Blog
RSS FeedPosted by Michael Wonder on 29 Dec 2020
European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis
28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
Posted by Michael Wonder on 08 Nov 2017
Company statement on resubmission of biosimilar trastuzumab and pegfilgrastim dossiers with EMA
7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...
Posted by Michael Wonder on 07 Nov 2017
Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency
6 November 2017 - The application for marketing approval is based on the COMPASS study. ...
Posted by Michael Wonder on 06 Nov 2017
Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL
6 November 2017 - Submission of application includes data from global, multi-center Phase II ELIANA and JULIET studies, including 6-month JULIET ...
Posted by Michael Wonder on 26 Jun 2017
Shire announces EMA validation of Veyvondi [von Willebrand factor (recombinant)] marketing authorisation application for treatment of von Willebrand disease
22 June 2017 - Veyvondi is the first and only recombinant von Willebrand factor treatment for adults with von Willebrand disease, ...
Posted by Michael Wonder on 23 Jun 2017
Kamada announces withdrawal of European marketing authorisation application for inhaled alfa-1 anti-trypsin for treatment of alfa-1 anti-trypsin deficiency disease
22 June 2017 - Kamada today announced that the company has withdrawn the marketing authorisation application for its proprietary inhaled ...
Posted by Michael Wonder on 23 Jun 2017
pSivida submits marketing authorisation application for approval of Durasert three year treatment for posterior segment uveitis in the European Union
22 June 2017 - pSivida has submitted a Marketing Authorization Application to the EMA, seeking approval to market the Company's Durasert ...
Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
Posted by Michael Wonder on 15 Jun 2017
Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba label
14 June 2017 - Novo Nordisk today announced the submission of a type II variation application to the EMA for including ...
Posted by Michael Wonder on 05 Jun 2017
Amgen submits regulatory applications for Repatha (evolocumab) cardiovascular outcomes data in US and Europe
5 June 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA and a ...
Posted by Michael Wonder on 04 Jun 2017
ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months. ...
Posted by Michael Wonder on 03 Jun 2017
Pfizer announces acceptance of regulatory submissions by U.S. FDA and EMA for Sutent (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial. ...
Posted by Michael Wonder on 31 May 2017
Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency
31 May 2017 - These regulatory submissions follow soon after two positive CHMP opinions for Sandoz biosimilars etanercept and rituximab further ...
Posted by Michael Wonder on 24 May 2017
Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...
Posted by Michael Wonder on 23 May 2017
Fujifilm Kyowa Kirin Biologics announces marketing authorisation application for FKB327 accepted for review by European Medicines Agency
22 May 2017 - Fujifilm Kyowa Kirin Biologics announces that on May 18, 2017, the EMA has accepted for review the ...