Reports: FDA may be close to approving drug for HIV prevention
NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.
The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.
According to the Centers for Disease Control and Prevention, PrEP, which involves taking antiretroviral drugs daily to lower the chances of HIV infection, has been shown as effective in heterosexual men and women and in men who have sex with men, a term used for men who have sexual relations with other men, but do not necessarily identify as gay or bisexual. The CDC also is conducting a study of whether PrEP works in intravenous drug users.
Seattle Genetics, Millennium start phase-3 trial of Adcetris
BOTHELL, Wash. — Seattle Genetics and Takeda’s cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.
Seattle Genetics and Millennium announced the start of a phase-3 trial of Adcetris (brentuximab vedotin) in patients relapsed cutaneous T-cell lymphoma that expresses the CD30 cell membrane protein. The study will enroll more than 120 patients who will be divided into two groups, one of which will receive Adcetris and another that will receive methotrexate or bexarotene.
"We recognize this is a significant milestone in our efforts to explore the potential of this targeted therapy in other indications," Millennium chief medical officer Karen Ferrante said. "Looking forward, this study may support the potential to supplement therapeutic options for patients, from traditional systemic chemotherapy to Adcetris, a targeted therapy."
The companies also plan to start phase-3 trials of the drug in patients with Hodgkin lymphoma later this year or early next year.
BioScrip reports Q1
ELMSFORD, N.Y. — BioScrip experienced a boost in revenue and gross profit during first quarter 2012 ended March 31.
First-quarter revenue was $155.6 million, while gross profit was $53.5 million, or 34.4% of revenue, compared with $51.4 million, or 39.2% of revenue, in the prior-year period. However, segment adjusted EBITDA and adjusted EBITDA from continuing operations experienced losses, dropping to $15 million and $8.4 million, respectively. The company also reported a net loss of $2.7 million or 5 cents per share, compared with net income of $2.9 million, or 5 cents per diluted share, in first quarter 2011.
BioScrip noted its first-quarter results financial statements reflect the results of its discontinued operations; BioScrip’s traditional and specialty pharmacy mail operations and community retail pharmacy stores were sold May 4. To underscore the sale of these assets, BioScrip also has changed the names of its operating and reportable segments from infusion/home health services and pharmacy services to infusion services, home health services and PBM services.
"Our first-quarter results demonstrated our ability to continue to execute on our strategic plan, while at the same time divesting a large portion of the company," BioScrip president and CEO Rick Smith said. "We closed the pharmacy services asset sale, marking a major milestone that allows us to accelerate the momentum of our infusion pharmacy platform expansion and to leverage our key strengths, including our differentiated offering and reputation for clinical excellence. Over the next couple of quarters we will continue to focus on reducing corporate overhead and maximizing operating efficiencies to improve operating performance and profitability."