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R&D Directions Insider

Archive for September, 2009

Oral opioid-induced constipation drugs present big opportunity for AstraZeneca

Wednesday, September 23rd, 2009

Earlier this week, AstraZeneca and Nektar Therapeutics signed a worldwide agreement for two development programs to address opioid-induced constipation for $125 million. NKTR-118 has completed a Phase II clinical trial and is being developed to treat constipation caused by the use of opioid pain products. NKTR-119, in preclinical development is ...

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More muscle needed for regulatory science …

Thursday, September 17th, 2009

Or all the billions of dollars poured into biomedical research and development in the U.S. wonâ€™t mean a thing. That was the prevailing message delivered yesterday by new FDA commissioner Margaret Hamburg during a candid keynote address at the Regulator Affairs Professionals Societyâ€™s annual conference in Philadelphia. â€œIn order to strengthen ...

Posted in Uncategorized | No Comments »

FDA OKs H1N1 vaccine

Wednesday, September 16th, 2009

The news is out: FDA has approved the new swine flu vaccine. Limited supplies are expected to arrive the first week of October, with about 45 million doses arriving around the middle of October. The vaccine will be available at up to 90,000 sites, including schools and clinics across the ...

Posted in H1N1, infectious diseases, vaccines | No Comments »

Regulatory minds meet in Philly

Tuesday, September 15th, 2009

Â The City of Brotherly Love is the site of this week's Regulatory Affairs Professionals Society'sÂ 2009 Annual Conference & Exhibition. With much change afoot these days at FDA and healthcare reform dominating the American consciousness (more on that later), it's no surprise the theme for this year's event is "Succeed in ...

Posted in Uncategorized, animals, cancer, clinical trials, vaccines | No Comments »

Researchers dig ‘hedgehog’ data

Friday, September 4th, 2009

Next month, R&D Directions will feature the magazineâ€™s 9th annual report on the top 10 areas of research. But first, of course, we must do our own research on what exactly it is researchers are researching these days. That requires, for yours truly, a fair amount of news digging and brain ...

Posted in animals, cancer, clinical trials, plants | No Comments »

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