08 DEC 2023 | US | FDA Approves First Cell-Based Gene Therapies Casgevy® and Lyfgenia® to Treat Sickle Cell Disease...
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Naomi Pearce
BioBlast w/e 01 Dec 23
01 DEC 2023 | US | Celltrion Files BLA for Interchangeable Prolia® (Denosumab) Biosimilar with the FDA The Korea...
LAA under water – the great cost of commercialising before filing a patent application
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 24 Nov 23
24 NOV 2023 | Celltrion Applies For EU Approval of CT-P42, Biosimilar to Regeneron’s Eylea® (aflibercept) Celltrion...
“Essence or Core” of an invention – Full Court adds non-statutory element to sufficiency in first appellate decision post-RTB
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 17 Nov 23
16 NOV 2023 | US | Approval Alert: AZ’s Truqap® (capivasertib) plus Faslodex® FDA Approved to Treat Advanced...
Confectionary chronicles: glucose jelly bean trade mark application appealed
On 9 August 2023, the Registrar of Trade Marks handed down a decision in favour of Nova Pharmaceuticals Australasia...
BioBlast w/e 10 Nov 23
10 NOV 2023 | EU | CHMP Positive Opinion for 8mg Eylea® (Aflibercept) Bayer announced that the EMA’s Committee for...
Generics take Sandoz Rivaroxaban Loss to Heart – Bayer’s Rivaroxaban Patents Valid & Sandoz AU Launch Delayed by Injunction (Appeal Pending)
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.
BREAKING NEWS: Bayer Rivaroxaban patents survive first AU challenge by Sandoz with ~150 generic products approved
With over 150 rivaroxaban products approved (9 of them for Bayer), the outcome of the Sandoz challenge to the validity...
BioBlast w/e 03 Nov 23
01 NOV 2023 | EU | Fresenius Kabi’s Launches First EU Tocilizumab Biosimilar Fresenius Kabi announced it has...
A hard lesson learnt: Commonwealth v Sanofi
The Australian government has made numerous claims for damages against patentees for savings forgone when an...
BioBlast w/e 27 Oct 23
27 OCT 2023 | US | Sanofi to Spin-Off Consumer Business and Focus on Biopharma by End Q4 2023 Sanofi announced that it...
BioBlast w/e 23 Oct 23
23 OCT 2023 | US | Approval Alert: FDA Approves Celltrion’s Zymfentra® (infliximab-dyyb), Biosimilar to Janssen’s...
BioBlast w/e 15 Oct 23
15 OCT 2023 | Samsung Bioepis Reveals SB16 (denosumab) Study Results at ASBMR Samsung Bioepis presented new data on...
Advanta succeeds again in second extension of time application opposed by Nufarm
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.