Regulation - Vaccines, GlaxoSmithKline


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EMA advises GlaxoSmithKline on Ebola vaccine development


The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…


GSK files EU regulatory submission for RTS,S malaria vaccine candidate


UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

CHMP positive opinion for GSK’s Cervarix two-dose schedule

CHMP positive opinion for GSK’s Cervarix two-dose schedule


UK pharma giant GlaxoSmithKline says that the European Medicines Agency's Committee for Medicinal Products…


US FDA clears GlaxoSmithKline’s H5N1 flu vaccine


The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

New data support GSK plan to file for approval of malaria vaccine in 2014

New data support GSK plan to file for approval of malaria vaccine in 2014


Results from a large-scale Phase III trial, presented today at the Multilateral Initiative on Malaria…

GlaxoSmithKlinePharmaceuticalRegulationResearchRTS,STropical diseasesVaccines

New Zealand proposals for influenza vaccines


New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list two…

Abbott LaboratoriesAsia-PacificFluarixGlaxoSmithKlineInfluvacPharmaceuticalPricingRegulationVaccines

GSK's Flulaval vaccine approved by US FDA


UK pharma giant GlaxoSmithKline (LSE: GSK) has had its Flulaval quadrivalent intramuscular influenza…

FluarixFlulavalGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US FDA approves shipment of quadrivalent flu vaccine to health care providers


The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA


The Japanese Ministry of Health, Labor and Welfare has decided to withdraw its recommendation for a vaccination…

Asia-PacificCervarixDaiichi SankyoGardasilGlaxoSmithKlineMerck & CoPharmaceuticalRegulationVaccinesWomen's Health

GlaxoSmithKline cleared for $91M flu vaccine plant in USA; Gets CRL on Q-Plan H5N1


UK pharma giant GlaxoSmithKline (LSE: GSK) and The Texas A&M University System (TAMUS) say that the US…

GlaxoSmithKlineNorth AmericaPharmaceuticalProductionQ-Plan H5N1RegulationVaccines

GlaxoSmithKline gains FDA approval of four-strain seasonal influenza vaccine


The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline's (LSE: GSK) Fluarix…

FluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

FDA advisory panel backs GlaxoSmithKline H5N1 influenza vaccine candidate


The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC)…

GlaxoSmithKlineNorth AmericaPharmaceuticalPumarixRegulationVaccines

EMA reviews hypothesis on Pandemrix hypothesis; finalizes on NSAIDs and CV events


The European Medicines Agency's Committee on Human Medicinal Products (CHMP) said Friday that it has…

Anti-Arthritics/RheumaticsdiclofenacGlaxoSmithKlineibuprofenInflammatory diseasesNaproxenNeurologicalPandemrixPharmaceuticalRegulationVaccines

News briefs from Threshold, Merck KGaA and GSK


US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) said yesterday that data from a Phase IIb trial…

BiotechnologyErbituxEuropeGlaxoSmithKlineMerck KGaAMerck SeronoOncologyPharmaceuticalRegulationResearchSynflorixTH-302Threshold PharmaceuticalsVaccines

FDA approves GlaxoSmithKline's new combo vaccine MenHibrix


The US Food and Drug Administration has approved US pharma giant GlaxoSmithKline's (LSE: GSK) MenHibrix…

GlaxoSmithKlineMenHibrixNorth AmericaPharmaceuticalRegulationVaccines

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