Report: Government officials question FDA’s approval of generic Lovenox
NEW YORK Government officials said problems have arisen with the Food and Drug Administration’s approval of a generic blood-thinning drug due to its previous relationship with the generic drug’s manufacturer, according to published reports.
According to The Wall Street Journal, a congressional committee was planning to release a report Tuesday showing that the FDA created the appearance of compromised integrity in its review and approval of an applicaton for a generic version of Sanofi-Aventis’ Lovenox (enoxaparin) submitted by Momenta Pharmaceuticals and Sandoz because Momenta had provided free consulting work in 2008 while the agency was investigating contaminated supplies of the blood thinner heparin imported from China. Sandoz, the generics arm of Swiss drug maker Novartis, is co-marketing the generic version of Lovenox with Momenta.
CVS/pharmacy, Warner Home Video support the Cystic Fibrosis Foundation
BETHESDA, Md. The Cystic Fibrosis Foundation announced on Monday that it will partner with CVS/pharmacy and Warner Home Video for the second year to raise funds for cystic fibrosis through the sale of classic family movies this holiday season.
From now through Dec. 28, CVS/pharmacy will sell four animated holiday movies from Warner Home Video, including “How the Grinch Stole Christmas,” “The Year Without a Santa Claus,” “Charlie Brown’s Christmas Tales” and “The Polar Express.” The videos will be sold exclusively at CVS/pharmacy. For every video purchased, CVS/pharmacy and Warner Home Video will donate $5 to benefit the Foundation.
Cystic fibrosis is a fatal genetic disease that causes life-threatening lung infections and premature death. It affects about 70,000 people worldwide. The foundation has fueled dramatic improvements in research and care that have changed the prognosis for people with the disease. Where most children with cystic fibrosis once died before reaching elementary school, now people with the disease live into their 30s and beyond.
RA patients may benefit from weekly injection of Orencia, study finds
NEW YORK Patients with rheumatoid arthritis derive about as much benefit from a weekly injection of a biotech drug made by Bristol-Myers Squibb for the disease as they do from receiving it via IV on a monthly basis, according to late-stage clinical trial data released Monday.
Bristol announced results of a phase-3 study showing that patients with moderate to severe RA receiving a weekly injection under the skin of Orencia (abatacept) showed similar improvements to those receiving the IV. Results of the study will be presented this week at the American College of Rheumatology’s annual scientific meeting in Atlanta.
The study included 1,457 patients who had moderate to severe RA and did not respond adequately to the drug methotrexate. Patients were placed at random in groups that received either weekly injections of Orencia with a single IV loading dose or IV Orencia with methotrexate. After six months, 69.8% of those receiving injections and 65% of those on IV were showing improvements.
“These findings are significant because they demonstrate that subcutaneous Orencia may provide an additional administration option for patients and physicians,” lead study author and Stanford University medical professor Mark Genovese said. “It is important for patients and physicians to have treatment options when managing RA.”