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RSS FeedPosted by Michael Wonder on 26 Feb 2019
Procedural update on submission of Type I variations to EMA in March, April and May 2019
26 February 2019 - EMA is encouraging marketing authorisation holders intending to submit Brexit-related Type IA and Type IB variations ...
Posted by Michael Wonder on 23 Feb 2019
FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder
22 February 2019 - FDA sets action date of 28 June 2019. ...
Posted 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 07 Feb 2019
Zogenix submits new drug application to U.S. FDA and marketing authorisation application to EMA for Fintepla for the treatment of Dravet syndrome
6 February 2019 - Zogenix today announced it has completed its rolling submission of a new drug application to the ...
Posted by Michael Wonder on 02 Feb 2019
CTI BioPharma receives results of the CHMP oral explanation for pacritinib in the treatment of myelofibrosis and provides development update
1 February 2019 - CTI BioPharma today announced that the Company will withdraw its European marketing authorisation application for pacritinib ...
Posted by Michael Wonder on 31 Jan 2019
Stemline Therapeutics announces validation of marketing authorisation application by the European Medicines Agency
30 January 2019 - Stemline Therapeutics today announced that the EMA has completed its validation of the marketing authorisation application for ...
Posted by Michael Wonder on 25 Jan 2019
ChemoCentryx announces withdrawal of Phase II-based conditional marketing authorisation application for ANCA-associated vasculitis in Europe
24 January 2019 - Companies plan to file for full marketing approval to EMA and FDA in 2020. ...
Posted by Michael Wonder on 16 Jan 2019
European Medicines Agency validates Oasmia Pharmaceutical's application to add efficacy data to the approved Apealea product information
15 January 2019 - Oasmia Pharmaceutical today announce that the EMA has validated a type II variation application to add ...
Posted by Michael Wonder on 09 Jan 2019
Karyopharm announces submission of marketing authorisation application to the European Medicines Agency for selinexor for the treatment of patients with penta-refractory multiple myeloma
8 January 2019 - Selinexor marketing authorisation application to be reviewed under accelerated assessment. ...
Posted by Michael Wonder on 08 Jan 2019
Stemline Therapeutics announces submission of European marketing authorisation application for Elzonris
7 January 2019 - Stemline Therapeutics announced today that it has submitted the marketing authorisation application for Elzonris (tagraxofusp) to ...
Posted by Michael Wonder on 07 Jan 2019
Janssen files Stelara in Europe for ulcerative colitis
7 January 2019 - Janssen has submitted a Group Type II Variation Application to the EMA seeking approval of Stelara ...
Posted by Michael Wonder on 20 Dec 2018
AbbVie submits new drug application to U.S. FDA and marketing authorisation application to EMA for upadacitinib for treatment of adults with moderate to severe rheumatoid arthritis
20 December 2018 - Regulatory applications supported by robust SELECT Phase 3 program evaluating more than 4,000 patients with moderate to ...
Posted by Michael Wonder on 17 Dec 2018
Novartis pulls EU filing for canakinumab
17 December 2018 - Novartis has pulled back its application to market canakinumab for the prevention of serious events such ...
Posted by Michael Wonder on 12 Dec 2018
CHMP extends review period for Portola Pharmaceuticals’ Ondexxya (andexanet alfa)
11 December 2018 - Portola Pharmaceuticals today announced that the CHMP of the EMA has extended the review period for the ...
Posted by Michael Wonder on 03 Dec 2018
Celltrion seeks European approval for Remsima SC
3 December 2018 - South Korean biopharmaceutical firm Celltrion said Monday that it has sought European approval for the sale ...