Weekly Roundup

This week we had our first snowfall.  The unseasonably cold temperatures have stayed, and so has the Congress, trying to do all of the things it did not do for two years in the last two months.  The tree is up, the house is decorated and most of the gifts bought.  There are menus to plan and travel arrangements to make.  And then… rest.

In the meantime, here is a bit of what happened this week:

  • AstraZeneca Gets CRL – The FDA sent AstraZeneca a Complete Response Letter yesterday regarding its antiplatelet treatment Brilinta.  The company said that the agency was not seeking new clinical studies, but was requesting additional analyses of existing data.  While a CRL is never the hoped for outcome, Brilinta did get a 7-1 favorable recommendation from the Advisory Committee in July and was approved for marketing in Europe earlier this month.
  • FDA Acts to Remove Breast Cancer Indication on Avastin – Anyone with a pulse heard yesterday that the agency has begun to move to take the indication for the treatment of breast cancer from the Avastin label.  This is a story that will continue to play out for some time, as the company has indicated that it will request a hearing on the matter.  The decision has many on both sides of the issue providing commentary and opinion and there have been published reports that Congressman Fred Upton, who is the incoming chair of the House Energy and Commerce Committee has indicated that hearings will be held on the matter.
  • Settlement Regarding Health Claims and Probiotics – The FTC announced this week a settlement with Dannon about health claims related to use of the products Activia and DanActive.  Specifically, the agency reported that Dannon will stop claiming that one daily serving of Activia relieves irregularity, and that DanActive helps people avoid catching colds or the flu.  There has been other activity this year on this issue, notably this fall when the FTC also filed a complaint around claims made related to pomegranate products.  It is an interesting and developing area to track.

Thats it for me this week.  Have a good weekend folks and stay warm!

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