Blog
RSS FeedPosted by Michael Wonder on 28 Mar 2024
IntraBio announces US FDA accepts new dug application for IB1001 for the treatment of Niemann-Pick disease type C
26 March 2024 - PDUFA date set for 24 September 2024. ...
Posted by Michael Wonder on 07 Oct 2022
Pembrolizumab in combination with platinum-based chemotherapy for treating recurrent, persistent or metastatic cervical cancer
5 October 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 12 Sep 2022
Nomination for an early re-entry resubmission - what exactly does it mean?
12 September 2022 - We compare and contrast the submissions nominated by the PBAC in March for an early re-entry ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 21 Jan 2022
National Medicines Policy Review – publication of submissions
21 January 2022 - On 30 August 2021, the National Medicines Policy Review Committee invited submissions to support the Review of ...
Posted by Michael Wonder on 10 Jul 2021
Application for cystic fibrosis medicine received by PHARMAC
9 July 2021 - PHARMAC is starting its funding assessment process for a new cystic fibrosis medication after receiving an ...
Posted by Michael Wonder on 06 Jul 2021
DoH publishes revised agenda for July 2021 PBAC meeting
6 July 2021 - Agenda revised on the eve of next scheduled meeting. ...
Posted 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 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 ...