Weekly Roundup 4.1.16

The year is now officially one-fourth done. We have a long, hot summer to slog through that will no doubt be followed by a tumultuous autumn election cycle, so it is perhaps best now to take time and enjoy the budding green, the delicate blossoms, the fragrant breezes and appreciate them fully.

That’s my advice anyway. And here is a bit of what was interesting in an very interesting week:

  • Revised Labeling for Mifepristone – First approved in 2000 for use in terminating  an early pregnancy, mifeprisone has had a label change to reflect the experience with the drug since it came to the market. This week, the label was revised to update both the dosing regimen and the route of administration as well including a modification to the gestational age up to which the drug has been shown to be safe and effective and the process for follow-up administration of the drug. The REMS program associated with the use of the drug was also updated. FDA set up a Q&A page regarding the changes.
  • Zika Blood Screening Test Made Available– As mosquito-summer months approach, another plank has been added to the public health platform being built around the potential for Zika transmission in the U.S.  This week FDA announced that an investigational test was cleared for use to screen donated blood for Zika to be utilized in areas where there has been active transmission. Making this screening tool available follows on the heels of the issuance of a guidance last month on donor screening and protecting the blood supply. On a related note, the World Health Organization announced this week that it had received notification of the first cases of transmission in Cuba and Domenica (which had resulted in the CDC posting a notice for those traveling to Cuba.
  • AdComm Recommends Approval for Parkinson’s Psychosis Drug – This week at a meeting of the Psychopharmacologic Drugs Advisory Committee members considered a new drug application for NUPLAZID (pimavanserin) for use in treating psychosis in patients with Parkinson’s. The drug application has Priority Review and has been designated as a Breakthrough Therapy. The ultimate vote on benefit/risk for the drug was 12-2 and the date for FDA action was acknowledged in the company release to be May 1, 2016. Background documents from the meeting can be found here.

That’s it for me this week folks. Have a good weekend and don’t fall for any April fool’s jokes!

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