USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet...
UK – Scientists to trial world-first long-acting injection for high blood pressure
Researchers from Queen Mary University of London and Barts Health NHS Trust are trialling an investigational medication for high blood pressure.
It marks the first...
France – HAS : Monkeypox : la stratégie vaccinale réactive précisée pour les primo-vaccinés...
Sur saisine du ministère chargé de la Santé, la HAS précise la stratégie vaccinale à mettre en œuvre autour d’un cas confirmé de variole...
UK – Digital cognitive behaviour therapies recommended by NICE across the NHS
The National Institute for Health and Care Excellence (NICE) has conditionally recommended digital cognitive behaviour therapies (CBT) for use in the NHS. It is...
Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine VidPrevtyn Beta as a booster in adults previously vaccinated with an mRNA or...
International – ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
USA – Industry experts tout potential for master protocols in pediatric clinical trials
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...
USA – FDA final guidance targets neonatal pharmacology studies
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is...
Europe – Guidance on the procedural aspects for the consultation to the European Medicines...
This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural...
UK – NICE recommends UCB’s Fintepla for Dravet syndrome
Fintepla is an oral solution developed to treat seizures associated with Dravet syndrome, a rare, lifelong form of epilepsy that begins in infancy. The...
