ORG – Page 281 – Talk Bio

Contineum Launches IPO Campaign to Accelerate Multiple Sclerosis Pipeline

1 year ago talkbio0Tagged Backed, Contineum, IPO, Johnson and Johnson, Multiple Sclerosis, Phase 2 Clinical Trials, PIPE-307, Public Offering

Contineum Therapeutics, Initial Public Offering (IPO), Johnson & Johnson (J&J) Backed, Multiple Sclerosis (MS) Pipeline, Phase II Trial, PIPE-307

Pfizer Reduces Stake in Haleon, Raising Over $2 Billion in Share Selloff

1 year ago talkbio0Tagged Consumer Health Spinoff, Debt Management, Haleon, Pfizer, Stake Reduction, Strategic Focus

Pfizer, Haleon, Consumer Health Spinoff, Share Selloff, Stake Reduction, GSK, Debt Management, Strategic Focus

FDA Grants Accelerated Approval to Madrigal’s Rezdiffra for MASH Treatment

1 year ago talkbio0Tagged Accelerated clearance, Adult, Antibody-Drug, Approved, Madrigal Pharmaceuticals, metabolic dysfunction-associated steatohepatitis, moderate-to-advanced liver fibrosis, Non-cirrhotic, resmetirom, Rezdiffra, United States Food and Drug Administration

FDA approval, Madrigal Pharmaceuticals, Rezdiffra (resmetirom), Metabolic dysfunction-associated steatohepatitis (MASH), Accelerated clearance, Adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis

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.

MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)

2 years ago talkbio0Tagged AbbVie, ADAM9 protein, human, Anti-ADAM9 ADC IMGC936, Effectiveness, issues, MacroGenics, Partnered ADC, Safety Concerns

MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues

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

Biden Ramps Up Fight Against High Drug Prices in State of the Union Address

2 years ago talkbio0Tagged Addresses (publication format), Biden administration, Big Pharma, Commercial Drug Sales, drug price, Generic Drug Cost-Sharing Limit, Cell & Gene Therapy, Inflation Reduction Act, Medicare Drug Negotiations, Out-of-Pocket Cap Expansion, Private insurance, Protections, Study models, Union

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

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

2 years ago talkbio0Tagged cisplatin, Combined, Opdivo, Overall Survival

Overall Survival, Combined, cisplatin, Opdivo

BeiGene Scores Two Major FDA Approvals – Trivimbra for Esophageal Cancer and Brukinsa for Follicular Lymphoma

2 years ago talkbio0Tagged Accelerated Approval, Approved, BeiGene, Brukinsa, Esophageal Neoplasms, Lymphoma, Follicular, obinutuzumab, tislelizumab, Trivimbra, United States Food and Drug Administration, zanubrutinib

BeiGene, Trivimbra (tislelizumab), Esophageal Cancer, Brukinsa (zanubrutinib), Follicular Lymphoma, FDA Approval, Accelerated Approval, Obinutuzumab

Merck KGaA Abandons Evobrutinib Development, Emphasizes Deal-Focused Pipeline Strategy

2 years 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