CER Daily Newsfeed

Long-Acting Lipoglycopeptides Could Be Alternative Step-Down for Serious Bacterial Infections, Study Finds

(5/22, Chris Dall, CIDRAP) reports “A comparative effectiveness study suggests that long-acting lipoglycopeptide (laLGP) antibiotics could be an alternative step-down treatment for serious gram-positive bacterial infections, researchers reported yesterday in JAMA Network Open...‘This is an encouraging finding for the off-label use of laLGPs and adds to the evidence base supporting the effectiveness of laLGPs among PWUD and non-PWUD individuals,’ the study authors wrote, adding that randomized clinical trials are needed and that future research should compare patient and clinician preferences and cost-effectiveness.” Full

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

(5/22, Vibha Sharma, Pink Sheet) reports “The International Council for Harmonisation has agreed on plans to develop new harmonized guidelines to help navigate key challenges involved with four areas - using real-world evidence (RWE) for drug effectiveness, leveraging registry and natural history data for rare diseases, evaluating biosimilars, and developing advanced therapies.” Subscription Required

Euro Roundup: MHRA Seeks Feedback on Using External Control Arms Based on RWD

(5/22, Nick Paul Taylor, Regulatory Focus) reports “...Using patient-level data collected outside of a clinical study for all or part of a control arm to estimate the comparative efficacy of an intervention frees sponsors from enrolling patients to receive placebo or standard of care. MHRA wants sponsors to continue running randomized controlled trials, when possible, but the draft guideline opens the door to submissions based on external control arms made from RWD.” Full

Researchers Address the Barriers to Remote Breast Cancer Symptom Monitoring in the US

(5/23, Kyle Doherty, OncLive) reports “Although the remote collection of patient-reported outcomes (PROs) has been proven to be feasible and effective in breast cancer in several studies, barriers to the wide adoption of the practice in the US persist, according to Gabrielle Rocque, MD.” Full