UK – Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary...
Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review which found that their benefits...
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...
Europe – EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and,...
USA – FDA draft guidance aims to help sponsors develop drugs for radiation exposure
The US Food and Drug Administration (FDA) on 19 April issued draft guidance that encourages sponsors to have “early and ongoing” communication with the...
USA – FDA issues final guidance on nicotine replacement therapy
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested...
UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines...
International – FDA, EMA officials discuss impediments to cell and gene therapies
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a “playbook” or platform approach for developing multiple cell and...
USA – FDA offers details on PDUFA VII STAR review pilot
The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten...
UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
The clinical study involved 16 patients with either colon, breast or lung cancers that had failed to respond to other treatments, and was made...
