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,
On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.
On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.
On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection
At its January 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.
On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The two biosimilars are indicated for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (branch RVO or central