Gilead warns against Hep C drugs from buyers clubs, says patients may be at risk

California-headquartered Gilead Sciences has warned against the use of generic versions of its blockbuster Hepatitis C drugs procured by patients directly through “buyers clubs.” A disruptive phenomenon, dozens of buyers clubs have mushroomed in recent years that enable supply of generic lifesaving medicines to thousands of patients afflicted with the fatal liver ailment. In its latest May 9 regulatory filings in Form 10K at the US Securities Exchange Com

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 ...

Scale Up of Hepatitis C Treatment Possible as Brazil Rejects Patent on Key Drug

Decision enables price reductions and scale-up of treatment that leads to cure in 95% of cases Rio de Janeiro, 31 March, 2017 – Treatment for hepatitis C using the key drug sofosbuvir could be vastly scaled up in Brazil after the decision by the National Agency of Health Surveillance (Anvisa) to reject a key patent application on the drug marketed by pharmaceutical corporation Gilead. The decision could pave the way to enable generic competition in Brazil

Two new hepatitis C therapies fast-tracked in Europe

Two drug combinations from Gilead and AbbVie that could improve treatment of chronic hepatitis C have been granted accelerated review in the EU. Gilead's application is for a three drug combination of NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir and pan-genotypic protease inhibitor voxilaprevir – given over 12 weeks – that could achieve a cure for chronic hepatitis C virus (HCV) patients who have failed other regimens. The new direc

How the U.S. can beat hepatitis C: Don’t buy the pills, buy the company

In a recent article in Forbes, MIT Sloan School of Management visiting scientist Mark Trusheim and co-author Peter B. Bach, a physician at Memorial Sloan Kettering Cancer Center in New York, propose a startling response to the prevalence of hepatitis C and the high cost of the leading therapy: The U.S. government should not just pay for the pills — they should buy their maker. The pharmaceutical company Gilead sells hepatitis C drugs that have 80 percent

Merck wins $2.54 billion in hepatitis C drug trial against Gilead

Merck & Co on Thursday was awarded $2.54 billion in royalties by a federal jury in a patent lawsuit against Gilead Sciences Inc over Gilead's blockbuster hepatitis C drugs Sovaldi and Harvoni. The jury in Delaware reached the verdict following a nearly two-week trial, finding that a patent acquired by Merck in 2014 on hepatitis C treatments was valid. "The jury's verdict upholds patent protections that are essential to the development of new medica

Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir

If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available as a Salvage Therapy for Patients Infected with HCV Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 8, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, o

USA: FDA Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection

Vemlidy is a Once-Daily Treatment that Demonstrated Similar Efficacy with Improved Renal and Bone Laboratory Safety Parameters Compared to Viread FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 10, 2016-- 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 li

Gilead’s hepatitis C freefall just keeps going. What’s the company to do?

"Not surprising...[is] Gilead’s move to stop working to improve on its suite of current hep C remedies, which already offer impressively high cure rates" Another quarter, another slump for Gilead’s hepatitis C franchise. The one-time powerhouses Sovaldi and Harvoni have fallen victim to competition and payer discounting, with sales plummeting 31% for the quarter. Gilead’s hep C top line got some help from inventory stocking and one-time revenue in othe...

A promising Hep C program seems to be working — and it could be a model for other countries

Close to 8% of the Georgian population is living with hepatitis C, an infection that can lead to serious liver problems, including cancer. Georgia, a country nestled against the Black Sea between Turkey and Russia with a population of 3.7 million, has since taken on a public health effort to help reduce its prevalence of hepatitis C (HCV for short) by 90% by 2020. To make it happen, the US Centers for Disease Control and Prevention is working with Geor