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Karyopharm Therapeutics

http://www.karyopharm.com/

Latest From Karyopharm Therapeutics

The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions

Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.

Real-World Evidence Review Pathway

Without An Alzheimer’s Blockbuster, Biogen Is A Ship Without A Growth Rudder

In addition to its uncertain attempt at near-term revenue growth with Eisai-partnered lecanemab, Biogen recently ended multiple R&D programs and will pay $900m to settle a whistleblower lawsuit.

Business Strategies Legal Issues

Deal Watch: Iktos Doubles Its 2022 Alliance Tally In Agreements With Galapagos, Zealand

French AI-driven drug design firm will employ multiple technology platforms in latest tie-ups. Apellis looks to augment Empaveli-led portfolio in C3 complement R&D alliance with Affilogic.

Deal Watch Business Strategies

Xpovio’s Solid Tumor Debut Faces Likely Three-Year Delay

Karyopharm will conduct another trial of the drug in p53 wild-type endometrial cancer after the FDA said SIENDO data were insufficient for approval.

Cancer FDA
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    • NPM Pharma, Inc.
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