CER Daily Newsfeed

MYL-1701P Efficient, Safe Compared With Aflibercept in Diabetic Macular Edema

(9/16, Julia Bonavitacola, The American Journal of Managed Care) reports “Patients with diabetic macular edema (DME) can use MYL-1701P without a decrease in efficiency or safety compared with reference aflibercept, according to a study published in JAMA Ophthalmology. These results make MYL-1701P an appealing alternative to aflibercept.” Full

AI Adds Complexities to Real-World Data in FDA Drug Approvals

(9/17, Nyah Phengsitthy, Bloomberg Law) reports “...The FDA said if sponsors use AI or other derivation methods, the protocol should specify the assumptions and parameters of the computer algorithms used; the data source from which the information was used to build the algorithm, whether the algorithm was supervised or unsupervised; and the metrics associated with validation of the methods. ‘This guidance underscores that they really will need to demonstrate a lot of rigor and discipline in connection with their collection and curation and use of real-world data and real-world evidence,’ said Jiayan Chen, partner at McDermott Will & Emery.” Subscription Required

Drug Price Controls Are Not the Answer

(9/16, Mary Vought, The Washington Times) comments “...On this side of the Atlantic, some states have created their own government boards to examine drug costs, which could lead to a NICE-style regime for American patients. For instance, last year, Democrats in Minnesota passed a law, signed by Gov. Tim Walz (D-MN), creating such a board in the Gopher State...With cost-effectiveness research explicitly included in the legislative text, it stands to reason that the Minnesota board will undertake such research and use that research to restrict access to expensive drugs.” Full