NICE ‘OK’ for Lynparza

UK – Final NICE green light for Pfizer’s Mylotarg

The guidelines, which do not cover the treatment of acute promyelocytic leukaemia, endorse NHS funding for patients aged 15 years and over, but only...
Renouvellement de la commission de la transparence de la HAS

France – Renouvellement de la commission de la transparence de la HAS

La HAS a procédé au renouvellement de la commission de la transparence le 24 octobre 2018. Vingt-trois membres ont ainsi été nommés pour 3...
FDA final guidance targets competitive generic therapies

USA – FDA Drafts Guidance on Using Metastasis-Free Survival Endpoints in Prostate Cancer Posted...

The US Food and Drug Administration (FDA) issued draft guidance on Tuesday to aid sponsors in using metastasis-free survival (MFS) as a clinical trial...
Stem cell-based Parkinson's therapy tested in Japan

Japan – Stem cell-based Parkinson’s therapy tested in Japan

Japanese researchers said on Friday (Nov 9) they have transplanted stem cells into the brain of a patient in the first stage of an...
New drug options, risk factors added to U.S. heart guidelines

USA – New drug options, risk factors added to U.S. heart guidelines

Updated U.S. guidelines on heart health advise more personalized assessment of risk as well as two newer types of cholesterol-lowering drugs for people at...
Conférence finale du projet JAMS sur les dispositifs médicaux : un modèle de coopération européenne piloté par l’ANSM

France – L’ANSM met en place un dispositif accéléré d’autorisation d’essais cliniques (Fast Track)

Afin de permettre un accès plus rapide aux traitements innovants pour les patients, l’ANSM met en place deux circuits courts (Fast Track) qui vont...
eCTD Technical Conformance Guide

USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen...

Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who...
NICE says no to expanding use of AZ’ Lynparza

UK – NICE says no to expanding use of AZ’ Lynparza

The drug’s recent expanded approval in Europe allows its use for maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal...
BREXIT : où en est-on ?

UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit

British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The...
NICE ‘OK’ for Lynparza

UK – NICE nod for Jazz’ AML chemo

In a Final Appraisal Determination the Institute has approved funding for the drug when used to treat adults with newly diagnosed, therapy-related t-AML or...

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