Young American patients approved to participate in Diamyd study
STOCKHOLM, Sweden The Food and Drug Administration has approved Diamyd Medical to include American children with Type 1 diabetes as young as 10 years old to participate in the company’s phase-three study for the diabetes vaccine Diamyd.
The aim of the study is to determine the ability of the Diamyd vaccine to stop or slow the autoimmune attack on the body’s insulin producing cells, therefore preserving the body’s own ability to produce insulin in children and adolescents with recent-onset Type 1 diabetes.
Prior to FDA authorization, diabetic children ages 16 to 20 years were the only approved age group for Diamyd Medical’s U.S. study. The problem is that this age group encompasses few recent-onset Type 1 diabetes patients.
“This is a big step forward giving us the opportunity to accelerate patient recruitment in the U.S.,” said Elisabeth Lindner, president and CEO of Diamyd Medical.
As the Institutional Review Board authorizes patients in the United States, Diamyd will also increase the number of American pediatric clinics in the study. The application for market approval is still planned for spring 2011.
Innovative Card Scanning teams up with RediClinic
PLANO, Texas Innovative Card Scanning, a developer and provider of insurance card and ID scanning solutions for physicians, hospitals, medical billers, pharmacies and retail clinics, has teamed up with RediClinic.
Innovative Card Scanning’s DocketPORT Scanning Technology is now in place at 21 RediClinic locations across Houston and Austin, with plans for the scanning technology to be placed in future locations.
“Our business is based around the treatment of common conditions that can be accomplished conveniently and quickly for patients. It’s very important for us to optimize our check-in process to be as quick and efficient as we can, and this is one more way to help make that a reality,” stated RediClinic COO Lori Knowles.
With the new system, RediClinic patients have their insurance card and/ or driver’s license immediately scanned upon the office visit, creating a secure electronic record that follows them throughout the billing process.
The RediClinic billing department uses these files as a reference throughout the process to quickly confirm information accuracy or identify and correct any errors in-house. This system eliminates the need for paper files or to perform outside research to correct errors, and saves payment and claims that would sometimes be lost due to insufficient contact information, according to the company.
RedicClinic will have the option to further upgrade to Innovative Card Scanning’s optical character recognition technology, which will automatically extract patient data and populate it into their EMR system.
Merck: Investigational drug did not meet endpoints
WHITEHOUSE STATION, N.J. Merck & Co. said Friday that preliminary results for the pivotal phase III study of rolofylline (MK-7418), the company’s investigational medicine for the treatment of acute heart failure, show that rolofylline did not meet the primary or secondary efficacy endpoints.
“Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive,” said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. “These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients.
The primary endpoint for the phase III study were that the drug would would improve symptoms of acute heart failure (compared with placebo). Secondary endpoints included reducing the risk of death, renal re-hospitalization 60 days after treatment and reducing the incidence of persistent kidney impairment.
Rolofylline was acquired by Merck through NovaCardia, which Merck purchased in 2007. Results from the PROTECT pilot study, presented at previous medical meetings and published in 2008, had showed an overall trend toward efficacy (more patients with improved shortness of breath, fewer patients with worsening renal function and/or worsening heart failure).
While Merck will continue to analyze the data with outside experts, the company will not file applications for regulatory approval this year. The results from this study will be presented at a medical meeting later this year.
Merck’s late-stage pipeline of investigational medicines for cardiovascular disease includes MK-524A (approved in some markets outside the U.S.), MK-524B, ezetimibe/atorvastatin, and anacetrapib (MK-0859) for atherosclerosis, and vernakalant for atrial fibrillation.