February 27, 2018 / 10:12 PM / 7 months ago

BRIEF-FDA rejects filing for Celgene MS drug

Feb 27 (Reuters) - Celgene Corp:

* CELGENE PROVIDES REGULATORY UPDATE ON OZANIMOD FOR THE TREATMENT OF RELAPSING MULTIPLE SCLEROSIS

* CELGENE CORP - ‍FDA DETERMINED NONCLINICAL AND CLINICAL PHARMACOLOGY SECTIONS IN NDA WERE INSUFFICIENT TO PERMIT A COMPLETE REVIEW​

* CELGENE - CO INTENDS TO SEEK IMMEDIATE GUIDANCE, INCLUDING REQUESTING A TYPE A MEETING WITH FDA

* CELGENE - GOT REFUSAL TO FILE LETTER FROM FDA ABOUT CO’S NDA FOR OZANIMOD IN DEVELOPMENT FOR TREATING PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS

* CELGENE - ‍SEEKING GUIDANCE WHICH INCLUDES REQUESTING MEETING WITH FDA, TO ASCERTAIN WHAT ADDITIONAL DATA WILL BE REQUIRED TO RESUBMIT NDA​ Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below