CER Daily Newsfeed

Infliximab Monotherapy Effective as Combo Therapy for Treating Inflammatory Bowel Disease

(11/1, Brian Nowosielski, Drug Topics) reports “Infliximab-dyyb (ZYMFENTRA®) monotherapy was just as effective as a combination therapy with immunosuppressants (IS) to treat Crohn’s disease (CD) and ulcerative colitis (UC), according to data presented in the post hoc analysis of the LIBERTY trials. With previous trials showing its efficacy over placebo for treating CD and UC, infliximab’s use as a monotherapy is now available as the first and only FDA-approved subcutaneous option for patients with inflammatory bowel disease (IBD).” Full

FDA Uses Cannabis To Test AI’s Value In Capturing RWE

(10/31, Luke Zarzecki, InsideHealthPolicy) reports “FDA is aiming to gauge whether it can use data from real-world evidence from unstructured electronic health records and insurance claims to monitor patients’ responses to cannabis and cannabis-derived products -- with results from an initial test of the approach, which if successful could potentially be expanded to other products, expected in spring 2025.” Subscription Required

Video: Key Benefits of RWD in Privacy and Targeting Effectiveness

(11/1, Miranda Schmalfuhs, PharmExec) “Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discussed how the use of Real-World Data has evolved in the healthcare industry in terms of privacy and targeting effectiveness.” View Video

HIMSSCast: Prior Authorization as Gatekeeper

(11/1, Susan Morse, Healthcare Finance News) reports “Prior authorization does not work for patients, providers or even payers, according to Peter Ax, founder and CEO of UpScriptHealth. The intention of prior authorization is to make an efficient use of health resources, Ax said. It has not worked. ‘Prior authorizations are hated universally by patients, by providers and frankly I don't think prior authorizations are helping payers achieve what they want to achieve,’ Ax said.” Full

Precision Medicine Can’t Fulfill its Promise Without Better Diagnostics

(11/1, Amit Agrawal, STAT) comments “...What I believe is needed is a new, holistic, collaborative approach that brings academia, early discovery and development in pharma, and diagnostics together to maximize their unique capabilities while minimizing time-consuming assay format transfers and contracts. The solution needs to be end to end, spanning every step from biomarker validation to global deployment, scientific education, and clinical adoption.” Full

AstraZeneca’s Wainzua Gains Another Approval in England and Wales

(10/31, Patrick Lavery, PharmTech) reports “The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending Wainzua (eplontersen) for treatment of hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or 2 polyneuropathy (PN) in England and Wales...” Full