Weekly Roundup – 10-11-13

For Washington, it is real quiet.  This week on my way to work while driving past the Lincoln Memorial, there was a man with a lawn mower unofficially mowing the lawn.  The Federal Register which reports on all of the meetings and activities of the U.S. government is really tiny.  Surprisingly, traffic at rush hour does not seem to have lessened very much. Everyone seems perplexed by that.

Yet despite the inaction, there has been some limited activity, and here is a bit of it:

  • Approval for Pulmonary Hypertension Drug – The agency announced approval of Adempas (riociguat) for the treatment of adults with two types of pulmonary hypertension.  It is a first-in-class drug treatment – called soluble guanylate cyclase stimulators that help arteries to releax thereby increasing blood flow and decreasing blood pressure.  The drug carries a boxed warning and REMS program because the drug should not be used in pregnant women.
  • FDA Approves New Pediatric Use for Liposorber Apheresis SystemFDA announced approval of Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before or after kidney transplantation where there is a recurrence of FSGS.  The condition as described in the release is one where there is scarring that develops on part of the kidneys causing a loss of protein from the blood into the urine.  A majority of children who have the condition will progress to end-stage renal disease and a high number of children affected who have a transplant experience a recurrence.
  • Senator Sends Letter to FDA Seeking Answers About Painkiller Meeting – Senator Joe Manchin of West Virginia sent a letter this week to FDA seeking answers to a series of questions in the wake of a Washington Post story regarding a meeting held to discuss painkiller clinical trials and efficacy standards that included academics, government officials and industry, but where industry was charged money to attend.  However, a spokesperson for FDA did make clear that the meeting was not initiated by FDA.

That’s it for me this rainy day in Washington.  Accept my wishes for a pleasant and restful weekend to you all.

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