FDA recommends Dynavax, Merck end trials for hepatitis B treatment
BERKELEY, Calif. Dynavax Technologies and Merck said Tuesday that they had received a notice from the Food and Drug Administration regarding their response to the agency’s request for safety information concerning a clinical hold on two approval applications for a hepatitis B vaccine.
The FDA told the two companies that the balance of risk and potential benefit no longer favored continuing clinical evaluation of the drug, Heplisav, in health adults and children. It also told the companies the balance might be better for patients with renal failure using the drug.
The two companies said they were considering the FDA’s response, but the clinical hold on the applications remains in effect.
FDA approves Teva application for fentanyl patch
JERUSALEM The Food and Drug Administration has approved Teva’s application for its fentanyl transdermal system, the Israeli drug maker announced Monday.
The patches, which will deliver the medication at rates of 25 to 100 micrograms per hour for treating pain, are a generic equivalent to Johnson & Johnson’s Duragesic patches.
Combined sales of the branded and generic versions of the drug were $1.2 billion during the 12 months ending June 30, according to IMS Health data.
Teva said shipment of the patches had begun already.
Medicaid cost hikes ‘unsustainable,’ HHS secretary warns state budgeters
WASHINGTON Spending for Medicaid is rising to “unsustainable” levels, and the program’s rapidly rising costs are threatening access to health care for poor and lower-income Americans, Health & Human Services Secretary Mike Leavitt warned Friday.
The U.S. Centers for Medicare & Medicaid Services is projecting that the Medicaid program will spend $4.9 trillion over the next 10 years. That marks an average annual increase of 7.9 percent annually, according to federal budgeters, significantly outpacing the U.S. economy’s growth rate.
CMS released its report Friday, prompting a grim warning from the HHS secretary at a meeting of state budget directors. “This report should serve as an urgent reminder that the current path of Medicaid spending is unsustainable for both federal and state governments,” Leavitt said. “If nothing is done to rein in these costs, access to healthcare for the nation’s most vulnerable citizens could be threatened.”
Combined, Medicaid and Medicare are expected to gobble up 6.9 percent of the gross domestic product by 2017 at current growth rates, according to HHS. This year, Medicaid will see its rolls swell to a projected 50 million beneficiaries, at an average annual cost per person of more than $6,100.