Regulatory approval application accepted for Exparel
PARSIPPANY, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.
The drug maker submitted its application for the long-acting painkiller Exparel (bupivacaine) in September.
The drug is a topical medication for managing pain following surgery. The FDA expects to finish reviewing the application in July 2011.
FDA approves revised dosage of HIV-combo drug
TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.
Tibotec Therapeutics, a J&J subsidiary, announced the FDA’s approval in adults of a once-daily combination of its Prezista (darunavir) and Abbott’s Norvir (ritonavir), which combines 800 mg of Prezista with 100 mg of Norvir. The previously approved dosage was 600 mg of Prezista and 100 mg of Norvir taken twice per day.
“With this once-daily dosing recommendation, boosted Prezista is now a viable option for more treatment-experienced patients,” Tibotec president Glenn Mattes said. “This approval reflects Tibotec’s ongoing commitment to optimizing dosing strategies for HIV patients.”
Recreating islet cells can boost insulin production, study finds
NEW YORK — In patients with Type 1 diabetes, the islet cells of the pancreas are destroyed, thus eliminating the organ’s ability to produce insulin.
But researchers at Georgetown University have found a way to recreate them using cells from the testicles, according to published reports.
WebMD reported that the researchers took the testicular tissue, extracted the stem cells and used them to create new islet cells. Injecting them into the pancreases of mice with diabetes. The researchers found that the cells began to secrete insulin.
Data from the study were scheduled for presentation at the American Society of Cell Biology’s annual meeting in Philadelphia.