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
On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024...
On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human...
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
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.
On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 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).
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.
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.
On 17 January 2025, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved...
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.
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®.
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.
On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to...
On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx®...