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Pfizer to Initiate P-III Study of Fordadistrogene Movaparvovec After FDA Lift Clinical Hold

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Pfizer to Initiate P-III Study of Fordadistrogene Movaparvovec After FDA Lift Clinical Hold

Pfizer to Initiate P-III Study of Fordadistrogene Movaparvovec After FDA Lift Clinical Hold

Shots:

  • Pfizer plans to open the first US sites in the P-III (CIFFREO) study evaluating fordadistrogene movaparvovec, in ambulatory patients with DMD
  • The study was paused in Dec 2021 to implement a protocol amendment following a fatal SAEs that occurred in a P-Ib study in the non-ambulatory cohort
  • Regulatory authorities in the UK, Canada, Taiwan, Spain and Belgium approve the re-start of the global P-III CIFFREO study and additional reviews are ongoing. The company anticipates all CIFFREO sites will open by the end of June 2022

Ref: Pfizer | Image: Pfizer

 

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Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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