Clinical hold lifted on studies of Allogene CAR-T treatment; spike in protocol changes for cancer drug trials

Allogene said that trials involving its off-the-shelf CAR-T therapies for blood cancer are resuming following a safety clearance by the FDA.  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 

Sponsored by      STAT+: FDA removes clinical hold on cancer studies of Allogene off-the-shelf CAR-T treatment By Adam Feuerstein Alex Hogan/STAT In October, the FDA placed five Allogene studies on hold after a single treated patient was found to have a “chromosomal abnormality.” Read More STAT+: Trial by fire: More study protocols are experiencing substantial — and costly — changes By Ed Silverman Adobe A new analysis finds changes to clinical trials – which can result in costly delays — are growing more common. Read More Sponsor content by Syntropy Contextualized data: the missing piece for researchers to develop new insights The global pandemic has illuminated important gaps for the healthcare industry, with underuse of data as one of the most glaring. Syntropy explores what processes need to change at an institutional level to capitalize on the momentum in data collaboration brought on with COVID-19. Read the full article.  Opinion: Out-of-pocket drug costs for Medicare beneficiaries need to be reined in By Reshma Ramachandran and Tianna Zhou and Joseph S. Ross Adobe For Medicare-covered seniors with chronic conditions, out-of-pocket costs for medications increased by more than 40% between 2009 and 2019. Read More STAT+: A preview of the burning biotech and health tech questions at JPM 2022 By STAT Staff Alex Hogan/STAT From biotech to health tech, here’s a look at the burning questions facing companies big and small at JPM 2022. Read More Tuesday, January 11, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser