Specialty Pharma Journal Specialty, Precision & Technology
NORTH CHICAGO, Ill., Nov. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET™ (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) …
Tag Archives: HCV
November, 2018
September, 2018
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25 September
Gilead Subsidiary to Launch Generics of Epclusa and Harvoni for the Treatment of Hepatitis C
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) announced today plans to launch authorized generic versions of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg), Gilead’s leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics LLC. The authorized generics will launch …
October, 2017
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20 October
Gilead Presents Positive Results from Studies of its Approved HCV and HBV Therapies
WASHINGTON–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other …
September, 2017
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29 September
Merck Discontinues MK-3682B and MK-3682C Development Programs
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced its strategic decision to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection. This decision was made based on …
August, 2017
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3 August
AbbVie’s Mavyret Approved by FDA for Treatment of Hepatitis C in All Major Genotypes
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 …
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2 August
FDA Expands Approval of Epculsa for the Treatment of Hepatitis C in Patients Co-Infected with HIV
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use …
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 …
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7 April
FDA Expands Approval of Harvoni and Sovaldi in Pediatric Patients 12 Years and Older with Chronic 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 supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis …