11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported...
BioBlast w/e 12 May 23
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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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BioBlast w/e 05 May 23
04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye...
Poor Drafting and Poor Choice of Expert Brings Calix Process Patent To Boiling Point
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
BioBlast w/e 28 Apr 23
28 April 2023 | US | FDA advisory committee supports approval of Merck’s Lynparza® (olaparib) combination for first...
Marlow Foods edible fungi patent amended but still obvious
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
BioBlast w/e 21 Apr 23
20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent®...
BioBlast f/e 14 Apr 23
Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding...
BioBlast w/e 31 Mar 23: Humira® AU price reduction | EMA recommends Samsung’s EPYSQLI™ eculizumab | US Supreme Court hears Amgen v Sanofi | Eli Lilly $1B mAb manufacture investment in Ireland | Daiichi Enhertu® JP approval | Coya and Dr. Reddy’s ww development agreement … and more!
Significant biosimilar activities this week include: 01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023...
High Court finds no wrinkles in PROTOX and INHIBOX brands
The High Court recently issued its decision in the case of Self Care IP Holdings Pty Ltd & Anor v Allergan...
EMA CHMP gives nod to Samsung Bioepis’ Epysqli™ eculizumab biosimilar
EMA recommended granting marketing authorisation for Samsung Bioepis’ Epysqli™ (eculizumab), biosimilar to Alexion’s...
Cipla/Alvotech’s biosimilar adalimumab and Juno’s biosimilar enoxaparin on AU PBAC Agenda for July 23
Two biosimilars are on the July 2023 PBAC meeting agenda seeking to be PBS reimbursed for Australia: Cipla Australia...
Approval alert: Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) approved in Japan for HER2 low metastatic breast cancer
Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health,...
Eli Lilly announced US$1B investment in new Irish monoclonal antibody manufacturing facility
Eli Lilly has announced a $1B investment to build a new biotech facility in Raheen (Ireland) for the manufacture of...
US Supreme Court hears oral submissions in Amgen Inc v Sanofi evolocumab/alirocumab dispute with decision on ‘enablement’ expected
The Supreme Court heard the opening oral arguments in the Amgen v Sanofi case (2020-1074; No. 21-757) this week. The...
BioBlast w/e 24 Mar 23: IPRs re Regeneron aflibercept patents | NMPA approves Xgeva® (denosumab) | FDA approves Hyrimoz® (adalimumab) | and more…
Significant biosimilar activities this week include: 22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs...
Coya and Dr Reddy’s enter exclusive worldwide agreement to develop COYA 302 (abatacept + COYA 301)
Coya Therapeutics, Inc. announced an exclusive worldwide licensing agreement with Dr Reddy’s Laboratories, Ltd for...