New York, NY -- (ReleaseWire) -- 04/12/2013 --Gilead Sciences Inc. (NASDAQ:GILD) announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.
The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States.
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Pfizer Inc. (NYSE:PFE) announced its investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for the potential treatment of patients with breast cancer.
“We appreciate the opportunity that Breakthrough Therapy designation provides to work closely with the FDA on the development of palbociclib,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology business unit. “Palbociclib is one example of Pfizer’s commitment to identifying and translating innovative science into meaningful new treatment options for cancer patients.”
Pfizer Inc., a biopharmaceutical company, discovers, develops, manufactures, and sells medicies for people and animals worldwide.
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