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Two Psoriasis Therapies Grab CHMP Backing For European Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

Novartis’s Cosentyx and Celgene’s Otezla are expected to be approved and launched in Europe in early 2015 for the dermatological indication.

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Cerdelga Becomes First Oral First-Line Therapy For Gaucher Disease

Sanofi’s Genzyme unit obtains U.S. approval for eliglustat as an oral, first-line therapy for adults with Type 1 Gaucher disease. The new product will augment its market-leading Cerezyme, and the company says it will price Cerdelga at par so that patient/physician choice will not be based upon price.

Merck’s Zontivity Label Isn’t Weighed Down With Safety Language

FDA approves antiplatelet inhibitor with a label that makes little mention of the safety concerns seen in lightweight patients, despite a vibrant FDA and advisory panel discussion on how to present the unfavorable data, but the company still has a big marketing challenge ahead.

Pipeline Watch: Clinical Trial Starts In COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.


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