Vertex seeks approval for cystic fibrosis drug
CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.
Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.
If the FDA grants Vertex’s request for priority review, it will reduce the amount of time needed to review the application from 10 months to six months.
"Kalydeco represents a completely new approach to the treatment of CF by targeting the underlying cause of the disease," Vertex president, chairman and CEO Matthew Emmens said. "This is our second new drug application in less than a year, which is a significant achievement and underscores our commitment to developing new medicines for people with serious diseases."
The FDA approved Vertex’s hepatitis C drug Incivek (telaprevir) in May.
First lady to showcase fresh-food offering at Chicago-area Walgreens
CHICAGO — First Lady Michelle Obama will be visiting with mayors from 10 U.S. cities on Oct. 25 at a Chicago-area Walgreens, according to published reports.
First Lady Obama, along with Chicago mayor Rahm Emanuel, will be discussing her "Let’s Move" campaign to reduce the incidence of childhood obesity.
The Walgreens hosting the First Lady has been expanded with a fresh food assortment as part of that chain’s 1,000-store pledge to alleviate urban food deserts. The locations offer more than 750 new food items, including fresh fruits and vegetables, frozen meats and fish, pasta, rice, beans, eggs, whole grain cereals and other healthy meal components.
BioPlus Specialty Pharmacy releases informational video
ALTAMONTE SPRINGS, Fla. — BioPlus Specialty Pharmacy has released a new video detailing the company’s operations and introducing company executives.BioPlus announced the release of a seven-minute video that includes one-on-one interviews with key executives, graphics, clips and commentary that discuss the company’s origins, its growth, use of technology and training and how it works with patients, physicians, the drug industry and payers.
"With our 20-year history, BioPlus has an important story to share," BioPlus president and CEO Stephen Vogt said. "We want viewers to know that we aren’t just a company dispensing medications; we treat each patient with an individual pharmaceutical care plan to make sure that their biologic specialty medicines have the intended results."