Blog
RSS FeedPosted by Michael Wonder on 14 Nov 2019
Health products portal – intent to apply
14 November 2019 - The Department of Health (the Department) has been working to digitise and simplify the PBS submission ...
Posted by Michael Wonder on 25 Jul 2019
Application process changes for access to Section 100 - Highly Specialised Drugs medicines
25 July 2019 - From 1 August 2019, hospital authorities will no longer be required to seek separate approval from ...
Posted by Michael Wonder on 14 May 2019
PHARMAC publishes list of applications to be considered by PTAC later this month
14 May 2019 - The list includes a number of medicines for patients with breast cancer. ...
Posted by Michael Wonder on 27 Feb 2019
Bayer completes rolling submission for darolutamide in U.S.
27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...
Posted by Michael Wonder on 07 Jan 2019
PBAC - 2018 in review
7 January 2019 - The PBAC considered 195 submissions in 2018; 173 were considered by the PBAC in 2017. ...
Posted by Michael Wonder on 03 May 2018
Treatment for families battling a devastating rare disease
3 May 2018 - New Zealand infants suffering from a rare neuromuscular condition may soon be eligible for compassionate access ...
Posted 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 ...