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Europe

Set Alert for Europe

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. 

Europe Drug Review

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.

United Kingdom Health Technology Assessment

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.

Europe BioPharmaceutical

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. 

Drug Review Regulation

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.

Europe Regulation

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.

Drug Review Liver & Hepatic

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.

Europe United Kingdom

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.

Cancer Reimbursement

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.

Europe Drug Review

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.

Europe Drug Review

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.

Drug Review Ophthalmic

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.

Europe United Kingdom
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