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On 10 January 2025, Samsung Bioepis and Teva announced they have entered into a licence, development and commercialisation agreement for Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), in the US.

Under the agreement, Samsung Bioepis will be...

On 10 January 2025, New Zealand’s Pharmac announced that it will be expanding access to Amgen’s Prolia® and Xgeva® (denosumab).

Both Xgeva® (70mg/ml solution for injection, for various bone-related cancer indications) and Prolia® (60mg/ml, for severe osteoporosis) ar...

On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or m...

On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG), as supported by f...

On 8 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted Fast Track designation to its posdinemab.  Posdinemab is a phosphorylated tau-directed monoclonal antibody being investigated to treat patients with early Alzheimer’s disease in the Pha...

On 8 January 2025, Astellas Pharma announced that China’s National Medical Products Administration (NMPA) has approved its Padcev™ (enfortumab vedotin) in combination with Merck’s (known as MSD outside the US and Canada) Keytruda® (pembrolizumab) for adult patients with loc...

On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®.  Biocon’s biosimilar ustekinumab will be commercialised and marketed in Japan ...