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EMA/FDA

Trump chooses Gottlieb to run FDA; Pharma breathes sigh of relief

U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the…

Atazanavir Mylan approved for use in Europe

Atazanavir Mylan, a generic version of Reyataz, has been granted a marketing authorisation for use in the European Union. For more information, click here.

European and US regulators agree on mutual recognition of inspections of medicines manufacturers

Transatlantic agreement will help to make better use of inspection capacity and reduce duplication Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections…

FDA: TECHNIVIE label updated

On February 27, 2017 the TECHNIVIE  (fixed-dose combination of ombitasvir, paritaprevir, and ritonavir) label was updated to expand the indication to patients with genotype 4 chronic hepatitis C virus infection…

EMA Patient Registries Workshop: Report now available online

The report of the Patient Registries Workshop, organized by the European Medicines Agency (EMA) and held on 28 October 2016, is now available on the EMA website. The report sets…

AbbVie receives CHMP positive opinion for hepatitis C regimen

AbbVie receives CHMP positive opinion for eight-week treatment option with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for patients with genotype 1b chronic hepatitis C - CHMP opinion brings AbbVie…

CHMP recommends extension of therapeutic indications for Truvada

At its February meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an extension of therapeutic indications for Truvada (emtricitabine/tenofovir disoproxil) with marketing authorisation holder…

CHMP recommends for approval generic version of Truvada

At its February meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval a generic version of Truvada – Emtricitabine/tenofovir disoproxil Krka d.d. (emtricitabine/tenofovir disoproxil)…

EMA: Consultation on revised policy on access to documents

Comments from stakeholders invited until 18 May 2017 The European Medicines Agency (EMA) launches today a public consultation on the proposed revision to its policy on access to documents. The…

Pharma industry shuns Trump push for radical shift at FDA

U.S. President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would…