Sunday, January 11, 2015

Merck Accelerates Drug-Submission for hepatitis C and lung cancer

Merck Accelerates Drug-Submission Plans

Mid-Year Applications Are Goal for Keytruda for Lung Cancer, New Hep C Treatment
By Peter Loftus
The Wall Street Journal
Jan. 11, 2015 11:04 p.m. ET

Merck & Co. has accelerated its plans to submit new drugs for hepatitis C and lung cancer for regulatory approval, in a bid to close the gap with competitors in two lucrative segments...

Merck also plans to file an application in the first half of this year for FDA approval to market a new two-drug, single-pill combination to treat the liver disease hepatitis C. The drugs, grazoprevir and elbasvir, cured at least 90% of infected patients in a mid-stage clinical trial and Merck is testing them in late-stage studies.

The company previously said it expected to file for regulatory approval of the hepatitis C regimen sometime during 2015...

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