We are proud to announce that the Pearce IP team of patent and trademark lawyers and attorneys has been selected as a finalist for the Lawyers Weekly Intellectual Property Team of the Year in the Australian Law Awards...
20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection) Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination...
11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology...
Congratulations to Executives Naomi Pearce and Katrina Crooks, each of who have been named as finalists for the Lawyers Weekly Partners of the Year Awards 2022 in the category of Intellectual Property. The Partner of...
02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable...
24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott...
20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®) Prestige’s trastuzumab rejected by CHMP The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s...
16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)Alvotech announces study results for AVT04, biosimilar ustekinumab Alvotech announced positive top-line results from a 3 arm, parallel design study...
Pearce IP is proud to announce that 6 patent practitioners and 4 trade marks practitioners are ranked amongst the world’s best by WIPR Leaders 2022. Among the 47 patent experts ranked for Australia are 6 Pearce IP team...
Introduction The promotion of medicinal cannabis products presents some specific challenges given that very few such products are approved therapeutic goods on the Australian Register of Therapeutic Goods (ARTG). In...
04 May 22 | Amneal published its Q1 2022 financial results, reporting a 1% increase YoY in net revenue. Amneal announced that it plans to expand into high growth areas including biosimilars and injectables. 10 May 22...
Innovation developed from plants and plant-derived material can be substantial and includes biotech crops, food production, feed, fibres, fuel and pharmaceuticals. However, as detailed in Part 3 of our series on...
As medicinal cannabis (MC) becomes more established in the medicinal sector due to regulatory and attitudinal changes, there has been a corresponding worldwide increase in applications for intellectual property rights...
Introduction As noted in part 1 of our blog series, the vast majority of medicinal cannabis products are not registered on the Australian Register of Therapeutic Goods (ARTG). Rather, they are unapproved therapeutic...
29 Apr 22 | Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in...
Pearce IP is proud to announce that Katrina Crooks, Head of Litigation and Executive Lawyer and Patent Attorney has been re-listed in Doyles Guide (for 2022) as a Leading Contentious Intellectual Property Lawyer. This...
Pearce IP congratulates three of its patent leaders for being recognised by Managing IP (MIP) in its 2022 IP Stars ranking. Two Pearce IP leaders Naomi Pearce and Jacinta Flattery-O’Brien PhD are again ranked by MIP...
Depression, anxiety and related disorders are serious conditions whose treatment is - in many cases - not adequately addressed by existing psychiatric or psychological therapies. Despite the efforts of those seeking...
Introduction Medicinal cannabis is now widely available in Australia. However, the vast majority of medicinal cannabis products are not registered on the Australian Register of Therapeutic Goods (ARTG). Rather, they...
21 Apr 22 | AU | Australia’s TGA granted orphan drug designation to Roche’s glofitamab. The TGA also provided approval for Roche to apply for registration using the provisional approval pathway, an expedited approval...
14 Apr 22 | CA | BIOJAMP announced the launch of SIMLANDI™/AVT02 (high-concentration, low volume, citrate-free biosimilar adalimumab) in Canada. JAMP Pharma has exclusive commercialisation rights to Alvotech’s AVT02...
Pearce IP is proud to announce that Executive Lawyer & Patent Attorney, Katrina Crooks, has been recognised by The Best Lawyers in Australia™ 2023 for Intellectual Property. As the longest standing peer review...
We recently reported on the decision in Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92 in which the Federal Court found certain batches of Juno’s generic parecoxib products fell within the claims of...
11 Apr 22 | CA | Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada. Yuflyma® is approved in Canada for ten indications: rheumatoid...
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