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EMA/FDA

U.S. FDA approves PREZISTA® (darunavir) for use in pregnant women with HIV

Data shows PREZISTA® is a safe and effective treatment option in pregnant women, with no reports of mother-to-child HIV transmission among women who continued therapy through delivery TITUSVILLE, NJ, July 18, 2016…

Fast advance in hepatitis C care prompts EMA to revise clinical trial guideline

EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that…

European Commission grants marketing authorization for Gilead’s Epclusa® for the treatment of all genotypes of chronic hepatitis C

Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus infection and is Gilead’s third sofosbuvir-based treatment FOSTER CITY, Calif., Jul.…

EMA: Statement on the outcome of the UK referendum

EMA’s procedures and work streams continue as usual The European Medicines Agency (EMA) acknowledges the outcome of the referendum of 23 June 2016. A majority voted against United Kingdom’s (UK)…

GeoVax announces filing of Investigational New Drug application for HIV human clinical trial

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today (June 30) the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug…

FDA approves Gilead’s Epclusa® for the treatment of all genotypes of chronic hepatitis C

Epclusa is the first and only all-oral, pan-genotypic single tablet regimen for chronic hepatitis C virus infection and Gilead’s third sofosbuvir-based regimen FOSTER CITY, Calif.--Jun. 28, 2016-- Gilead Sciences, Inc.…

Gilead’s new hepatitis C drug approved by FDA, priced at $74,760

Epclusa is first treatment for all forms of the disease Drug will mainly be used in patients with genotypes 2 and 3 Gilead Sciences Inc.’s hepatitis C drug was approved…

Odefsey approved in Europe

European Commission grants marketing authorization for Gilead’s single tablet regimen Odefsey® (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV Odefsey is the second single tablet regimen containing the Descovy…

CHMP adopts positive opinion for generic atazanavir

On 23 June 2016 the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion, recommending the granting of a…

Brexit spells upheaval for EU and UK drug regulation

Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based European Medicines Agency (EMA), which approves treatments for all EU countries, expected to have…