Blog
RSS FeedPosted by Michael Wonder on 18 Feb 2017
Consultation on revised policy on access to documents
17 February 2017 - Comments from stakeholders invited until 18 May 2017. ...
Posted by Michael Wonder on 07 Feb 2017
Ablynx submits a marketing authorisation application to the EMA for caplacizumab, its anti-vWF nanobody, for the treatment of aTTP
6 February 2017 - Ablynx is on track to report results of the confirmatory Phase III HERCULES study in the second ...
Posted by Michael Wonder on 07 Feb 2017
Ariad announces submission of marketing authorisation application for brigatinib to the European Medicines Agency
6 February 2017 - Ariad Pharmaceuticals today announced the submission of a marketing authorisation application for its investigational oral anaplastic ...
Posted by Michael Wonder on 31 Jan 2017
BioCryst announces the acceptance of peramivir MAA filing by the European Medicines Agency
30 January 2017 - BioCryst Pharmaceuticals announced today that the EMA has accepted the filing of its peramivir marketing authorisation ...
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 24 Jan 2017
Novelion Therapeutics announces acceptance of marketing authorisation application for metreleptin by European Medicines Agency
23 January 2017 - Novelion Therapeutics today announced that the EMA has accepted for review the marketing authorisation application for metreleptin ...
Posted by Michael Wonder on 19 Jan 2017
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...
Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review ...
Posted by Michael Wonder on 23 Dec 2016
Novelion Therapeutics’ subsidiary files for European approval for metreleptin as a treatment for generalised lipodystrophy and a subset of patients with partial lipodystrophy
21 December 2016 - If approved, metreleptin would be the first medication available in the EU to treat generalized and ...
Posted by Michael Wonder on 20 Dec 2016
Sarepta Therapeutics announces EMA validation of eteplirsen authorisation application for treatment of Duchenne muscular dystrophy amenable to exon skipping 51
19 December 2016 - Sarepta Therapeutics today announced that the EMA validated the previously submitted marketing authorisation application for eteplirsen to ...
Posted by Michael Wonder on 08 Dec 2016
Sanofi and Regeneron announce marketing authorisation application for Dupixent (dupilumab) accepted for review by the EMA
8 December 2016 - Sanofi and Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation ...
Posted by Michael Wonder on 07 Dec 2016
Novo Nordisk files for regulatory approval of once-weekly semaglutide in the US and EU for the treatment of type 2 diabetes
5 December 2016 - Novo Nordisk today announced the submission of a new drug application to the US FDA and ...
Posted by Michael Wonder on 02 Dec 2016
Amgen and Allergan submit biosimilar marketing authorisation application to EMA for ABP 215, a biosimilar candidate to bevacizumab
2 December 2016 - Supported by phase 3 study in patients with non-squamous non-small-cell lung cancer. ...
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 ...