Tag Archives: hepatitis B

June, 2018

6 June
Hookipa and Gilead Partner to Develop Immunotherapies Against HIV and Hepatitis B

Vienna, Austria and Foster City, CA, 5 June 2018 – Hookipa Biotech AG (“Hookipa”), a clinical-stage biotech company pioneering an innovative class of active immunization therapies for oncology and infectious diseases and Gilead Sciences, Inc., (“Gilead”), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet …
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20 October
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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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 …
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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™, …
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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 …
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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 …
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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 …
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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 …
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