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RSS FeedPosted by Michael Wonder on 15 Feb 2018
GSK submits landmark IMPACT data to European Medicines Agency to support expanded label for Trelegy Ellipta
14 February 2018 - GlaxoSmithKline and Innoviva today announced the submission of the landmark IMPACT data to the European Medicines ...
Posted by Michael Wonder on 10 Jan 2018
Vertex receives expanded EU approval for Orkambi (lumacaftor/ivacaftor) in children ages 6-11 years
10 January 2018 - Existing reimbursement agreements in countries like Ireland will enable rapid access to Orkambi; country-by-country reimbursement processes will ...
Posted by Michael Wonder on 16 Nov 2017
Trelegy Ellipta once-daily single inhaler triple therapy gains marketing authorisation in Europe for the treatment of COPD
16 November 2017 - GlaxoSmithKline and Innoviva today announced that the European Commission has granted marketing authorisation for Trelegy Ellipta ...
Posted by Michael Wonder on 26 Sep 2017
European Commission approves Symtuza for the treatment of HIV-1 in adults and adolescents in Europe
26 September 2017 - Symtuza is the only darunavir-based single-tablet regimen approved for the treatment of HIV-1 in the European Union. ...
Posted by Michael Wonder on 16 Sep 2017
Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD
15 September 2017 - GlaxoSmithKline and Innoviva today announced that the EMA CHMP has issued a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 25 Aug 2017
Vertex announces acceptance of its applications for review of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis by the FDA and EMA
24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018. ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces U.S. FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 31 Jul 2017
European Commission grants marketing authorisation for Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for the treatment of all genotypes of chronic hepatitis C
28 July 2017 - European Commission also extends marketing authorisation for Harvoni (sofosbuvir/ledipasvir), enabling first direct-acting anti-viral regimen for adolescent ...
Posted by Michael Wonder on 29 Jul 2017
European Commission grants AbbVie's Maviret (glecaprevir/pibrentasvir) marketing authorisation for the treatment of chronic hepatitis C in all major genotypes (GT1-6)
28 July 2017 - AbbVie's investigational, pan-genotypic HCV treatment is also under priority review by the U.S. FDA. ...
Posted by Michael Wonder on 27 Jul 2017
Chiesi Group receives the European marketing authorisation for Trimbow (inhaled corticosteroid / long-acting β2-agonist / long-acting muscarinic antagonist)
24 July 2017 - Chiesi today announced that the European Commission has granted the marketing authorisation for Trimbow for the ...
Posted by Michael Wonder on 24 Jul 2017
GSK submits EU filing for extended use of Relvar Ellipta in patients with controlled asthma on an ICS/LABA combination
21 July 2017 - GSK and Innoviva today announced a submission to the EMA for the extended use of once-daily Relvar ...
Posted by Michael Wonder on 21 Jul 2017
Janssen receives positive CHMP opinion for Symtuza the first darunavir based single tablet regimen for the treatment of HIV
21 July 2017 - Proven efficacy and durability of darunavir combined with the improved renal laboratory and bone mineral density profile ...
Posted by Michael Wonder on 23 Jun 2017
AbbVie receives CHMP positive opinion for Maviret (glecaprevir/pibrentasvir) for the treatment of chronic hepatitis C in all major genotypes
23 June 2017 - Maviret would also be an additional HCV treatment option for patients with specific treatment challenges, such as ...
Posted by Michael Wonder on 23 Jun 2017
Two new medicines recommended for the treatment of chronic hepatitis C
23 June 2017 - Maviret and Vosevi evaluated under accelerated assessment. ...
Posted by Michael Wonder on 04 Jun 2017
ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months. ...