BioMarin Pharmaceuticals saw its stock-market value increase by more than a fifth on Friday as the biopharmaceuticals maker got U.S. government approval to sell a first-of-its-kind drug.

BioMarin Pharmaceutical (nasdaq: BMRN - news - people ), which focuses on drugs for rare genetic diseases, received approval from the U.S. Food and Drug Administration late Thursday to begin shipping its phenylketonuria medication. The daily pill, called Kuvan, or sapropterin dihydrochloride, is the first treatment to hit the market for phenylketonuria, a rare genetic disorder that can cause mental retardation.

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Forbes.com

The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs). The changes have been issued as a direct final rule and as proposed rules with comments due by February 19, 2008. Should no significant comments be received, the rule will be finalized on April 17, 2008.

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biopharminternational.com

13/12/2007 - The first steps in tightening the safety controls on the pharmaceutical ingredients imported to the US from China have been taken following months of negotiations between the regulatory bodies of the two countries.

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in-pharmatechnologist.com

14/12/2007 - Merck has been hit with a contamination threat prompting the recall of a million of its childhood Hib vaccines across the US, right alongside the Canadian suspension of its MMR vaccine.

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in-pharmatechnologist.com