Hemispherx files new drug application for CFS
PHILADELPHIA Hemispherx Biopharma announced Thursday that it filed a new drug application to market its treatment for chronic fatigue syndrome, the Philadelphia Business Journal reports.
The company filed the application with the Food and Drug Administration for its experimental therapeutic called Ampligen. Hemispherx’s submission to the FDA includes clinical trial data involving more than 1,200 subjects and about 90,000 dose administrations.
The company said it has been developing the drug for more than 30 years, and was considered a potential treatment for AIDS and cancer before chronic fatigue. Initially, the drug was discovered and developed at Johns Hopkins University and it was later licensed to Hemispherx.
According to the Centers for Disease Control, CFS affects more than 1 million people in the United States.
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.