14 Mar 22 | OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar...
Pearce IP BioBlast®: w/e 18 March 2022
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Naomi Pearce
Naomi is listed in IAM Patent 1000 as one of Australia's leading patent litigators. Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from first hand experience and knowledge as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm.
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Pearce IP BioBlast®: w/e 11 March 2022
03 Mar 22 | US | FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support...
Reminder – new .au domain names coming to Australia from 24 March 2022
Priority given to owners of corresponding Australian domain names in the .au race
We previously wrote that, from 24 March 2022, individuals, businesses and organisations with an Australian presence...
Pearce IP BioBlast®: w/e 25 February 2022
18 Feb 22 | Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab)....
Pearce IP BioBlast®: w/e 18 February 2022
11 Apr 22 | CA | Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and...
Pearce IP BioBlast®: w/e 11 February 2022
07 Feb 22 | The International Generic and Biosimilar medicines Association (IGBA) announced that it has established a...
Pearce IP BioBlast®: w/e 04 February 2022
01 Feb 22 | JAMP Pharma announced the creation of a new division BIOJAMP™ dedicated to biosimilars. The creation of...
Comments period on draft new National Medicines Policy extended – now closing on 2 March
Last week we alerted you to the release of a draft new National Medicines Policy (NMP) for public comment. The draft...
No time to lose! Comments on the consultation draft of the new National Medicines Policy close on 16 February
On 2 February a draft of a new National Medicines Policy (NMP) was made available for public comment. The draft NMP...
Pearce IP BioBlast®: f/e 31 January 2022
18 Jan 22 | Alvotech announced $21 million in additional commitments for private placement (PIPE) of Oaktree II common...
Pearce IP BioBlast®: w/e 14 January 2022
10 Jan 22 | CA | Alvotech and JAMP Pharma announced that Health Canada has approved Simlandi (high-concentration,...
Pearce IP BioBlast®: w/e 07 January 2022
30 Dec 21 | US | Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the...
Pfizer quest for Samsung Bioepis etanercept documents continues
Shortly before Christmas, the judgment handed down by Justice Burley on 18 November 2021 on a second preliminary...
Pearce IP BioBlast®: f/e 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...
PTE Alert (part 2): Bad Patent Term Extension Enables Generics to Avoid Preliminary Injunction in Australia
Newly appointed Justice Rofe delivered an early Christmas gift for generic and biosimilar companies in Australia in...
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...