04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye...
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Naomi Pearce
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...
BioBlast w/e 17 Mar 23: Alvotech ustekinumab | Samsung Bioepis’ ustekinumab | Humira® US Medicare Rebates | Apotex aflibercept IPR | J&J US$25M Remicade® settlement | Lantus® price cut | Samsung Biologics US$1.5B plant … and more
Significant biosimilar activities this week include: 01 March 2023 | CA | Study finds nonmedical switching policy did...