Investigational drug, in combo with chemo, shown to help colorectal cancer patients survive longer
PARIS — An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.
The phase-3 trial combined the drug Zaltrap (aflibercept) with a combination of the chemotherapy drugs folinic acid (leucovorin), 5-fluorouracil and irinotecan, also known as the FOLFIRI regimen.
“We are pleased with the results of the Zaltrap phase-3 study in this group of patients,” stated Debasish Roychowdhury, SVP and head of Sanofi-Aventis’ global oncology division. “We are committed to bringing Zaltrap to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine.”
FDA looks to simplify drug info packets
NEW YORK — The Food and Drug Administration is working on creating new and simplified drug information sheets for consumers to replace the multipage and sometimes labyrinthine packets supplied with drugs at retail pharmacies, according to published reports.
The Wall Street Journal reported that the agency was testing the information sheets while the U.S. Pharmacopeia Convention was developing a new standard for drug labels.
The large inserts — called consumer medication information, or CMI — that accompany drugs have long been cited as a problem for consumers because of their tiny print and the confusing way they present drug indications, guidelines and warnings.
In 2008, the FDA conducted a study that found that while 94% of shoppers received CMI with their prescriptions, about 75% of CMI met the “minimum criteria for usefulness,” a number that the agency said fell short of its goal of having 95% of prescriptions accompanied by useful CMI by 2006.
Wolters Kluwer to acquire Lexi-Comp
PHILADELPHIA — Market research firm Wolters Kluwer Health will acquire drug information provider Lexi-Comp, Wolters Kluwer said Wednesday. Financial terms of the deal were not disclosed.
Wolters Kluwer already had a relationship with Lexi-Comp through the former’s UpToDate business, which provides electronic clinical information through the Internet and mobile devices to more than 400,000 clinicians and other users. Lexi-Comp, based in Cleveland, provides drug information and medical reference content to more than 1,500 hospitals around the world and publishes drug monographs on more than 1,700 products.
Wolters Kluwer said the acquisition would strengthen its position in the clinical decision support and point-of-care segments and provide customers with more robust drug information and clinical content, allowing pharmacists, nurses and physicians to use an extended suite of mobile capabilities and online platforms.