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RSS FeedPosted by Michael Wonder on 20 May 2017
European Medicines Agency validates application for Bristol-Myers Squibb’s Sprycel (dasatinib) in children with chronic myelogenous leukaemia
19 May 2017 - Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous ...
Posted by Michael Wonder on 20 May 2017
Merck receives CHMP positive opinion recommending approval of Isentress (raltegravir) 600 mg in the European Union
19 May 2017 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 20 May 2017
CHMP recommends Veltassa for the treatment of hyperkalaemia in the EU
19 May 2017 - Opinion includes treatment of patients who develop hyperkalaemia while on RAAS inhibitors. ...
Posted by Michael Wonder on 20 May 2017
Brodalumab, a novel biologic for people with moderate-to-severe psoriasis, receives positive opinion from European CHMP
18 May 2017 - LEO Pharma today announced that it received a positive opinion from the European CHMP recommending marketing authorisation ...
Posted by Michael Wonder on 20 May 2017
CO.DON: decisive step towards European expansion
18 May 2017 - Positive opinion from relevant committee for EU approval of articular cartilage product ...
Posted by Michael Wonder on 02 May 2017
Sunesis Pharmaceuticals announces withdrawal of European marketing authorisation application for vosaroxin as a treatment for relapsed/refractory AML
1 May 2017 - Company’s primary development focus is non-covalent reversible BTK inhibitor SNS-062. ...
Posted by Michael Wonder on 27 Apr 2017
Kiadis Pharma announces filing of marketing authorisation with the European Medicines Agency for ATIR101 in blood cancers
26 April 2017 - Kiadis Pharma today announces it has submitted a marketing authorisation application to the EMA for its ...
Posted by Michael Wonder on 26 Apr 2017
EMA publishes withdrawal assessment report for Graspa
25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...
Posted by Michael Wonder on 25 Apr 2017
EMA publishes withdrawal assessment report for Zioxtenzo
25 April 2017 - On 18 January 2017, Sandoz officially notified the CHMP that it wishes to withdraw its application ...
Posted by Michael Wonder on 29 Mar 2017
Cempra withdraws solithromycin marketing authorisation application in Europe
28 March 2017 - Company plans to resubmit application with additional data, in alignment with FDA strategy. ...
Posted by Michael Wonder on 25 Mar 2017
Almirall and Sun Pharma announce regulatory filing of tildrakizumab in Europe
24 March 2017 - Almirall and Sun Pharmaceutical Industries announced today the validation of the regulatory filing of tildrakizumab with ...
Posted by Michael Wonder on 24 Mar 2017
Lundbeck and Otsuka's brexpiprazole for adult patients with schizophrenia accepted for review by EMA
23 March 2017 - The EMA is expected to complete its review in second quarter of 2018. ...
Posted by Michael Wonder on 22 Mar 2017
First anniversary of PRIME – experience so far
22 March 2017 - Registration opens for stakeholder meeting on 19 May 2017. ...
Posted by Michael Wonder on 16 Mar 2017
EMA publishes updated list of applications for new human medicines under evaluation by the CHMP
16 March 2017 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA ...
Posted by Michael Wonder on 06 Mar 2017
Merck and Pfizer announce U.S. FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes
6 March 2017 - Investigational SGLT2 Inhibitor submitted as monotherapy and in fixed-dose combinations with Januvia (sitagliptin) or metformin. ...