Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2018
CADTH Common Drug Review will accept submissions up to six months pre-Notice of Compliance
8 March 2018 - Operational change can help reduce the time between regulatory approval and reimbursement recommendations for prescription drugs ...
Posted by Michael Wonder on 16 Nov 2017
Industry fees are applicable to all CDR resubmissions
13 November 2017 - All resubmissions that are filed by manufacturers on or after 2 January 2018 will be subject to ...
Posted by Michael Wonder on 15 Nov 2017
Revised procedure for the CADTH Common Drug Review resubmissions
13 November 2017 - In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements ...
Posted by Michael Wonder on 13 Nov 2017
Sunovion announces FDA acceptance for review of new drug application for dasotraline for the treatment of ADHD
10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 10 Nov 2017
FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in the treatment of ADPKD
9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program ...
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 08 Nov 2017
GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease
7 November 2017 - GlaxoSmithKline today announced the submission of a supplemental biologics license application to the United States FDA, ...
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 05 Nov 2017
Trevena announces submission of new drug application to U.S. FDA for Olinvo (oliceridine injection)
2 November 2017 - Filing supported by positive Phase 3 APOLLO and ATHENA studies. ...
Posted by Michael Wonder on 15 Aug 2017
Posting of key milestones for CDR projects
14 August 2017 - Key milestones for CDR submissions, resubmissions, and requests for advice will now be posted within the ...
Posted by Michael Wonder on 01 Aug 2017
Sharing patient input submissions for the CDR program
1 August 2017 - Since February 2014, CADTH has shared patient input submissions on our website, when permission has been ...
Posted by Michael Wonder on 23 Jul 2017
Tackling submission and publication bias
17 July 2017 - Evoniuk and colleagues analysed whether submission and publication bias are based on study outcome. ...
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 ...