Blog
RSS FeedPosted by Michael Wonder on 17 Jan 2020
Isturisa (osilodrostat) approved
15 January 2020 - Recordati announces that the European Commission has granted marketing authorisation for the orphan medicinal product Isturisa (osilodrostat), ...
Posted by Michael Wonder on 16 Jan 2020
Janssen seeks expanded use of Spravato (esketamine) nasal spray in Europe as a treatment for depressive symptoms in adults with major depressive disorder who have current suicidal ideation with intent
15 January 2020 - In two pivotal Phase 3 trials, Spravato combined with comprehensive standard of care achieved statistically significant ...
Posted by Michael Wonder on 14 Jan 2020
PTC Therapeutics provides corporate update
13 January 2020 - PTC-AADC MAA submitted; BLA now expected to be submitted in 2Q 2020. ...
Posted by Michael Wonder on 12 Jan 2020
Sanofi secures expanded European approval for Toujeo in type 1 diabetes
10 January 2020 - Sanofi has revealed that the European Commission has expanded the existing label for Toujeo (insulin glargine ...
Posted by Michael Wonder on 12 Jan 2020
Acerus provides update on Natesto approval process in Europe
10 January 2020 - Acerus Pharmaceuticals today announced that the dossier filed as a decentralised Procedure in 19 European countries ...
Posted by Michael Wonder on 11 Jan 2020
ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
10 January 2020 - ViiV Healthcare with Pfizer and Shionogi, today announced the submission of a marketing authorisation application to ...
Posted by Michael Wonder on 09 Jan 2020
Human medicines: highlights of 2019
9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...
Posted by Michael Wonder on 08 Jan 2020
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for pemigatinib in patients with cholangiocarcinoma
7 January 2020 - Incyte today announced the validation of the Company’s marketing authorisation application for pemigatinib for the treatment of ...
Posted by Michael Wonder on 06 Jan 2020
Kyowa Kirin announces marketing authorisation application for istradefylline validated by European Medicines Agency
6 January 2020 - Kyowa Kirin today announces that its marketing authorisation application for istradefylline (KW-6002) as an adjunctive treatment ...
Posted by Michael Wonder on 05 Jan 2020
Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand
27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...
Posted by Michael Wonder on 03 Jan 2020
EMA accepts regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukaemia
2 January 2020 - Innate Pharma today announced that the EMA has accepted the marketing authorisation application for Lumoxiti (moxetumomab ...
Posted by Michael Wonder on 03 Jan 2020
Aerie Pharmaceuticals announces acceptance for review of the Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% marketing authorisation application in Europe
2 January 2020 - Aerie Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for Roclanda ...
Posted by Michael Wonder on 24 Dec 2019
U.S. FDA approves Eisai's Dayvigo (lemborexant) for treatment of insomnia in adult patients
23 December 2019 - Orexin receptor antagonist proven effective for both sleep onset and sleep maintenance in clinical development program of ...
Posted by Michael Wonder on 24 Dec 2019
European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...
Posted by Michael Wonder on 21 Dec 2019
Bristol-Myers Squibb receives European Commission approval for Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma
20 December 2019 - Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma ...