SIGN UP TO VIEW THE FULL ARTICLE

Receive a 90-day free trial of Celltelligence and get instant access to our full offering.

EMAIL BLASTS

Curated cell therapy industry news in your inbox multiple times each week

SEARCHABLE LIBRARY

A full archive of cell therapy news, insights, and context

THE MAP

A 24/7 information center that lets you make unique connections

The price for access is $0.00.

Do you have a discount code? Click here to enter your discount code.

Account Information

Username

Password

Confirm Password

Work E-mail Address

Confirm E-mail Address

Occupation

Other

Full Name LEAVE THIS BLANK

Payment Information We accept all major credit cards

Card Number

Expiration Date

CVC

Discount Code

I want to receive updates from celltelligence.com.

By selecting this, I agree to receive emails from celltelligence.com.

Processing...

Already have an account? Log in here

RETURN TO HOME

Autologous, BCMA, CAR-T

July 30, 2020

BMS and bluebird bio Resubmit Ide-cel to FDA; Dynamic H1 2021 BCMA Launch Environment Expected with Janssen

Here is a brief preview of this blast: On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel's potential approval, and the possible benefit a delayed ide-cel launch could have for Janssen.

About The Author

The Celltelligence Team

Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.