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Merck’s new Gardasil 9 gains backing from US FDA

Merck’s new Gardasil 9 gains backing from US FDA

11-12-2014

The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent…

Gardasil 9Merck & CoOncologyPharmaceuticalRegulationUSAVaccines

EMA committee concludes no evidence Fluad caused deaths

EMA committee concludes no evidence Fluad caused deaths

04-12-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

EuropeFluadNovartisPharmaceuticalRegulationVaccines

FTC puts conditions on GSK/Novartis consumer JV

27-11-2014

The US Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition…

Dr Reddy's LaboratoriesGlaxoSmithKlineHabitrolMergers & AcquisitionsNicodermNovartisPharmaceuticalRegulationUSAVaccines

US FDA approves first vaccine to prevent serogroup B meningococcal disease

30-10-2014

The US Food and Drug Administration yesterday granted accelerated approval for pharma major Pfizer’s…

PfizerPharmaceuticalRegulationTrumenbaUSAVaccines

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

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

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

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

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