Roche, Biogen Idec halt ocrelizumab trials
BASEL, Switzerland Roche and Biogen Idec are suspending trials of a drug for treating autoimmune disorders amid reports that its safety risks may outweigh its benefits, the two drug makers announced Monday.
A review of data from a clinical trial of the monoclonal antibody ocrelizumab in patients with rheumatoid arthritis by an independent data and safety monitoring board found evidence of infections, some of which were fatal. Many drugs for treating autoimmune disorders work by lowering the body’s immune system, and this has been known to raise patients’ risk of infections when taking some of the drugs.
Two studies of ocrelizumab — a study of rheumatoid arthritis patients and a study of lupus patients — were halted due to safety risks. A study of the drug in multiple sclerosis patients is ongoing.
“Patient safety is of the utmost importance in all of our drug-development programs,” Roche chief medical officer and EVP Hal Barron said. “In light of the [data and safety monitoring board] recommendations, we have decided to suspend ocrelizumab treatment in the RA clinical development program.”
McKesson named ‘World’s Most Admired’ by Fortune
SAN FRANCISCO A healthcare services and information technology company was ranked among the “World’s Most Admired” in an annual survey conducted by Fortune magazine and the Hay Group.
Fortune’s “World’s Most Admired” award measures corporate reputation and performance against nine key attributes: innovation, people management, use of corporate assets, social responsibility, quality of management, financial soundness, long-term investment, quality of products and services and global competitiveness. McKesson ranked No. 1 in all nine categories for the wholesale healthcare sector.
“At McKesson, corporate social responsibility principles are embedded within our mission to help our customers improve patients’ lives,” said John Hammergren, McKesson chairman and CEO. “As we continue to focus on making healthcare safer, more efficient, and less expensive we’re proud to be recognized as a leader among U.S. corporations.”
Coalition wants pharmacists to play role in drug safety programs
ALEXANDRIA, Va. Seventeen organizations and pharmacy chains hope the Food and Drug Administration will let pharmacists have a role in ensuring that patients use medication safely and effectively as it evaluates risk evaluation and mitigation strategies, also known as REMS.
The National Community Pharmacists Association, the American Pharmacists Association, Bartell Drugs, Shopko and 13 others sent a letter to the FDA about pharmacists’ ability to prevent adverse events and evaluate patients’ levels of understand via consultation.
“Studies have shown that community pharmacists providing face-to-face patient interactions may have a greater impact on patient behavior compared to other methods of service delivery,” the letter read. “Clearly, these services could be utilized to meet the goals of a REMS program.”