Blog
RSS FeedPosted by Michael Wonder on 30 Jul 2018
Special Access Scheme online system
30 July 2018 - On Monday 30 July 2018, an online system was introduced to enable the electronic submission of SAS ...
Posted by Michael Wonder on 20 Jul 2018
Sanofi withdraws TGA submission for Kevzara
20 July 2018 - Outcome only made public after the publication of an AusPAR. ...
Posted by Michael Wonder on 18 Jul 2018
$50 million to provide life-saving support to cancer patients
18 July 2018 - The Australian Government will provide $50 million to support some of Australia’s sickest patients, battling the most ...
Posted by Michael Wonder on 17 Jul 2018
Federal Government to announce $50 million custom cancer drug trial
17 July 2018 - Almost 600 Queenslanders will have their cancer’s DNA tested to identify the drugs that will keep ...
Posted by Michael Wonder on 13 Jul 2018
TGA calls on drug company to improve warnings over children's asthma drug after suicide
13 July 2018 - The TGA has called on manufacturers of the asthma medication Singulair to add warnings inside the ...
Posted by Michael Wonder on 12 Jul 2018
Two boys, one horrific disease, different wonder drug funding
12 July 2018 - A young boy dying of a rare and horrifying genetic disease faces losing access to a ...
Posted by Michael Wonder on 12 Jul 2018
Opdivo + Yervoy: first combination immunotherapy for advanced renal cell carcinoma (kidney cancer) receives TGA approval
11 July 2018 - Opdivo now approved in Australia for ten indications across six cancer types. ...
Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate ...
Posted by Michael Wonder on 05 Jul 2018
International work-sharing pilot - apalutamide (Erlyand)
5 July 2018 - Apalutamide (Erlyand) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 28 Jun 2018
Medicines Australia welcomes shortages legislation
28 June 2018 - Medicines Australia welcomes the introduction of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 ...
Posted by Michael Wonder on 27 Jun 2018
Sandoz restrained from selling MabThera biosimilar in Australia
21 June 2018 - Australia's first biosimilar interlocutory injunction. ...
Posted by Michael Wonder on 26 May 2018
Indivior announces regulatory submission to Australia’s Therapeutic Goods Administration for Sublocade (buprenorphine extended-release) injection for the treatment of opioid dependence
25 May 2018 - Indivior today announced that it has filed a regulatory submission with Australia’s TGA for Sublocade (buprenorphine ...
Posted by Michael Wonder on 09 May 2018
Outcomes of the consultation on the draft list of permitted indications
8 May 2018 - On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under Section ...
Posted by Michael Wonder on 01 May 2018
Opdivo (nivolumab) is the first and only anti-PD-1 therapy approved by TGA for adjuvant treatment of melanoma
30 April 2018 - Opdivo now approved in Australia for nine indications across six cancer areas in under three years. ...
Posted by Michael Wonder on 23 Apr 2018
Celltrion’s Truxima approved in Australia
20 April 2018 - Celltrion said Sunday it has recently won approval from the Australia's Therapeutic Goods Administration for the ...