France – FDA launches online forum for drug repurposing

The FDA has launched what it calls the CURE Drug Repurposing Collaboratory, an online forum for exchanging clinical practice data to identify potential new uses for existing...

France – La relocalisation de la production de médicaments en cinq questions

Assurer la souveraineté sanitaire de la France. C'est l'un des leitmotivs du gouvernement depuis la crise sanitaire du Covid-19. Afin d'éviter d'éventuelles pénuries de...

Europe – Le cahier Orphanet « List of expert reviewers 2019 » est en ligne

Experts were identified through their publications, and their activity related to the given disease/group of diseases (research projects, clinical trials, expert centres and dedicated networks): more...

USA – FDA seeks input on genotyping for pediatric codeine use

The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to...

UK – NICE sticks to Zytiga rejection

Around 4,000 men newly diagnosed with high-risk metastatic hormone-sensitive prostate cancer (mHSPC) would have been eligible for treatment abiraterone acetate in combination with prednisone/prednisolone...
NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

UK – NICE rejects Novartis’ Mayzent for secondary progressive MS

According to the Institute, clinical trial results show that the drug reduces the number of relapses and slows disability progression compared with placebo. However, it...

Europe – First COVID-19 treatment recommended for EU authorisation

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12...

Europe – Emer Cooke nominated as new EMA Executive Director

The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. At an extraordinary virtual session on 25 June,...

UK – NICE green light for Roche’s Rozlytrek

As a histology independent treatment, the drug targets all solid tumours that have a certain genetic mutation (a neurotrophic tyrosine receptor kinase (NTRK) gene...

USA – FDA gives Project Renewal update at AACR

Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress...

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