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Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

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

24-07-2014

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

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

Positive WHO assessment of China’s vaccines regulatory authority

Positive WHO assessment of China’s vaccines regulatory authority

06-07-2014

China's national vaccine supervision system has met or passed all the standard requirements of the World…

ChinaPharmaceuticalRegulationVaccines

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

16-06-2014

The US Food and Drug Administration has licensed Swiss pharma major Novartis’ manufacturing facility…

FlucelvaxNovartisPharmaceuticalProductionRegulationUSAVaccines

UK about turn, as JCVI now recommends meningitis B vaccination for infants

21-03-2014

The UK’s Joint Committee on Vaccination and Immunization has recommended that the meningitis B vaccine…

BexseroNorthern EuropeNovartisPharmaceuticalRegulationUKVaccines

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

17-03-2014

The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini…

Anti-viralsCanadaDiabetesEuropeInterviewsMerck & CoMK-3475OncologyPharmaceuticalRegulationUKVaccines

Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

China bans BioKangtai hepatitis B vaccine

26-12-2013

Chinese authorities on Friday issued a circular to ban the use of the recombinant hepatitis B vaccine…

Anti-viralsAsia-PacificBioKangtaiChinaHealthcarePharmaceuticalRegulationVaccines

AstraZeneca’s Fluenz Tetra cleared in EU

AstraZeneca’s Fluenz Tetra cleared in EU

06-12-2013

The European Commission has granted Marketing Authorization to Fluenz Tetra, the product’s maker Anglo-Swedish…

Anti-viralsAstraZenecaEuropeFluenz TetraPharmaceuticalRegulationVaccines

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

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

28-11-2013

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

CervarixEuropeGlaxoSmithKlineOncologyPharmaceuticalRegulationVaccines

US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

26-11-2013

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

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25-10-2013

Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

Updated EU labeling for Pfizer’s Prevenar 13

Updated EU labeling for Pfizer’s Prevenar 13

17-10-2013

The European Commission has approved updates to the Summary of Product Characteristics for US pharma…

EuropePfizerPharmaceuticalPrevenarRegulationVaccines

Sanofi Pasteur MSD first vaccine company in pilot for rapid European HTA

17-10-2013

Sanofi Pasteur MSD, a vaccines joint venture between drug major Sanofi of France’s Sanofi Pasteur…

Merck & CoPharmaceuticalRegulationSanofiSanofi Pasteur MSDVaccinesZostavax

Newly accessible Japanese encephalitis vaccine will make saving children easier in developing countries

09-10-2013

A newly accessible vaccine against Japanese encephalitis which will make the protection of more children…

China National BiotecGlobalPharmaceuticalRegulationVaccines

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

08-10-2013

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

21-08-2013

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

16-08-2013

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

FluarixFlulavalGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Novartis MenB vaccine approved in Australia

15-08-2013

Swiss drug major Novartis (NOVN: VX) revealed this morning (August 15) that the Australian Therapeutic…

Asia-PacificBexseroNovartisPharmaceuticalRegulationVaccines

Bavarian Nordic smallpox vaccine cleared in EU

08-08-2013

The European Commission has granted marketing authorization for Denmark-based Bavarian Nordic' (OMX:…

Bavarian NordicEuropeImvanexPharmaceuticalRegulationVaccines

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

06-08-2013

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

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

FDA expands age indication for Menveo, quadrivalent meningococcal vaccine

02-08-2013

The US Food and Drug Administration late yesterday (August 1) approved Swiss drug major Novartis' (NOVN:…

MenveoNorth AmericaNovartisPharmaceuticalRegulationVaccines

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