Blog
RSS FeedPosted 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 07 Jun 2018
Reform of the orphan drug program - End of transition arrangements
7 June 2018 - On 1 July 2017 amendments to the Therapeutic Goods Regulations 1990 (the Regulations) came into effect that ...
Posted by Michael Wonder on 06 Jun 2018
Big pharma wants to invest more in Australian biotech says Greg Hunt
6 June 2018 - Big pharma is "looking at Australia as the next destination in the developed world, the emerging first-world ...
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 08 May 2018
Federal budget 2018: $1.3 billion plan to make Australia a medical technology leader
8 May 2018 - The Coalition has taken up calls for genetic and precision medicine innovations, announcing a new $1.3 ...
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 ...
Posted by Michael Wonder on 18 Apr 2018
2018 influenza vaccines now available
18 April 2018 - More than 4.5 million Australians who are most at risk of getting sick during this year’s flu ...
Posted by Michael Wonder on 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...
Posted by Michael Wonder on 16 Apr 2018
Provisional approval pathway - first determination decision
16 April 2018 - Olaratumab (Lartruvo) is the first medicine to be granted a provisional approval determination under the new ...
Posted by Michael Wonder on 09 Apr 2018
Medical research caught in cross-fire of R&D tax overhaul
9 April 2018 - Industry commercialising medical research caught in cross-fire of R&D tax overhaul. ...
Posted by Michael Wonder on 06 Apr 2018
MorphoSys announces approvals for Tremfya (guselkumab) for the treatment of moderate-to-severe plaque psoriasis in Brazil and Australia
5 April 2018 - MorphoSys announced today that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been ...