USA – Califf: FDA committed to boosting complex generic drug development

Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase...

USA – Prenatal cannabis exposure associated with mental disorders in children that persist into...

Prenatal cannabis exposure following the middle of the first trimester—generally after five to six weeks of fetal development—is associated with attention, social, and behavioral...

UK – MSD’s pembrolizumab therapy gets NICE approval

An estimated 1,500 people aged 12 years and over with melanoma are set to benefit from MSD’s –  known as Merck & Co in the...

International – Genetically modified herpes combats advanced cancers

Researchers have found that RP2 – a modified version of the herpes simplex virus – has showed signs of effectiveness in a quarter of...
Spécificités méthodologiques d’évaluation clinique des Dispositifs Médicaux Connectés

France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de...

La HAS confirme sa recommandation d’administrer une dose additionnelle de vaccin contre la Covid-19 aux personnes à risque de faire une forme sévère de...

Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants

The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to...

Europe – Biosimilar medicines can be interchanged

EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference...

Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV)...

EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease...

Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines

EMA’s human medicines committee (CHMP) has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorisations....

International – Pfizer doses first patients with mRNA-based influenza vaccine

Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically offer only 40% to 60% protection, with...

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