Specialty Pharma Journal Specialty, Precision & Technology
NORTH CHICAGO, Ill., Aug. 3, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for …
Tag Archives: hep C
August, 2017
July, 2017
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18 July
FDA Approves Gilead’s Vosevi for Re-Treatment of Adults with Hepatitis C
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vosevi™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, …
April, 2017
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24 April
Merck Announces New Mid-Stage Data on Investigational Triple Combination Therapy for Hepatitis C
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first sustained virologic response1 (SVR) results 12 weeks after completion of therapy (SVR12, considered virologic cure) from C-SURGE, an ongoing, open label Phase 2 clinical trial evaluating MK-3682B [uprifosbuvir (MK-3682)2/grazoprevir3/rusazvir4], the company’s …
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21 April
AbbVie’s Pan-Genotypic HCV Regimen Achieves a 99% Cure Rate in Late-Stage Study
AMSTERDAM, April 20, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with its …
February, 2017
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22 February
The 2017 Hepatitis C Treatment Landscape
Last year, 2016, brought a whirlwind of changes and progress to the hepatitis C field, particularly when it comes to direct-acting antiviral medications. This included various drug approvals and access improvements for hepatitis C medications, including Daklinza, Epclusa, Sovaldi/velpatasvir, Viekira, and Zepatier. As we make our way deeper into 2017, …
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15 February
Understanding the Hepatitis C Testing Process
Many of your patients will likely need to be screened for hepatitis C, which means that they will have many questions during the testing process. This blog geared to patient education can help your patients understand each step of what can be a stressful time in their lives. Q: Do …
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3 February
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 …
January, 2017
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25 January
HCV: Relapse or Reinfection?
Today’s hepatitis C medications offer extremely high cure rates. In fact, the few cases of a previously treated patient later testing positive for hepatitis C has some patients wondering “did I relapse or could I have been reinfected?” There are six different genotypes of the hepatitis C virus (as well …
December, 2016
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19 December
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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14 December
Let’s Screen Everyone
Too many people infected with the hepatitis C virus (HCV) simply don’t know their disease status. As many as one in four cases of HCV infection are undiagnosed, as I pointed out in a blog earlier this year (Finding the Missing Cases), even when current federal guidelines for hepatitis C …