Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2019
Aerie Pharmaceuticals submits marketing authorisation application for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% in Europe
3 December 2019 - Aerie Pharmaceuticals today announced that it has submitted the marketing authorisation application for Roclanda (netarsudil and latanoprost ...
Posted by Michael Wonder on 01 Nov 2019
Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis
31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...
Posted by Michael Wonder on 08 Oct 2019
Vivus announces acceptance of Qsymia decentralised marketing authorisation application in Europe
7 October 2019 - Vivus announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland have ...
Posted by Michael Wonder on 07 Sep 2019
Lonsurf (trifluridine/tipiracil) receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer
6 September 2019 - Servier and its partner Taiho Pharmaceutical announced today that the European Commission has approved the use ...
Posted by Michael Wonder on 03 Aug 2019
AbbVie's Maviret (glecaprevir/pibrentasvir) approved by European Commission to shorten treatment duration to eight weeks for treatment naïve patients with chronic hepatitis C and compensated cirrhosis
2 August 2019 - Maviret is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C ...
Posted by Michael Wonder on 29 Jul 2019
ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV
29 July 2019 - The marketing application is based on phase III ATLAS and FLAIR pivotal trials in which the once-monthly, ...
Posted by Michael Wonder on 29 Jul 2019
Lonsurf (trifluridine/tipiracil) receives positive opinion from CHMP in the EU for patients with previously treated metastatic gastric cancer
26 July 2019 - Servier and its partner Taiho Pharmaceutical announced today that the CHMP of the EMA has issued a ...
Posted by Michael Wonder on 03 Jul 2019
ViiV Healthcare receives EU marketing authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection
3 July 2019 - Authorisation based on GEMINI pivotal trials in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, three-drug ...
Posted by Michael Wonder on 28 Apr 2019
ViiV Healthcare announces CHMP positive opinion for Dovato (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection
26 Apri 2019 - Recommendation based on landmark GEMINI 1 & 2 studies which demonstrated non-inferior efficacy of dolutegravir + lamivudine ...
Posted by Michael Wonder on 01 Mar 2019
Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet
28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...
Posted by Michael Wonder on 22 Jan 2019
Vertex announces European Commission approval for Orkambi (lumacaftor/ivacaftor) for treatment of children with cystic fibrosis aged 2 to 5 years old with most common form of the disease
21 January 2019 - Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic ...
Posted by Michael Wonder on 14 Jan 2019
EMA approves Flutiform for children with asthma
14 January 2019 - The EMA has approved Flutiform pMDI for use in the treatment of children with asthma aged ...
Posted by Michael Wonder on 12 Dec 2018
The Menarini Group announces meropenem/vaborbactam European marketing authorisation
11 December 2018 - The first combination of a carbapenem and a beta-lactamase inhibitor approved for clinical use in Europe. ...
Posted by Michael Wonder on 29 Nov 2018
European Commission approves Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate), a once-daily fixed-dose combination tablet as a complete regimen and Pifeltro (doravirine), an NNRTI, both for the treatment of HIV-1 in appropriate patients
28 November 2018 - Approvals based on findings from the Pivotal Phase 3 DRIVE-AHEAD and DRIVE-FORWARD trials evaluating the efficacy and ...
Posted by Michael Wonder on 28 Nov 2018
Melinta Therapeutics granted European Commission marketing authorisation for Vabomere (meropenem with vaborbactam)
27 November 2018 - Melinta Therapeutics today announced that the European Commission has approved Vabomere (meropenem and vaborbactam) for use in ...