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EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
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 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.
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.
European Medicines Agency says recently deceased colleague Jordi Llinares Garcia will be dearly missed.
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’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.
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.
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.
Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.
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’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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