CDSCO panel rejects Novartis Phase III CT protocol for Lanalumab

Citing that the clinical trial protocol missed some inclusion/exclusion criteria, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has rejected Novartis Healthcare's Phase III clinical trial protocol for monoclonal antibody Ianalumab.

In addition to this, the expert panel has opined the drug maker Novartis to present the protocol in detail to CDSCO for further review. This came after the firm presented Phase III clinical trial protocol before the committee.

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Novartis Phase III CT Protocol For Lanalumab Rejected By CDSCO Panel