Blog
RSS FeedPosted by Michael Wonder on 19 Nov 2018
Vertex receives European CHMP positive opinion for Orkambi (lumacaftor/ivacaftor) for treatment of children with cystic fibrosis aged 2 to 5 years old with most common form of the disease
16 November 2018 - If approved, lumacaftor/ivacaftor will be the first medicine in Europe to treat the underlying cause of ...
Posted by Michael Wonder on 12 Nov 2018
Once-daily Trelegy Ellipta gains expanded COPD indication in Europe
9 November 2018 - First single inhaler triple therapy to be specifically indicated for COPD patients not adequately treated with dual ...
Posted by Michael Wonder on 01 Nov 2018
Vertex announces European authorisation for third cystic fibrosis medicine Symkevi (tezacaftor/ivacaftor), to be used in combination with ivacaftor (Kalydeco), for people with CF aged 12 and older with certain mutations in the CFTR gene
1 November 2018 - First medicine in the EU to treat the CFTR protein defect in patients who have one copy ...
Posted by Michael Wonder on 24 Sep 2018
Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe
21 September 2018 - GlaxoSmithKline and Innoviva announced that the EMA CHMP has issued a positive opinion today supporting the use ...
Posted by Michael Wonder on 24 Sep 2018
Melinta Therapeutics receives positive CHMP opinion for Vabomere (meropenem and vaborbactam)
21 September 2018 - Recommended to be approved for treatment of patients with bacterial infection of various sites. ...
Posted by Michael Wonder on 24 Sep 2018
Merck receives positive CHMP opinion for Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) and Pifeltro (doravirine) in the European Union for the treatment of HIV-1 infection
20 September 2018 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending granting of ...
Posted by Michael Wonder on 14 Sep 2018
ViiV Healthcare submits regulatory application to EMA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
14 September 2018 - ViiV Healthcare today announced submission of a marketing authorisation application to the EMA for a single-tablet, ...
Posted by Michael Wonder on 29 Aug 2018
Duzallo, a fixed-dose combination therapy for gout, approved in Europe
28 August 2018 - Grünenthal announced that the European Commission has followed the positive opinion of the CHMP and granted ...
Posted by Michael Wonder on 27 Aug 2018
Vyxeos receives marketing authorisation in the European Union for treatment of certain types of high-risk acute myeloid leukaemia
27 August 2018 - Jazz Pharmaceuticals today announced that the European Commission approved Vyxeos 44 mg/100 mg powder for concentrate for ...
Posted by Michael Wonder on 31 Jul 2018
Vertex receives European CHMP positive opinion for Symkevi (tezacaftor/ivacaftor) for people with cystic fibrosis aged 12 and older with certain mutations in the CFTR gene
27 July 2018 - If approved, Symkevi (tezacaftor/ivacaftor)will be Vertex’s third medicine to treat the CFTR protein defect in patients ...
Posted by Michael Wonder on 26 Jun 2018
European Commission grants marketing authorisation for Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection
25 June 2018 - In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through 48 weeks. ...
Posted by Michael Wonder on 22 May 2018
ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV
21 May 2018 - Juluca maintains viral suppression with two drugs in the smallest single pill regimen. ...
Posted by Michael Wonder on 30 Apr 2018
European CHMP adopts positive opinion for Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide)
27 April 2018 - In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through 48 weeks. ...
Posted by Michael Wonder on 23 Mar 2018
ViiV Healthcare gains CHMP positive opinion for Juluca (dolutegravir/rilpivirine) in Europe
23 March 2018 - ViiV Healthcare today announced that the European CHMP has issued a positive opinion recommending marketing authorisation for ...
Posted by Michael Wonder on 09 Mar 2018
GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma
8 March 2018 - GlaxoSmithKline and Innoviva today announced that the European Commission has approved a label update for the ...