Oncology

The FDA's New Breakthrough Therapy Designation The FDA recently added a new designation, ‘Breakthrough Therapy’, to its roster of pharmaceutical regulatory terminology in order to ensure that truly innovative compounds get to the patients who need them most as soon as possible.  This new designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA).  The Breakthrough Therapy designation will provide companies with the opportunity for [...]

Interesting Data for Pharma and Biotech Drug Developers ASCO’s second meeting of the year, ASCO GU, is coming up next week, and here is our list of anticipated data releases for renal cell carcinoma.  (Note that full abstracts won’t be available until February 12, so it is impossible to comment on the significance of these results until then.) It looks to be a quiet meeting this year for RCC, [...]

Abstract titles are up for ASCO GI, and here’s a list of the abstracts we are looking forward to seeing next week.  (Note that full abstracts won’t be available until January 22, so it is impossible to comment on the significance of these results until then.) Abraxane positive in phase III for pancreatic cancer The Abraxane study in pancreatic cancer (abstract 67) is likely to be the major news from [...]

A Possible Development Pathway for Biotech Companies with PanHER Inhibitors? Many Breast Cancer Patients Not Helped by Herceptin For more than ten years oncologists have been aware of the role that Herceptin (trastuzumab, Roche/Genentech) has played in extending the lives of women with HER2 overexpressed breast cancer. Herceptin works by blocking the HER2 receptor from receiving activating stimuli from outside of the cell. In addition there is a second [...]