As discussed in Part 1 of this blog series, TGA has invited submissions by 23 March 2021 on its consultation paper released last Thursday designed to facilitate indication “repurposing”. In particular, TGA has sought submissions on the potential obstacles and...
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication “repurposing”, a phrase coined by TGA to describe the Australian registration of new indications for known medicines. In particular, the TGA has...
On 01 December NPS Medicine Wise published its annual list of the top 10 PBS drugs by cost to the Australian government. Biologics dominated the list, taking 7 of the top 10 places, including the top 5 positions. The top product aflibercept costs the government $392...
The Generic and Biosimilar Medicines Association announced it has appointed Ms Jane Halton AO PSM as its inaugural Independent Chair. Halton will bring a wealth of experience to the role, as former head of the Department of Health (2002-2014), and Department of...
Next year, the UK will conclude its transition from the EU, with the regulation of all medicines and devices to be transferred from EMEA to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This new regime will apply from 01 January 2021,...
The TGA has approved GW Pharma’s Epidyolex® (cannabidiol) as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients over 2 years of age. Epidyolex® was developed by GW Pharma in partnership with Chiesi...
