Read our latest updates & insights

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 bispecific antibody, is indicated for the treatment of adult patients with relapsed/refractory ...

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®.

Under the agreement, Intas Pharmaceu...

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 Padcev® (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizu...

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 another.

AstraZeneca’s Imfinzi® (durvalumab) will be reimbursed for use i...

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-...