Weekly Roundup 3.18.16

St. Patrick’s Day is behind us, Easter is before us. And yet, there is a forecast of snow for our area here in the mid-Atlantic looming before us for the weekend. Yes, it is that delightful time of the year when on a recent warm day edging into the mid-seventies you might be inspired to plant your herbs even though something tells you it is too early, and then Mother Nature reminds you that in fact, it was.

Still, we persevere and here are a few things that happened this week I wanted to convey:

  • FDA Starts New Twitter Feed – This week the agency added yet another twitter feed to its assembly of twittering pronouncements called FDA Patient Network – a/k/a @FDA_Patient_Network – making of a total of 18 FDA Twitter feeds. As of this writing, the feed had only two tweets, but the description on the home page for the feed states that they will cover a “range of FDA-specific topics and conducts numerous activities that are of interest to patients” – which seems pretty broad, but hey the more, the merrier. And if you are interested, the @eyeonfda twitter feed has a list to which you can subscribe where you can see all FDA tweets (and feeds) and what FDA is saying.
  • FDA Provides Alteration to Approving Generics – Recently you may have noticed many headlines reporting where the price of a single available generic product were raised astronomically to much public criticism. This week, FDA responded by issuing a new policy that will speed up approvals for generic drugs and prioritize approvals where there is only one product available. This could dramatically speed up the number of competitive generics available thereby making such pricing actions less practical.
  • Expanded Use of Biologic for Use in Lung Cancer – FDA announced expanded approval of Xalkori (crizotinib) for use non-small cell lung cancer for treating tumors that have an ROS-1 gene alteration. As noted in the agency’s press release one of the things that makes lung cancer so difficult to treat is the existence of different mutations. This is the first treatment approved by the agency for treating this particular mutation. The expanded use application had FDA breakthrough status, priority review as well as being designated orphan status. You can review the meaning of these status designations here. You can see the company press release here.

That’s it for me this week folks. Have a great weekend.

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