FDA approves Erwinaze for acute lymphoblastic leukemia
SILVER SPRING, Md. — The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.
The FDA announced the approval of EUSA Pharma’s Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with ALL who have developed an allergy to E. coli-derived asparaginase and pegaspargase chemotherapy drugs.
The drug is injected directly into the muscle three times a week and works by breaking down asparagine, an amino acid that is present in the blood and is necessary for cell growth. Leukemia cells can’t produce asparagine, so they die when the patient receives the drug. But normal cells, which can produce enough of the amino acid on their own, are not affected.
NACDS RxImpact Day pushed back due to congressional schedule
ALEXANDRIA, Va. — The National Association of Chain Drug Stores has announced that the dates of the 2012 NACDS RxImpact Day on Capitol Hill in Washington, D.C., have been changed because of an alteration in the 2012 congressional calendar. The new dates for the two-day pharmacy advocacy event will be March 21 and 22, 2012.
The event was previously scheduled for the prior week in March, which now falls during a congressional district work period in which members of Congress will be in their home states and districts.
“There is much at stake with the healthcare delivery system today, and its imperative that pharmacy advocates engage with their elected officials during their visit to Washington, D.C. The rescheduling of the two-day event to March 21 and 22 will now enable pharmacy advocates from across the country to engage with lawmakers on pro-patient and pro-pharmacy issues,” explained NACDS president and CEO Steve Anderson. “In its fourth year, this high-energy event will bring together advocates from all sectors of the industry to meet with key lawmakers to illustrate the unsurpassed value of community pharmacy in improving patient health and reducing costs.”
NACDS will mobilize hundreds pharmacy advocates from all across the country — many wearing pharmacy white coats — during the fourth annual NACDS RxImpact Day on Capitol Hill. The event brings pharmacy and retail executives, division and store managers, pharmacists, pharmacy school deans and students to Washington, D.C., for the two-day event.
Bristol-Myers Squibb, AstraZeneca present analysis of dapagliflozin studies
PRINCETON, N.J. — Bristol-Myers Squibb and AstraZeneca presented an analysis Wednesday of 14 clinical trials at the American Heart Association’s Scientific Sessions in Orlando, Fla., the companies said.
The phase-2b and phase-3 trials all involved the investigational Type 2 diabetes drug dapagliflozin and, the companies said, showed that use of the drug did not lead to an unacceptable risk to adult patients’ cardiovascular health compared with other treatments.
The analysis included 6,228 patients, with 4,287 taking dapagliflozin and 1,941 taking other drugs.
"This comprehensive analysis provides valuable information that can be used to better understand cardiovascular safety profile of dapagliflozin as a monotherapy or as an add-on therapy to common antidiabetic treatments," Bristol-Myers Squibb SVP global development and medical affairs Brian Daniels said.