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FDA “Breakthrough Therapy” designation for GSK’s malaria drug tafenoquine; EU Cervarix news

FDA “Breakthrough Therapy” designation for GSK’s malaria drug tafenoquine; EU Cervarix news


The US Food and Drug Administration has granted “Breakthrough Therapy” designation for tafenoquine,…

CervarixEuropeGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationtafenoquineTropical diseases

IFPMA and the Global Fund collaborate to help protect patients from fake medicines


The International Federation of Pharmaceutical Manufacturers and Associations and the Global Fund to…

Anti-viralsAntibiotics and Infectious diseasesGlobalMarkets & MarketingPharmaceuticalRegulationTropical diseases

US FDA delays approval of Paladin’s Impavido

US FDA delays approval of Paladin’s Impavido


Canada-based specialty pharmaceutical company Paladin Labs says that the US Food and Drug Administration…

ImpavidoNorth AmericaPaladin LabsPharmaceuticalRegulationTropical diseases

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

Eisai gains WHO prequalification for DEC; launches high-dose Aricept in Korea


Japanese drug major Eisai (TYO: 4523) has received prequalification from the World Health Organization…

AriceptAsia-PacificdiethylcarbamazineEisaiMarkets & MarketingNeurologicalPharmaceuticalRegulationTropical diseases

US orphan designation for DengueCide


USA-based drug developer NanoViricides (OTC BB: NNVC) says that DengueCide, its drug candidate for the…

DengueCideNanoViricidesNorth AmericaPharmaceuticalRegulationTropical diseases

Annual approvals of new drugs for neglected diseases nearly doubled since early 2000s and 2009-12; Tufts


The annual number of new drug approvals worldwide to treat neglected diseases has nearly doubled in recent…

Anti-viralsPharmaceuticalRegulationResearchTropical diseases

Treatments for malaria, sleeping sickness and Chagas disease added to WHO's list of pediatric medicines


The World Health Organization has released its updated Model List for Essential Medicines for Children…

artesunate-mefloquineBayerbenznidazoleCiplaGenericsGlobalNifurtimox-eflornithinePharmaceuticalRegulationSanofiTropical diseases

News briefs: Novartis drops Ruvise MAA; B-MS settlement; Germany donates to Global Fund


The European Medicines Agency says it has been formally notified by Swiss drug major Novartis (NOVN:…

Anti-viralsBMS-986094Bristol-Myers SquibbFinancialLegalNovartisPharmaceuticalRare diseasesRegulationRuviseTropical diseases

Sanofi Pasteur's dengue vaccine proves effective and safe; FDA identifies cGMP deviations


French drug major Sanofi (Euronext: SAN) vaccines subsidiary Sanofi Pasteur sais this morning that its…

PharmaceuticalRegulationResearchSanofiSanofi PasteurTropical diseasesVaccines

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