Blog
RSS FeedPosted by Michael Wonder on 14 Oct 2016
TGA publishes AusPAR for Zurampic
14 October 2016 - The TGA has published an AusPAR for AstraZeneca's Zurampic. ...
Posted by Michael Wonder on 14 Oct 2016
TGA publishes AusPAR for Entresto
14 October 2016 - The TGA has published an AusPAR for Novartis' Entresto. ...
Posted by Michael Wonder on 11 Oct 2016
Biotech sector crafts response to R&D tax incentive review
11 October 2016 - AusBiotech members are invited to gather at briefings in Sydney, Brisbane and Melbourne to contribute to ...
Posted by Michael Wonder on 11 Oct 2016
TGA boss warns about streamlining approvals
3 October 2016 - The head of the Therapeutic Goods Administration, John Skerritt, has warned that federal government reforms to ...
Posted by Michael Wonder on 05 Oct 2016
Bill Ferris defends R&D reform proposals
5 October 2016 - Fewer than 1% of the 10,000 companies receiving cash refunds as part of the research and development ...
Posted by Michael Wonder on 30 Sep 2016
Fast-track approval of medicines in Australia
30 September 2016 - The Australian Government has recently taken steps to fast track the registration of new medicines, generics, and ...
Posted by Michael Wonder on 28 Sep 2016
TGA performance statistics report: July 2015 to June 2016
28 September 2016 - The TGA, through the Performance Statistics Report, provides detailed statistical information on its performance to stakeholders. ...
Posted by Michael Wonder on 27 Sep 2016
Idelvion now registered in Australia
27 September 2016 - CSL Behring's Idelvion is now approved by the TGA. ...
Posted by Michael Wonder on 27 Sep 2016
Zinbryta approved by TGA
27 September 2016 - The TGA has approved Biogen's Zinbryta. ...
Posted by Michael Wonder on 27 Sep 2016
TGA approves new use for Takeda's Adcetris
27 September 2016 - The TGA has approved a new use for Takeda's CD 30 receptor antagonist. ...
Posted by Michael Wonder on 21 Sep 2016
TGA publishes AusPAR for Orkambi
21 September 2016 - The TGA has published an AusPAR for Vertex's combination product for cystic fibrosis. ...
Posted by Michael Wonder on 19 Sep 2016
TGA pre-submission phase option for prescription medicines
19 September 2016 - The pre-submission pilot for prescription medicines will conclude at the end of September 2016 and continue as ...
Posted by Michael Wonder on 15 Sep 2016
Streamlined approvals means faster access to medicines for patients
15 September 2016 - Medicines Australia welcomes the commitment of the Australian Government to improve the way medicines are assessed for ...
Posted by Michael Wonder on 15 Sep 2016
TGA approves Simponi for axial spondyloarthritis
15 September 2016 - The TGA has approved a new use for Simponi. ...
Posted by Michael Wonder on 15 Sep 2016
TGA approves new indication for Alprolix
15 September 2016 - The TGA has approved a new use for Biogen's Alprolix. ...