Read our latest updates & insights

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept.  The order is currently sealed. 

As p...

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03  (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®.   

Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive r...

On 11 June 2024, Regeneron announced that the FDA approved its Kevzara® (sarilumab) for active polyarticular juvenile idiopathic arthritis (PJIA).  Kevzara® is jointly developed by Regeneron and Sanofi under a global collaboration agreement. 

Kevzara® is approved in ...

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.  The target PDUFA action date is 2...

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC® (infliximab)...

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis.  FKS518 was shown to have th...