FDA Awards Breakthrough Therapy Designation to Boehringer’s Lung Cancer Candidate
News Jan 06, 2016
BI 1482694 is a third-generation EGF mutant-specific tyrosine kinase inhibitor that has demonstrated strong anti-tumor activity and a favorable safety profile in patients whose tumors have stopped responding to currently available EGFR-directed therapies, according to the company.
The FDA awarded the designation based on results from Phase 1/2 clinical trial presented at the ESMO Asia 2015 Congress in Singapore.
Boehringer has an exclusive license and collaboration agreement with Hanmi Pharmaceutical for the development and commercial rights to BI 1482694, except in South Korea, China and Hong Kong.
Researchers Discover Key Link Between Mitochondria and Cocaine AddictionNews
Researchers were able to block response in mitochondria to cocaine.READ MORE
Insulin Goes Viral: Diabetes and Cancer-causing Mechanisms ExploredNews
Every cell in your body responds to the hormone insulin, and if that process starts to fail, you get diabetes. In an unexpected finding, scientists have identified four viruses that can produce insulin-like hormones that are active on human cells. The discovery brings new possibilities for revealing biological mechanisms that may cause diabetes or cancer.READ MORE
Pre-Clinical Safety in Cancer Drug Development: “Attitude to Safety Needs to Change”News
Many companies involved in cancer drug research and development need to re-think their use of safety data in helping to bring new drugs to cancer patients.
Dr Richard Knight of ApconiX will tell this month’s conference, that greater focus on pre-clinical safety should be fundamental to the development of new cancer therapies.