Clinical trial results support experimental Gilead drug for hepatitis C as safe, effective, FDA records show
NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration’s website ahead of an expert panel meeting to take place Friday.
The FDA’s Antiviral Drugs Advisory Committee will meet Friday to decide whether or not to recommend approval for sofosbuvir combined with the generic antiviral ribavirin or biotech drugs used to treat hepatitis C called interferons. Gilead is seeking FDA approval for the drug in treating patients with hepatitis C genotypes 1-4. Advisory committee votes do not guarantee whether the FDA will approve a drug, but the agency usually follows them.
According to the review, a combination of sofosbuvir with ribavirin in patients with genotypes 2 and 3 of the virus would provide the treatment consisting entirely of orally administered drugs, without interferons, as well as shorter treatment times and better safety than treatments including interferons. While effective in treating and curing hepatitis C, interferons have many side effects, including severe depression.
In addition, the review said the drug would be more effective and faster in patients with genotypes 1 and 4 when combined with interferons and ribavirin.
Cloud computing demands to increase as e-prescribing grows, report finds
NEW YORK — The growing use of electronic prescribing is driving the growth of cloud computing in health care, according to a new report.
The report, by Kalorama Information, found that the global market for cloud computing in health care would grow to $3.9 billion this year, a 2.1% increase over last year and that use of e-prescribing technologies had jumped from less than 10% in 2004 to about 35% in 2010. Over the next few years, the use of e-prescribing will continue to grow due to regulatory disincentives for using paper patient records. Because of this, retail pharmacies, as well as physician offices and hospitals, will adopt cloud computing systems, which are off-site servers that can store information remotely.
"E-Prescribing creates a variety of storage responsibilities for both the physician and the pharmacy, leading to demand for server space," Kalorama publisher Bruce Carlson said. "In health care, space is often limited, and the last thing organizations want is a bulky server."
ACHC renews accreditation for Axium Healthcare Pharmacy
LAKE MARY, Fla. — A group that accredits healthcare organizations has renewed its certification for the Kroger Co.’s specialty pharmacy division.
Axium Healthcare Pharmacy said Wednesday that it received a renewal of its accreditation status from the Accreditation Commission for Health Care for its specialty pharmacy services.
"The renewal of our ACHC accreditation status is a testament to our commitment to our patients, as well as our healthcare partners," Axium president and CEO Mark Montgomery said. "In receiving this continued validation from ACHC, we have demonstrated that our focus on the highest standards in specialty pharmacy has not gone unnoticed."
Review by the ACHC includes onsite surveys by industry experts and assessments of a healthcare company’s organizational structure, policies, procedures, fiscal activities, human resources, quality outcomes, infection control, patient and employee safety and more.