Delays to cancer testing and treatment ‘inevitable’ after Brexit

UK – Delays to cancer testing and treatment ‘inevitable’ after Brexit

Clinicians have been urged to reduce their workload in the days after 29 March, when the UK is due to leave the European Union. BBC...
CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease

Europe – CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic...

EMA’s human medicines committee (CHMP) has recommended the authorisation of Palynziq (pegvaliase), a new medicine for patients aged 16 and older with phenylketonuria, a...
Complex Generic Drugs: FDA Offers Two Draft Guidances

USA – Complex Generic Drugs: FDA Offers Two Draft Guidances

The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development...
New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe – New add-on treatment to insulin for treatment of certain patients with type...

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type...
NICE U-turn on Crystiva for rare bone disease

Europe – NICE U-turn on Crystiva for rare bone disease

The U-turn is good news for the Japan company, which negotiated on the price of the treatment behind closed doors after the NICE's  conclusionthat the...
S. Korean officials extend seasonal flu vaccine to very young children

South Korea – S. Korean officials extend seasonal flu vaccine to very young children

C Pharma (formerly known as Green Cross) has announced that it has received approval from the South Korean Ministry of Food and Drug Safety...
Médicaments : d’inquiétantes ruptures de stock

France – Médicaments : d’inquiétantes ruptures de stock

La liste ne cesse de s’allonger. Alors que des centaines de médicaments et vaccins disparaissent des rayons des pharmacies et des hôpitaux, comment expliquer...
Reflection paper on the qualification of non-genotoxic impurities

Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and...

This document updates and replaces the Annex previously included in the Guideline CPMP/463/00 Rev. 1. It is an integral part of the European Commission guideline...
La HAS accorde le Forfait Innovation au système WISE CRT, dispositif médical implantable de resynchronisation cardiaque

France – La commission de la transparence précise et adapte ses principes d’évaluation des...

La commission de la transparence (CT) de la Haute Autorité de Santé (HAS), est chargée de rendre aux pouvoirs publics un avis scientifique sur...
NICE nod for Takeda’s Adcetris in advanced stage CTCL

UK – AbbVie’s Venclyxto hit with NICE rejection

The National Institute for Health and Care Excellence said there were uncertainties with both the clinical evidence and the economic modeling provided. Clinical trial evidence...

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