Blog
RSS FeedPosted by Michael Wonder on 30 Sep 2016
AbbVie's investigational HCV regimen receives U.S. FDA breakthrough therapy designation
30 September 2016 - Breakthrough therapy designation granted based on Phase 2 clinical data for genotype 1 patients who failed previous ...
Posted by Michael Wonder on 31 Aug 2016
TGA approves Zepatier
31 August 2016 - The TGA has approved MSD's Zepatier (grazoprevir with elbasvir). ...
Posted by Michael Wonder on 08 Aug 2016
New FDA documents reveal history of breakthrough therapy designation for Epclusa
5 August 2016 - Sofosbuvir with velpatasvir was originally granted fast track designation by the FDA on 30 September 2013 ...
Posted by Michael Wonder on 28 Jul 2016
EMA publishes EPAR for Zepatier (grazoprevir with elbasvir)
28 July 2016 - The EMA has published an EPAR for Merck's Zepatier. ...
Posted by Michael Wonder on 28 Jul 2016
EMA publishes EPAR for Epclusa (sofosbuvir with velpatasvir)
28 July 2016 - The EMA has published an EPAR for Gilead's Epclusa. ...
Posted by Michael Wonder on 25 Jul 2016
AbbVie receives U.S. FDA approval of once daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C
25 July 2016 - New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of Viekira ...
Posted by Michael Wonder on 15 Jul 2016
Gilead receives approval in Canada for Epclusa (sofosbuvir/velpatasvir), the first once-daily pan-genotypic (genotypes 1-6) single tablet regimen for the treatment of chronic hepatitis C
14 July 2016 - Two week treatment with Epclusa provides high cure rates for all six hepatitis C genotypes. ...
Posted by Michael Wonder on 08 Jul 2016
European Commission grants marketing authorization for Gilead’s Epclusa (sofosbuvir/velpatasvir) for the treatment of all genotypes of chronic hepatitis C
8 July 2016 - Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis ...
Posted by Michael Wonder on 28 Jun 2016
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
28 June 2016 - The U.S. FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with ...
Posted by Michael Wonder on 15 Jun 2016
Hepatitis C sufferers’ ire at activist-website ban
14 June 2016 - A website which raises awareness about a medical cure for hepatitis C could be hidden from Australians. ...
Posted by Michael Wonder on 27 May 2016
Highlights from the CHMP 23-26 May 2016 meeting
27 May 2016 - Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval. ...
Posted by Michael Wonder on 27 May 2016
Two new combination therapies against chronic hepatitis C
27 May 2016 - Direct-acting antivirals Epclusa and Zepatier recommended for approval. ...
Posted by Michael Wonder on 25 May 2016
Health Canada approves Daklinza (daclatasvir dihydrochloride) for difficult-to-treat hepatitis C patient populations
24 May 2016 - Daklinza is approved in Canada in combination with other agents for the treatment of chronic hepatitis C ...
Posted by Michael Wonder on 23 May 2016
Agenda for the May 2016 CHMP meeting
23 May 2016 - The agenda for the 23-26 May 2016 CHMP meeting is now available. ...
Posted by Michael Wonder on 26 Apr 2016
AbbVie receives FDA approval of supplemental new drug application for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in genotype 1b chronic hepatitis C patients with compensated cirrhosis
25 April 2016 - AbbVie today announced that the FDA has approved a supplemental new drug application for the use of ...