Europe – EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of...

EMA’s human medicines committee (CHMP) has issued advice on the use of Lagevrio (also known as molnupiravir or MK 4482) for the treatment of...
Updated Brexit-related guidance for companies will be published shortly.

Europe – Annex 2: HaRP (Harmonisation of RMP Project) – methodology of harmonising RMPs

In HaRP, active harmonisation will be pursued in RMPs in the following two domains: • Domain 1 - RMPs for which data exclusivity of the...
Nitrosamine contamination: new web page on EDQM response

Europe – Évolution des délais de traitement des demandes de CEP par l’EDQM

Depuis le 1er octobre 2021, la Direction européenne de la qualité du médicament & soins de santé (EDQM) utilise un nouvel outil informatique pour gérer les demandes...
EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list

Europe – CAT monthly report of application procedures, guidelines and related documents on advanced...

The Committee for Advanced Therapies (CAT) held its 119th meeting on 9 – 11 October 2019. The CAT Monthly Report includes statistical data on CAT...
NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

Europe – NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

The draft guidance recommends against its use for adults after two or more lines of systemic therapy, concluding that it is not cost effective...

UK – NICE turns down bluebird bio’s gene therapy Zynteglo

The draft guidance, published today, said that clinical trials evaluating Zynteglo (betibeglogene autotemcel; beti-cel) were ‘small’, with participants not having been followed up for ‘very...
Advice for Management of Clinical trials in relation to Coronavirus

UK – ACCESS Consortium guidance on strain changes in authorised COVID-19 vaccines

This document is only applicable to COVID-19 vaccines which have already been authorised, based on adequate data on pharmaceutical quality, safety and efficacy from...

Europe – A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19

Open dialogue between regulators and companies, better product and process knowledge, good manufacturing practice (GMP) compliance, and an effective pharmaceutical quality system are the main ingredients...
NICE refuses Keytruda, Inlyta cancer combo

UK – NICE refuses Keytruda, Inlyta cancer combo

NICE already routinely commissions various drugs for first-line treatment of RCC, including Aveo’s Fotivda (tivozanib), Pfizer’s Sutent (sunitinib) and an Opdivo (nivolumab) Yervoy (ipilimumab)...

UK – Updated guidelines for managing long-term effects of COVID-19 published

This includes an update to the original list of common symptoms to now include hair loss, nasal congestion, post-traumatic stress disorder symptoms, weight loss,...

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