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EMA/FDA

EMA: How to make better use of patient registries to collect high-quality data on medicines

Workshop to be broadcast live on 28 October A workshop on patient registries will discuss concrete solutions to better use existing patient registries that collect high-quality data from the use…

EMA provides public access to clinical reports

Opening up clinical data on new medicines As of today (October 20), the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised…

Gilead asks FDA to expand exclusivity for a key HIV drug

In the latest development in a heated battle between Gilead Sciences and the US Food and Drug Administration, the company petitioned the agency this month to retroactively grant five years…

First comprehensive overview of global initiatives on medicine regulation published

Mapping aims to improve international collaboration The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by…

FDA, EMA officials: Regulators must adapt to effectively regulate precision medicine

In order to effectively regulate precision medicine, regulators must adapt to alternative methods of evidence generation, say top officials at the US Food and Drug Administration (FDA) and European Medicines…

CHMP recommends for approval generic versions of Truvada and Viread

At its October meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval two generic versions of Truvada – Emtricitabine/Tenofovir disoproxil Mylan (emtricitabine/tenofovir disoproxil)…

HCV drugs may reactivate HBV, FDA warns

Patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation if they take any of nine direct-acting antivirals for hepatitis virus C (HCV)…

New judicial decisions at odds with EMA’s efforts to allow access to documents on medicines

EMA appeals interim measures The European Medicines Agency (EMA) has appealed two interim orders by the President of the General Court of the European Union (EU) to suspend the release…

AbbVie’s investigational HCV regimen receives U.S. FDA Breakthrough Therapy Designation

Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs) Currently in Phase 3 clinical trials, glecaprevir/pibrentasvir…

First generic version of dolutegravir approved by the FDA

Aurobindo Pharma receives US FDA tentative approval for dolutegravir – the first generic version to be approved. This generic dolutegravir is expected to be launched in sub-Saharan Africa in late…