CER Daily Newsfeed

Area Hospitals Concerned over Changes to 340B

(12/8, Maury Thompson, Press-Republican) reports “...Pharmaceutical companies say use of the program has steadily grown, and the cost to the industry has exceeded what Congress originally intended. Those costs get passed on to other customers, according to the pharmaceutical industry. A National Pharmaceutical Council study estimated that, from 2017-23, employer-based health plan premiums were $4.5 billion higher because of 340B. At the same time as legislation is being drafted, the Trump Administration is evaluating a restructuring of 340B through regulation.” Subscription Required

FDA Sets Higher Bar for CAR-T Cancer Treatments, Saying New Entrants May Need to Prove Superiority

(12/8, Zachary Brennan, Lei Lei Wu, Endpoints News) reports “New CAR-T treatments for cancer will need to prove that they’re better than existing therapies to win FDA approval, the agency’s biologics chief Vinay Prasad said in a journal article Monday, raising the bar on the data that will be required for the products...‘The onus is on sponsors to justify what aspect of the unmet need their product would address if approved,’ the FDA officials wrote. That could include ‘either lack of available therapies or, when there are available therapies, based on improved effect on serious outcome of the condition, improved safety, or other clinically meaningful therapeutic advantage over available therapies.’” Subscription Required

Utilizing Real-World Data to Overcome Challenges in Rare Disease Research

(12/9, Jam Bensilum, GlobalData) reports “...At a recent meeting, Channa Debruyne, global clinical development lead, late-stage and LCM oncology, at Servier, explained how real-world data from similar patient populations to those in a study cohort can be utilised as a comparator. The data should preferably be at the patient level and populations should be matched in terms of key demographics and prognostic baseline variables, she said...Furthermore, data from multiple registries with different parameters needs to be harmonised, which will require close collaboration among stakeholders, and this is currently one of the biggest challenges in this space, according to Debruyne.” Full