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UK – NICE recommendation for new Alexion PNH treatment
Alexion, AstraZeneca Rare Disease, announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Voydeya (danicopan).
This first-in-class,...
UK – UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before...
On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s...
Europe – Fostering regulatory collaboration to improve access to mpox medicines
International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for mpox. The report presents the outcomes...
WEBINAR – Produits Thérapeutiques Issus du Microbiome : du développement à...
Intervenant :
Dr Magali CORDAILLAT-SIMMONS
Consultant MCS BIOINNOVATION - Translational Expertise for Microbiome Sciences
Modérateurs :
Dr Frédéric LALLEMAND
Expert CMC, Consultant
Dr Aurelio ZERIAL
Expert Affaires Réglementaires et Formation, Consultant
Qu'attendre...
China – China Issues Guidelines on Children’s Cosmetics
On August 31, 2023, the National Institute of Food and Drug Control (“NIFDC”) issued a notice on the “Technical Guidelines for Children’s Cosmetics” (the...