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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

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

Sinovac rockets on strong data for Enterovirus 71 vaccine

15-03-2013

Chinese vaccines maker Sinovac Biotech Ltd. (Nasdaq: SVA) saw its shares leap 53% to $4.88 in morning…

Asia-PacificEnterovirus 71PharmaceuticalRegulationResearchSinovacVaccines

News briefs from Sanofi, Biogen/SOBI and Novartis

01-11-2012

French drug major Sanofi (Euronext: SAN) and subsidiary Genzyme have reported results from pivotal studies…

AgrippalBiogen IdecBiotechnologyFluadLemtradaNeurologicalNovartisPharmaceuticalRegulationResearchSanofiSwedish Orphan BiovitrumVaccines

News briefs from Threshold, Merck KGaA and GSK

18-09-2012

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

BiotechnologyErbituxEuropeGlaxoSmithKlineMerck KGaAMerck SeronoOncologyPharmaceuticalRegulationResearchSynflorixTH-302Threshold PharmaceuticalsVaccines

PDUFA Action Date for Astellas enzalutamide; Urogenix facility to close

07-08-2012

The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date…

Astellas PharmaenzalutamideGenito-urinaryMedivationOncologyPharmaceuticalRegulationResearchUrogenixVaccines

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

25-07-2012

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

PharmaceuticalRegulationResearchSanofiSanofi PasteurTropical diseasesVaccines

GlaxoSmithKline warned by US FDA over cGMP violations at UK plant; positive malaria vaccine news

20-10-2011

UK pharma giant GlaxoSmithKline ILSE: GSK) has received a warning letter from the US Food and Drug Administration…

Antibiotics and Infectious diseasesGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

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