FDA establishes PDUFA rates
WASHINGTON The Food and Drug Administration has established user fee rates for fiscal 2008 under the Prescription Drug User Fee Act, which will lasts until Sept. 30, 2008.
The revenue amount for fiscal 2008 is $459,412,000, including application, establishment and product fees which will provide one-third of the total revenue. The FDA also estimates that 35 establishment fee waivers will be made for 2008, with 10 waivers coming from a new orphan drug exemption in the FDA Amendments Act, which reauthorized the PDUFA.
Synta and GSK enter into $1.1 billion deal
LONDON and LEXINGTON, Mass. Synta Pharmaceuticals and GlaxoSmithKline have agreed on a collaboration for the joint development and commercialization of STA-4783, a new drug entering phase-three clinical development for the treatment of metastatic melanoma.
Under the terms of the agreement, the companies will share responsibility for the development and commercialization of the drug in the United States, with GlaxoSmithKline having exclusive rights outside of the United States. Synta can earn up to $1.1 billion as a result of this agreement in development, upfront payments, stock purchases and milestone payments.
“This agreement confirms GSK’s growing status as a world leader in the development of new oncology medicines for use in the treatment, prevention and supportive care of cancer patients. It further strengthens our late stage oncology pipeline, which currently includes ten phase-three programs, and also demonstrates our commitment to identifying compounds that have the potential to deliver real benefit to patients,” said Moncef Slaoui, chairman of research and development at GSK. “The data we have seen from the phase-two trials conducted by Synta have given us confidence in the potential of STA-4783 as a novel means of treating metastatic melanoma, a disease for which there is high unmet medical need.”
CMS updates Medicare Part D Web site
WASHINGTON The Centers for Medicare and Medicaid Services has updated its Medicare Prescription Drug Plan Finder, so that senior citizens and other beneficiaries can begin to review 2008 Part D drug plans.
The finder offers beneficiaries a chance to compare drug plans and health plans, view premiums, formularies and availability of coverage in the gap. CMS wanted to make the finder as easy as possible to use and provide as much information as possible so that beneficiaries are ready before the open enrollment begins on Nov. 15.