Keyword: DBV Technologies
FDA chief Scott Gottlieb steps down; Gilead loses oncology leader; Deciphera CEO to retire; and DBV loses two executives ahead of peanut drug refile.
COO Charles Ruban and CDO Laurent Martin are both set to leave their positions at the end of next week.
The departure of Septién-Velez is part of a wider reshuffle that gives DBV’s management a new look as it seeks to get its BLA back on track.
The French biotech pulled the BLA after talks with the agency revealed gaps in the manufacturing and quality-control sections of the filing.
The trial's size and AnaptysBio’s analysis of the data leave scope for questions about the results and their implications for the anti-IL-33 antibody.
The study detected a statistically significant desensitization to milk among a subgroup, although the overall data set leaves questions unanswered.
Aimmune plans to file for FDA approval by the end of 2018 to give patients a way to protect themselves against accidental exposure to peanut protein.
Shares in DBV rose on the back of the data, going a little way to erasing the big drop it suffered after missing its primary efficacy endpoint.
DBV Technologies’ peanut allergy patch missed the mark in a phase 3 trial but is still at least 50:50 for FDA approval, say analysts at Jefferies.
DBV has posted data showing response rates to its peanut allergy patch hold up after three years of treatment.