Tag Archives: hepatitis B

June, 2018

October, 2017

November, 2016

  • 30 November

    Arrowhead Pharma Halts Work on Lead Hepatitis B Drugs, Focuses on Subcutaneous and Extra-Hepatic RNAi Therapeutics

    PASADENA, Calif.–(BUSINESS WIRE)–Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced a strategic redeployment of resources to support the development of RNAi therapeutics that utilize the company’s new proprietary subcutaneous (subQ) and extra-hepatic delivery systems. Arrowhead will discontinue development of clinical stage drug candidates ARC-520, ARC-521, and ARC-AAT, which utilize the DPCiv™, …

  • 14 November

    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 …

  • 11 November

    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 …

October, 2015

  • 19 October

    FDA Approves Roche’s HBV and HCV Viral Load Tests

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® HBV and cobas® HCV viral load tests, the first assays approved by the United States Food and Drug Administration (FDA) for use on the cobas® 6800 and cobas® 8800 Systems. The fully automated …

April, 2015

  • 13 April

    FDA Clears Arrowhead to Continue its Hepatitis B Trial

    Pasadena-based Arrowhead Research Corporation announced that US health regulators gave the company the green light to continue with its mid-stage hepatitis B infection study. The company said that the US Food and Drug Administration (FDA) informed the company that it can proceed with a multiple-dose Phase 2b clinical study of …