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Feb 12, 2025
On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for
Feb 11, 2025
On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations:
Feb 11, 2025
On 11 February 2025, MSD announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage
Feb 11, 2025
On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3
Feb 10, 2025
On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab), biosimilar to J&J’s Simponi® and Simponi Aria®.
Feb 10, 2025
On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of
Feb 10, 2025
On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting
Feb 10, 2025
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
Feb 9, 2025
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
Feb 8, 2025
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 the treatment of patients with macular oedema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal
Feb 7, 2025
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
Feb 6, 2025
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
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