22 Nov 20 | Innovent released results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced...
Pearce IP BioBlast™: w/e 27 November 2020
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Preliminary discovery not justified by fear of a future product launch
In Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648, the Federal Court of Australia declined to order preliminary discovery against Sandoz, the holder of an ARTG...
Pearce IP BioBlast™: w/e 20 November 2020
Significant biosimilar activities this week include 15 Nov 20 | US | Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and...
Pearce IP BioBlast™: w/e 13 November 2020
Significant biosimilar activities this week include 05 Nov 20 | Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted....
Pearce IP BioBlast™: w/e 06 November 2020
Significant biosimilar activities this week include 05 Nov 20 | Teva released its Q3 2020 financial results, reporting a 2% increase in generic and biosimilar revenues in North...
Pearce IP BioBlast™: w/e 30 October 2020
Significant biosimilar activities this week include 22 Oct 20 | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced...
Pearce IP BioBlast™: w/e 23 October 2020
Significant biosimilar activities this week include 15 Oct 20 | Henlius and Essex announced they have entered into a co-development and exclusive license agreement for HLX04...
Pearce IP BioBlast™: w/e 16 October 2020
Significant biosimilar activities this week include 09 Oct 20 | CN | Innovent and Eli Lilly jointly announced China's NMPA has granted marketing approval for Halpryza®...
MHRA Releases Post-Brexit Biosimilar Guidelines
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...
Pearce IP BioBlast™: w/e 09 October 2020
Significant biosimilar activities this week include 05 Oct 20 | Medicure announced it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a...
Pearce IP BioBlast™: w/e 02 October 2020
Significant biosimilar activities this week include 28 Sep 20 | Innovent announced its Ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt®...
TGA Approves Second Registered Medicinal Cannabis Product
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...
Pearce IP BioBlast™: w/e 25 September 2020
Significant biosimilar activities this week include 21 Sep 20 | EU | Alexion announced it has received a positive opinion from the EU's CHMP for a new 100mg/mL formulation of...
Pearce IP BioBlast™: w/e 18 September 2020
Significant biosimilar activities this week include 14 Sep 20 | Novartis announced the results of Ph III trials of Beovu® (brolucizumab) in diabetic macular edema. Novartis...
Pharmaceutical patentees beware – the Australian Patent Office lays down the law on patent term extensions!
The Australian Patent Office, in Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, has emphatically confirmed that a patent term extension (PTE) request must be based on the...
Pearce IP BioBlast™: w/e 11 September 2020
Significant biosimilar activities this week include 08 Sep 20 | The Centre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming...
Pearce IP BioBlast™: w/e 04 September 2020
Significant biosimilar activities this week include 31 Aug 20 | US | Mylan and Biocon announced the launch of Semglee® (insulin glargine) in vial and pre-filled pen...
Pearce IP BioBlast™: w/e 28 August 2020
Significant biosimilar activities this week include 24 Aug 20 | JP | Merck announced Keytruda® (pembrolizumab) has received two additional approvals from the Japanese...
COVID-19 – Patent Rights in the Time of a Pandemic
First published in Australian Intellectual Property Law update Vol. 33, No. 2, Jun 2020: 35-38 The COVID-19 pandemic and the urgent global need for effective treatments and/or a...
Pearce IP BioBlast™: w/e 21 August 2020
Significant biosimilar activities this week include 11 Aug 20 | In an online press conference, Samsung Biologics announced it plans for a fourth manufacturing plant within...
PBAC defers decision on PBS listing of Chiesi’s unregistered medicinal cannabis product
On 21 August 2020, PBAC published the results of the July meeting at which PBAC deferred its decision regarding Chiesi's application to list Epidyolex® (cannabidiol). The PBAC...
Pearce IP BioBlast™: w/e 14 August 2020
Significant biosimilar activities this week include 05 Aug 20 | In its Q4 FY20 earnings call, Aurobindo Pharma announced that its wholly owned subsidiary CuraTeQ Biologics...
IP Australia Increases Patent and Trade Mark Fees from 01 October 2020
Commencing 1 October 2020, IP rights in Australia will come with a slightly higher price tag. The new fees are not global but are selective across all types of IP rights. As...
Self-knowledge, narcissism, and accessibility of Australia’s patent system
His scholarship focuses on philosophy and the history of ideas. His published works include: “Plotinus, Self and the World”, which addresses the question of the individual...
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