The Burrill Report


Bristol-Myers Squibb is looking to settle more than $500 million in claims from liver-disease patients and the families of those killed or injured during the clinical trial of an experimental hepatitis C drug last year, according to The Wall Street Journal. The clinical trial for BMS-986094, a nucleotide polymerase inhibitor, was halted in August 2012 after one patient died and several others reported suffering heart injuries, kidney damage, or were hospitalized. Four trial participants have filed lawsuits and ten more are expected. The outcomes of discussions with a mediator will be reported to a federal court in Texas by the end of the January, according to court documents.

In a revised report released in December 2012, United States Department of Agriculture staff wrote that during an October inspection of Santa Cruz Biotechnology it found 841 goats housed in a barn near the Santa Cruz office that were previously not disclosed. Antibody facilities are required to report the number of animal their health status to the USDA's Animal and Plant Health Inspection Service. Federal officials have found animal welfare violations at Santa Cruz Biotechnology in numerous inspections over the past five years, and originally filed a complaint against the antibody facility in September, 2012, for ongoing violations including improper handling of animals, inadequate veterinary care, improper food, and unqualified personnel. In 2012, Santa Cruz Biotechnology was the second-largest supplier in the $1.6 billion global market for research antibodies, according to The Scientist and market-research firm Frost & Sullivan.

Amgen’s Aranesp failed to meet its primary endpoint in a late-stage trial for the treatment of anemia to improve morbidity and mortality in systolic heart failure patients. The trial of 2,278 patients with symptomatic systolic heart failure and anemia was initiated in 2006 and did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure. The therapy is already approved by the U.S. Food and Drug Administration and the European Union in 2001 for treatment of anemia associated with chronic renal failure and again in 2002 for the treatment of anemia caused by myelosuppressive chemotherapy in patients with non-myeloid malignancies.

New data shows that blood levels of certain sleeping pills taken at night are high enough in the morning to impair activities that require alertness, such as driving. This has prompted the U.S. Food and Drug Administration to recommend lower doses of zolpidem-containing sleep aids, such as Ambien, Ambien CR, Edluar, Zolpimist and related generics. The risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs, Ambien CR, and generics. Women appear to be more susceptible because they eliminate zolpidem from their bodies more slowly than men.


January 18, 2013
http://www.burrillreport.com/article-bms_moves_to_wrap_up_litigation_over_failed_trial.html