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Good morning, everyone, and welcome to another working week. We hope the weekend respite — which was an extended break on this side of the pond — was relaxing and invigorating, because that oh-so-predictable routine of meetings, deadlines, and the like has, of course, returned. What can you do? The world, after all, keeps spinning. So now that the short people have trudged off to their respective destinations, we are firing up the coffee kettle and digging in for a busy day. On that note, here are some tidbits to get you going. Hope your day is swell and do keep in touch …

Novartis (NVS) pricing is about to be tested after it won European Union approval for a blindness-fighting gene therapy whose $850,000 list cost in the U.S. has been labeled too expensive by some groups, Reuters reports. Luxturna, sold by Spark Therapeutics (ONCE) in the U.S. but by Novartis elsewhere, is a one-time treatment for a rare genetic disease that causes blindness in about 1 in 200,000 people. But the list price could face hurdles in Europe where authorities are taking a tough look at expensive medicines.

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  • OnSun Pharma and their “star crossed” site in Cranbury NJ. Consider from their 2010 warning letter [Aug 25th] – 2 (a) a. Although your firm was aware of imploding bottles of Gemfibrozil Tablets, 600mg, in September 2009, you did not initiate a root-cause investigation or conduct a recall to the retail level until our inspection. The retain samples from fifteen lots of Gemfibrozil Tablets, 600 mg, imploded while in your retain sample room ….”
    Odd that they did not notice? And the street address struck me at the time – same one as for Able Labs of “unhappy memory.”
    Note: This was covered in Pharmalot at the time

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