Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: harvoni
September, 2018
October, 2017
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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 …
April, 2017
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7 April
FDA Expands Approval of Harvoni and Sovaldi in Pediatric Patients 12 Years and Older with Chronic Hepatitis C
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis …
December, 2015
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2 December
Hepatitis C Deaths Still On Rise
The headlines are compelling when it comes to new medications for treating infection with the hepatitis C virus (HCV): Harvoni cures up to 98% of patients with genotype 1 HCV. Viekira Pak cures 100% of those with genotype 1b HCV. Sovaldi cures 95% of those with genotype 2 HCV. With …
November, 2015
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13 November
FDA Expands Approval for Gilead’s Hepatitis C Drug
FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 12, 2015– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, …
September, 2015
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9 September
Is Sicker Better?
With a cure for hepatitis C finally in reach, it’s disheartening to learn that one in four hepatitis C patients hear a “no” the first time they seek treatment. According to Yale researchers, one-quarter of patients with chronic infection of the hepatitis C virus (HCV) are denied their first pre-authorization …
April, 2015
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7 April
Value vs. Cost
Ever since new (and admittedly high-cost) hepatitis C treatments hit the market, the price of curing hepatitis C has been under the microscope. News outlets repeatedly cite the $1,000 per pill price of Sovaldi or the $84,000 total price tag for the 12-week treatment course. So what are patients getting …
March, 2015
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26 March
FDA Issues Warning of Life-Threatening Effect When Combining A Heart Drug with New Hepatitis C Drugs
The US Food and Drug Administration (FDA) issued a warning about the risk of potentially life-threatening slowing of the heart rate that can occur when a common heart drug is taken with new hepatitis C medications. The agency said that this complication can occur when the antiarrhythmic drug amiodarone is …
January, 2015
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9 January
A Cure at a Lower Cost
As 2015 arrives, it is wonderful to kick off the first blog of the new year with a story of hope. Last year, the excitement of newly approved hepatitis C virus (HCV) medications quickly morphed into cost concerns, as it became clear that these wonder cures came at a price …