Sagent gets approval for generic bladder inflammation treatment
SCHAUMBURG, Ill. The Food and Drug Administration has approved a generic injectable drug for preventing bladder inflammation that can result from a certain chemotherapy treatment.
Sagent Pharmacueticals announced that the FDA had approved mesna in the 1 mg-per-milliliter strength, used to reduce the incidence of hemorrhagic cystitis caused by ifosfamide chemotherapy, itself used to treat testicular, bone and other cancers.
Mesna had sales of around $12 million in 2009, according to IMS Health.
Schnucks’ O’Brien to serve on Department of Agriculture advisory committee
ST. LOUIS An executive from Schnuck Markets will serve on an advisory committee of the Department of Agriculture, Schnucks said this week.
Agriculture secretary Tom Vilsack announced that Schnucks VP produce and floral Mike O’Brien would be one of 25 people appointed to a two-year term on the USDA’s Fruit and Vegetable Industry Advisory Committee. O’Brien is also vice chairman of the Produce Marketing Association.
“I am honred to represent Schnuck Markets and the retail produce industry as a member of this committee,” O’Brien said. “I am looking forward to the opportunity to contribute and to make a difference for families across the nation.”
The committee, originally chartered in 2001, advises the secretary of agriculture on industry issues related to fruits and vegetables.
Gilead commences phase 3 trial for single-tablet HIV treatment
FOSTER CITY, Calif. Gilead Sciences has started a late-stage clinical trial of an investigational 4-in-1 treatment for HIV, the drug maker said.
Gilead announced the initiation of a phase 3 trial of its “Quad” HIV drug, a single-tablet treatment that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The study will compare the Quad regimen with the standard of care among adults with HIV-1 who have not taken antiretroviral treatments. The company is also investigating cobicistat as a standalone boosting agent for antiretroviral drugs.
“We are pleased to announce that the Quad phase 3 clinical program is underway,” Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. “Efficacy and safety results from the phase 2 study suggest that the Quad may represent an important new option for patients with HIV.”