Media Contact:
Stephen Majors
Vice President, Global Communications
smajors@alliancerm.org
Washington, DC
ARM commends FDA for, among other things, the inclusion of two priority elements supported by ARM in the agency’s Prescription Drug User Fee Act VII (PDUFA) commitment letter that will advance cell and gene therapy.
Washington, DC
The regenerative medicine and advanced therapies sector completed its best-ever six-month period of financing, raising $14.1B from January through June and reaching 71% of the record amount raised in all of 2020, according to the Alliance for Regenerative Medicine’s (ARM) H1 2021 Report released today.
Washington, DC
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) today released Project A-Gene, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case study of a viral vector commonly used in gene therapies.
WASHINGTON, DC
ARM commends Reps. Upton and DeGette for their continued leadership in driving scientific innovation and patient access. The Cures 2.0 discussion draft released today would help accelerate the development and delivery of life-changing cell and gene therapies. Harnessing real-world evidence, providing educational programming and training for caregivers, and requiring the FDA to provide more clarity around CMC standards for breakthrough and RMAT-designated therapies would help bring the future of medicine to patients in need.
