Harvard research discusses the heart’s interactions with the body
BOSTON Despite the once-common view of the heart as a standalone pump, the organ has connections to other organs throughout the body. A special section in the September 2009 issue of the Harvard Heart Letter explores interactions between the heart, brain, lungs, bones and other parts of the body.
For example, chronic lung diseases such as emphysema can enlarge the heart’s right ventricle, while kidney damage increases the chances of a heart attack or stroke, and mental conditions such as depression, loneliness and anger can promote or exacerbate heart attacks.
Japanese drug maker permitted to start clinical trials of diabetes drug
OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.
Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.
The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.
FDA rejects application for new epilepsy drug
TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.
Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.
J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.