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EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

Shots:EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunologyAs per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…

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Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Shots:The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA statesIn trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…

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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…

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xbrane

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…

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Celltrion

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…

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