Regulatory News for September 2009

Regulatory News Archive

FDA and EMEA grant orphan drug designation for Antisense Pharma's investigational drug trabedersen in pancreatic carcinoma FDA and EMEA grant orphan drug designation for Antisense Pharma's investigational drug trabedersen in pancreatic carcinoma

Orphan drug designation ensures market exclusivity for seven to ten years after market approval.

Heart disease patients don’t take their medicines Heart disease patients don’t take their medicines

At least a quarter of people with heart disease don’t take vital medicines that have been prescribed to them to prevent heart attacks and strokes.

NICE issues guidance on the use of other treatment options for renal cancer NICE issues guidance on the use of other treatment options for renal cancer

The National Institute for Health and Clinical Excellence (NICE) recently issued guidance on the use of bevacizumab, sorafenib and temsirolimus for the treatment of renal cell carcinoma and the use of sorafenib and sunitinib for second-line treatment options for people with renal cell carcinoma.

NICE recommends cetuximab for the first-line treatment of metastatic colorectal cancer NICE recommends cetuximab for the first-line treatment of metastatic colorectal cancer

The National Institute for Health and Clinical Excellence (NICE) recently published final guidance on the use of cetuximab for the first-line treatment of metastatic colorectal cancer.