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Mar 8, 2024
Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD). The...
Mar 8, 2024
Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet...
Mar 6, 2024
On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medicines Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with...
Mar 6, 2024
On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma. Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA...
Mar 5, 2024
On 5 March 2024, a study published in Modern Rheumatology found that LG Chem's LBEC0101, the biosimilar of etanercept, matches up to the reference product in terms of effectiveness and safety in the real-world treatment of rheumatoid arthritis. This evidence was...
Mar 5, 2024
Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US. J&J/Janssen argue that the alleged...
Mar 5, 2024
On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic...
Mar 5, 2024
On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz's Wyost® and Jubbonti®. The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. The US launch date for the newly...
Mar 5, 2024
Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes. In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and...
Mar 5, 2024
On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME). Vabysmo® was first approved in the US by the FDA in January 2022 and is...
Mar 5, 2024
A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed...
Mar 4, 2024
On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The...
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