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Morning Read: One less reason to rag on the FDA?

June 20, 2012 8:41 am by | 0 Comments

An assistant professor at Yale is offering up more proof that the FDA isn’t as slow as people think in approving new drugs. In an original study published in NEJM, Joseph Ross and colleagues found that the amount of time a new drug application actually spent being reviewed by the FDA (in the 2001-2010 time period) was nearly two months shorter than the time it took at the European Medicines Agency and Health Canada.

A new, second round of number crunching looks at the total amount of time from submission to approval and finds that, although there are much greater variations in approval time with the FDA, it’s still quicker on average. (However, the analysis only includes drugs that were eventually approved). Take a look at this chart and breakdown from Forbes.

With one-fifth of its population uninsured, California is one of the biggest beneficiaries of President Obama’s healthcare law and would take a hard hit if the Supreme Court does away with it. Officials say the state would lose out on as much as $15 billion annually.

HHS has committed $400 million to companies including GlaxoSmithKlineand Novartis to speed up the development and manufacturing of treatments against bioterror and pandemic threats.

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Not only are many companies bringing healthcare services on-site, they’re now bringing pharmacies, too, according to NPR. Employers see this as a way to keep workers at the office and promote drug adherence.

California-based StemCells Inc. reported encouraging results from an early trial using human neural stem cells to treat Pelizaeus-Merzbacher disease. If it succeeds in larger trials, the therapy could lead to new treatments for multiple sclerosis, cerebral palsy and Alzheimer’s disease, the company says.

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Deanna Pogorelc

By Deanna Pogorelc MedCity News

Deanna Pogorelc is a Cleveland-based reporter who writes obsessively about life science startups across the country, looking to technology transfer offices, startup incubators and investment funds to see what’s next in healthcare. She has a bachelor’s degree in journalism from Ball State University and previously covered business and education for a northeast Indiana newspaper.
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