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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 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, Emily Dwyer | Nov 29, 2022

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

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, Emily Dwyer | Nov 21, 2022

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

BioBlast w/e 11 Nov 22: Dupixent® recommended by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar approved, Alvotech’s adalimumab IC data, Mylan’s IPR win against Regeneron aflibercept patents, MHRA biosimilars guidance, Amgen biosimilars data, Coherus’ ranibizumab

by Naomi Pearce, Emily Dwyer | Nov 14, 2022

Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for...

BioBlast w/e 04 Nov 22: dupilumab study, Accord cleans up at Global Generics and Biosimilars Awards, Amgen’s Supreme Court petition for certioriari regarding enablement granted, AU tocilizumab COVID shortage measures lifted, Bio-Thera’s secukinumab, Outlook’s ophthalmic bevacizumab, Rani Therapeutics’ oral ustekinumab

by Naomi Pearce, Emily Dwyer | Nov 7, 2022

Significant biosimilar activities this week include: 04 Nov 22 | New dupilumab study suggests serum dupilumab levels...

BioBlast® w/e 28 Oct 22: Expanded indications in CA for Roche’s tocilizumab, AU PBAC outcomes, Alvotech financial results, Biogen seeks PI against Sandoz in natalizumab dispute, JSR/Similis Bio agreement, Regeneron/Mylan expedited aflibercept hearing, Genentech trade secrets sentencing

by Naomi Pearce, Emily Dwyer | Oct 31, 2022

Significant biosimilar activities this week include: 28 Oct 22 | Health Canada approves additional COVID-19 indication...

BioBlast® w/e 21 Oct 22: Spectrum’s eflapegrastim, Eylea® paediatric exclusivity, Saskatchewan biosimilars switching program, AbbVie acquires DJS Antibodies, Lupin FDA observations, Alvotech and JAMP expand partnership, Alvotech/Fuji Pharma, Biocon’s ustekinumab, denosumab

by Naomi Pearce, Emily Dwyer | Oct 24, 2022

Significant biosimilar activities this week include: 21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™...

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...