Weekly Roundup 2.13.15

Happy Friday the 13th and the day before Valentine’s Day. It is cold.  There is fierce wind. Boston is due more snow. As if there aren’t enough reasons to dislike February….

For me the week flew by and I hope your’s did as well.  Here is a little bit of what happened that caught my eye as I work on a few things for next week:

  • Thyroid Cancer Approval – Continuing the pattern of last year, FDA approved another drug under priority review this week, this time a kinase inhibitor called Lenvima which is indicated for differentiated thyroid cancer (DTC) for patients who have seen their disease progress despite the fact that they received radioactive iodine therapy. FDA states that DTC is the most common type of thyroid cancer. The company recently announced the Phase III study results published in the New England Journal of Medicine.
  • OPDP Issues First Regulatory Action Letter of the Year – OPDP issued the first Untitled Letter of the year this week, continuing a trend that seems to have taken hold where the division is putting out guidance via regulatory action letters in a trickle, and seems usually aimed at smaller companies. The letter involved the production of a video and the violations cited included minimization of risk, lack of adequate directions for use, omission of material fact and a misleading claim. On the misleading claim, the statement cited was regarding the impact of the product on the well-being of a patient.  Characterizing patient outcomes in video, as written many times here, can easily convey an impression that is outside of what is written in the label.
  • FDA Sets Second AdComm for Biosimilar Product Consideration – A meeting of the Arthritics Drugs Advisory Committee has been scheduled for March 17 to consider a BLA application for another biosimilar – this time for the reference product Remicade® (infliximab) submitted by Celltrion. As noted in an earlier Weekly Roundup at the beginning of the year, the first advisory committee meeting was held to consider a biosimilar application and unanimously voted to recommend approval. It appears the stage is set for a new era of biosimilars in spite of outstanding policy/regulatory questions.
  • FDA Issues Round of Guidance and Policy Docs on Compounding – For some time, FDA has been putting into place the structure around the agency’s newly acquired authority over compounding. On Friday the agency issued four new draft guidance documents and provided an example of a memorandum of understanding between states and the agency. You can find all of the documents in the FDA’s press release on it and the Compounding Tab at the Eye on FDA site has links to all these and more related to the issue.

That’s it for me this week folks.  Stay warm and well. And have a good weekend.

Note:  After original publication on February 13, 2015, this posting was modified to add the later-breaking news of the compounding documents.

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