Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in...
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have...
Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.
The medicine has been approved in the EU...
UK – NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis
The recommendation is specifically for adult patients with the condition who are eligible for systemic treatment, only if the disease has not responded to...
UK – NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC
The treatment recommendation is specifically for eligible adults for whom surgery or radiation treatment is not appropriate. NICE’s decision means eligible patients will be...
USA – FDA issues draft guidance on dosage and administration labeling
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section...
Europe – Public consultation on a multi-stakeholder platform to improve clinical trials in the...
On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a...
USA – Pharma groups say ICH guideline on viral safety evaluation needs to incorporate...
US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but...
France – Pénurie d’amoxicilline : les recommandations de l’ANSM pour une utilisation rationnelle
Depuis plusieurs semaines, d'importantes perturbations sont observées sur le marché international des spécialités orales à base d'amoxicilline seule (CLAMOXYL et génériques) ou associée avec l'acide clavulanique...
USA – NCI official raises concerns about FDA’s cancer drug dose optimization guidance
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA)...
UK – Ipsen reacts to NICE’s Cabometyx verdict
Ipsen has expressed its disappointed regarding the National Institute for Health and Care Excellence’s (NICE) preliminary guidance which does not recommend Cabometyx – also...
