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RSS FeedPosted by Michael Wonder on 11 May 2017
UK patients get early access to AbbVie’s hepatitis regimen
11 May 2017 - AbbVie’s glecaprevir/pibrentasvir has become the first treatment for chronic hepatitis C to be included in the ...
Posted by Michael Wonder on 11 May 2017
European Commission grants approval for Merck’s new Pergoveris pen for fertility treatment
10 May 2017 - With this approval, Pergoveris becomes the first product with a combination of FSH and LH hormones ...
Posted by Michael Wonder on 27 Feb 2017
AbbVie receives CHMP positive opinion for eight week treatment option with Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) for patients with genotype 1b chronic hepatitis C
27 February 2017 - CHMP opinion brings AbbVie one step closer to approval of an eight-week regimen of Viekirax + Exviera ...
Posted by Michael Wonder on 24 Jan 2017
EMA validates Gilead’s marketing authorisation application for investigational chronic hepatitis C therapy sofosbuvir/velpatasvir/voxilaprevir
20 January 2017 - Sofosbuvir with velpatasvir and voxilaprevir granted an accelerated assessment by the EMA. ...
Posted by Michael Wonder on 24 Jan 2017
European Medicines Agency grants accelerated assessment, validates marketing authorisation application for AbbVie's investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
24 January 2017 - Marketing authorisation application is supported by data from global registrational clinical development program across all major ...
Posted by Michael Wonder on 18 Jan 2017
Suliqua approved in the European Union for the treatment of adults with type 2 diabetes mellitus
17 January 2017 - Sanofi announced today that the European Commission has granted marketing authorisation in Europe for Suliqua, the once-daily ...
Posted by Michael Wonder on 02 Dec 2016
GSK files EU regulatory submission for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD
2 December 2016 - GlaxoSmithKline and Innoviva today announced the filing by GSK of a regulatory submission with the EMA ...
Posted by Michael Wonder on 13 Sep 2016
Janssen submits marketing authorisation application for darunavir-based single tablet regimen for treatment of HIV-1 to European Medicines Agency
12 September 2016 - Janssen today announced the submission of a Marketing Authorisation Application to the EMA, seeking approval for ...
Posted by Michael Wonder on 05 Sep 2016
EMA publishes EPAR for Aerivio Spiromax
5 September 2016 - The EMA has published an EPAR for Teva Pharmaceuticals' version of GSK's Seretide/Advair. ...
Posted by Michael Wonder on 22 Aug 2016
European Commission grants marketing authorization for Gilead’s once-daily Truvada for reducing the risk of sexually acquired HIV-1
22 August 2016 - Truvada is the first anti-retroviral medicine to be licensed in Europe for pre-exposure prophylaxis, in combination with ...
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 27 Jul 2016
EMA publishes EPAR for Qtern (saxagliptin hydrochloride with dapagliflozin propanediol monohydrate)
27 July 2016 - The EMA has published an EPAR for AstraZeneca's Qtern. ...
Posted by Michael Wonder on 25 Jul 2016
CHMP grants positive opinion for shorter treatment duration with AbbVie's Viekirax (ombitasvir/paritaprevir/ritonavir tablets) for patients with genotype 4 chronic hepatitis C with compensated cirrhosis (Child-Pugh A)
25 July 2016 - The CHMP opinion represents a positive advance toward approval of the 12-week regimen of Viekirax with ribavirin ...
Posted by Michael Wonder on 22 Jul 2016
First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU
22 July 2016 - Truvada to enhance existing HIV prevention strategies. ...