The Australian Government has reached an agreement with Sanofi and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to ensure Dupixent® (dupilumab) remains listed on the Pharmaceuticals Benefits Scheme (PBS) for eczema treatment, as it has been since 2021
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 following retinal vein occlusion (RVO).
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…
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).
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).
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®.
At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.
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 relapsed or refractory multiple myeloma (RRMM).
On 9 December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), in the Middle East and North Africa (MENA).
On 9 December 2024, MSD (known as Merck in the US and Canada) announced that its Phase 3 KEYLYNK-0001 trial for Keytruda® (pembrolizumab) plus chemotherapy, followed by maintenance with AstraZeneca’s Lynparza® (olaparib)…
On 9 December 2024, Celltrion announced that Omlyclo® (CT-P39), biosimilar to Genentech/Novartis’ Xolair® (omalizumab) was approved by Health Canada. The approval is for all…
On 9 December 2024, GSK announced that the US FDA has accepted for review data to support a new indication for the use of Nucala® (mepolizumab) as an add-on maintenance treatment for…
On 8 December 2024, Johnson & Johnson (J&J) announced data showing that Darzalex Faspro® (daratumumab and hyaluronidase-fihj) )-based regimens improve overall and sustained minimal residual disease negativity rates and progression-free survival
On 8 December 2024, Johnson & Johnson (J&J) announced data from the Phase 3 AQUILA study (NCT03301220) showing...
On 6 December 2024, Novo Holdings A/S, Novo Nordisk’s holding company, announced that the European Commission approved...
On 6 December 2024, New Zealand’s Pharmac announced that it would, in partnership with AstraZeneca, be providing...