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Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that familiar routine of meetings, deadlines, and what-not has, predictably, returned. To cope, we are resorting, as always, to cups of stimulation. And all the better to help us tune out a long-running windstorm attacking the Pharmalot campus and nearby environs. The ongoing, 60-mile-per-hour gusts give new meaning to the idea that life is a breeze. Meanwhile, here are some tidbits. Hope your day goes well and do stay in touch.

Roche (RHHBY) is buying Spark Therapeutics (ONCE) for $4.8 billion in hopes of expanding its presence in the market for treating hemophilia, The Wall Street Journal reports. Hemophilia is a new and emerging category for Roche; in 2017, the Food and Drug Administration approved a hemophilia A treatment, Hemlibra, which analysts expect will have billions of dollars in yearly sales. Moreover, as STAT notes, the deal underscores the desire among the largest drug makers to sell gene therapies and that such big biopharma deals are back.

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  • If Commissioner G and Director Woodcock are correct that imported drugs are truly safe, then does that mean the multiple 483’s posted by CDER are just chaff? Or are the companies (notably in India) correct to say the findings are ‘merely procedural’ as opposed to being serious?
    What was the name of that B&W TV quiz show … “Who do you trust,” perhaps? Just sayin ….

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