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The FDA published a new draft guidance outlining how early sponsors should incorporate pediatric patients, and the relevant age groups, for systemic therapies for atopic dermatitis. Read More
The FDA published a new draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, telling sponsors that data are needed to inform safe and effective treatment during pregnancy, and that it is appropriate to enroll pregnant women in certain situations. Read More
For vaccines that target a second type B strain in addition to the other three strains, a B/Phuket/3073/2013-like virus is considered appropriate, EMA said. Read More
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness. Read More
Such a framework would “inform negotiations between drug manufacturers and payers and… could guide development of value-based payment models,” the panel said. Read More
The President’s Cancer Panel highlighted the sharp increase in U.S. cancer drug prices in a 70-page report to President Trump, calling for more value-based pricing, more competition in the drug market and “meaningful communication” about treatment options. Read More
The FDA announced plans for additional research into the impact of drug promotion on consumers’ understanding of prescription drug risks and benefits, and said a more targeted presentation of risks may help consumers retain key information. Read More
A Gastrointestinal Drugs Advisory Committee panel voted unanimously in favor of including a 16-week induction dosing regimen of 10mg Xeljanz (tofacitinib) twice daily in patients who have not reached “adequate therapeutic benefit” by Week 8 on the product label. Read More
The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks, a full month longer than the average 10 years ago, according to new research from the Tufts Center for the Study of Drug Development. Read More