Medarex, BMS delay ipilimumab following FDA meeting
PRINCETON, N.J. Medarex and Bristol-Myers Squibb have announced that after meeting with the Food and Drug Administration, that they will delay the Biologics License Application submission for ipilimumab, a drug for skin cancer.
The drug failed to meet an FDA requirement that at least 10 percent of patients respond to treatment, the companies said Dec. 10. The medicine is designed to combat skin cancers called melanomas that spread to other organs. The company was seeking approval of the drug for patients not helped by other treatments.
The companies don’t expect to submit an application for marketing approval to the FDA this year, Medarex and Bristol-Myers said April 25 in a statement.
Anderson highlights NACDS achievements in annual speech
PALM BEACH, Fla. The National Association of Chain Drug Stores president and chief executive officer Steve Anderson addressed the attendees yesterday at the association’s annual meeting with his “State of the Association” speech.
“I think the stakes are very high and we are ready to live and to thrive in this moment,” said Anderson. “In January 2009, we are going to have a new president in the White House, and a new administration that will be serving that president. We are going to have a new congress, new governors and state legislators, and the healthcare debate is going to rage and the response to economic conditions are going to dominate.”
Anderson highlighted some of the policy victories of the association over the past year. This includes a six-month delay of the tamper-resistant paper requirement for Medicaid prescriptions, the two-year delay of California’s e-pedigree requirement, the preservation of access to retail pharmacy for military families and veterans through the TRICARE program and the temporary injunction won by NACDS and the National Community Pharmacists Association to block the Medicaid pharmacy reimbursement cuts that would have gone into effect in January 2008.
“NACDS talked about the cost when patients don’t take their medications as prescribed—by one estimate, $177 billion annually,” said Anderson. “We talked about the seven most common chronic diseases. We cited there a $1.3 trillion annual drag on the economy, not to mention the human suffering. … We talked about the ability of retail pharmacy to make a difference if we are only given the chance.”
Anderson also talked about strengthening the presence of the pharmacy in the health care system. He called for the industry to take action, at this “defining age” in health care. Anderson said, “We have a vision for the future. We are branding pharmacies as the face of neighborhood healthcare.”
“The state of your association is very strong, in large part, because our staff team is working very well together,” said Anderson, who noted that results on issues are the best indicator of strength. “… No silos, no egos—that is way this is supposed to work.”
He also made reference to the economic impact that retail stores have on the economy. “Based on our analysis, retail stores with pharmacies have a total annual economic impact of $2.2 trillion,” said Anderson. This was after he noted that the stores had annual sales of $758 billion, so therefore the effect is almost tripled by pharmacies. For every $1 spent in these stores has a ripple effect of $2.93 throughout the entire economy.
“We do all those things that drive our nation’s economy and produces millions of jobs in this country,” said Anderson. “This is what you do and I think that is pretty amazing.”
Mylan’s Digitek recalled by Actavis
WASHINGTON Actavis Totowa has notified health care professionals of a Class I nationwide recall of all strengths of Mylan Pharmaceuticals’ drug Digitek.
The drug is used to treat heart failure and abnormal heart rhythms.
The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.