France – Evaluer le circuit des Médicaments de thérapie Innovante (MTI)
Les nombreuses spécificités des MTI (médicaments stériles, OGM, stockage cryogénique…) nécessitent une rigueur pharmaceutique et une logistique robuste pour permettre une prise en charge...
France – L’ANSM renforce l’information des patients et des pharmaciens sur les risques liés...
Après avoir sollicité l’ensemble des parties prenantes, l’ANSM a élaboré ces documents afin de renforcer l’information sur le bon usage et les risques d’effets...
International – Covid-19 nasal vaccine is here: Price, benefits, all you need to know
Vaccine maker Bharat Biotech's intranasal vaccine for Covid-19, the first in the world, is set to be launched soon and is already available on...
USA – FDA draft guidance on controlled correspondence reflects GDUFA III commitments
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency...
UK – AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer
The recommendation follows updated results from the DESTINY-Breast03 phase 3 trial, announced by the companies earlier this month, in which Enhertu demonstrated a statistically...
UK – Sanofi Pasteur COVID-19 vaccine authorised by MHRA
VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the seventh COVID-19...
UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients...
France – Accès précoce: des efforts restent à faire pour améliorer le recueil de...
PARIS (TICpharma) - Près de 18 mois après l'entrée en vigueur de la réforme de l'accès précoce, des efforts restent à faire en matière...
Europe – Facilitating Decentralised Clinical Trials in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs)...
USA – FDA revises guidance on responding to ANDA complete response letters
The US Food and Drug Administration (FDA) has revised its guidance on timeframes for responding to complete response letters (CRL) to abbreviated new drug...
