After a surprisingly mild August, September begins with summer in full force – heat, humidity and a mosquito rally that is immensely annoying. Forecasts however predict that we only have one more day of this and then a break to temperatures that appear to be much closer to the gentle welcome of autumn. I hope.
I also hope that you enjoyed the short week as a result of the Labor Day holiday. In the meantime, here is a bit of what happened this week (short week – short roundup):
- Approval of Keytruda (pembrolizumab) for Advanced Melanoma – FDA announced this week the accelerated approval of Merck’s new treatment for patients with advanced or unresectable melanoma who are no longer responding to other drugs. Keytruda is a humanized monoclonal antibody andis the first approved drug that works by blocking a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells, but is the sixth melanoma drug approved since 2011. Keytruda was granted breakthrough therapy designation by FDA based on the agency’s assessment that Keytruda may offer a substantial improvement over existing therapies. The company’s press release can be found here.
- First Test for Assessing Risk of Developing Acute Kidney Injury – The NephroCheck Test System was cleared for marketing by FDA – a first-of-a-kind laboratory test to help determine if certain critically ill hospital patients are at risk of developing moderate to severe acute kidney injury. Currently tests can only assess if a patient may already be experiencing acute kidney injury, however this test assess the patient’s risk of developing the condition within 12 hours of the administration of the test.
- Speaking Next Friday at CBI Conference – Next Friday in Philadelphia I will be attending the Social Media Compliance Strategies and Benchmarking Summit where I will be giving a talk providing my take on issues that are outstanding related to FDA’s regulation of social media platforms. You can see the full agenda here.
Have a good weekend everyone. Next week is a long one!
