Patients over the age of 65 and males should be excluded from treatment with Zelnorm (tegaserod) for chronic constipation, FDA gastrointestinal advisory committee says. Concerns about the risk of ischemic colitis and severe diarrhea, and lack of efficacy, in older patients were cited by committee members.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.
If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.
