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Jan 22, 2025
On 22 January 2025, Zai Lab announced that the US FDA has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate, for the
Jan 22, 2025
On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won (approx. USD2.78bn), a 23% increase compared to 2023. According to the Korea Herald, this makes Samsung...
Jan 22, 2025
On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for...
Jan 22, 2025
On 22 January 2025, PMLive reported that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Imfinzi® (durvalumab) in combination with chemotherapy
Jan 22, 2025
On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B.
On the same day, Genmab announced that worldwide annual net sales of Darzalex® (daratumumab) for 2024, as reported by J&J, totalled USD11.7 billion.
Jan 20, 2025
Jan 20, 2025
On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its plans to launch CT-P41, biosimilar to Amgen’s Prolia® (denosumab) in the US, Europe and Japan in 2025, at a significant...
Jan 20, 2025
On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive®/Baiama® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, has been granted marketing approval by the European Commission. The approval covers all countries in the European Economic Area and indications for nAMD, diabetic macular oedema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular oedema following retinal vein occlusion (RVO).
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.
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.
Jan 17, 2025
On 17 January 2025, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi® (toripalimab) for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on...
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.
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