CER Daily Newsfeed

Cognitive Therapy, Modafinil, Combo All Beneficial for Multiple Sclerosis Fatigue

(10/29, HealthDay News) reports “...‘Results of this randomized comparative effectiveness research trial of telephone-based CBT, modafinil, and combination therapy suggest that each treatment offers largely equivalent, clinically meaningful benefits for the effects of multiple sclerosis fatigue in people with multiple sclerosis, with high acceptance, good adherence, and good tolerability,’ the authors write.” Full

Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence’ Standard For Rare Disease Drugs

(10/28, Sarah Karlin-Smith, Pink Sheet) reports “...Janet Woodcock is spearheading a legislative push to establish a third way for rare disease drug developers to meet the Food, Drug, and Cosmetic Act’s ‘substantial evidence’ standard, which could be one of the most dramatic transformations to the drug approval process since Congress first mandated drugs be shown to be effective as well as safe in 1962.” Subscription Required

EU HTA Reg: CoI Rules Limit Participation Of Experts In Joint Clinical Assessments

(10/29, Francesca Bruce, Pink Sheet) reports “...The European Commission has now adopted the third implementing act for the Health Technology Assessment Regulation. This sets out rules for managing conflicts of interest of anyone involved in joint clinical assessments or joint scientific consultations under the regulation.” Subscription Required