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Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

by Bioblast Editor | Jan 18, 2025

On 18 January 2025, Daiichi Sankyo announced that Daiichi/Astra Zeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults with unresectable or metastatic hormone receptor positive HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy. According to Daiichi, the drug will be available in the US by prescription in approximately two weeks.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

Novo Nordisk’s High Dose Semaglutide Demonstrates 20.7% Weight Loss in Ph 3b Trial

by Bioblast Editor | Jan 17, 2025

On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly. The results reportedly demonstrate a statistically significant and superior weight loss at week 72 with semaglutide 7.2 mg versus placebo, with patients treated with the high dose semaglutide achieving weight loss of 20.7% compared to a reduction of 17.5% with semaglutide 2.4 mg and a reduction of 2.4% with placebo.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

Samsung Bioepis Publishes Eighth Biosimilar Market Report

by Bioblast Editor | Jan 16, 2025

On 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report. The report has been released every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

Bio-Thera and World Medicine Partner to Commercialise Ustekinumab Biosimilar in Turkey

by Bioblast Editor | Jan 16, 2025

On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s BAT2206 (ustekinumab), biosimilar to Janssen’s Stelara®.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

Outlook Therapeutics Plans BLA Resubmission to FDA for Ophthalmic Bevacizumab Following Positive Clinical Trial Results

by Bioblast Editor | Jan 16, 2025

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (LytenavaTM, ophthalmic bevacizumab) in wet AMD. The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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®).

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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”.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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)

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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).

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

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.

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