Clinical Trials – Page 5

Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application

2 months ago talkbio0Tagged Biologics License Application, Clinical Trials, COVID19 (disease), Effectiveness, Influenza, Moderna, mRNA-1083, Prices, United States Food and Drug Administration, Vaccines, Vaccines, Combined

Moderna; mRNA-1083; combination vaccine; flu; COVID-19; FDA; Biologics License Application; vaccine efficacy; clinical trial; share price

FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies

2 months ago talkbio0Tagged Clinical Trials, Invasive, Malignant neoplasm of urinary bladder, mitomycin, Non-Muscle, Oncologic Drugs Advisory Committee, Pharma, RCT, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen

FDA; UroGen Pharma; UGN-102; bladder cancer; Oncologic Drugs Advisory Committee; mitomycin; RCT; non–muscle invasive bladder cancer; clinical trials

Vinay Prasad’s First Major Policy: Challenging Covid Vaccine ‘Dogma’ at FDA

2 months ago talkbio0Tagged Clinical Trials, COVID19 (disease), Policy, Prasad, public health medicine (field), Recommendation, Regulatory Framework, United States Food and Drug Administration, Vaccines, Vinay

Vinay Prasad; FDA; Covid-19 vaccines; policy change; clinical trials; vaccine recommendations; public health; regulatory framework

FDA Advisory Committee Splits Votes on Genentech and J&J Cancer Drugs

2 months ago talkbio0Tagged Advisory Committees, applicability, cancer drugs, Clinical Trials, Columvi, genentech, J&J, ODAC, STARGLO, United States Food and Drug Administration, Voting

FDA; advisory committee; Genentech; J&J; cancer drugs; Columvi; ODAC; clinical trials; diffuse large B-cell lymphoma; applicability; STARGLO; voting

FDA Institutes Stricter, Targeted COVID Vaccine Policy, Moving Away from ‘One-Size-Fits-All’ Approach

2 months ago talkbio0Tagged Clinical Trials, COVID19 (disease), Elderly (population group), Eligibility Determination, high-risk groups, Policy, public health medicine (field), United States Food and Drug Administration, Vaccines

FDA; COVID-19; vaccine policy; vaccine eligibility; clinical trials; high-risk groups; elderly; policy change; public health

Korro Bio Lays Off 20% of Workforce to Extend Runway for Genetic Medicine Trials and Novo Nordisk Partnership

2 months ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, Genetic Medicine, Korro Bio, KRRO-110, layoffs, Nordisk, restructuring, RNA Editing

Korro Bio; layoffs; biotech; genetic medicine; RNA editing; KRRO-110; Novo Nordisk; clinical trial funding; restructuring; AATD

Prime Medicine CEO Exits Amidst Layoffs and Restructuring as Sole Clinical Gene Therapy Shelved

2 months ago talkbio0Tagged CEO, Clinical Trials, Exit, gene therapy, layoffs, pipeline pivot, PM359, Prime Editing, Prime Medicine, restructuring

Prime Medicine; CEO exit; gene therapy; layoffs; restructuring; biotech; PM359; prime editing; clinical trial; pipeline pivot

Pfizer-backed CellCentric Secures $120M for Myeloma Drug Trials

2 months ago talkbio0Tagged Accelerated, Approved, CellCentric, Clinical Trials, Inobrodib, Multiple Myeloma, oral drug, p300/CBP inhibitor, Pfizer, Series C

CellCentric; Pfizer; multiple myeloma; Series C funding; inobrodib; p300/CBP inhibitor; oral drug; clinical trials; phase 2/3; accelerated approval

Neurogene Details New Safety Measures After Young Patient’s Death in Rett Syndrome AAV Gene Therapy Trial

2 months ago talkbio0Tagged AAVS1 gene, ASGCT, Clinical Trials, Dosage, gene therapy, Individual Adjustment, Lymphohistiocytosis, Hemophagocytic, Measures, MECP2 gene, Neurogene, NGN-401, Rett Syndrome, Safety, United States Food and Drug Administration

Neurogene; AAV gene therapy; Rett syndrome; NGN-401; ASGCT; safety measures; HLH; clinical trial; MECP2 gene; FDA; dose adjustment

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

2 months ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy