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Report: Sandoz has as many as 10 follow-on biologics in works
NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.
Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.
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Vascugel granted fast-track designation by FDA
CAMBRIDGE, Mass. — The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.
The FDA granted fast-track review status to the cell-based therapy Vascugel, made by Pervasis Therapeutics. The FDA grants the status to accelerate review of treatments for serious and life-threatening conditions, particularly those that address serious, unmet medical conditions.