FDA Encourages Inclusion of Older Patients in Cancer Trials

USA – FDA Issues Draft Guidance on NASH Drug Development

The US Food and Drug Administration (FDA) on Monday issued draft guidance on developing drugs to treat patients who have noncirrhotic nonalcoholic steatohepatitis (NASH)...
Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

USA – Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances,...
Update on the review of CEP applications for sartans

Europe – Update on the review of CEP applications for sartans

Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd ,...
Le CNOP dévoile trois rapports sur la prévention, les nouvelles technologies et la pharmacie clinique

France – Le CNOP dévoile trois rapports sur la prévention, les nouvelles technologies et...

Avec pour objectif de placer le pharmacien au cœur de la transformation du système de santé français amorcée en 2018, Carine Wolf-Thal, Présidente du...
Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines' Initial Release

Europe – Review and update of EMA guidelines to implement best practice with regard...

In February 2014, CHMP and CVMP published a joint concept paper announcing a review and update of EMA guidelines to implement best practice with...
NCCN: Updated NSCLC Guidelines Hone in on PD-L1 Testing

UK – Immunotherapy extends the life of head and neck cancer patients

The study, by The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, found that the drug – MSD’s Keytruda (pembrolizumab) -...
ANSM – Comité d’interface du 6 Février – EUDAMED

France – Nouveau rappel de médicaments à base de valsartan

Un important rappel de médicaments à base de valsartan est réalisé le jeudi 29 novembre 2018, en raison de l'identification de la présence éventuelle...
NICE u-turn on Opdivo for skin cancer recurrence

UK – NICE u-turn on Opdivo for skin cancer recurrence

The Institute rejected use of the drug in this setting earlier this year on grounds that it was not cost-effective enough, but has now...
How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?

International – How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?

Implantable technologies have come a long way over the years, and advancements in micro and nanotechnologies have helped device developers continue to push the...
NICE ‘OK’ for Lynparza

UK – Bayer’s Stivarga wins NICE backing for advanced liver cancer

Stivarga (regorafenib) is to be offered to advanced liver cancer patients in England and Wales whose liver is well-functioning but unable to be surgically...

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