Europe – European Commission approves cystic fibrosis treatment for six to 11-year-olds

The European Commission (EC) has granted approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with ivacaftor. This has been recommended for...

Europe – Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation...

EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused by the Omicron variant which is now spreading...
Health Canada Begins Release of Clinical Data on Drugs and Devices

USA – Manufacturers object to provisions in FDA’s microbiological quality guidance

An industry trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality...

Europe – EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir)...

EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA...

UK – The NICE recommends Rinvoq for psoriatic arthritis patients

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending Rinvoq (upadacitinib) 15mg as a new option...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated...

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and...

USA – FDA’s drug volume reporting requirements face pushback

As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies...
FDA: 2019 Continues Uptick in Orphan Drug Approvals

USA – FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure...
Spécificités méthodologiques d’évaluation clinique des Dispositifs Médicaux Connectés

France – Covid-19 : accès précoce accordé au Xevudy® en traitement curatif

En complément de la campagne de vaccination, et notamment la campagne de rappel, et du renforcement des gestes barrières et des mesures de distanciation...

UK – NICE recommends MSD’s Keytruda in combination with chemotherapy for routine treatment of...

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending MSD’s (known as Merck in the US...

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