The European Commission (EC) has expanded marketing authorisation for Gilead's Epclusa (sofosbuvir/velpatasvir/sofosbuvir) to include the treatment of children with chronic hepatitis C infection (HCV).
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced the presentation of more than 40 abstracts reflecting the breadth of research from the company’s programs addressing significant challenges in viral hepatitis, nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) at The Digital International Liver Congress™ 2020 (ILC) from August 27-29.
US FDA granted expanded approval for Mavyret that will allow patients to be treated for the hepatitis C virus in eight weeks.
The Food and Drug Administration (FDA) has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All these medicines contain a hepatitis C virus (HCV) protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment. In most patients, symptoms resolved or new onset worsening of liver function improved after stopping the medicine. These medicines have been widely used and are safe and effective in patients with no or mild liver impairment.
The Food and Drug Administration identified dozens of cases in which patients who weren't supposed to take a newer kind a hepatitis C medication did, and then got sicker, leading the agency to issue a safety warning Wednesday.
Particle Sciences, a Lubrizol LifeSciences company and pharmaceutical contract development and manufacturing organization (CDMO), has broadened its Drug Enforcement Administration (DEA) registration to become an authorized manufacturer of Schedule I substances. The expanded registration was granted following inspection by the DEA and will allow Particle Sciences to carry out analytical testing, development and manufacturing of cannabis-derived materials to be used in pharmaceutical applications for medically justified, legal uses in the U.S
Health and corrections officials in Louisiana are one step closer to treating thousands of hepatitis C patients who previously haven't had access to the latest drugs. The state chose Gilead Sciences’ new generics business, Asegua Therapeutics, to team up on its “Netflix” subscription model for unlimited access to an authorized Epclusa copycat.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 8, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), a once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA).
AbbVie`s latest hep C push highlights Mavyret`s time-to-cure advantage
Takeda is about to buy its way to a number 1 spot in the top tier of drugmakers fielding the most expensive drugs on the planet.