France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
L’Agence européenne des médicaments (EMA) vient de modifier les autorisations de mise sur le marché (AMM) accordées aux vaccins à ARN messager développés par...
USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of...
Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a...
USA – House report finds Trump officials sought to influence FDA during COVID pandemic
Officials in the Trump administration pressured the US Food and Drug Administration (FDA) during the first year of the COVID-19 pandemic to make regulatory...
USA – FDA allows sponsors to spread out costs in revised IND charging guidance
The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...
USA – FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients...
Europe – New measures to minimise risk of meningioma with medicines containing nomegestrol or...
EMA’s human medicines committee (CHMP) has endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of medicines containing nomegestrol or...
Europe – Review of pholcodine medicines started
The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk...
Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing...
EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during...
Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron...
