Weekly Roundup – 4.18.14

There were audible gasps all over the Internet from people experiencing yet more snow this week – the week of Easter break for many.  Freeze warnings here threatened my young herbs planted only a few days before over a warm and languid weekend.  But at last, it appears that Spring has made its arrival, just lacking a little in confidence.

But there hasn’t been much of a thaw at FDA.  Not many press releases, no speeches, no testimonies and very little warning letter action.  Still, here are a few tidbits from the week that I thought would be of interest:

  • New Type 2 Diabetes Drug Approval FDA announced approval of GSK’s Tanzeum (albiglutide), a once-weekly subcutaneous injection to improve glycemic control for adults with Type 2 diabetes.  The agency said that the drug was being approved with a Boxed Warning and a REMS program as well as a requirement for several types of post-marketing studies, including dosing, efficacy and safety in pediatric patients and a cardiovascular outcomes trial.  According to the company release, albiglutide has been approved in Europe in March and expects to launch in the U.S. sometime in the third quarter of this year.
  • FDA Approves New Allergen for Ragweed Earlier in the month FDA approved the first sublingual allergen extract for the treatment of grass pollen allergies and this week approved the first sublingual product to treat short ragweed pollen induced allergic rhinitis (also known as hayfever).  The newly approved product, called Ragwitek, is to be used 12 weeks before the beginning of the ragweed season with the first dose being administered in the physician’s office and the balance at home.  There is a Boxed Warning for the product informing that severe allergic reactions, some of which can be life threatening, can occur and the product will come with a MedGuide.
  • IMS Report on Medicine Use – The IMS Institute for Healthcare Informatics released the report – “Medicine Use and Shifting Costs of Healthcare:  A Review of Medicines Used in the U.S. in 2013”.  Among other things, the report finds that after a decline in 2012, drug spending increased in 2013 once again, new products were launched and fewer patents expired.  It is filled with a wealth of information from the fact that prescriptions for pain meds dropped by 1 percent to an increase in contraceptive medications by 4.6 percent.  The release of the report includes videos overviewing the key findings and if you want the report you can download it from the IMS Institute site or you can get the IMS Health App on an iPad and get it there, which is pretty neat.
  • FDA Discourages Use of Procedure for Removal of Uterine Fibroids – FDA made a safety related announcement yesterday that made the front page of some papers today.  The agency announced this week that the use of laparascopic power morcellation – a procedure that is one of several available for treatment for fibroids – was discouraged as a treatment by the agency after finding that approximately 1 in 350 women who are undergoing a hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer.  The procedure works by dividing the tissue into smaller pieces or fragments that can be removed through laparascopy. FDA said there dis a risk the procedure could spread the cancerous tissue, thus posing a risk.

That’s it for me this week folks.  Please have a good weekend.

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