Immunologic Factor – Page 16 – Talk Bio

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Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

5 months ago talkbio0Tagged COVID19 (disease), flu/COVID-19, Moderna, Policy, Recommendation, Regulatory Setback, United States Food and Drug Administration, vaccine access, Vaccines

Moderna; COVID-19 vaccine; FDA policy; combination flu/COVID-19 shot; vaccine access; mRNA-1083; vaccine recommendations; regulatory setback

InflaRx Halts Rare Skin Disease Study for Vilobelimab After Futility Signal

5 months ago talkbio0Tagged Clinical Trials, COVID19 (disease), Drug Development, Futility, INF904, InflaRx, Pyoderma Gangrenosum, vilobelimab

InflaRx; vilobelimab; pyoderma gangrenosum; futility; clinical trial; COVID-19; drug development; INF904

Prothena Halts Drug and Plans Major Layoffs After Second Rare Disease Trial Failure

5 months ago talkbio0Tagged AL, birtamimab, business options, drug failure, layoffs, Phase 3 Clinical Trials, Primary amyloidosis, Prothena, spending

Prothena; birtamimab; AL amyloidosis; Phase III trial; drug failure; layoffs; biotech; spending cuts; business options

GlycoEra Raises $130M to Advance Protein Degraders Toward Clinic

5 months ago talkbio0Tagged Autoantibodies, Autoimmune Diseases, Clinical Trials, Funding, GE8820, GlycoEra, Holdings, Immunoglobulin IgG4, Precision Immunology, protein degraders

GlycoEra; protein degraders; $130 million funding; autoimmune diseases; GE8820; IgG4 autoantibodies; Novo Holdings; clinical trial; precision immunology

Merus Phase 2 Data: Analysts See Strong Survival in Head & Neck Cancer, ‘Home Run’ Hopes Emerge

5 months ago talkbio0Tagged Cancer of Neck, Clinical Trials, Head, Keytruda, Merus, Overall Survival, pembrolizumab, Petosemtamab, Phase 2, Reaction, scenario

Merus; petosemtamab; Phase 2; overall survival; head and neck cancer; Pembrolizumab; Keytruda; clinical trial; analyst reaction; home run scenario

Jazz Releases Full Survival Data for Zepzelca in Lung Cancer at ASCO 2025

5 months ago talkbio0Tagged ASCO, atezolizumab, IMforte trial, Jazz, lurbinectedin, Malignant neoplasm of lung, Overall Survival, Progression-Free Survival, Small cell carcinoma of lung, Tecentriq, Zepzelca

Jazz Pharmaceuticals; Zepzelca; lurbinectedin; lung cancer; small cell lung cancer; Tecentriq; atezolizumab; IMforte trial; overall survival; progression-free survival; ASCO 2025

FDA Expects ‘Timely Availability’ of Covid Shots as Advisors Update Formula Recommendation

6 months ago talkbio0Tagged Advisory Committees, Availability of, COVID19 (disease), formula update, JN.1-lineage, KP.2 strain, United States Food and Drug Administration, Vaccines

FDA; Covid-19; vaccine; formula update; timely availability; advisory committee; JN.1-lineage; KP.2 strain; 2025-2026

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

6 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

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

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

6 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