Europe
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Sanofi Genzyme’s Treatment For Pompe Disease On Track For EU Approval
EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
Pemaryze Wins Cost-Effectiveness Thumbs Up For Rare Bile Duct Cancer In England
Bavencio, Taltz, Cosentyx, and Opdivo plus Yervoy were this week also the subject of final recommendations from the health technology assessment body, NICE, on whether or not they should be used on the National Health Service for certain indications.
Sanofi/GSK’s Vidprevtyn Is Fifth COVID-19 Vaccine Candidate Under Rolling Review at EMA
Sanofi and GSK are way behind in the COVID-19 vaccine race and the start of a rolling review of Vizprevtyn at the European Medicines Agency is an important step.
EU Decision Time On Broader Indication For AbbVie’s Skyrizi
The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU.
Jordi Llinares Garcia, Driver Behind EMA’s Flagship PRIME Initiative, Dies Aged 52
European Medicines Agency says recently deceased colleague Jordi Llinares Garcia will be dearly missed.
Intercept Wants More Time to Address EMA’s Questions Over Its NASH Treatment
The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.
England Unveils £680m Innovative Medicines Fund
England’s Innovative Medicines Fund is aimed at providing earlier access to promising new treatments, including gene therapies, when further data is needed for routine commissioning.
Frustration Over English Funding Rejection For Zytiga And A Win For Ledaga
Janssen and UK health technology assessment body NICE are being urged to sit down together and agree a suitable price for using Zytiga as a first-line treatment for advanced prostate cancer.
Kyowa Awaits EU Decision On Drug For Treating Parkinson’s ‘Off’ Time
The European Medicines Agency is meeting this week to decide whether two new drugs, including one that enhances anti-parkinsonian activity, should be approved for use in the EU. Also, the sponsor of a treatment for the rare degenerative muscle disorder, Pompe disease, is expected to attend an oral explanation meeting to address last-minute questions.
Orphan Drugs Nefecon, Maribavir & Copanlisib Among New EU Filings
Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.
Roche Seeks EU Marketing Approval For Novel Eye Disease Drug Faricimab
If approved, Roche’s bispecific antibody could become the first in a new class of medicines in years for treating macular degeneration and diabetic macular edema.
England: HTA Body’s Income Hit By COVID-19
England’s health technology assessment body NICE did not recover costs for technology appraisals through fees thanks to the COVID-19 pandemic.
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