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Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved vali...

Korea Biomed reported that LG Chem’s Xelenka®, biosimilar to AbbVie’s Humira® (adalimumab), has been approved by the Korean Ministry of Food and Drug Safety to treat rheumatoid arthritis, psoriatic arthritis, uveitis in adults, Crohn’s disease, and juvenile idiopathic...

Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

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Korea Biomedical Review reported that MSD Korea’s Tukysa® (tucatinib) was approved by Korea’s Ministry of Food and Drug Safety to treat HER2 (human epidermal growth factor receptor)-positive locally advanced or metastatic breast cancer that has recurred after at least...

Harbour BioMed’s wholly-owned subsidiary Nona Biosciences announced that it has entered into an exclusive license agreement with Pfizer for the global clinical development and commercialisation of HBM9033, Nona’s MSLN-targeted antibody-drug conjugate (ADC).  MSLN is a...

Celltrion filed an inter partes review (IPR) petition challenging Regeneron’s Eylea® aflibercept  patent no. 11,253,572, in IPR proceeding IPR2024-00260.  Celltrion also filed a motion for joinder with Samsung Bioepis’ IPR (IPR2023-00884) of the ‘572 patent which was instit...

CSL announced that the FDA accepted its Biologics License Application (BLA), and the EMA has accepted its Marketing Authorisation Application (MAA), for CSL312 (garadacimab) to treat prophylactic treatment for hereditary angioedema (HAE).  If approved, CSL312 would be the f...

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that its phase III clinical trial of CT-P47, biosimilar to Genentech’s Actemra®/Roactemra® (tocilizumab), demonstrated equivalence with the originator product in patients with r...