UK – NICE approves funding for Novartis gene therapy
NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec.
The treatment is a potentially curative one-off gene therapy...
Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union...
International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation
The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...
Brazil – ANVISA approves skinny labeling in Brazil
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...
Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT
Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to comply with the EU’s GMP Annex 1...
USA – FDA approves first drug to delay onset of type 1 diabetes
The company submitted positive results from the randomised, double-blind, placebo-controlled TN-10 trial that included 76 patients with stage 2 type 1 diabetes.
Results showed that,...
USA – FDA finalizes neurodegenerative disease gene therapy guidance
The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In...
France – Virus de la variole du singe : recommandations pour sécuriser les dons...
Ces recommandations sont détaillées dans une note publiée sur notre site internet, mise à jour en novembre 2016. Elles concernent la collecte de selles pour la...
Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a...
France – HAS : Agrément des Bases de données sur les Médicaments
Conformément à l’article L. 161-38 du Code de la sécurité sociale, la HAS est chargée de l'agrément des bases de données sur les médicaments...
