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July 2007

July 31, 2007

Abbott To File In Thailand For Kaletra Pediatric AIDS Indication

In an apparent change of position, Abbott will file for approval of a pediatric formulation of its antiretroviral protease inhibitor Kaletra (lopinavir/ritonavir) tablets in Thailand, the firm announced July 27.

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July 30, 2007

Chinese Province Implements Pilot Quality System To Strengthen Drug Safety

SHANGHAI – In the latest effort to strengthen drug safety measures in China, Guangdong province has taken a page out of the international quality systems playbook, launching a pilot system July 20 that assigns responsibility for drug manufacturing quality to a designated company official.

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Sepracor Signs Agreement With Eisai To Market Lunesta In Japan

Eisai will develop and market Sepracor's insomnia treatment Lunesta (eszopiclone) in Japan under an in-licensing agreement announced by the companies July 26.

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Guangdong’s Online Bidding System Drives Down Drug Prices

SHANGHAI – Public medical institutions in China’s Guangdong province will look to lower drug prices by purchasing pharmaceuticals directly from manufacturers via a new online bidding system set to launch in August, according to government officials.

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Weekly Roundup: July 30, 2007

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Drug Firms Model Ensuring Import Safety; China's Inconsistencies Worry FDA

Firms using Chinese imports to make dietary supplements and other products can look to drug firms for lessons on ensuring the safety of raw materials from China, where adherence to food and drug production regulations remains inconsistent, current and former FDA executives tell a Senate panel.

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Blame China? Experts Advise Congress, Industry Take A Wider View

The global scope of food safety is becoming apparent, and recent problems with products imported from China are but a part of U.S. food safety concerns, industry experts say.

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NPD Group Now Watching China

Market research firm NPD Group will begin tracking prestige beauty sales in China, the company announces.

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July 24, 2007

Nuon Turns To Innovator Kissei For Advice Developing Mature Drug Tranilast In New Indications

Nuon Therapeutics has formed a licensing, supply and collaboration agreement with tranilast innovator Kissei Pharmaceutical that will enable the start-up to tap the Japanese firm's expertise as it develops the mature drug in new autoimmune indications, Nuon CEO Rodney Pearlman explained in an interview with "The Pink Sheet" DAILY.

Continue reading "Nuon Turns To Innovator Kissei For Advice Developing Mature Drug Tranilast In New Indications" »

July 23, 2007

New Registration Provisions Will Strengthen Chinese Oversight Of Pharma Industry

SHANGHAI – China’s State Food and Drug Administration revised its drug registration provisions July 12, improving supervision and tightening approval standards in the wake of widespread concern related to drug safety.

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