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V ClinBio taps Camargo for 505(b)(2) development
May 2018
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CINCINNATI—V ClinBio Inc. and Camargo Pharmaceutical Services LLC have announced a set of agreements, under which Camargo will provide end-to-end regulatory consulting and strategic development services for CLX-106 and CLX-103, including pre-IND meeting planning and preparations through NDA submissions. CLX-106 and CLX-103 are being advanced for the treatment of relapsing-remitting multiple sclerosis and ulcerative colitis, respectively, and once V ClinBio receives data from initial proof-of-concept trials in humans, it expects to enact clinical programs for both compounds.
 
“With our rich pipeline of products, we are excited to partner with Camargo to bring these two promising medical advancements to patients with RRMS and UC respectively,” said Bob Oliver, president and CEO of V ClinBio. “The management team at V ClinBio determined that our best path to market with our lead compounds CLX-103 and CLX-106 would be the 505(b)(2) regulatory pathway, and as such, our aim was to collaborate with a leader in the field.”

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