U.S.: Dynavax Announces FDA Approval of HEPLISAV-B™ for Prevention of Hepatitis B in Adults

First and Only Two-Dose Vaccine in United States for Prevention of Hepatitis B in Adults. First New Hepatitis B Vaccine in United States in More than 25 Years.  BERKELEY, CA--(Marketwired - November 09, 2017) - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hep

The Week in Review: July 28 – August 4, 2017

Friday, August 4, 2017 Treatment: This last week saw the approval in the U.S. of AbbVie’s Mavyret, a pangenotypic also indicated as recuperation therapy for those with GT1 who have failed treatment with DAAs. U.S.: FDA approves Mavyret for Hepatitis C As well, the FDA has approved updated labeling for Epclusa to include use in patients co-infected with HIV. U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatmen...

U.S.: FDA approves Mavyret for Hepatitis C

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibi

U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic 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 in patients co-infected with HIV. “HCV co-infection remains a major cause

FDA approves Vosevi for Hepatitis C

SILVER SPRING, Md., July 18, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been pre

The Week in Review: March 31, 2017 – April 7, 2017

Friday, April 7, 2017 News Recap Canada Effective April 2017, Alberta Health has expanded access to treatments for hepatitis C in line with what the provinces of British Columbia, Ontario, Saskatchewan, and Québec have just done (Alberta expands drug coverage for hepatitis C patients). As Dr. Shafran, who is clearly worried about continued restrictions, says, “The funders have now opened the doors to let us treat people with mild liver disease … if ...

U.S.: FDA approves two hepatitis C drugs for pediatric patients

The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing th

U.S.: FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis

Test speeds treatment decisions, contributes to better patient careINDIANAPOLIS, March 21, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its hepatitis C virus (HCV) quantitative RNA test to be used as an aid in the diagnosis of HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrenceFriday, February 5, 2016 12:47 pm EST--PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without r

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

January 28, 2016 - The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparen