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
On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine
On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from
On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable
On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure
On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab)
On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV...
On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their...
On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.
On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry®...
On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to...