USA – FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the...

Europe – Strengthening global collaboration on COVID-19 real-world evidence and observational studies

Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate regulatory decision-making on COVID-19 treatments and vaccines...

UK – ICR urges change as NICE rejects Keytruda plus chemotherapy

Although NICE reversed a draft rejection of Keytruda (pembrolizumab) and has now recommended it for use on the NHS as a first-line treatment for...

USA – FDA plans master protocols to monitor COVID vaccine safety, efficacy

After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements,...

France – Premiers résultats encourageants pour la plateforme eNephro de télésuivi des malades rénaux...

NANTES (TICpharma) - La télésurveillance médicale des patients atteints de maladie rénale chronique tend à diminuer la durée cumulée sur un an des hospitalisations...
HAS - Webinaire sur l'évaluation des dispositifs médicaux : visionnez le replay

France – HAS : COVID-19 – VEKLURY : Demande de remboursement retirée par le...

Avis favorable au remboursement uniquement dans la prise en charge des patients âgés de 12 ans ou plus et pesant au moins 40 kg,...
ANSM : Antibiotiques et Résistance Bactérienne : Une Menace Mondiale, des Conséquences Individuelles

France – L’ANSM publie sa décision sur la demande d’une RTU pour l’hydroxychloroquine dans...

Nous avons reçu une demande de recommandation temporaire d’utilisation (RTU) de l’hydroxychloroquine dans la prise en charge de la maladie Covid-19, de la part...

Europe – Euro Regulatory Roundup

The United Kingdom has introduced legislation on the temporary authorization of unlicensed drugs and vaccines to support the rollout of COVID-19 products. Through the...

USA – FDA Approves First Treatment for COVID-19

Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older...

Europe – Recommendations on eligibility to PRIME scheme

During its October 2020 meeting, the CHMP reviewed eight recommendations for eligibility to PRIME: four were granted, three were denied, and one is currently...

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