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Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

BioBlast® w/e 27 May 22 : Prestige’s trastuzumab rejected by CHMP; Additional EU indications for Merck’s Keytruda; Jury trial set in BMS/AstraZeneca patent infringement suit re durvalumab; First patients dosed in Biond Biologics trials for BND-22 (SAR444881); FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim).. and more

By Naomi Pearce | May 30, 2022

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20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®)
Prestige’s trastuzumab rejected by CHMP

The CHMP recommended refusing the marke...
GBMA hosts 2022 Biosimilars Awareness Week

By Bioblast Editor | May 30, 2022

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Australia’s Generic and Biosimilar Medicines Association hosts 2022 Biosimilar Awareness Week with the key focus on delivering equitable access to affordable medicines to all Australians.
FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim)

By Bioblast Editor | May 27, 2022

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Amneal Pharmaceuticals announced that the FDA has approved its ABLA for Fylnetra™ (biosimilar pegfilgrastim). Fylnetra™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppre...
BioBlast® w/e 20 May 22: Alvotech’s biosim ustekinumab study results, Samsung Bioepis’ biosim ranibizumab approved in KR, Teva/BioEq’s biosim ranibizumab approved in the UK; Celltrion’s PhIII clinical trial for tocilizumab biosim

By Naomi Pearce | May 25, 2022

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16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)Alvotech announces study results for AVT04, biosimilar ustekinumab
Alvotech announced positive top-line results ...
Intervet inventive step in a veterinary injectable formulation holds on appeal from patent office

By Naomi Pearce | May 25, 2022

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Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. [2022] FCAFC 88

Date:

Court:

Judges:

18 May 2022

Ful...
Pearce IP practitioners prominent in WIPR Leaders 2022

By Pearce IP | May 25, 2022

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Pearce IP is proud to announce that four patent practitioners and three trade marks practitioners are ranked amongst the world’s best by WIPR Leaders 2022.
Among the 47 patent...
Multiple interlocutory decisions in long-running mining systems infringement cases

By Naomi Pearce | May 24, 2022

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Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd & Ors (No 2) [2022] FCA 88(experimental evidence) Australian Mud Company Pty Ltd & Anr v Globaltech Corporati...
FDA lifts partial clinical hold on NEON-2 pembrolizumab trial

By Bioblast Editor | May 24, 2022

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Alpine Immune Sciences announced that the FDA has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (first-in-class conditional CD28 costimulator and dual checkpoint inhibitor) in combination with pembrolizumab in adults with advanced mali...
UK NICE recommends Vabysmo® (faricimab) for AMD and DMO

By Bioblast Editor | May 24, 2022

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The UK’s NICE published final draft guidance recommending Vabysmo® (faricimab) for the treatment of adult patients with wet age-related macular degeneration (AMD) or diabetic macular oedema (DMO).
Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims

By Bioblast Editor | May 24, 2022

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Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.