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
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
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
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
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
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)
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
On 5 February 2025, Shanghai Henlius Biotech announced that Hetronifly® (serplulimab) was approved by the European Commission for use in combination with carboplatin and etoposide as a
On 5 February 2025, Formycon announced that its partner, Klinge Biopharma has entered an exclusive licence agreement with Taiwan-based Lotus Pharmaceutical for the commercialisation of
On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the
On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection). Susvimo® is the first
On 4 February 2025, Merck (known as MSD outside the US and Canada) revealed its Q4 and full year 2024 financial results, including reporting that global Keytruda® (pembrolizumab) sales for 2024 grew 18%
On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication extension for its subcutaneous Rybrevant® (amivantamab)
Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologic Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).
On 31 January 2025, Celltrion announced that the US FDA has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations
On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide,