Vertex And Schering Hold Hep C Lead, But Others Look To Deal Themselves In
The potential for combination therapy involving direct-acting antivirals in the growing hepatitis C space has garnered significant attention from industry firms big and small. At present, even though the standard of care - ribavirin plus one of two branded pegylated interferons (Roche's Pegasys and Schering-Plough's Pegintron) - is effective only in about half of all HCV patients, those drugs generate annual net sales of roughly $2.5 billion
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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.