FDA accepts approval application for osteoporis treatment
THOUSAND OAKS The Food and Drug Administration has accepted a biotech company’s submission of an approval application for a monoclonal antibody to treat and prevent postmenopausal osteoporosis and bone loss in patients receiving hormone therapy for prostate or breast cancer.
Amgen announced on Feb. 18 that the FDA had accepted its biologics license application for denosumab, which belongs to the class known as RANK Ligand inhibitors. The company has also applied for approval in Canada, the European Union, Switzerland and Australia.
The FDA will decide whether to approve the application in October.
FDA approves Takeda’s chronic hyperuricemia drug
OSAKA, Japan The Food and Drug Administration has approved a new drug from Takeda for treating chronic hyperuricemia in patients with gout, the Japanese drug maker and its North American subsidiary announced last week.
Takeda said Friday that the FDA had approved Uloric (febuxostat) in the 40-mg and 80-mg strengths. It said the once-daily pill is the first new treatment option in more than 40 years for the condition. Tokyo-based Teijin Pharma discovered the drug and licensed it to Takeda for the United States market.
“The approval of Uloric offers clinicians and their patients who have hyperuricemia associated with gout a new treatment option that helps prevent uric acid production,” Takeda Global Research & Development Center Inc., U.S. president Nancy Joseph-Ridge said in a statement. “In the years that we’ve dedicated to studying patients who have gout, I know that many patients go to their doctor during a flare not understanding that gout is a chronic disease that needs to be managed on a long-term, daily basis.”
NACDS to provide 85 pharmacy school scholarships
ALEXANDRIA, Va. The National Association of Chain Drug Stores Foundation will give $172,000 in pharmacy school scholarships.
The foundation announced Wednesday that it gives the awards as part of its Pharmacy Student Scholarship Program. The amount includes 85 scholarships, including the Robert J. Bolger Scholarship and the Taro Research Foundation Scholarship. The NACDS Foundation gave 60 scholarships in 2007 and 40 in 2006.
Students selected for Foundation scholarships must be enrolled as full-time pharmacy students, have experience in community pharmacy and have a desire to pursue a career in community pharmacy.
The Robert J. Bolger Scholarship is named after the former NACDS president and CEO; Barr Labs, where Bolger served on the board for 14 years, sponsors the award. The recipients this year are University of Maryland School of Pharmacy student Rita Kasliwal and Texas A University Health Science Center Irma Lerma Rangel College of Pharmacy student Hui Yun.
The Taro Research Foundation Scholarship is named for a private research foundation whose main purpose is to support public charitable organizations that conduct medical research, facilitate medical education and provide assistance to people with medical disorders. This year’s recipients are University of Pittsburgh School of Pharmacy student Sarah Providence and Duquesne University Mylan School of Pharmacy student Emily Lunz.