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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

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

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

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