Weekly Roundup 9.18.15

For those of us hungry for it, we had our first taste of autumn. It has been lovely to sleep with windows open. Granted the long shadows appear earlier than they used to and the sun is setting from a new angle. The Farmer’s Markets are selling off the tomatoes and corn and the root vegetables are beginning to appear in greater number. Summer storms have stopped and the leaves will soon grow tired.

But we won’t. Here is a bit of what happened this week:

  • New FDA Commish On the Way? – To the surprise of no one, the White House announced a slew of new appointments this week and among them was the name of the newly proposed FDA Commissioner Dr. Rob Califf. Since March 2015, Dr. Califf has been the Deputy Commissioner for Medical Products and Tobacco at FDA and has came to the agency from the Duke University School of Medicine and the Duke University Medical Center. And he is a former advisory committee member, having served on the FDA Cardiovascular and Renal Drugs Advisory Committee from 1996 until 2000. He has many other accolades, achievements and qualifications for the job which you can read here. The appointment gets him part of the way there, the next hurdle will be confirmation by the Senate.
  • FDA Blocks Sale of New Ciggies – The agency announced this week that it had issued orders to block the further sale and distribution of four brands of cigarettes being marketed by R.J. Reynolds Tobacco Company. According to the FDA release, the four products entered the market under a provisional period where the company had to submit an application outlining substantial equivalence of the product to an existing, valid “predicate” product. In examining the applications, the agency found differences existed between the products and their predicates that made them not substantially equivalent and therefore issued the orders.
  • Fast Trackers and Breakthroughs – Two notable fast track status updates, both on the same day. Mapp Biopharma announced that the company had received fast track status from FDA for ZMapp™, an investigational compound being researched in relation to treating Ebola. Also Can-Fite Biopharma announced fast track status had been granted to CF-102 being studied as second-line treatment of hepatocellular carcinoma (HCC). Both drugs had already received orphan designation. Additionally this week breakthrough therapy status was given to BMS’ Opdivo being considered for the potential indication of treating advanced or metastatic renal cell carcinoma (RCC). Need a brush up on the different status designations of Fast Track, Breakthrough, Priority Review and Accelerated Approval?  Then click here.
  • New Approval in Schizophrenia and Bipolar – Vraylar™ (cariprazine) capsules received FDA approval this week in the treatment of schizophrenia and bipolar disorder in adults, the agency announced. As with all other FDA-approved drugs to treat these conditions the label will carry a Boxed Warning. The company press release can be found here.

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

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