Thursday, January 6, 2011

Hepatitis/Merck Boceprevir Beats Vertex Telaprevir to FDA Hep C Filing

See Press Release;
Boceprevir Receives FDA Priority Review and EMA Accelerated Assessment

The U.S. Food and Drug Administration accepted Merck's approval filing for its hepatitis C drug boceprevir, the company said Thursday. The news from Merck is a bit of a surprise since the company hadn't previously announced or confirmed that boceprevir had been filed with U.S. regulators.
It's also a tad embarrassing for Vertex, which is still waiting to hear back from FDA about the acceptance of the approval filing for telaprevir, its competing hepatitis C drug. That news should come by Jan. 24, based on Vertex's previous announcement that it filed the drug's application on Nov. 23.
Still, it seems as if Merck beat Vertex to the FDA by at least two weeks.
Continue reading.....................
,

No comments:

Post a Comment