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EMA unit backs new hep C drugs Exviera and Viekirax from AbbVie

EMA unit backs new hep C drugs Exviera and Viekirax from AbbVie

21-11-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

AbbVieAnti-viralsEuropeExvieraPharmaceuticalRegulationViekirax

Gilead Sciences’ Harvoni gains EU approval

Gilead Sciences’ Harvoni gains EU approval

19-11-2014

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists…

Anti-viralsBiotechnologyEuropeGilead SciencesHarvoniRegulationSovaldi

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

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

Bristol-Myers’ hep C drug Daklinza approved in Europe

Bristol-Myers’ hep C drug Daklinza approved in Europe

27-08-2014

US pharma major Bristol-Myers Squibb says that the European Commission has approved Daklinza (daclatasvir),…

Anti-viralsBristol-Myers SquibbDaklinzaEuropeGilead SciencesPharmaceuticalRegulationSovaldi

Janssen’s hepatitis C drug Olysio cleared in EU

16-05-2014

Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson, says that its next…

Anti-viralsBiotechnologyEuropeJanssen-CilagJohnson & JohnsonOlysioRegulation

Positive CHMP opinion for Janssen’s simeprevir for chronic hepatitis C

24-03-2014

US health care giant Johnson & Johnson’s European subsidiary Janssen R&D Ireland has received a positive…

Anti-viralsEuropeJanssenJohnson & JohnsonMedivirOlysioPharmaceuticalRegulationsimeprevir

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

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

20-01-2014

US antivirals specialist Gilead Sciences has received marketing authorization from the European Commission…

Anti-viralsBiotechnologyEuropeGilead SciencesPricingRegulationSovaldi

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