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EMA/FDA

EMA validates Gilead’s Marketing Authorization Application for investigational hepatitis C therapy

European Medicines Agency validates Gilead’s Marketing Authorization Application for investigational chronic hepatitis C therapy sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) SOF/VEL/VOX granted an accelerated assessment by the European Medicines Agency FOSTER CITY, Calif., Jan.…

CytoDyn files for Breakthrough Therapy Designation with the FDA for PRO 140 in HIV therapy

VANCOUVER, Washington, Jan. 11, 2017 -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced the Company…

European Commission grants marketing authorization for Gilead’s Vemlidy® for the treatment of hepatitis B

Vemlidy® is the first new treatment for chronic hepatitis B infection to be approved in the European Union in nearly a decade FOSTER CITY, Calif., Jan. 11, 2017-- Gilead Sciences,…

Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B

Further studies needed to assess risk of liver cancer with these medicines The European Medicines Agency (EMA) has confirmed its recommendation to screen all patients for hepatitis B before starting…

AbbVie submits to FDA its investigational pan-genotypic regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C

If approved, glecaprevir/pibrentasvir will provide an eight week once-daily, ribavirin-free treatment option for HCV patients without cirrhosis across all major genotypes AbbVie's investigational regimen was granted Breakthrough Therapy Designation by…

CHMP recommends extension of therapeutic indication for Tivicay

At its December meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an extension of the existing therapeutic indication for Tivicay. Summary of opinion is…

EMA hosts workshop on adaptive pathways

Broad range of stakeholder questions addressed The European Medicines Agency (EMA) has hosted a workshop with stakeholders to discuss adaptive pathways, an approach to medicines development that aims to facilitate…

Trump is considering a radical to lead FDA. That’s dangerous for public health

Imagine being prescribed a medicine when neither your doctor nor the manufacturer has any clue whether it will actually work — because the government never required it to be tested for…

Gilead submits New Drug Application to FDA for the investigational single tablet regimen sofosbuvir/velpatasvir/voxilaprevir

If approved, SOF/VEL/VOX would be the first once-daily single tablet regimen available as a salvage therapy for patients infected with HCV genotype 1-6 who have failed prior treatment with DAA…

EMA warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

Review of liver cancer risk not conclusive and further studies are needed EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that patients treated with medicines known as direct-acting antivirals for…