PHARMACY

Roadside Medical Clinic + Lab to open 11 new sites

BY Antoinette Alexander

LAS VEGAS Roadside Medical Clinic + Lab, which operates a network of retail health clinics for over-the-road professional truck drivers, announced on Thursday that emergency room physician Royce Brough has received licenses for 11 sites throughout six states.

Brough, a practicing emergency room physician with more than 35 years of experience, will be opening a location in Oklahoma City, Okla., within the next 90 days followed by Dallas in the first quarter 2010. The remaining sites, to be located in California, New Mexico, New Jersey and Indiana, will be open “as quickly as possible.”

“Keeping with our mission to deliver convenient healthcare to professional drivers coast to coast we are pleased to be working with Dr. Royce Brough to grow a national network of velocity through franchising and licensing,” stated Bob Perry, president of Roadside Medical Clinic + Lab and vice chair of the American Transportation Association Safety Management Council’s Health & Wellness Working Group. “Dr. Brough is an accomplished physician and we are fortunate to have him on board with Roadside Medical Clinic + Lab.”

Brough is also founder of The Brough Group and Hospital Physicians of America.

Roadside Medical Clinic + Lab began offering franchising and licensing opportunities within a limited number of markets in February 2009. Since then the company has secured sites in Tennessee, Arkansas, Illinois and Georgia.

Through an exclusive partnership with Pilot Travel Centers, the company provides cost-effective convenient care medical services including DOT physicals and compliance, wellness programs, sleep apnea studies and treatment and nutritional products for drivers. Pilot is the largest operator of truck stops in the United States with more than 300 locations in 41 states. Roadside Medical Clinic + Lab has planned for a total of 80 sites throughout the United States located exclusively at Pilot Travel Centers in order to meet the needs of the 4.2 million over-the-road professional drivers.

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D2 Pharma Consulting launches interactive Web site

BY Michael Johnsen

ST. CHARLES, Mo. D2 Pharma Consulting on Wednesday launched its new interactive Web site — www.D2Rx.com. The Web site will integrate a “D2Rx Blog” with up-to-date industry information focused on keeping pharmaceutical and biotech executives current with industry information.

“We believe it’s our highly experienced, hands-on approach that differentiates us from similar service providers,” stated Dean Erhardt, D2 principal.

D2 provides outsourced solutions to emerging and established companies for the commercialization, distribution and marketing of pharmaceuticals, medical devices and biotech pharmaceuticals. Together with their strategic partners, D2 offers commercialization services for the clients’ approved products across the traditional, medical device and specialty pharmaceutical categories.

“D2 has the experience and knowledge to facilitate the commercialization process for the emerging BioPharma and Pharma companies,” stated fellow D2 principal Dan Steiber. “Our site is designed to assist both established and emerging organizations on key issues that may impact their commercialization efforts.”

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FDA approves Hib vaccine from GSK

BY Allison Cerra

PHILADELPHIA In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae Type b, GlaxoSmithKline has received accelerated approval from the Food and Drug Administration for Hiberix as a booster dose in children 15 months through 4 years of age.

Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.

The Hib vaccine [Haemophilus b conjugate vaccine (tetanus toxoid conjugate)] shortage began in 2007 when another vaccine manufacturer temporarily suspended manufacturing of its Hib-containing vaccines. This led the Centers for Disease Control and Prevention to recommend temporary deferral of the booster dose for healthy children not at increased risk for Hib disease, GSK said.

Earlier this summer, the CDC reinstated the routine Hib booster dose due to an increase in supply. However, supply was not sufficient to support a mass catch-up effort for the millions of children who did not receive the booster dose during the shortage. Hiberix will help restore supply so children who missed the booster dose can get caught-up. Additionally, children coming in for routine visits can receive the Hib booster shot on time.

The CDC recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization in infants.

The review of Hiberix for the booster indication was conducted under accelerated approval regulations due to the shortage of Hib vaccine supply in the United States. GSK submitted safety and efficacy information from clinical studies conducted outside the United States for this review. In those studies, a booster dose of Hiberix following primary series vaccination provided protective levels of antibodies against Hib bacteria, regardless of the priming vaccine that was used.

“We are pleased that we were able to respond to this public health need,” said Peter Lammers, VP U.S. vaccines at GlaxoSmithKline. “GSK was able to act swiftly to increase supply of Hib vaccine so that children can complete the vaccination schedule as recommended by the CDC.”

More than 54 million doses of Hiberix have been distributed outside the United States since the 1996 launch in Germany, and the vaccine currently is registered in nearly 100 countries.

The vaccine is expected to be available within several weeks.

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