Weekly Roundup 5.23.14

We were all feeling a little pent up this Winter and delighted to see Spring.  And what is more delightful than seeing others delighted?  Check out the Weekly Roundup video of dairy cows greeting the meadow after a winter in the barn.  It will make you feel good.

And while you are busy feeling good and before enjoying the holiday weekend, take note of a few of the things that happened this week out of FDA:

  • FDA Moves on Illegal Online Pharmacies – In conjunction with other federal and international agencies, FDA went after online pharmacies selling unapproved prescription drugs to U.S. consumers.  Inspections were conducted at U.S. based international mail facilities resulting in discovery of many packages that were ordered from online sources outside of the U.S.  The action was part of an operation that resulted in detention and seizure of nearly 20,000 packages containing unapproved or counterfeit drugs.  According to the FDA spokesperson people ordering drugs outside of the legitimate supply chain cannot know if the product they receive even contains the correct active ingredient, dose or even if it is the intended medicine.
  • FDA Approves First Gene-Based Test to Determine Red Blood Cell Types in Transfusion – BioArray Solutions Ltd. of Warren, New Jersey received approval for its Immucor Precise Type Human Erythrocyte Antigen (HEA) Melectular BeachChip Test, the first molecular assay to be used to assist in determining blood compatibility in the U.S.  The product was reviewed in March by the Blood Products Advisory Committee.  An FDA spokesperson was quoted as saying that the assay “provides an alternative to serological typing and may enhance patient care in certain situations”.
  • FDA Approves New Ulcerative Colitis and Crohn’s Disease Treatment – An injectable to treat adults with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease  was approved this week by FDA.  While not a cure, the treatment offers a new option for patients who have not responded adequately to convention therapies.  Entyvio is an itegrin receptor antagonist.  While no cases of progressive multifocal leukoencephalopathy (PML) were seen in clinical trials of this drug, PML has been seen in use with another type of integrin receptor antagonist and so post-marketing studies will continue on that front.

That’s it for me this week.  Kick back and enjoy your time in the meadow.

Video courtesy of Anne Becker.

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