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On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.2 mg/ml solution for injection) for nAMD ...

Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300m...

On 8 February 2025, at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting, Regeneron presented positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept, 8 mg injection, known as Eylea™ 8mg in the EU and Japan) for ...

On 7 February 2025, Bio-Thera announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).

BAT2506 is being developed and manufactured by Bio-Thera and will be...

On 7 February 2025, the Australian Therapeutic Goods Administration (TGA) approved UCB’s Rystiggo® (rozanolixizumab) in 140mg/mL solution for injection, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-...

On 6 February 2025, the US Judicial Panel on Multijurisdictional Litigation granted Amgen’s request to centralise its BPCIA litigation alleging that each of Samsung Bioepis, Fresenius Kabi and Accord Biopharma are infringing US patents covering Amgen’s Prolia® and Xgeva® (d...

On 6 February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab) and Darzalex Faspro® (daratumumab and hyaluronidase-fihi), used in treating multiple myeloma...

On 5 February 2025, Novo Nordisk released its financial results for 2024, reporting a 26% sales increase (at constant exchange rates (CER)) to DKK 128.3 billion.  Sales in Novo Nordisk’s diabetes care segment (including Ozempic® (semaglutide), Rybelsus® (oral semaglutide) a...