Functional Concept – Page 78

Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks

1 year 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

FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment

1 year ago talkbio0Tagged cisplatin, Combined, Opdivo, Overall Survival

Overall Survival, Combined, cisplatin, Opdivo

Boehringer Ingelheim Caps Out-of-Pocket Costs for Asthma and COPD Inhalers in the U.S.

1 year ago talkbio0Tagged Asthma, boehringer ingelheim, Caps, Chronic Obstructive Airway Disease, Inhaler, June 1, 2024, List price reduction, Out of Pocket Payment, under-insured, Uninsured

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 Evobrutinib Development, Emphasizes Deal-Focused Pipeline Strategy

1 year ago talkbio0Tagged BTK Inhibitor, Deal-driven Pipeline Strategy, Discontinuation of Development, evobrutinib, Failed, Merck KGaA, Multiple Sclerosis, Phase 3 trials

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

1 year 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

1 year 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

1 year 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

Bayer Acquires European Rights to BridgeBio’s Acoramidis for ATTR-CM Therapy

1 year ago talkbio0Tagged 2025, Acoramidis, Approved, ATTR-CM, Bayer, Blockbuster Potential, BridgeBio Pharma, Cardiovascular Infrastructure, Clarity, Clinical action, EMA Approval, European Rights, Exclusive License, Hope (emotion), investor, low-thirties, milestone payments, November 2024, PDUFA, Phase 3 Data, royalties, Split Strategy, Vyndaqel Rival

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.

J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations

1 year ago talkbio0Tagged amivantamab-vmjw, Approved, carboplatin-pemetrexed chemotherapy, Disease Progression, EGFR Exon 20, first-line, Insertion Mutation, Johnson and Johnson, Mortality Risk, Non-Small Cell Lung Carcinoma, Objective Response Rate, ORR, Progression-Free Survival, Reduced, Rybrevant, United States Food and Drug Administration

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)

Sarepta’s ELEVIDYS Gaining Ground Amidst Anticipation for Expanded Label Approval

1 year ago talkbio0Tagged Age, Child, Commission, ELEVIDYS, Labels (device)

ELEVIDYS, Age, Muscular Dystrophy, Duchenne, Sarepta, Labels (device), Child