CER Daily Newsfeed

The Comparative Effectiveness Research Daily Newsfeed®, known for short as the CER Daily Newsfeed®, offers the latest news, research and related information on comparative effectiveness research, real-world data and evidence, value assessment and other important health care topics. 

News from Friday, September 23, 2022


FDA Officials Urge 'Comprehensive' Approach to Accelerated Approval Reforms

(9/22, Mary Ellen Schneider, Regulatory Focus) reports “...Critics of the [FDA’s] accelerated approval pathway have focused on the need to generate confirmatory evidence faster and to withdraw products that fail to show benefit. But officials in FDA's Oncology Center of Excellence suggest that focus is also needed on different trial designs and end points that could help build quality and efficiency into the front end of the process.” Full


Convergence: RWE Regulatory Successes Offer Lessons for US Applications

(9/23, Mary Ellen Schneider, Regulatory Focus) reports “...When FDA receives an application containing RWE, officials consider whether the real-world data (RWD) in the application is ‘fit for use,’ whether the trial or study used to generate the RWE can provide adequate scientific evidence to answer the regulatory question and whether the study conduct meets FDA regulatory requirements, [ John Concato, MD, associate director for real-world evidence analytics in the Office of Medical Policy at CDER,] said.” Full


Lyfegen Raises $8M for its Value-Based Drug Contracting Platform

(9/23, Katie Adams, MedCity News) reports “...Lyfegen’s software digitizes value-based drug pricing contracts between payers and pharmaceutical manufacturers. Its platform uses algorithms to collect and analyze real-world data and then matches those data points against contract conditions. Essentially, the startup promises to automate the entire process of determining whether a drug has provided benefits to a patient, as well as produce an analysis of the price that a drug should have depending on the outcome it has delivered.” Full


'Practically Clean' FDA User Fees Reauth Will Be Included in Spending Bill Wrapping Up Next Week

(9/22, Zachary Brennan, Endpoints News) reports “...An aide to Sen. Patty Murray (D-WA), the chair of the Senate Health Committee, told Endpoints via email: Senator Murray has reached a deal on a practically clean reauthorization that ensures Congressional inaction won't force FDA to send out pink slips along with some additional policies.” Full


UK: MSD’s Pembrolizumab Therapy Gets NICE Approval

(9/23, John Pinching, PharmaTimes) reports “...An estimated 1,500 people aged 12 years and over with melanoma are set to benefit from MSD’s – known as Merck & Co in the US and Canada – pembrolizumab (Keytruda), which reduces the chance of it returning, following guidance issued by the National Institute for Health and Care Excellence. This is the first adjuvant treatment recommended by (NICE) for this stage of melanoma (2B and 2C) following surgery to remove the tumours.” Full


From Real-World Electronic Health Record Data to Real-World Results Using Artificial Intelligence

Rachel Knevel, Katherine P Liao

September 23, 2022, Annals of the Rheumatic Diseases

Annals of the Rheumatic Diseases


Comparative Effectiveness of Coronary Artery Bypass Graft Surgery and Percutaneous Coronary Intervention for Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Clinical Trials

Tanveer Ahamad Shaik, et al.

September 23, 2022, Cureus