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NEWS

SetPoint Medical Receives the US FDA’s Approval for its SetPoint System to Treat Rheumatoid Arthritis

Shots: The US FDA has approved the SetPoint System to treat adults with mod. to sev. rheumatoid arthritis (RA) who are inadequately managed by or intolerant to existing advanced therapies, incl. biologics & targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) Approval was based on RESET-RA study evaluating SetPoint System vs sham device in 242 pts, which…
July 31, 2025

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xbrane
NEWS

Xbrane Biopharma Reclaims Rights of BIIB801 (Biosimilar, Cimzia) from Biogen 

Shots:  Xbrane Biopharma will reclaim full rights of BIIB801 from Biogen after the termination of their commercialization and license agreement. BIIB801 is a biosimilar version of Cimzia (certolizumab pegol), under non-clinical development  The agreement was signed b/w Xbrane & Biogen in Feb 2022, under which Xbrane received a non-refundable $8M upfront. It has been terminated…
August 1, 2024

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Celltrion
NEWS

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications  

Shots:   The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA)   Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…
February 24, 2024

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Top Performing Drug – Enbrel (June Edition)
INSIGHTS+

Top Performing Drug – Enbrel (June Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have covered Enbrel as the top-performing drug of the month Enbrel is a biologic drug classified as a TNF inhibitor used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other autoimmune diseases PharmaShots…
June 28, 2023

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