The Week in Review: August 11 – August 18, 2017

Friday, August 18, 2017 Canada Great news in Canada. Two new drug regimens have been approved:  Vosevi from Gilead is a pangenotypic for retreatment of those who have failed previous DAA therapy Gilead Receives Approval in Canada for VOSEVI™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-treatment of Certain Patients with Chronic Hepatitis C Virus (HCV) Infection. And MAVIRET from AbbVie is the first and only 8-week, pan-genotypic treatment for hepatit...

Gilead Receives Approval in Canada for VOSEVI™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-treatment of Certain Patients with Chronic Hepatitis C Virus (HCV) Infection

VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead's Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment o

CHMP Backs Two Pan-Genotypic Antivirals for Hep C

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of two new drugs, Maviret and Vosevi, for the treatment of chronic hepatitis C virus (HCV) infection in adults. Maviret (AbbVie Ltd), administered once daily as three oral tablets, contains the NS3/4A protease inhibitor glecaprevir (100 mg) and the NS5A inhibitor pibrentasvir (40 mg). Vosevi (Gilead Sciences) is a once-daily single

Nova Scotia Lists EPCLUSA™ on Public Drug Plan to Treat All Six Genotypes of Chronic Hepatitis C Infection

Nova Scotia Also Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions MISSISSAUGA, ON, May 1, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced, effective immediately, Nova Scotia will provide public access to EPCLUSA™ (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

The Week in Review: Jan 27, 2017 – Feb 3, 2017

Friday, February 3, 2017 News Recap Hepatitis C and Rheumatic, Kidney & Heart Disease As you may remember there have been quite a few news items over the past few months about the extrahepatic effects of hepatitis C, which is more and more coming to be recognized as a multi-organ disease.  Not only is the hepatitis C virus (HCV) the cause of liver diseases in up to 170 million people worldwide, it also has many extrahepatic disease manifestation...

Health Canada Grants Priority Review to AbbVie’s Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

If approved, G/P may provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis AbbVie's New Drug Submission is supported by data from its global registrational clinical development program across all major HCV genotypes and in patients with specific treatment challenges MONTREAL, Feb. 1, 2017 /CNW/ - AbbVie, a global biopharmaceutical company, today announced it has sub...

AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

If approved, G/P will provide an eight week once-daily, ribavirin-free treatment option for HCV patients without cirrhosis across all major genotypes AbbVie's investigational regimen was granted Breakthrough Therapy Designation by the FDA for genotype 1 patients not cured with prior direct-acting antivirals AbbVie is on track to submit a Marketing Authorization Application for G/P in the European Union in early 2017 NORTH CHICAGO, ...

Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients

If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens.  U.S. NDA Planned for Q4 2016 FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 20, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an

U.S.: AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation

 Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs)  Currently in Phase 3 clinical trials, glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6  Breakthrough Therapy Designation is granted to investigational treatments for seri...

Hepatitis C cure approved by Health Canada

(July 13, 2016) – Health Canada has approved a drug being touted as a cure for hepatitis C, a disease believed to have infected hundreds of thousands of Canadians, many of whom are unaware they harbour the virus. The drug, sold under the brand name Epclusa, is a once-daily pill taken for 12 weeks that can rid the body of all six strains of hepatitis C, a blood-borne virus that can lead to severe liver damage and liver cancer if left untreated. “This ...