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EMA/FDA

Regulus announces continuation of RG-101 clinical hold

FDA requests longer-term follow-up data from ongoing studies LA JOLLA, Calif., Jan. 27, 2017 -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines…

EMA grants accelerated assessment, validates Marketing Authorization Application for AbbVie’s investigational hepatitis C therapy

European Medicines Agency grants accelerated assessment, validates Marketing Authorization Application for AbbVie's investigational regimen of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C in all major genotypes (GT1-6) -…

EMA report: Conditional marketing authorisation – 10 years of experience

Conditional marketing authorisations give patients access to important new medicines earlier EMA publishes report with data collected between 2006 and June 2016 Conditional marketing authorisation (CMA) can speed up access…

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…