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Hepatitis C

FDA Expands Approval of AbbVie’s Mavyret for a Shortened 8-Week Treatment Duration for Patients with Hepatitis C and Compensated Cirrhosis

NORTH CHICAGO, Ill., Sept. 26, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of MAVYRET® (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes …

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FDA Issues Warning Regarding Rare Instances of Serious Liver Injury or Failure with Certain HCV Treatments

SILVER SPRING, Md., Aug. 28, 2019 /PRNewswire/ — “Hepatitis C virus remains a significant public health issue, but effective therapeutic options have helped patients to receive important curative treatments,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products within the FDA’s Center for Drug Evaluation and Research. “Chronic …

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FDA Grants Breakthrough Therapy Designation to Eiger’s Treatment for Hepatitis Delta Virus Infection

PALO ALTO, Calif., Aug. 20, 2019 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for peginterferon lambda (Lambda) for the treatment of hepatitis …

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Roche Expands Global Access Program Beyond HIV to Include Diagnostic Tests for Tuberculosis, Hepatitis and HPV

Basel, 22 July 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and middle income country programs where the disease burden is the …

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VBI Vaccines Announces Positive Top-Line Results from Phase 3 Study of its Investigational Hepatitis B Vaccine Sci-B-Vac

CAMBRIDGE, Mass., June 17, 2019 (GLOBE NEWSWIRE) — VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced positive top-line results from the randomized, double-blind, pivotal Phase 3 study, PROTECT, designed to evaluate the efficacy and safety of a 10 µg …

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FDA Approves AbbVie’s Mavyret as First Treatment for all Genotypes of Hepatitis C in Pediatric Patients

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017. “Direct-acting antiviral drugs reduce the amount of HCV in the body …

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Boehringer Ingelheim Exercises Option on Second Hepatic Disease Target From Research Collaboration with Dicerna

INGELHEIM, Germany & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Boehringer Ingelheim and Dicerna Pharmaceuticals (NASDAQ: DRNA), a leading developer of investigational RNA interference (RNAi) therapeutics, today announced that Boehringer Ingelheim has exercised an option to receive exclusive rights to a second hepatic disease target emerging from its research collaboration and license agreement with Dicerna. The collaboration, established …

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FDA Grants Breakthrough Therapy Designation to Eiger’s Lonafarnib for Treatment of Hepatitis Delta Virus Infection

PALO ALTO, Calif., Dec. 17, 2018 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lonafarnib for the treatment of hepatitis delta virus …

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AbbVie’s Mavyret Shows High Virologic Cure Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis

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) …

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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 …

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