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Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time

BMS/Bluebird’s Abecma Approved But Demand Exceeds Supply

Executive Summary

The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.

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Public Company Edition: Genenta, Cingulate, ImmixBio, Bionomics and NeuroSense launched initial public offerings, grossing just $118m between them. But Amylyx, with a recently filed ALS drug, has filed to raise up to $100m. In follow-on offerings, Legend took advantage of ASH goodwill to raise $300m. 

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Management outlined its growth strategy to investors, highlighting plans to file 14 novel drugs with more than $1bn in peak sales by 2025.

Janssen's Lebowitz On J&J's Oncology Expansion Plans Outside Of Hematology

Janssen global oncology therapeutic area head Peter Lebowitz talked to Scrip about the company's next big ambitions in lung, bladder and prostate cancer.

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