Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: sovaldi
April, 2017
November, 2016
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22 November
HCV Research Round-up
Hepatitis C treatment options continue to be a vibrant field full of exciting research, including the following: Genotype 3 of the hepatitis C virus (HCV) has remained harder-to-treat among the six main genotypes. New research presented at the 2016 AASLD conference now offers promising news for treating genotype 3. According …
February, 2016
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9 February
New Hepatitis C Combo On the Way
Another once-daily pill is on-track for approval by the U.S. Food and Drug Administration (FDA) for the treatment of hepatitis C, adding to the growing number of treatment options for this life-threatening disease. This time, it’s a combination of Sovaldi® (sofosbuvir) with a new NS5A inhibitor called velpatasvir from Gilead …
January, 2016
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5 January
FDA Grants Priority Review to Gilead’s Latest Hepatitis C Combo
FOSTER CITY, Calif.–(BUSINESS WIRE)–Jan. 4, 2016– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in …
December, 2015
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28 December
The Promise of Pan-Genotype Cure
One treatment which works against all strains of the hepatitis C virus (HCV) appears to be getting closer to reality all the time, as I wrote about on October 20, 2015 in One Pill for All Hepatitis C Strains. Gilead Sciences’ Sovaldi (sofosbuvir) combined in one pill with an NS5A inhibitor called …
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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 …
April, 2015
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23 April
Gilead and Merck Present Positive Data for Next-Generation Hepatitis C Drug Regimens
At The International Liver Congress, both Gilead Sciences and Merck announced positive results from hepatitis C trials, evaluating their next-generation hepatitis C combo drugs. Gilead revealed preclinical data and results from a mid-stage study supporting the development of its investigational all-oral, three-drug regimen of Sovaldi (sofosbuvir), the investigational NS5A inhibitor …
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14 April
Specialty Drugs Drove Significant Increase in US Drug Spending in 2014
Driven by innovative, yet expensive new specialty drugs, US spending on prescription drugs jumped 13 percent to $374 billion in 2014, the largest percentage increase since 2001, according to a new report. The significant increase was primarily due to the introduction of expensive breakthrough drugs, manufacturer price hikes and a …
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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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31 March
Study Finds New Expensive Hepatitis C Drugs Are Only Cost-Effective for Certain Patients
A study, led by Boston Medical Center (BMC) researchers, assessed the cost-effectiveness of expensive new hepatitis C drugs and found that while they are highly effective, they are cost-effective and provide the greatest value in a specific groups of patients with hepatitis C. Findings from the study, led by Benjamin …