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On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD).  The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in significant im...

On 21 May 2024, Celltrion announced positive two-year results from its extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) for Zymfentra™ (infliximab-dyyb) in adults with moderately to severely active Crohn’s disease and ulcerative colitis after induction with intrav...

On 20 May 2024, Samsung Bioepis and Biocon won the race to be the first FDA approved interchangeable biosimilars to Regeneron’s Eylea® (aflibercept). Both Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf) are approved for nAMD, macular ed...

On 20 May 2024, Teva and Alvotech announced that their interchangeable high concentration citrate-free adalimumab biosimilar Simlandi® (adalimumab-ryvk, AVT02) is now available in the US.  Simlandi® is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psori...

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC).  The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients receiv...

On 20 May 2024, Regeneron and Sanofi announced the results of the NOTUS Phase 3 trial for use of  Dupixent® (dupilumab) as a maintenance treatment in adults with uncontrolled COPD and type 2 inflammation. The results were published in the New England Journal of Medicine on ...

On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety approved MSD’s Keytruda® (pembrolizumab) for the following additional indications:

locally advanced cervical cancer; and
as an adjuvant a...

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®...