30 Dec 21 | US | Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the...
Pearce IP BioBlast® w/e 07 January 2022
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Emily Dwyer
Emily provides broad paralegal services including litigation support services, legal research, IP monitoring and tracking services, and document management.
A self professed “legal junkie” she loves exploring legal arguments and is excited about new legal developments.
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Pearce IP BioBlast® 31 December 2021
20 Dec 21 | US | Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab. 20 Dec...
Pearce IP BioBlast® w/e 17 December 2021
11 Dec 21 | Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I...
PTE Alert – interlocutory injunction refused in Tecfidera® dispute
In early November Pearce IP reported on a number of Federal Court decisions which appear to indicate flaws in the...
Pearce IP BioBlast® w/e 10 December 2021
06 Dec 21 | AU | Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of...
Pearce IP BioBlast® w/e 03 December 2021
01 Dec 21 | CN | Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the...
Pearce IP BioBlast® w/e 26 November 2021
21 Nov 21 | CN | Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar)...
Breaking News – Parliament delivers early Christmas present for Health Care
In the last sitting of Parliament for 2021, the House of Representatives delivered the long-awaited Zimmerman Report,...
Pearce IP BioBlast®: w/e 19 November 2021
15 Nov 21 | EU | Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with...
Hold onto your Hats! – Expedited Patent Litigation in Australia
The speed of getting a case to trial is a key metric of any litigation system. Pharmaceutical patent litigation often...
Pearce IP BioBlast®: w/e 12 November 2021
09 Nov 21 | Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201...
Pearce IP BioBlast®: w/e 05 November 2021
01 Nov 21 | The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its...
PTE Alert: Recent cases create fertile ground for PTE challenges
In the last year, two significant Federal Court decisions, reported here and here have exposed key flaws in the...
Pearce IP BioBlast®: w/e 29 October 2021
22 Oct 21 | Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue year on...
Pearce IP BioBlast®: w/e 22 October 2021
14 Oct 21 | Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin...
Strategies for generic/biosimilar market entry in Australia
Originally published in World Intellectual Property Review 3 2021 After surviving the Great Patent Cliff of 2011–2016,...