Phenomenon or Process

Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations

3 weeks ago talkbio0Tagged compounding pharmacy, East Windsor facility, Empower Pharmacy, Facility (object), Glucagon-Like Peptide 1, Inspection (procedure), layoffs, manufacturing shutdown, New Jersey operations, Outsourcing, Qualitative form, United States Food and Drug Administration, Workforce reduction

Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction

Nektar Digs Into Mid-Stage Data To Establish Alopecia Efficacy of Rezpeg

4 weeks ago talkbio0Tagged Alopecia, Autoimmune Diseases, Effectiveness, eli lilly, IL-2 pathway, mid-stage trial, Nektar Therapeutics, Phase 3 planning, REZOLVE-AA, Rezpeg, Rezpegaldesleukin, SALT score * *, Signal

Nektar Therapeutics; rezpegaldesleukin; Rezpeg; REZOLVE-AA; Phase 2b; alopecia areata; hair loss; SALT score; mid-stage trial; efficacy signal; Eli Lilly; IL-2 pathway; autoimmune disease; Phase 3 planning

Strategic solutions for cost, time and quality challenges in drug development – recent developments

1 month ago talkbio0Tagged Acceleration, Candidiasis, Chronic Mucocutaneous, CDMO/CRO, Clinical Development, cost-reduction, Drug Development, Efficiency, Optimization, Pharma, quality management, Study models, supply chain risk, TimeLine Fluoride Releasing Resin

drug development; cost reduction; timeline acceleration; quality management; integrated CDMO/CRO models; AI in pharma; CMC optimization; clinical development efficiency; supply chain risk; biotech strategy

UniQure restates FDA’s negative feedback on Huntington’s trial; Neurimmune expands AstraZeneca alliance

1 month ago talkbio0Tagged AMT-130, antibody collaboration, AstraZeneca, biopharmaceutical partnerships, external control group, Feedback - system communication, gene therapy, Nerve Degeneration, Neurimmune, UniQure, United States Food and Drug Administration

UniQure; AMT-130; FDA feedback; external control group; gene therapy; Neurimmune; AstraZeneca; neurodegeneration; antibody collaboration; licensing deal; biopharmaceutical partnerships

Japan Approves Anti-CD19 Monoclonal Antibody UPLIZNA for Suppression of Relapse in Immunoglobulin G4-Related Disease (IgG4-RD)

2 months ago talkbio0Tagged Anti-CD19 Monoclonal Antibody, Approved, IgG4-RD, IgG4-Related Disease, Immunoglobulin IgG4, inebilizumab, Japan, Ministry of Health, MITIGATE trial, Mitsubishi Tanabe Pharma, Relapse, Uplizna, Visual Suppression, Welfare

UPLIZNA; Inebilizumab; Anti-CD19 monoclonal antibody; IgG4-related disease (IgG4-RD); Immunoglobulin G4; Japan approval; Relapse suppression; MITIGATE trial; Mitsubishi Tanabe Pharma; Ministry of Health, Labour and Welfare

Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial

4 months ago talkbio0Tagged Biopharma, cash runway, Clinical Research, Feedback - system communication, layoffs, Microbiome, Microbiome SER-155, Seres, United States Food and Drug Administration

Seres Therapeutics; layoffs; microbiome; FDA feedback; SER-155; phase 2 trial; workforce reduction; biopharma; clinical studies; cash runway

Vinay Prasad Explains FDA’s Revocation of Pfizer’s Covid Vaccine EUA for Children

5 months ago talkbio0Tagged Child, COVID19 (disease), Emergency Situation, Emergency Use Authorization, EUA, Pfizer, Policy, Prasad, risk-benefit analysis, United States Food and Drug Administration, Vaccines

FDA; Pfizer; COVID-19 vaccine; emergency use authorization (EUA); children; Vinay Prasad; vaccine policy; risk-benefit analysis

Shrinking Budgets and Rising Targets Pile Pressure on Pharma Marketers: Survey Highlights 2025 Challenges

7 months ago talkbio0Tagged Budgets, constraints, healthcare marketing trends, innovation, Pharma, Pressure- physical agent, Rising, shrinking budgets, Surveys, targets

pharma marketing; shrinking budgets; rising targets; 2025 survey; healthcare marketing trends; budget constraints; innovation; marketing pressure

Schott Pharma Invests Over €100M in New Sterile Cartridge Facility at Hungary Site

7 months ago talkbio0Tagged Automation, Diabetes, expansion, Glucagon-Like Peptide 1, Hungary, Impacts, Environmental, Investments, Lukácsháza, Manufacturing, Pharma, pharma packaging, RTU cartridges, Schott, sterile cartridge facility

Schott Pharma; Hungary; sterile cartridge facility; €100 million investment; RTU cartridges; pharma packaging; manufacturing expansion; Lukácsháza; GLP-1 drugs; diabetes; automation; environmental impact

From deal to disaster: Drugmakers face a changed Washington as Trump embraces most favored nation prices

8 months ago talkbio0Tagged Disasters, drugmakers, Medicaid, MFN, Nation, Policy, Prices, Transplant Registry Unified Management Program, U.S.

Prices, Transplant Registry Unified Management Program, MFN, Nation, Disasters, Medicaid, Policy, drugmakers, U.S.