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HIV combination therapy gets US approval
03 Oct 2008
Regulatory Affairs
Bristol-Myers Squibb has announced that its HIV drug Reyataz has gained an approval from the US Food and Drug Administration.
The 300 milligram (mg) dose of the medicine has been approved for use as part of a combination therapy with ritonavir 100mg in previously untreated patients infected with HIV-1.
According to the firm, the approval decision is based on results measured at 48 weeks in the Castle study, which found the treatment had similar clinical efficacy as twice-daily lopinavir/ritonavir.
Elliott Sigal, executive vice-president, chief scientific officer and president of research and development at Bristol-Myers Squibb, stressed his company's commitment to the development of medicines which "enhance the care of people living with HIV and Aids".
He continued: "Reyataz provides healthcare professionals [with] a newly approved, once-daily dosing option as part of combination therapy for patients naive to HIV therapy."
Bristol-Myers Squibb has this week appointed a new vice-president and general manager of its Devens biologics manufacturing facility.
Christopher Perley moves into the role, in which he will have responsibility for supervising the project to build the facility and will subsequently manage the site when it becomes operational in 2011.
