HEALTH

Schering-Plough moves forward on Zegerid switch, responds to FDA complete response letter

BY Michael Johnsen

SAN DIEGO There is still an opportunity for a second proton-pump inhibitor to join Novartis Consumer Healthcare’s Prevacid 24HR this fall.

Santarus on Tuesday announced that Schering-Plough HealthCare Products has submitted its response to the Food and Drug Administration’s complete response letter issued in January.

Schering-Plough had licensed the OTC switch rights from Santarus for Zegerid, an omeprazole/sodium bicarbonate combination product, in 2006.

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Vitamin Shoppe to sell Jarrow Formulas probiotic

BY Michael Johnsen

LOS ANGELES, Calif. Jarrow Formulas on Friday announced that Vitamin Shoppe will be the first national retailer to sell Jarro-Dophilus CDS, a vegetarian capsule of seven clinically-documented probiotic strains to provide a broad spectrum of health benefits.

“Jarro-Dophilus CDS contains a high concentration of 20 billion total probiotic bacteria per capsule,” stated Peilin Guo, EVP Jarrow Formulas. “A gel-forming matrix helps protect them during transit through the stomach to assure effectiveness. All of these features make it a unique, premium product with great value.”

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WHO: Rotavirus vaccination should be included in all national immunization programs

BY Michael Johnsen

GENEVA The World Health Organization on Friday recommended that rotavirus vaccination be included in all national immunization programs in order to provide protection against a virus that is responsible for more than 500,000 diarrheal deaths and 2 million hospitalizations annually among children.

“This is a tremendous milestone in ensuring that vaccines against the most common cause of lethal diarrhea reach the children who need them most,” stated Thomas Cherian, coordinator of the expanded program on inmunization, WHO Department of Immunization, Vaccines and Biologicals.

More than 85% of these deaths occur in developing countries in Africa and Asia, WHO stated. This new policy will help ensure access to rotavirus vaccines in the world’s poorest countries.

The new recommendation by the WHO’s Strategic Advisory Group of Experts, extends an earlier recommendation made in 2005 on vaccination in the Americas and Europe, where clinical trials had demonstrated safety and efficacy in low- and intermediate-mortality populations. New data from clinical trials which evaluated vaccine efficacy in countries with high child mortality has led to the recommendation for global use of the vaccine. This is reported in the Weekly Epidemiological Review published June 5.

The GAVI Alliance, vaccine manufacturers and the public health community made an unprecedented commitment to understand how these vaccines would work in developing-world conditions. The clinical trial, funded in part by GAVI and conducted by PATH, WHO, GlaxoSmithKline and research institutions in high-mortality, low-socioeconomic settings of South Africa and Malawi, found that rotavirus vaccine significantly reduced severe diarrhea episodes due to rotavirus.

In 2006, the GAVI Alliance added rotavirus vaccines to its portfolio of vaccines for which it provides financial support to developing countries, underscoring GAVI’s commitment to reduce the traditional 15- to 20-year lag between the introduction of new vaccines in wealthy countries and their availability in the developing world.

“The GAVI Alliance welcomes this exciting recommendation,” stated GAVI CEO Julian Lob-Levyt. “It represents another important step in our ability to achieve significant impact on under-five deaths in the world’s poorest communities and make progress towards the Millennium Development Goals. We are extremely excited about the potential to offer African and Asian countries funding to introduce rotavirus vaccines.”

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