FDA advisory committee favorably reviews Cervarix
PHILADELPHIA A Food and Drug Administration advisory committee has given a favorable review to a new cervical cancer vaccine.
GlaxoSmithKline announced that the FDA’s Vaccines and Related Biological Products Advisory Committee voted that data from clinical trials support the efficacy and safety of Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant), which the company hopes to market as a competitor to Merck & Co.’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant).
“This is an important step in cancer prevention for the millions of girls and young women at risk for cervical cancer,” GSK director and VP North American vaccine development Barbara Howe said in a statement. “If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year.”
The vaccine works by preventing infection by human papillomavirus types 16 and 18, the two most common strains that cause cervical cancer.
Studies: Continuous glucose monitor use increases diabetes control for all age groups
NEW YORK Two studies have concluded that continuous glucose monitor use is the primary determinant in improving diabetes control.
The findings of two studies from the major multi-center trial, funded by the Juvenile Diabetes Research Foundation, were published online by the journal Diabetes Care. The first showed that regular use of CGM devices is the principal factor in achieving better diabetes control, rather than the age of people using the monitors, or other demographic, clinical, or psychosocial factors. The second showed that people using CGM to help manage their disease were able to sustain good diabetes control; and just as important, that continued strong control came while actually lowering the incidence of hypoglycemia – dangerous low-blood-sugar incidents that can occur with tightly managed Type 1 diabetes.
The JDRF CGM study was a randomized and controlled trial involving 451 adults and children from ages 8 to 72 at 10 sites, including the Atlanta Diabetes Associates, the Joslin Diabetes Center, Kaiser Permanente Southern California, Nemours Children’s Clinic – Jacksonville, Fla., the Lucile Packard Children’s Hospital at Stanford University, the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver, the University of Iowa, the University of Washington, and Yale University, and coordinated by the Jaeb Center for Health Research in Tampa, Florida. Three age groups were analyzed separately: 8 to 14 years of age, 15 to 24 years of age, and 25 years of age or older.
According to one Diabetes Care paper (Factors Predictive of Use and of Benefit from CGM in Type 1 Diabetes), in the first six months of the JDRF trial, more frequent CGM use was associated with a greater reductions in HbA1c levels – a finding that was present in all age groups using the devices. Successful use of the devices was defined as an average of six days or more per week.
“Based on these results and previous JDRF CGM trials published over the past 12 months, we know that these devices can help people get in control of their diabetes, help people already managing their disease maintain good control, and help people stay in control over an extended period of time, while lowering their risk for hypoglycemia,” said William V. Tamborlane, M.D., of Yale University, a co-chair of the JDRF funded study.
Mylan parts ways with CFO
PITTSBURGH Generic drug maker Mylan is looking for a new chief financial officer, the company announced Tuesday.
Mylan said it had decided to “part ways” with CFO Jolene Varney and had enlisted executive recruiting firm Korn/Ferry International to look for a new one while continuing business in the interim.
Pittsburgh-based Mylan is one of largest generic drug companies in the world, with operations in more than 140 countries and territories.