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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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Gilead and Precision BioSciences Collaborate to Develop Therapies Against Hepatitis B Virus Using ARCUS Genome Editing

FOSTER CITY, Calif. & DURHAM, N.C.–(BUSINESS WIRE)–Gilead Sciences (Nasdaq: GILD) and Precision BioSciences announced today that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS. An estimated 257 million people are living with …

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Janssen and Arcturus Partner to Discover and Develop New Hepatitis B Drugs

SAN DIEGO, Oct. 19, 2017 (GLOBE NEWSWIRE) — Arcturus Therapeutics, Inc., a leading RNA medicines company, announced today that it has entered into a research collaboration and worldwide license agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The two companies will work …

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