Blog
RSS FeedPosted by Michael Wonder on 14 Feb 2019
Eisai submits application in Europe seeking approval for Fycompa as treatment for paediatric patients with epilepsy
13 February 2019 - Eisai announced today that it has submitted an application to the EMA for its in-house discovered ...
Posted by Michael Wonder on 11 Feb 2019
European Commission approves Bristol-Myers Squibb’s Sprycel (dasatinib) in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia
11 February 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Sprycel (dasatinib) in combination with chemotherapy ...
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 17 Dec 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending Sprycel (dasatinib) for paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
17 December 2018 - Bristol-Myers Squibb today announced that the CHMP of the EMA has recommended the expanded approval of ...
Posted by Michael Wonder on 30 Nov 2018
Vertex announces European Commission approval for Kalydeco (ivacaftor) to treat patients with cystic fibrosis aged 12 to <24 months with certain mutations in the CFTR gene
29 November 2018 - Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic ...
Posted by Michael Wonder on 22 Oct 2018
Vertex receives European CHMP positive opinion for Kalydeco (ivacaftor) to treat patients with cystic fibrosis aged 12 to <24 months with certain mutations in the CFTR gene
19 October 2018 - If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic ...
Posted by Michael Wonder on 02 Oct 2018
Boosting the development of medicines for children
2 October 2018 - The EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published ...
Posted by Michael Wonder on 23 Sep 2018
Novartis receives positive CHMP opinion for Gilenya for the treatment of children and adolescents with MS, marking a major medical advance for young MS patients in Europe
21 September 2018 - Positive opinion is based on the landmark Phase III PARADIGMS trial, which showed Gilenya (fingolimod) substantially reduced ...
Posted by Michael Wonder on 30 Aug 2018
European Commission approves Nucala (mepolizumab) for the treatment of children with severe asthma
30 August 2018 - First anti-IL-5 biologic treatment for paediatric patients with severe eosinophilic asthma in Europe. ...
Posted by Michael Wonder on 30 Aug 2018
European Commission approves Blincyto (blinatumomab) for use in paediatric patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
29 August 2018 - Approval Based on Data From the Phase 1/2 '205 Study. ...
Posted by Michael Wonder on 24 May 2018
Development of antibiotics for children - towards a global approach
24 May 2018 - Workshop with regulators from EU, Japan and US open for registration ...
Posted by Michael Wonder on 31 Jan 2018
How to better apply the paediatric legislation to boost development of medicines for children
31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...
Posted by Michael Wonder on 22 Jan 2018
European Commission approves Bristol-Myers Squibb’s Yervoy (ipilimumab) for treatment of paediatric patients 12 years and older with unresectable or metastatic melanoma
22 January 2018 - Yervoy is the first and only immuno-oncology agent to receive approval in the European Union in this ...
Posted by Michael Wonder on 30 Dec 2017
GW Pharmaceuticals submits marketing authorisation application in Europe for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
29 December 2017 - GW Pharmaceuticals today announced it has submitted its marketing authorisation application to the EMA for Epidiolex (cannabidiol) ...