupations, operationally, pandemic preparedness, public health protection, Renewable Energy, research, Research and Development, Speke/ Liverpool, Surgical construction, Taxes, UK vaccine

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

“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”

2 years ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Antisense Therapy, Approved, Clinical Trials, masitinib, Patient advocacy, regulatory uncertainty, Relyvrio, risk-benefit analysis, United States Food and Drug Administration

ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy