BMS announced that the FDA accepted its New Drug Application for repotrectinib, a tyrosine kinase inhibitor for the...
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Naomi Pearce
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.
BioBlast w/e 12 May 23
11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported...
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.