Naomi Pearce, Author at Pearce IP

BioBlast w/e 24 Feb 23: Abbvie in hot water over Humira® pricing, Celltrion’s Yuflyma® delays explained, MSD/Moderna mRNA vaccine/ Keytruda treatment, French Court overturns Novartis/Roche €444M cartel fine, Amgen’s Amjevita® savings, Genetech new biologics facility, Regeneron new aflibercept product, Amgen’s Bekemv® eculizumab

by Naomi Pearce | Feb 27, 2023

Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira®...

Federal Court confirms the ‘protective and remedial’ operation of extension of time provisions

by Naomi Pearce, Donna Meredith | Feb 27, 2023

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 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

by Naomi Pearce | Feb 20, 2023

Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of...

Nailed It – Full Federal Court upholds purposive construction of fuel cell claims

by Naomi Pearce, Donna Meredith | Feb 20, 2023

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 f/e 10 Feb 2023: Alvotech’s ustekinumab & omalizumab, new US indication for Eylea®, Sandoz’s US denosumab biosimilar, Amgen US Amjevita® (adalimumab) launch, Sandoz’s citrate-free adalimumab, Celltrion’s Vegzelma™ (bevacizumab), MSD Keytruda® trial, Celltrion aflibercept IPR, Sanofi’s Dupixent® (dupilumab) approval

by Naomi Pearce | Feb 13, 2023

Significant biosimilar activities this week include: 09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04...

BioBlast® w/e 27 Jan 23: Alvotech Simlandi® (biosimilar adalimumab) approval, Alvotech completes private placement round, PTAB institutes Mylan aflibercept challenges, Dr Reddy’s rituximab, BeiGene’s denosumab, MHRA grants Ximluci® (biosimilar ranibizumab) marketing authorisation, NMPA approves BAT1806 (biosimilar tocilizumab), Genentech and Tanvex settlement, Luye Pharma denosumab

by Naomi Pearce | Jan 30, 2023

Significant biosimilar activities this week include: 24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s...

BioBlast® w/e 13 Jan 23: Alvotech’s golimumab, Alvotech and Fuji commercialisation partnership, Dong-A ST’s ustekinumab, Coherus and Klinge’s deal for US aflibercept, Boan Biotech and CP Qingdao denosumab deal, Rani and Celltrion’s oral ustekinumab biosimilar

by Naomi Pearce | Jan 16, 2023

Significant biosimilar activities this week include: 16 Jan 23 | Dong-A ST publishes the results of Ph III trials of...

BioBlast® w/e 06 January 2023: Biocon insulin, Alvotech ustekinumab, Celltrion Vegzelma™ (bevacizumab), Lannett’s biosimilar insulin products, Alteogen and Celltrion agreement, Samsung Bioepis adalimumab interchangeability, Amgen’s adalimumab, Ontario biosimilar switching program, Hikma and Celltrion bevacizumab agreement, Samsung Bioepis Hadlima® approval, Keytruda® trials, Celltrion’s subcutaneous infliximab, Alvotech adalimumab, Dr Reddy’s tocilizumab, ustekinumab biosimilar

by Naomi Pearce | Jan 9, 2023

Significant biosimilar activities this week include: 07 Jan 23 | Biocon receives complete response letter over...

Threats of infringement unjustified after swimming pool door hinge patents revoked

by Naomi Pearce | Dec 21, 2022

TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493Date:Court:Judge:14 December 2022Federal Court of...

BioBlast w/e 16 Dec 22: Doer Biologics and Merck collaboration, expanded Dupixent® indications, Fresenius US citrate-free Idacio® (adalimumab) approval, Merck and Moderna cancer vaccine trial results, Amgen acquires Horizon, Alvotech lists on Nasdaq Iceland Main Market, Regeneron seeks expedited motion in aflibercept dispute

by Naomi Pearce | Dec 19, 2022

Significant biosimilar activities this week include: 15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials...

BioBlast w/e 09 Dec 22: Roche’s glofitamab, Paras Biopharma’s new biosimilars division, Biogen’s biosimilar tocilizumab, Alvotech/Stada’s EU Hukyndra® roll out, Biocon closes Viatris biosimilars acquisition

by Naomi Pearce | Dec 12, 2022

Significant biosimilar activities this week include: 11 Dec 22 | New study reports glofitamab is effective in diffuse...

Fall from Grace: Patent Office allows extension of time for claim to grace period but patent still found invalid

by Naomi Pearce | Dec 9, 2022

Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2 Generic Partners Pty Ltd v Neurim Pharmaceuticals...

BioBlast w/e 02 Dec 22: Janssen sues Amgen over ustekinumab, Capstone’s insulin, Erasca trials, Alvotech leadership changes, MHRA Dupixent® guidance, Merck sues JHU on Keytruda patents, Hikma and Celltrion ustekinumab deal

by Naomi Pearce | Dec 5, 2022

Significant biosimilar activities this week include: 03 Dec 22 | Alvotech announces changes to share listings and...

BioBlast w/e 25 Nov 22: AbbVie’s risankizumab, FDA investigating Prolia® (denosumab) risk, Amneal’s filgrastim launch, Junshi Biosciences’ adalimumab, US biosimilars bill, Teva and Sandoz biosimilars ramp-up

by Naomi Pearce | Nov 29, 2022

Significant biosimilar activities this week include: 23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s...

Account of profits/damages as complex as validity/infringement

by Naomi Pearce | Nov 25, 2022

Aristocrat Technologies Australia Pty Limited v Konami Australia Pty Limited (No 3) [2022] FCA 1373...

BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide

by Naomi Pearce | Nov 21, 2022

Significant biosimilar activities this week include: 18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin...

ALL BLOGS BY

Naomi Pearce

Federal Court confirms the ‘protective and remedial’ operation of extension of time provisions

Nailed It – Full Federal Court upholds purposive construction of fuel cell claims

BioBlast® w/e 13 Jan 23: Alvotech’s golimumab, Alvotech and Fuji commercialisation partnership, Dong-A ST’s ustekinumab, Coherus and Klinge’s deal for US aflibercept, Boan Biotech and CP Qingdao denosumab deal, Rani and Celltrion’s oral ustekinumab biosimilar

Threats of infringement unjustified after swimming pool door hinge patents revoked

BioBlast w/e 09 Dec 22: Roche’s glofitamab, Paras Biopharma’s new biosimilars division, Biogen’s biosimilar tocilizumab, Alvotech/Stada’s EU Hukyndra® roll out, Biocon closes Viatris biosimilars acquisition

Fall from Grace: Patent Office allows extension of time for claim to grace period but patent still found invalid

BioBlast w/e 02 Dec 22: Janssen sues Amgen over ustekinumab, Capstone’s insulin, Erasca trials, Alvotech leadership changes, MHRA Dupixent® guidance, Merck sues JHU on Keytruda patents, Hikma and Celltrion ustekinumab deal

BioBlast w/e 25 Nov 22: AbbVie’s risankizumab, FDA investigating Prolia® (denosumab) risk, Amneal’s filgrastim launch, Junshi Biosciences’ adalimumab, US biosimilars bill, Teva and Sandoz biosimilars ramp-up

Account of profits/damages as complex as validity/infringement

BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide

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