Phenomenon or Process

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

6 days 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

2 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

3 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

5 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

6 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

7 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.

FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers

7 months ago talkbio0Tagged Allogeneic bone graft, Disease Outbreaks, guidances, Mycobacterium tuberculosis, standards characteristics, United States Food and Drug Administration

United States Food and Drug Administration, Allogeneic bone graft, Mycobacterium tuberculosis, guidances, Disease Outbreaks, standards characteristics

France pauses chikungunya vaccinations in the elderly after patient death

7 months ago talkbio0Tagged Adverse event, Age, Chikungunya Fever, Disease Outbreaks, Elderly (population group), France, Latex Fixation Tests, older, Reunion Island, Vaccination, Vaccines

Vaccines, Chikungunya Fever, Elderly (population group), Adverse event, France, Latex Fixation Tests, Reunion Island, Disease Outbreaks, Age, older, Vaccination

Mercks Gardasil sales sink further amid China market pressure

7 months ago talkbio0Tagged China, Gardasil, Gardasil sales, Growth, Market, Pressure- physical agent

Market, China, Gardasil, Gardasil sales, Pressure- physical agent, Growth, China

Facing added pressure from Eli Lilly, Novo Nordisk submits for FDA approval of oral GLP-1 obesity drug

7 months ago talkbio0Tagged Approved, competition, eli lilly, Glucagon-Like Peptide 1, Market, Nordisk, Novo, Obesity, Oral cavity, Pressure- physical agent, semaglutide, United States Food and Drug Administration

Nordisk, Obesity, Approved, Oral cavity, Glucagon-Like Peptide 1, Market, Pressure- physical agent, eli lilly, competition, Novo, semaglutide, United States Food and Drug Administration, United States Food and Drug Administration