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On 13 December 2024, Roche announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6mg) for treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema fol...

On 12 December 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FL...

On 14 May 2024, we reported that Cipla had commenced Federal Court proceedings challenging the patent term extension (PTE) to Novo Nordisk’s liraglutide formulation patent (AU2004290862).  Liraglutide is marketed by Novo Nordisk in Australia as Victoza®.  Cipla argued that ...

At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for CSL’s Andembry® (garadacimab) for prevention of recurrent attacks of hereditary angioedema (HAE).  Galderma’s...

On 12 December 2024, Gedeon Richter and Hikma Pharmaceuticals announced that FDA has accepted for review Hikma’s BLA for RGB-14 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.

Pursuant to an exclusive licence agreement entered in December 2021, Hikma is respon...

At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.

Four of these are Celltrion biosimilars: Eydenzelt®/CT-P42 (aflibercept), biosimilar to Regeneron/Bayer’s...

On 11 December 2024, AstraZeneca and MSD announced positive results for Lynparza® (olaparib) in the treatment of breast cancer, as demonstrated in the OlympiA Phase III trial presented at the San Antonio Breast Cancer Symposium 2024.  

Lynparza® reduced the risk of d...

On 9 December 2024, GSK announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a treatment for relapse...