FDA

FDA's Pazdur in the middle of intense debate

admin — Tue, 18 Mar 2008 07:59:59 -0400

The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Patient groups and Read more...

FDA mulls tougher standards on diabetes research

admin — Tue, 11 Mar 2008 07:59:59 -0400

The FDA is taking a look at a fresh set of standards that demand new tests to determine if diabetes drugs elevate heart risks. Safety advocates sounded approving after seeing the FDA draft guidance Read more...

Are researchers facing FDA crackdown on trial fraud?

admin — Tue, 26 Feb 2008 06:59:59 -0500

The RPM Report is predicting--or perhaps just speculating--that the FDA is gearing up for a significant crackdown on drug investigators. Clinical investigators found to have committed fraud or Read more...

U.S. pipeline bone dry for new antibiotics

admin — Tue, 29 Jan 2008 06:59:59 -0500

Even as the demand for new antibiotics grows, new research programs to advance fresh therapies have been drying up fast. While existing antibiotics steadily weaken against the onslaught of some Read more...

Study outlines billions in potential R&D savings

admin — Tue, 30 Oct 2007 07:59:59 -0400

Better standardization of data collection and analysis could save between 25 percent and 48 percent of R&D expenses for each new drug approved by the FDA, according to a new study sponsored by Read more...

Compounds that rev up SSRI drugs

admin — Tue, 11 Sep 2007 06:59:59 -0400

A researcher has identified a method for boosting the activity of antidepression drugs--an advance that could revolutionize the way these therapies work. Huge amounts of Read more...

FDA to address nanotech standards

maureen — Thu, 26 Jul 2007 15:19:46 -0400

Nanotechnology has enormous potential to revolutionize the drug, medical device, cosmetic and food industries, but according to a new report, the FDA lacks a standard regulatory procedure for Read more...

Two new diabetes drug targets identified

admin — Mon, 11 Jun 2007 20:01:39 -0400

Scientists at Penn and Howard Hughes Medical Institute believe that their investigation of the role fat metabolism plays in the development of Type 2 diabetes has pointed to a new drug target. Their focus is a protein that plays a role in fat metabolism. The protein Akt2/PKB prevents fat metabolism by adding a phosphate group to PGC-1a, which is needed to trigger the genes needed for fat metabolism. Both PGC-1a and Akt2/PKB are good targets for new drug development, according to the …

Glaxo turns to auto company for research ideas

admin — Mon, 09 Apr 2007 20:01:39 -0400

GlaxoSmithKline had to play a serious game of catch-up in its quest to develop a new vaccine for cervical cancer. Four years ago, Glaxo's vaccines division--GSK Bio--concluded that it was two years behind Merck's program for an HPV vaccine. In order to bridge that yawning gap, researchers at the company adopted a new approach developed by automaker Renault called the "one roof" approach. The company plucked a variety of experts it needed from different fields and put them together under …

Bacteria may help treat depression

admin — Mon, 09 Apr 2007 20:01:39 -0400

An experimental cancer therapy may help point the way to a new treatment for clinical depression. The approach was inspired by work done by Dr. Mary O'Brien at the Royal Marsden Hospital in London, who injected lung cancer victims with Mycobacterium vaccae, a harmless version of bacteria that causes tuberculosis and leprosy. After the therapy was injected, the physician noted not only fewer symptoms of cancer, but an improvement in emotional health as well. Researchers followed …