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New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

by Bioblast Editor | Jan 16, 2025

On 16 January 2025, Johnson & Johnson (J&J) announced that Health Canada has approved its Rybrevant® (amivantamab for injection) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Formycon/Fresenius’ Biosimilar Ustekinumab Approved in UK and Canada

by Bioblast Editor | Jan 15, 2025

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

New Indication Alert: FDA Approves Eli Lilly’s Omvoh® for Crohn’s Disease

by Bioblast Editor | Jan 15, 2025

On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This follows FDA approval of Omvoh® for ulcerative colitis in October 2023.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Lexaria Bioscience to Commence Human Study of Oral Liraglutide Formulation

by Bioblast Editor | Jan 15, 2025

On 15 January 2025, Lexaria Bioscience announced that it has received independent ethics board approval to begin its first-ever human study of oral liraglutide, formulated from the DehydraTECH-processing of conventional injected liraglutide (Novo Nordisk’s Saxenda®).

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Positive Topline Results for Ph 1 & 3 Studies of Mochida/Richter’s Tocilizumab Biosimilar

by Bioblast Editor | Jan 15, 2025

On 15 January 2025, Gedeon Richter and Mochida Pharmaceutical Co. announced positive topline results from Phase 1 and...

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Celltrion Challenges Regeneron’s US Aflibercept Formulation Patent in IPR Filing

by Bioblast Editor | Jan 15, 2025

On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. The petition challenges claims 1-17, 19-42, 44-50 as invalid for lack of novelty and claims 1-50 as obvious.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

MSD Planning 2025 SC Pembrolizumab Launch

by Bioblast Editor | Jan 14, 2025

At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck (known as MSD outside the US and Canada) announced that it is expecting to “file, have approval, and launch [its] subcutaneous pembrolizumab in 2025”.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

US FDA Accepts Eisai/Biogen’s BLA for Leqembi® Subcutaneous Maintenance Dosing

by Bioblast Editor | Jan 14, 2025

On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Henlius and Abbott Partner on Biosimilar Commercialisation in Emerging Markets

by Bioblast Editor | Jan 13, 2025

On 13 January 2025, Shanghai Henlius announced that it has entered a product licence and supply agreement with Abbott under which Abbott is granted exclusive or semi-exclusive rights to the commercialisation of four biosimilars and one innovative biologic. The commercialisation rights cover 69 emerging markets in Asia, Latin America, Middle East and Africa.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Amgen’s Ocrelizumab Biosimilar in Phase 3 Trials

by Bioblast Editor | Jan 13, 2025

At the JP Morgan Annual Healthcare conference on 13 January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) in Phase 3 trials. The Phase 3 study (NCT06700343), which begins enrolment this month in the US, is aimed at demonstrating

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Teva and Klinge/Formycon Partner to Commercialise Aflibercept Biosimilar in EU and Israel

by Bioblast Editor | Jan 13, 2025

On 13 January 2025, Teva Pharmaceuticals announced that it has entered into a strategic collaboration agreement with Klinge Biopharma and Formycon for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Europe (excluding Italy)

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Samsung Bioepis and Teva Strike Partnership for US Commercialisation of Eculizumab Biosimilar

by Bioblast Editor | Jan 10, 2025

On 10 January 2025, Samsung Bioepis and Teva announced they have entered into a licence, development and commercialisation agreement for Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), in the US.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

New Zealand’s Pharmac Widens Access to Amgen’s Denosumab

by Bioblast Editor | Jan 10, 2025

On 10 January 2025, New Zealand’s Pharmac announced that it will be expanding access to Amgen’s Prolia® and Xgeva® (denosumab).

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Astellas’ Vyloy® Combo Approved in Canada and China for Gastric and GEJ Cancer

by Bioblast Editor | Jan 9, 2025

On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive. Canada’s Drug Agency (CDA-AMC) recently issued a draft recommendation to reimburse Vyloy™ with conditions.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

by Bioblast Editor | Jan 9, 2025

On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study. J&J submitted a Biologics Licence Application (BLA) to the FDA seeking approval for this indication in August 2024.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

J&J’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease

by Bioblast Editor | Jan 8, 2025

On 8 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted Fast Track designation to its posdinemab. Posdinemab is a phosphorylated tau-directed monoclonal antibody being investigated to treat patients with early Alzheimer’s disease in the Phase 2b “AuTonomy” study.

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