Celgene's ASH briefing notes 'unprecedented' MRD-negative data in Phase I study in multiple myeloma development program for CAR-T therapy bb2121; firm sees potential opportunity for the marker to pave way for approval in earlier-line settings of the disease.
Celgene Corp. believes minimal residual disease (MRD) may someday be the ticket to approval of its investigational chimeric antigen receptor T-cell (CAR-T) therapy in early lines of multiple myeloma, even though the regulatory path is currently uncertain.
The company's management spoke about the prospects for MRD to serve as a surrogate endpoint supporting approval during a Dec
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.
