Weekly Roundup 11.6.15

Every year I am concerned that I will run out of Halloween candy. I never do. Every year there is some left over. Apparently this is my trick and my treat.

We have had an unusual warm spell in the East, making it a balmy opening to November, but nevertheless I find myself craving comfort foods – chili, soups, stews. (Feel free to visit my food blog – www.settingforone.com and don’t worry, the postings are infrequent – it is a hobby.)

It was a relatively quiet week at FDA and OPDP continues to appear dormant when it comes to enforcement. So far this year there are still only nine Warning or Untitled letters issued for the entire year, making this year to be the lowest level of enforcement seen since I’ve been keeping tabs (since 1997 when there were 139 letters issued). And when enforcement has occurred, it has involved relatively small companies – a trend seen over the past few years.

In the meantime, here are a few things that did happen:

  • Guidance Document on HIV Drugs – FDA announced availability this week a guidance document on the development of HIV drugs and is accepting comment related to the guidance. The guidance pertains both to drug and biologic treatments and is for all phases of development, including non-clinical development, early phases, phase 3 protocol designs and endpoints. The guidance also pertains to the range of need – from new drugs to treat to drugs needed to treat those who have viral infection where there is the development of resistance to treatment. The guidance is making final the draft guidance on the same topic and has been revised to reflect comments collected. Additional comment can be submitted at regulations.gov.
  • And Speaking of HIV, A New Treatment Approval – A new combination treatment for HIV was approved this week. Gilead’s Genvoya, a combo fixed dose tablet comprised of elvitegravir, combicistat, emtricitabine, and tenofovir alafenamide as a complete regimen for HIV 1 treatment in adults and pediatric patients 12 years of age and older. The tenofovir in Genvoya is a new form that had not been previously approved and provides lower levels of drug in the blood stream while higher levels within the cells where HIV-1 replicates.  The FDA release also notes that Genvoya appears to have less kidney toxicity and decreases in bone density than previously approved tenofovir regimens and patients also appear to experience greater increases in total cholesterol. Genvoya will carry a boxed warning. The company’s press release can be found here.
  • FDA Approves New Treatment for Severe Asthma – FDA gave the thumbs up to Nucala for the treatment of severe asthma in patients 12 years and older with a history of severe attacks in spite of treatment. Nucala is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells. The treatment is administered once every four weeks by subcutaneous injection into the upper arm, thigh or abdomen. The press release from the company can be found here.

That’s it for me this week. The last of the peanut butter cups (now frozen) will disappear over the weekend, you can bet. Have a good one folks.

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