Convergence Pharmaceuticals Receives Orphan-Drug Designation for Nav1.7 Blocking Pain Drug CNV1014802
Designation granted by FDA for the treatment of trigeminal neuralgia.
Convergence Pharmaceuticals announced that its novel sodium channel blocker, CNV1014802 (‘802), has been granted orphan-drug designation by the US Food and Drug Administration for the treatment of trigeminal neuralgia (TN). Orphan-drug designation gives Convergence various incentives and advantages in the development of ‘802, including the potential availability of certain grants for clinical studies and assistance from the FDA with clinical protocol design. The designation also grants US market exclusivity, distinct from other types of exclusivity, for seven years if ‘802 is approved.
‘802 is a small molecule that penetrates the central nervous system and blocks Navs in a highly state-dependent fashion, while exhibiting selectivity against the 1.7 subtype. The drug is currently in a Phase II trial.
Source: Convergence Pharmaceuticals
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
