trending Market Intelligence /marketintelligence/en/news-insights/trending/9dmnlUd4qHc9N9PMnaPHGw2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

Celgene files with US FDA for approval of MS treatment following 2018 rejection

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


Celgene files with US FDA for approval of MS treatment following 2018 rejection

Celgene Corp. has again filed with the U.S. Food and Drug Administration for approval of its multiple sclerosis treatment ozanimod just over a year after an initial rejection from the agency.

The FDA issued a refusal-to-file letter for ozanimod in February 2018, requiring more nonclinical and clinical pharmacological information.

The New Jersey company based the newest filing on data from two late-stage studies called Sunbeam and Radiance, both of which reached their primary goals.

Celgene also filed with the European Medicines Agency for ozanimod earlier in March.

"New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS," Celgene Chief Medical Officer Jay Backstrom said in a March 25 press release.

Ozanimod is predicted to be a pillar of revenue for Celgene and the company's prospective acquirer Bristol-Myers Squibb Co. The deal is valued at $95 billion and is expected to close in the third quarter pending shareholder approval.

Celgene expects sales of its best-selling cancer drug Revlimid to erode as exclusivity ends in 2026, and executives on the most recent earnings call said they look to drugs like ozanimod to fill the gap.

Bristol-Myers has also alluded to the lineup of prospects in Celgene's pipeline to support the acquisition.