1. Scrip
  2. >>New Products

Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time

Manufacturing Inspection Delays Could Impact Decision Due 27 March

 
• By Mandy Jackson

In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.

business financial ideas concept with coins stack and alarmclock isolate background with free copyspace for your creativity ideas text
Celgene shareholders get a payout from BMS if ide-cel and two other drugs are approved by specific deadlines • Source: Shutterstock

Bristol-Myers Squibb Company and bluebird bio have managed to get their B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor T-cell (CAR-T) therapy idecabtagene vicleucel in to the US Food and Drug Administration with a fighting chance at making the deadline for a contingent value right (CVR) payout that Bristol owes Celgene Corporation shareholders under the companies’ 2019 merger agreement.

Bristol and bluebird announced 22 September that the FDA accepted their biologic license application (BLA) for idecabtagene vicleucel (ide-cel, formerly...

Welcome to Scrip

Create an account to read this article

Already a subscriber?

More from New Products

S&E In Brief: Launch Trends And Regulatory Updates Among SMID Biopharmas

 
• By Jessica Merrill

Ultragenyx updated investors on interactions with the US FDA on gene therapy, while new drug launches were themes for Ionis and Organon in Q2 reporting.

Pipeline Watch: Ten Approvals And Fourteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Biogen Edges Closer To Growth On Strong Q2

 
• By Jessica Merrill

Sales of Leqembi, Zurzuvae and Skyclarys contributed to Biogen’s sales and earnings guidance raise, positioning the company closer to potential growth.

PTC To Challenge BioMarin In PKU With Oral Sephience

 
• By Joseph Haas

PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.

More from Scrip

Direct-To-Consumer And Lower Prices Key To Novo Nordisk’s Wegovy Fightback

 
• By Andrew McConaghie

The company’s incoming CEO Mike Doustdar has promised greater agility, competitiveness and execution, but investors are yet to be convinced.

Can Bayer’s Pharmaceuticals Division Help It Weather A Perfect Storm?

 
• By Aakash Babu

Bayer continues to keep faith in its pharmaceuticals business despite a plethora of problems for the wider group with job cuts, continued debt concerns and ongoing glyphosate litigation claims.

BridgeBio Becomes The Victim Of Its Own Success As Attruby Gathers Steam

 
• By Manas Mishra

Shares of the Palo Alta, CA-based firm fell as Attruby sales missed elevated investor expectations in the second full quarter since its launch.