Ajovy bags NICE approval

International – NICE and Canadian counterpart to offer joint advice service

The service will offer guidance that will help pharma develop value-based evidence by providing feedback on the company’s clinical and economical evidence generation plans. Feedback...
L'Italie saisit la justice européenne sur la relocalisation de l'Agence du médicament à Amsterdam

Europe – L’Italie saisit la justice européenne sur la relocalisation de l’Agence du médicament...

L'Italie et la ville de Milan ont saisi la justice européenne pour contester la décision de l'UE de relocaliser l'Agence européenne du médicament (EMA)...
NCCN: Updated NSCLC Guidelines Hone in on PD-L1 Testing

UK – Mapping of oesophageal cancer gene mutations leads to new drug targets

The news, which was published in Nature Genetics, comes from Cancer Research UK researchers at the University of Cambridge, who used whole genome sequencing and...
USP’s Generics Access Plan to Aid FDA Efforts

USA – USP’s Generics Access Plan to Aid FDA Efforts

USP last week unveiled a new Generic Access Plan as part of its collaboration with the US Food and Drug Administration (FDA) to better...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA Announces Plans for Advancing Cell and Gene Therapies

In anticipation of a surge of investigational new drug applications for cell and gene therapies in the next few years, FDA Commissioner Scott Gottlieb...
NICE ‘OK’ for Lynparza

UK – Kymriah gets NICE approval for DLBCL

Kymriah (tisagenlecleucel) - the only CAR-T cell therapy available for NHS patients in England and Wales for two distinct blood cancers - will be...
Guide technique pour l’élaboration des monographies de vaccins et sérums pour usage humain - Mise à jour

Europe – Guide technique pour l’élaboration des monographies de vaccins et sérums pour usage...

Lors de sa 162e Session, la Commission européenne de Pharmacopée a approuvé une nouvelle édition du Guide pour l’élaboration et l’utilisation des monographies de vaccins et...
Médicaments : quelle(s) réalité(s) ?

France – REVUE PRESCRIRE : LA LISTE NOIRE DES 68 MÉDICAMENTS DANGEREUX

Jeudi 30 janvier, la revue médicale Prescrire a publié une nouvelle liste de médicaments à "écarter" en raison des risques qu'ils font encourir aux...
Biologic and Biosimilar Misinformation: FDA Drafts Guidance

USA – Marketing Status Notifications: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new...
Advice for Management of Clinical trials in relation to Coronavirus

Europe – UK and Russia sign MoU on Regulatory Cooperation on Medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MoU) with its Russian counterpart; the State Institute of Drugs...

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