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Emily Dwyer

Emily provides broad paralegal services including litigation support services, legal research, IP monitoring and tracking services, and document management. A self professed “legal junkie” she loves exploring legal arguments and is excited about new legal developments.

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BioBlast® w/e 14 Oct 22: BioFactura’s ustekinumab, Prestige’s trastuzumab, Merck/Moderna personalised cancer vaccine combo, Regeneron’s aflibercept, Jacobio Pharma/Merck’s cetuximab, Janssen’s guselkumab/golimumab, Alvotech’s aflibercept

by Naomi Pearce, Emily Dwyer | Oct 17, 2022

Significant biosimilar activities this week include: 14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable...

BioBlast® w/e 07 Oct 22: Samsung Bioepis’ adalimumab interchangeability, Celltrion’s adalimumab interchangeability, FDA biosimilars program, Amneal bevacizumab launch, Medicare Part B biosimilar payment increase

by Naomi Pearce, Emily Dwyer | Oct 10, 2022

Significant biosimilar activities this week include: 08 Oct 22 | US | Samsung to pursue adalimumab interchangeability...

BioBlast® w/e 30 Sep 22: Biogen’s tocilizumab, Celltrion’s bevacizumab, Samsung Bioepis’ aflibercept and ranibizumab, Merck’s pembrolizumab, Intas’ ranibizumab, Pfizer/BioNTech/Moderna COVID vaccine patents, biosimilars executive order

by Naomi Pearce, Emily Dwyer | Oct 4, 2022

Significant biosimilar activities this week include: 30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA Biogen...

BioBlast® w/e 23 Sep 22: Stada/Alvotech’s adalimumab launch, AZ/Merck olaparib PRC approval, AVEO’s ficlatuzumab US fast-tracked, Sandoz’s denosumab, interchangeability in the EU, Coherus’ US ranibizumab launch, Celltrion invalidates Rituxan® patent, Formycon’s pembrolizumab, Celltrion’s bevacizumab

by Naomi Pearce, Emily Dwyer | Sep 26, 2022

Significant biosimilar activities this week include: 22 Sep 22 | CH | STADA launches Alvotech’s Hukyndra® (100mg/mL...

BioBlast® w/e 16 Sep 22: Celltrion ustekinumab Ph III trials, Genentech/Samsung Bioepis’ US Avastin® settlement, Biogen natalizumab suit ats Sandoz/Polpharma, Lupin etanercept Rymti® CA approval, Prestige’s bevacizumab withdrawal, Apotex’s tocilizumab IPR (Regeneron), STADA/Xbrane ranibizumab approval; Biosimilars PiPCast®

by Naomi Pearce, Emily Dwyer | Sep 19, 2022

Significant biosimilar activities this week include: 07 Sep 22 | Celltrion’s ustekinumab biosimilar Ph III trials...

BioBlast® w/e 09 Sep 22: Lupin & I’rom’s denosumab, Lupin & DKSH to supply Alvotech products, Cipla/Alvotech’s AU biosimilar adalimumab approved, Formycon half year results, Celltrion’s tocilizumab IPRs instituted, Regeneron aflibercept studies, Organon’s AU biosimilars roadmap

by Naomi Pearce, Emily Dwyer | Sep 12, 2022

Significant biosimilar activities this week include: 25 Aug 22 | JP | Lupin and I’rom sign licence for denosumab in...

BioBlast® w/e 02 Sep 22: Teva’s skinny label case, Merck’s Keytruda® data, Outlook’s ophthalmic bevacizumab, Biocon FDA observations, Alvotech and STADA financial results, Fresenius Kabi’s Stimufend® FDA approved

by Naomi Pearce, Emily Dwyer | Sep 5, 2022

Significant biosimilar activities this week include: 12 Aug 22 | US | Alvotech, Mylan & others file amicus curiae...

BioBlast® w/e 26 Aug 22: Novartis to spin off Sandoz, Moderna sues Pfizer and BioNTech over COVID vaccine, Amgen’s eculizumab, Alvotech’s denosumab, Samsung Bioepis’ ranibizumab, Formycon’s ranibizumab, JAMP’s CA win against AbbVie

by Naomi Pearce, Emily Dwyer | Aug 29, 2022

Significant biosimilar activities this week include: 23 Aug 22 | Amgen announces the results of Ph III eculizumab...

BioBlast® w/e 19 August 2022: J&J Remicade decline, ALX evorpacept, FDA approves 100mg/mL Hadlima™, Formycon Ph III ustekinumab trials, Beovu® additional indication, EC approves Vegzelma™, Fresenius Kabi tocilizumab, Cipla pegfilgrastim, Merck/Orna Therapeutics collaboration

by Naomi Pearce, Emily Dwyer | Aug 22, 2022

Significant biosimilar activities this week include: 11 Aug 22 | ALX Oncology initiates Ph II trials of evorpacept in...

BioBlast® w/e 12 August 2022: Mylan Eylea® IPR, Daiichi Sankyo trastuzumab deruxtecan, Alvotech Icelandic listing move, Opthea funding for OPT-302, Merck Keytruda® clinical trials, Qila denosumab study

by Naomi Pearce, Emily Dwyer | Aug 15, 2022

Significant biosimilar activities this week include: 27 Jul 22 | CN | Ph III trial shows Qila’s denosumab biosimilar...

BioBlast® w/e 05 August 2022: Viatris’ etanercept; Celltrion’s seeks IC for Yuflyma®; Samsung Bioepis’ 3rd AU suit against Fresenius Kabi; AbbVie’s patent thicket; New Stelara® indication; Fresenius Kabi’s tocilizumab; Coherus’ ranibizumab US approved with IC; Regeneron sues Viatris (aflibercept); Coherus’ high concentration adalimumab

by Naomi Pearce, Emily Dwyer | Aug 9, 2022

Significant biosimilar activities this week include: 27 Jul 22 | AU | Viatris (Mylan) seeks PBS listing for etanercept...

The Rise and Rise of CAR-T cell therapy and the Future of Patent Disputes in Australia

First published by WIPR on 22 June 2022

by Naomi Pearce, Kate Legge, Emily Dwyer | Aug 2, 2022

Chimeric Antigen Receptor (CAR)-T cell therapy is a pioneering technology that is successfully changing the way we...

Bringing home the bacon – or are you?

The future of labelling for plan based protein products

by Naomi Pearce, Emily Dwyer | Aug 2, 2022

Introduction Plant based protein products are already a well established destination in the supermarket aisle. ...

BioBlast® w/e 29 July 2022: FDA approves Sandoz’s natalizumab, TGA approves Henlius/Cipla trastuzumab, Prestige/Intas bevacizumab deal, Biocon biosimilars revenue up

by Naomi Pearce, Emily Dwyer | Aug 1, 2022

Significant biosimilar activities this week include: 25 Jul 22 | US | FDA accepts ABLA for natalizumab biosimilar...

BioBlast® w/e 22 July 2022: Hikma/Celltrion adalimumab deal, Erasca/Lilly cetuximab clinical supply agreement, Celltrion’s tocilizumab clinical trial, Alvotech denosumab study, 100mg/mL Hyrimoz® adalimumab sBLA and Novartis/Sandoz update

by Naomi Pearce, Emily Dwyer | Jul 25, 2022

18 Jul 22 | MENA | Hikma and Celltrion enter into commercialisation agreement for YuflymaTM Hikma Pharmaceuticals...

BioBlast® w/e 15 July 2022: Alvotech board expansion, [vic-]trastuzumab duocarmazine BLA accepted, second Zylonta® + rituximab DLBCL trials, Polpharma natalizumab MAA and eight-year Perjeta® data

by Naomi Pearce, Emily Dwyer | Jul 18, 2022

11 Jul 22 | Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL Overland ADCT BioPharma...

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