EMA update on metformin diabetes medicines

Europe – EMA update on metformin diabetes medicines

EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. The...
PRAC recommendations on safety signals : Expected publication dates

Europe – PRAC recommendations on safety signals : Expected publication dates

When PRAC has recommended a product information update, marketing authorisation holders (MAHs) are expected to submit the requested variation according to the timeline specified...
9 nouveaux étalons de référence de la Ph. Eur. et 20 lots de remplacement libérés en novembre 2019

Europe – 9 nouveaux étalons de référence de la Ph. Eur. et 20 lots...

Nouvelles libérations Nouveaux étalons de référence de la Ph. Eur. Lots de remplacement d’étalons de référence de la Ph. Eur. Suppressions Prochaines suppressions Changement d’unités...
New ‘smart pill’ technology reports 100% success rate

UK – New ‘smart pill’ technology reports 100% success rate

Highlighting the vast scope of the adherence problem, a study published by The National Centre for Biotechnology Information found in 2018 that between 25%...
EMA update on metformin diabetes medicines

Europe – European authorities working to avoid shortages of medicines due to Brexit –...

On 29 March 2017 the United Kingdom (UK) notified the European Union (EU) of its intention to withdraw from the EU (‘Brexit’). According to...
EC Explains What it Means to Authorize Clinical Trials With Conditions

Europe – EC Explains What it Means to Authorize Clinical Trials With Conditions

For the second time in less than a month, the European Commission (EC) has updated its questions and answers (Q&As) document on the incoming...
NICE grants Lynparza expansion for advanced ovarian cancer

UK – NICE grants Lynparza expansion for advanced ovarian cancer

The label extension now covers relapsed, platinum-sensitive high grade epithelial ovarian, fallopian tube or peritoneal cancer in adults whose disease has responded to platinum-based...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) - Novembre 2019

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – Novembre 2019

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...
EMA update on metformin diabetes medicines

Europe – EMA Subgroup Questions Use of NBs to Assess Companion Diagnostics

While discussing the use of genomics data in regulatory processes, a subgroup of the European Medicines Agency (EMA) also called for a reconsideration of...
NICE approves Ibrance via Cancer Drugs Fund

UK – NICE approves Ibrance via Cancer Drugs Fund

Pfizer announced that the recommendation is based on data from the Phase III clinical trial, PALOMA-3, in which Ibrance delayed disease progression by 6.6...

NOS PROCHAINES FORMATIONS