Activity – Talk Bio

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

2 days ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold

FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments

2 days ago talkbio0Tagged ELEVIDYS, gene therapy, Liver Failure, Market, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Authority, United States Food and Drug Administration, Withdraw (activity)

FDA; Sarepta Therapeutics; Elevidys; gene therapy; market withdrawal; patient deaths; Duchenne muscular dystrophy; liver failure; regulatory authority

Vertex, NHS England Finalize Reimbursement Deal for CF Drug Alyftrek

7 days ago talkbio0Tagged ALYFTREK, Cystic Fibrosis, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation, Health care facility, NHS England, Nitroglycerin/Sodium Citrate/Ethanol Solution, Reimbursement, triple therapy, UK

Vertex; NHS England; Alyftrek; cystic fibrosis; reimbursement agreement; triple therapy; CFTR gene mutation; NICE; UK healthcare

Recent Developments in Building Measurable Patient Support Programs (2025)

1 week ago talkbio0Tagged 2025, care activity, collaborative healthcare, Efficiency, Financial cost, measurable outcomes, Medicare reforms, Programs - Publication Format, trends qualifier

patient support programs; measurable outcomes; collaborative healthcare; 2025 trends; Medicare reforms; cost efficiency; access to care

UnitedHealth Group Names Mike Cotton as New Medicaid CEO in Executive Reshuffle

2 weeks ago talkbio0Tagged Appointments, Bobby Hunter, CEO, executive changes, Gossypium, government programs, Leadership, Medicaid, UnitedHealth Group

UnitedHealth Group; CEO appointment; Medicaid; Mike Cotton; executive changes; government programs; Bobby Hunter; leadership transition

Amgen Adjusts Phase 3 Dosing for MariTide After Midstage Side Effects Concerns

4 weeks ago talkbio0Tagged Adverse event, amgen, Clinical Trials, Dosage, Escalation, gastric inhibitory polypeptide receptor, GLP-1 receptor, MariTide, Obesity, Phase 3, Vomiting

Amgen; MariTide; Phase 3; obesity treatment; dose escalation; vomiting; adverse events; clinical trial; GLP-1 receptor; GIP receptor

Recent Developments in Immune Profiling for Early Immuno-Oncology Trials

1 month ago talkbio0Tagged Aortic Valve Insufficiency, Biological Markers, Clinical Trials, Discover, immune profiling, immuno-oncology, Immunotherapy, microenvironment, multi-omic strategies, Neoplasms, Precision Medicine, spatial proteomics

immune profiling; immuno-oncology; clinical trials; AI in immunotherapy; multi-omic strategies; tumor microenvironment; spatial proteomics; biomarker discovery; personalized medicine

FDA Reinstates Generic Drug Policy Group After April Firings

1 month ago talkbio0Tagged Administrative action, Departure - action, development aspects, drug price, Generic Drugs, layoffs, Office, Policy, reinstatement, Transection (procedure), United States Food and Drug Administration

FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave

Odyssey Therapeutics Abandons IPO Plans in Latest Sign of Tough Environment for Biotech Listings

1 month ago talkbio0Tagged Autoimmune, IPO, Market, Odyssey, seconds, turbulence, Withdraw (activity)

Odyssey Therapeutics; IPO; biotech; withdrawal; SEC; market turbulence; autoimmune

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss

2 months ago talkbio0Tagged Application procedure, Clinical Trials, Daiichi, Deruxtecan, HER3, Merck, Non-Small Cell Lung Carcinoma, Overall Survival, patritumab, Sankyo, therapeutic autologous dendritic cells, United States Food and Drug Administration, Withdraw (activity)

Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal