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Hepatitis C

AbbVie’s Hepatitis C Treatment Receives Priority Review from the FDA

NORTH CHICAGO, Ill., Feb. 2, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of all …

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Regulus Therapeutics Announces Continuation of FDA Clinical Hold on RG-101

LA JOLLA, Calif., Jan. 27, 2017 /PRNewswire/ — Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for RG-101 remains on …

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Quest Diagnostics Launches New HBV Test to Help Assess Response to Antiviral Therapy

MADISON, N.J., Jan. 18, 2017 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced the launch of a new test service that helps physicians evaluate a patient’s response to drug therapies used to treat infection with the hepatitis B virus (HBV). The first …

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AbbVie Submits NDA for Regimen of Glecaprevir/Pibrentasvir for Treatment of All Major Genotypes of Hepatitis C

NORTH CHICAGO, Ill., Dec. 19, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company’s investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of chronic hepatitis C …

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Express Scripts Announces Enhancements to Industry Leading SafeGuardRx Programs

LOUIS, Dec. 12, 2016 /PRNewswire/ — As part of its ongoing mission to put medicine within reach, Express Scripts (NASDAQ: ESRX) today announced enhancements to its landmark SafeGuardRxSM programs focusing on hepatitis C and cancer. Beginning Jan. 1, 2017, the company’s Hepatitis Cure Value Program® will now include both Viekira …

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Gilead Submits NDA to FDA for Once-Daily Triple Combo Hepatitis C Pill

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of …

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FDA Rejects Dynavax’s Hepatitis B Vaccine

BERKELEY, CA — (Marketwired) — 11/14/16 — Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years …

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FDA Approves Gilead’s Vemlidy for Treatment of Hepatitis B

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Vemlidy has a boxed warning in its product label …

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FDA Grants Breakthrough Therapy Status to AbbVie’s Hepatitis C Regimen

NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus …

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Major Treatment Expansion Could Essentially Eliminate Hepatitis C in R.I. by 2030

PROVIDENCE, R.I. [Brown University] — A new Brown University study projects that increasing the number of Rhode Islanders treated every year for hepatitis C virus infection (HCV) to about 2,000 by 2020 would reduce cases by 90 percent and prevent more than 70 percent of expected liver-related deaths in the …

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