UK – Roche’s Polivy recommended by NICE for lymphoma therapy
In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse...
USA – FDA details approach for finding optimal dosages for new cancer drugs
The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical...
International – Contre le Covid-19, l’exécutif mise aussi sur le Paxlovid, l’antiviral de Pfizer
En cette période de vague ascendante de Covid-19 et de fêtes qui approchent, les pouvoirs publics misent sur la responsabilisation des Français, en leur...
UK – MHRA to recognize foreign regulatory approvals for medicines and medical technologies and...
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high...
USA – FDA to require mail-back envelopes for unused opioids
Drugmakers will soon have to provide patients with postage-paid envelopes to send back unused opioids for safe disposal under a new requirement announced by...
UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...
The following legal obligations apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are...
Canada – Notice – Implementation of ICH E19: A selective approach to safety data...
Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to...
Europe – EMA medical terms simplifier
This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for materials prepared...
France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de...
La HAS confirme sa recommandation d’administrer une dose additionnelle de vaccin contre la Covid-19 aux personnes à risque de faire une forme sévère de...
UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE’s decision...
