Blog
RSS FeedPosted by Michael Wonder on 13 Aug 2020
Seattle Genetics announces Tukysa (tucatinib) approved within months for all countries participating in FDA’s Project Orbis initiative
12 August 2020 - Australia joins U.S., Switzerland, Canada and Singapore in approval of Tukysa for the treatment of patients with ...
Posted by Michael Wonder on 13 Aug 2020
TGA approves new gene therapy from Novartis
13 August 2020 - Luxturna has been for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 ...
Posted by Michael Wonder on 12 Aug 2020
Australian scientists say too early to pick COVID-19 vaccine race winner in advice to Federal Government
13 August 2020 - The leading group of scientists advising the Federal Government says there is still no clear frontrunner in ...
Posted by Michael Wonder on 11 Aug 2020
Local doctor may have breakthrough coronavirus cure
11 August 2020 - Local doctor Thomas Borody has found what may be a cheap and easy treatment for COVID-19 patients ...
Posted by Michael Wonder on 11 Aug 2020
Alkindi approved in Australia
10 August 2020 - Diurnal Group announces that Alkindi (hydrocortisone granules in capsules for opening) has been approved by the ...
Posted by Michael Wonder on 29 Jul 2020
TGA approves new medicine for basal cell carcinoma
29 July 2020 - Cemiplimab (Libtayo) has been provisionally registered by the TGA. ...
Posted by Michael Wonder on 27 Jul 2020
TGA approves Zeposia for patients with multiple sclerosis
27 July 2020 - Zeposia has been approved under the Black Triangle Scheme. ...
Posted by Michael Wonder on 23 Jul 2020
Delays to the commencement of certain medical device regulatory changes
23 July 2020 - The Governor-General in Council has made regulations which delay the commencement of a number of medical ...
Posted by Michael Wonder on 22 Jul 2020
Australia left in the dark as manufacturers race to make Oxford COVID-19 vaccine
22 July 2020 - Australia may have to compete with other nations to import supply of the University of Oxford's ...
Posted by Michael Wonder on 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...
Posted by Michael Wonder on 20 Jul 2020
Australian COVID researchers warn vaccines will have to be made overseas
20 July 2020 - Researchers at Monash University say if their COVID-19 vaccine is successful they will be forced to ...
Posted by Michael Wonder on 16 Jul 2020
Actual and potential harm caused by medical software
16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...
Posted by Michael Wonder on 15 Jul 2020
Deciphera announces Australian Therapeutic Goods Administration’s approval of Qinlock (ripretinib) for the treatment of fourth-line gastro-intestinal stromal tumour
14 July 2020 - Qinlock is the first approved tyrosine kinase inhibitor designed specifically for GIST regardless of patients’ mutational status. ...
Posted by Michael Wonder on 14 Jul 2020
Gilead rushes to meet remdesivir demand as virus pressures grow
15 July 2020 - Global pharmaceuticals giant Gilead has flagged the supply of its coronavirus treatment remdesivir will be constrained ...
Posted by Michael Wonder on 13 Jul 2020
TGA publishes more details on its approval of COVID-19 medicine Veklury
13 July 2020 - Remdesivir granted conditional approval in record time. ...