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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We hope to tidy up around the castle, spend time with our short person, and catch up on our napping. And what about you? As always, the great outdoors is beckoning this time of year. So why not flee the confines of your own castle? Or perhaps this is good time to connect with someone special. Or if you are feeling brave, you could loll about and ponder the future. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon …

The White House is, once again, insisting that drug and device makers pay 100 percent of the funds needed for product reviews conducted by the Food and Drug Administration. “In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it,” the White House said in a statement issued after the House of Representatives passed a bill renewing user fee payments through 2022.


An FDA advisory panel unanimously supported approval of two biosimilars based on two different Roche drugs, BioWorld reports. Amgen hopes to sell a version of the Avastin cancer drug and Mylan and Biocon want to market a version of the Herceptin cancer drug. Although manufacturing issues were not raised at the meeting, these have caused a regulatory issue for the Mylan/Biocon biosimilar in Europe.

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  • For those of you reveling in the possibility of health insurance becoming non mandatory and you develop psoriasis like me, you will either pay $60,000 a year or become a recluse because of ugly, itchy scaly psoriatic plaques covering you from head to toe.

    OR, you could buy health insurance and get yourself qualified for a co-payment assistance program like Abbvie has with Humira, and pay $5/dose.

    Your call.

  • Interesting end to a saga – “The FDA approved a new Johnson & Johnson psoriasis drug called Tremfya that will compete AbbVie’s Humira, …” If you don’t remember, J&J sued AbbVie (when it was still Abbott) over Hunira. They claimed it was an unapproved copy of Remicade; guess not ….. otherwise why would they need Tremfya?

  • No double entendre meant here, but as David Crosby sang “It’s been a long time coming”. One would think these ads have grown tiresome-NOT. I don’t know the technical term, but one important metric is the percentage of a commercial that people actually watch. Viagra, even recently demonstrated a 76% retention, meaning that a 60 second ad on average was watched for about 45 seconds.
    However, the question remains, “is she still the one?”

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