Well, I am late again with the Weekly Roundup and I once again seek forgiveness. I didn’t even get much time to tweet! It has been a rowdy few weeks and the summer is shaping up to be unruly. We began summer in earnest this week and are already sitting on the cusp of the July 4 holiday. Everything in the garden is growing like weeds, especially the weeds. The grass I never planted sits in a bag in the shed, waiting now for the fall planting. It is just that kind of summer.
Hopefully you have a few moments however to kick back and look at a few of the things that happened this week:
- Diabetes Drug Afrezza Gets FDA Approval – The top approval news this week belongs to Mannkind’s Afrezza, a form of insulin to treat Type 1 and Type 2 diabetes that is administered through inhalation. The inhalation powder is a fast-acting insulin that is inhaled at the beginning of each meal, or within 20 minutes after starting a meal. The approval has been long-sought and is an example of a company coming back after receiving a Complete Response Letter from FDA, not once but twice – in March 2010 and again in January 2011. The agency announced the approval on Friday, stating that Afrezza would have a Boxed Warning regarding the potential for acute bronchospasm in patients with COPD and a REMS program regarding informing physicians of same. In addition, there are post-marketing studies slated for the drug. You can view the company press release here.
- New Device Approval for People with Spinal Injury – FDA also announced approval of the first motorized device that is intended to act as an exoskeleton to be used by people who have lower body paralysis due to a spinal cord injury. Named “ReWalk” – the device is worn over the legs and extends to part of the upper body. The agency said in its release that ReWalk is for people with paraplegia due to spinal injuries at specific sites. In order to use the device, patients and their caregivers will have to undergo training in a program designed by the manufacturer – Argo Medical Technologies which will also be conducting a post-marketing clinical study that will consist of a registry to collect data on adverse events related to the use of the device and to assess the training program. A film news report is available here.
- Nano Nano. FDA Issues Guidances on Nanotechnology Development – There have been a frenzy of guidances recently out of FDA and three final guidance documents and one draft guidance document were issued by FDA regarding the development of products involving nanotechnology in FDA regulated products. Nanotechnology, the agency states, is emerging technology that allows for the creation, exploration and manipulation of materials on a scale that is measured in nanometers (very, very small). Among other things, it may be used to improve food packaging and in the making of cosmetics. FDA has a webpage devoted to the technology. The three final guidances are: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Assessing the Effects of Significant manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives (try tweeting that!); and Safety of Nanomaterials in Cosmetic Products. The draft guidance is on Use of Nanomaterials in Food for Animals.
Time to go enjoy the summer weekend. Have a good one everyone!