CER Daily Newsfeed

J&J's Erleada Prevails Over Astellas, Pfizer’s Xtandi in Real-World Prostate Cancer Study

(10/2, Kevin Dunleavy, Fierce Pharma) reports “While they were both approved several years back to treat the same two types of prostate cancer, Astellas and Pfizer’s Xtandi has held a larger slice of the market than Johnson & Johnson’s rival medicine Erleada. But a real-world, head-to-head study of the pair of androgen receptor pathway inhibitors (ARPI) indicates that Erleada provides an edge in overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC).” Full

SC Efgartigimod Shows Noninferiority to IV Formulation in gMG

(10/2, The American Journal of Managed Care) reports “...‘Incidence of infections is higher in patients with gMG than in those without the disease, potentially predisposed by use of immunosuppressive treatment,’ wrote the researchers. ‘Importantly, while efgartigimod does reduce total IgG level, it does not lead to complete IgG removal and the reduction is transient, with no impact on other immunoglobulins. Preclinical studies of [neonatal Fc receptor]blockade have shown there is no impact on IgG production and it does not prevent the generation of an immune response to vaccination.’” Full

FDA Finalizes Q&A Guidance on Electronic Records in Clinical Trials

(10/2, Joanne S. Eglovitch, Regulatory Focus) reports “...The guidance revises a draft version that was released for comment last year by clarifying the applicability of Part 11 to real-world data submitted to the agency as part of a marketing application...Some of the changes made to the guidance include clarifying the applicability of part 11 to real-world data sources submitted to FDA, and clarifying the applicability of part 11 to clinical investigations conducted outside of the United States.” Full

England's NHS to Offer Lilly's Weight-Loss Drug to Some Patients

(10/3, Reuters) reports “...The drug, called Mounjaro in the UK and Zepbound in the U.S., would be initially offered to obese people with at least three weight-related health conditions, the National Institute for Health and Care Excellence said. The conditions are hypertension, sleep apnea, cardiovascular disorders and unhealthy levels of lipids like cholesterol.” Full

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

(10/3, Eliza Slawther, Pink Sheet) reports “...Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.” Subscription Required