Weekly Roundup 1.15.16

In the mid-Atlantic, it has been a winter without snow. In fact, despite a few genuinely chilly days, it has largely been balmy. I know some people don’t miss it – in fact perhaps most. But I always think there is a spirit-calming benefit to a vast, deep, downy snow that brings traffic – both pedestrian and vehicular – to a halt while we are relegated to sitting inside, making comfort foods and being shaken from our busy routine. Nothing on the horizon for the rest of January, so we can only wait to see what February will bring.

And while we wait, here is a bit of interest from the week:

  • Califf Gets Support from Senate PanelDr. Robert Califf, currently the Deputy Commissioner for Medical Products and Tobacco at FDA and tapped by President Obama as the next Commissioner for the agency received the unanimous support from the Senate HELP Committee this week in a voice vote. However, it was reported in Stat this week as well that the nomination faces some opposition from one Senator over the issue of labeling for genetically modified food – particularly salmon. You can check out the story here.
  • FDA AdComm Recos Approval for Opioid Addiction Treatment – The Psychopharmacologic Drugs Advisory Committee voted 12 to 5 to recommend FDA approve Probuphine as the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction. The treatment must be surgically inserted and removed, treating dependence for up to six months. According to one of the sponsoring companies, this submission was made and accepted by FDA in August 2015 and the action date is February 27, 2016.
  • Developments in Duchenne – This week FDA issued a complete response letter to the company sponsoring an investigational compound, drisapersen, to treat Duchenne Muscular Dystrophy following concerns raised issues during an advisory committee meeting held last year. According to the company release, FDA had outstanding concerns that substantial evidence of efficacy had not yet been met. The company said that extension studies would continue and that patients currently receiving it would continue on drug. While currently there is no FDA approved treatment for this life-threatening genetic disorder, FDA will be considering another candidate at an advisory committee meeting to be held this month. You can read up on the condition, which affects male children, here.

That’s it for me this week folks. It is a long holiday weekend and I hope you all have a pleasant one.

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