Coherus announced it is launching YUSIMRY® (adalimumab-aqvh) biosimilar to AbbVie’s Humira®, in July 2023 with a list...
Coherus 85% discount for US launch of YUSIMRY® (biosimilar adalimumab) & partnership with Mark Cuban
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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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New indication alert: FDA approves AZ’s Lynparza® plus abiraterone for mCRPC
The FDA announced that it has approved AstraZeneca’s Lynparza® (olaparib) with abiraterone and prednisone (or...
Celltrion phase I data for biosimilar to Genentech’s Actemra® (tocilizumab)
Celltrion has released its clinical phase I data for its tocilizumab product CT-P47, biosimilar to Roche’s Actemra®...
FDA accepts Priority Review for BMS’s NDA for repotrectinib for NSCLC
BMS announced that the FDA accepted its New Drug Application for repotrectinib, a tyrosine kinase inhibitor for the...
Lupin & Enzene (Alkem) collaborate on biosimilar to Eli Lilly and Merck’s Erbitux® (cetuximab)
Lupin announced a strategic collaboration with Enzene Biosciences (Aklem Laboratories’ biological arm) to launch...
Approval alert: EC grants MA for Samsung Bioepis’ Epysqli® biosimilar to Alexion’s Soliris® (eculizumab)
The European Commission (EC) has granted Marketing Authorisation for Samsung Bioepis’ Epysqli® (eculizumab),...
Roche successfully concludes talks with p-CPA for Vabysmo® (faricimab)
Roche has announced that it has successfully concluded meetings with pan-Canadian Pharmaceutical Alliance (pCPA)...
BioBlast w/e 26 May 23
26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea...
PiPCast™ | Best Method and why it is relevant to patents in Australia
PiPCast™ | Best Method and why it is relevant to patents in Australia
CHMP recommends withdrawal of MA for Novartis’s Adakveo® (crizanlizumab)
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Adakveo® (crizanlizumab) should...
Alnylam sues Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines
Alnylam commenced proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer...
MHRA announces new regulatory recognition routes with seven international partners
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory...
Beware the shifting sands of patent term extensions (PTE) in Australia
Recent Australian decisions have resulted in both new opportunities to challenge patent term extensions in Australia...
PiPCast™ | Patent oppositions & litigation – what about estoppel?
PiPCast™ | Patent oppositions & litigation – what about estoppel?
BioBlast w/e 22 May 23
22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of...
Grains of Justice | Preliminary discovery order extended to wheat product samples in CSIRO case
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.