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PTSM: Pharmaceutical Technology Sourcing and Management

Although North America accounts for the largest share of the pharmaceutical market, Brazil, China, India, Indonesia, Mexico, Russia, and Turkey are projected to account for almost one-fifth of the global market by 2020. The rising participation in select countries' drug-development activities is evident by recent investment and outsourcing by the pharmaceutical majors.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The United States Pharmacopeia announced that its implementation period for the USP-National Formulary General Notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter 467 has been extended from July 1, 2007 to July 1, 2008.

ePT--the Electronic Newsletter of Pharmaceutical Technology

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.

Innovations Abound

Here's a look at some of the most interesting and thematic responses you-our readers-provided for Pharmaceutical Technology's anniversary survey of industry advances and directions.

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Trenton, NJ (May 18)-Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey (HINJ). Modest job growth in this field is expected for the next four years, states the report.

ePT--the Electronic Newsletter of Pharmaceutical Technology

June 21 (London)-The European Medicines Agency agreed to follow up with patients affected by Roche Registration Limited's (Basel, Switzerland) "Viracept" (nelfinavir), which was recalled earlier this month. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing.

ePT--the Electronic Newsletter of Pharmaceutical Technology

New York (June 19)-The US District Court for the Southern District of New York affirmed the validity and enforceability of Sanofi-Aventis's patent on clopidogrel bisulfate, the active ingredient in the company's coronary artery disease treatment "Plavix."

ePT--the Electronic Newsletter of Pharmaceutical Technology

Basel, Switzerland (June 6)-Roche, in an agreement with the European Medicines Agency and the Swiss Agency for Therapeutic Products, recalled all batches of "Viracept" (nelfinavir) powder and tablets in Europe and some other regions of the world.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Cambridge, MA (June 7)-Genzyme Corp. is growing, with a new biomanufacturing plant planned and other expansions nearing completion.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Thousand Oaks, CA (June 4)-Amgen agreed to acquire Ilypsa (Santa Clara, CA), a private company that develops nonabsorbed drugs for renal disorders, for $420 million.