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April 25, 2014

Vol. 11 No. 82

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FDA Hosts Drug Development Meeting for Neurologic Manifestations of Inborn Metabolism Errors

The meeting is one step toward fulfilling the agency’s patient-focused drug development requirements under PDUFA V. Read More

Eisai Introduces Access to Medicines Website

Eisai says the site is written at a level aimed at the general public, but includes specific drug inserts for professionals. Read More

DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

The FDA is getting some new, though not unexpected, authority this week by way of its parent organization, the U.S. Department of Health and Human Services. Read More

Vietnam Pharma Market to Grow 20 Percent By 2017

Vietnam’s pharmaceutical market grew nearly 17 percent last year to a value of over $3 billion, and is expected to grow a further 20 percent by 2017, say new market forecasts. Read More

Dr. Reddy’s Laboratories Launches Lipid Controlling Drug in U.S. Market

Pharma major Dr. Reddy’s Laboratories has launched Fenofibrate capsules, a therapeutic equivalent generic version of Antara capsules, in the U.S. market. Read More

GAVI Alliance to Present Plans to Expand Impact of Vaccines By 2020

As five African countries prepare to celebrate World Immunization Week with the impending introduction of new vaccines, the GAVI Alliance is finalizing plans to build on its successes with a major drive to increase access to vaccines and the impact of immunization programs by 2020. Read More

Gates-Backed TB Drug to Enter Late-Stage Testing

The first experimental drug, financed in part by the Bill & Melinda Gates Foundation, that fights both conventional and drug-resistant forms of tuberculosis is advancing to late-stage clinical testing, researchers said on Wednesday, raising hope for a new way to stem the growing threat of drug-resistant TB. Read More

Nuvo, Ferndale Partner to Develop Two Topical Dermatology Products

Canadian pharmaceutical firm Nuvo Research has entered into a collaboration involving Ferndale Laboratories and a leading Contract Research Organization with significant dermatology experience for the development of two topical dermatology products. Read More