AstraZeneca, Targacept: TC-5214 ‘well-tolerated,’ did not meet endpoint in phase-3 trial
NEW YORK — AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.
The drug makers said that while the drug was "well-tolerated" among study subjects, the study did not meet its primary endpoint of change after eight weeks of treatment with TC-5214, compared with placebo. The study was part of the Renaissance clinical trial program, which consists of four randomized, double-blind, placebo-controlled phase-3 studies and a fifth long-term safety study.
A new drug application for TC-5214 is expected to be filed in the United States during the second half of 2012.
Roche seeks FDA approval for vismodegib
BASEL, Switzerland — The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.
Roche said that the FDA accepted its NDA for vismodegib, designed to treat advanced basal cell carcinoma in adults for whom surgery is considered inappropriate. The application was granted priorit review status and has a confirmed action date of March 8, 2012.
“We are pleased the FDA has granted priority review for vismodegib and we look forward to working with the Agency on the review of the data," Roche chief medical officer and head of global product development Hal Barron said. “We hope to provide people with the first FDA-approved medicine for this potentially disfiguring, and in some cases fatal, disease as soon as possible.”
Survey: U.S. adults struggle to pay medical bills, forgo recommended care due to cost
CHICAGO — More than 1-out-of-4 U.S. adults were unable to pay or encountered problems paying medical bills in the past year, according to a new survey published by the Commonwealth Fund.
While 27% of U.S. adults struggled with paying medical bills, 42% did not visit a doctor, fill a prescription or get recommended care when needed. Meanwhile, cost-related access problems and medical bill burdens were prevalent among those adults under 65 years old. Compared with Medicare-aged adults ages 65 years and older, adults under 65 years old significantly were more likely to forgo care due to payment burdens, researchers found.
These conclusions were based on an analysis of the "2011 Commonwealth Fund International Health Policy Survey of Sicker Adults in Eleven Countries," which included more than 18,000 adults ages 18 years and older who were in fair or poor health, had recently been hospitalized or had major surgery, or had a serious illness or injury in the past year in the Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States. The survey found that among all of these high-income nations, the United States "stood out for having cost and access problems." Only about 1% to 14% of adults in the other countries had issues paying medical bills.