FDA warns GSK over promotional claims regarding Tykerb
WASHINGTON The Food and Drug Administration stated that GlaxoSmithKline left out important safety information in promotional materials the manufacturer sent to health care professionals concerning its new breast cancer drug Tykerb.
“These letters, which were part of the launch campaign for Tykerb, are misleading in that they omit and minimize the most serious and important risk information for Tykerb and selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug,” the FDA said in the Nov. 21 warning letter.
The drug was approved in March to be used in combination with Roche Holdings’ cancer drug Xeloda in women with breast cancer who test positive for a protein called HER2 and who haven’t responded to prior treatment with other drugs. The drug is taken in a 21-day cycle.
Diamyd partners with NIH diabetes group in type 1 vaccine trial
STOCKHOLM, Sweden Diamyd Medical and the National Institute of Diabetes and Kidney Diseases have joined together to initiate a clinical trial with Diamyds’ GAD-alum diabetes vaccine. The clinical trial will involve 126 new onset type 1 diabetes patients. The NIDDK-sponsored consortium type 1 diabetes TrialNet will conduct the clinical study.
The trial will include extensive immunological studies to clarify the mechanism of action and to evaluate the correlation between the clinical and immunological outcomes of GAD-alum Diamyd treatment in recent onset type 1 diabetes patients. The detailed analysis may provide important information into the ability of Diamyd to protect islet cells from autoimmune attack as an instrument for maintaining insulin production. Additionally, the immunological data may prove beneficial for designing future diabetes prevention studies.
“We are extremely excited to be working with NIDDK and TrialNet on this new Diamyd clinical study,” stated Anders Essen-Moller, chief executive officer of Diamyd Medical. “TrialNet is uniquely positioned to conduct clinical studies and to evaluate the molecular and cellular mechanisms of potential diabetes therapies. The insights expected from this trial should prove very valuable for Diamyd, the scientific community and for diabetes patients.”
Take Care clinics offer flu shots for CDC’s National Influenza Vaccination Week
CONSHOHOCKEN, Pa. Take Care Health Systems is set to bring awareness to local communities by offering flu shots in honor of the Centers for Disease Control and Prevention’s National Influenza Vaccination Week from Nov. 26 to Dec. 2.
Dubbed one of the largest convenient retail clinic managers in the United States, and a wholly-owned subsidiary of Walgreens, Take Care is stocked with the immunization, and will offer flu shots every day of the week at all of its 102 locations. The flu shot costs $24.99 and is covered by most insurance providers.
According to the CDC, each year an average of 5 to 20 percent of the U.S. population contracts the flu, more than 200,000 people are hospitalized for flu complications and 36,000 die from it.
Additionally, the CDC’s Advisory Committee on Immunization Practices recommends that the influenza vaccine be offered throughout the entire flu season, even after it has appeared or begun appearing in a community. It takes two weeks after the vaccination for the body to be fully prepared to protect against the flu.
“Annual vaccination is the most effective way to prevent the flu and is best performed early in the season, which can last as late as May,” said Sandra Ryan, chief nurse practitioner officer for Take Care Health Systems. “Take Care Health Clinics, which are open seven days a week with no appointments and accept most major insurance plans, offer an accessible, convenient and affordable way for individuals to protect themselves and their loved ones against the flu this year.”
Though Take Care Health Clinics are dedicated to immunizing local communities from the flu, the professionals at the retail clinics also treat patients 18 months and older for common illnesses, offer diagnostic screenings and write prescriptions.
Take Care Health Systems manages 102 locations in 11 states, including Atlanta, Chicago, Cincinnati and Houston.