FDA grants waivers to Abaxis for point-of-care analyzers
UNION CITY, Calif. The Food and Drug Administration has given blood-analysis system manufacturer Abaxis a waived status for two analytes, creatine kinase and phosphorus, when used by healthcare professionals with the Piccolo and Piccolo Xpress point-of-care analyzers, Abaxis said last week.
The company said Thursday that as a result of the waived status, healthcare professionals have better access to the Renal Function and MetLyte 8 panels and can conduct this testing at the point-of-care under a certificate of waiver.
“The waiver of these two panels bolsters our already comprehensive offering to healthcare professionals, enabling them to conduct important testing at the point of care in order to manage patients in real time,” Abaxis chairman and chief executive officer Clint Severson said in a statement. “We believe rapid and accurate diagnostic testing can lead to improved patient care while reducing some of the administrative burden healthcare practices face on a daily basis.”
The panels are respectively used to determine renal function status and to assess several metabolic conditions across several medical specialties, including pediatrics and cardiology.
Gilead sues Teva over approval application for generic Truvada
NEW YORK Gilead Sciences has filed a lawsuit against Israeli generic drug maker Teva Pharmaceutical Industries and a subsidiary.
Gilead, which filed the suit Friday in a United States District Court in New York, alleged that Teva committed patent infringement when it filed an approval application with the Food and Drug Administration for a generic version of Truvada (emtricitabine), a drug for treating HIV.
Gilead has a license to manufacture and sell the drug from Emory University in Atlanta.
Take Care adds another clinic to its network in Miami/Fort Lauderdale area
CONSHOHOCKEN, Pa. Take Care Health Systems, which is owned by Walgreens, has opened one new clinic in the Miami/South Fort Lauderdale area. The opening marks the 10th Take Care Clinic in the market.
The company currently operates 313 clinics in 18 states.