Uncategorized – Page 279

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

Boehringer Ingelheim and Sosei Sign Potential $732 Million Collaboration for Schizophrenia Treatment

1 year ago talkbio0Tagged boehringer ingelheim, cellular targeting, GPR52 gene, Partnership, portfolio, Schizophrenia, Sosei

Boehringer Ingelheim, Sosei, Schizophrenia Treatment, Partnership, $732 Million Deal, GPR52 Targeting Portfolio

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

1 year 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

1 year 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

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

1 year 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

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

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

1 year 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