FDA Devising New Guidelines To Expedite Testing, Approval Of Multidrug Regimens. The Wall Street Journal reported that the FDA is creating new guidelines aimed at expediting the testing and approval process for multidrug regimens that include new, experimental drugs for some deadly diseases. The agency normally requires each treatment in a drug cocktail to be tested and approved separately. FDA Commissioner Margaret Hamburg said the move "represents a bigger issue -- the strengthening of regulatory science" to include scientific advances.
FDA Changing Rules For Testing Tuberculosis Drugs.
Bloomberg News reported that the Food and Drug Administration is now "changing rules for testing tuberculosis drugs to enable Johnson & Johnson, Sanofi-Aventis SA, and Pfizer, Inc. to speed up approval of new combination treatments by decades." In a March 18 statement, the "Global Alliance for TB Drug Development, a research group funded by the Bill & Melinda Gates Foundation and national governments," announced that "at least 10 companies agreed to work together to test experimental tuberculosis treatments simultaneously in new combinations," instead of developing "each component of a therapy...independently," a process that requires "24 years to make novel combinations."
Insulin patch is on track for clinical trials.
Phosphagenics Limited’ s TPM (Targeted Penetration Matrix) insulin project should begin human trials in the first half of 2010. For this product, the company has adapted the patch technology that it had developed for its oxycodone program. The company also has achieved dose optimization that reduces substantially the amount of insulin required for a therapeutic dose and has demonstrated through tests on animals that the product lowers glucose levels.
New Study Aims To Identify Effective Breast Cancer Treatments Quickly.
"Breast cancer researchers say they could cut years off the time required to test new drugs for treating certain kinds of tumors under a study about to begin at the University of Minnesota and the Mayo Clinic." The study is designed to help researchers "quickly identify which drugs are effective for different groups of patients, based on the genetic or molecular makeup of their tumors." The "drugs that show no benefit can be quickly dropped, without wasting years and millions of dollars on further study."
Three companies have joined the government in the "$26 million trial set to last five years," The trial includes five drugs, which "the FDA is now involved in fast-tracking...but says it is important to find the right drug for the right patient." Dr. Anna Barker, deputy director of the National Cancer Institute, "says that as a result" of the study, "life-saving drugs will get to patients much faster."
There are reports that patients will be matched to the drugs based on their DNA, and the drugmakers agreed to share information on predicting patient response using their genes. The study will include Abbott Laboratories' veliparib, Amgen's conatumumab and AMG 386, and Pfizer Inc.'s figitumumab and neratinib.
Different Pediatric Asthma Cases Do Best With Different Step-Up Treatments.
Researchers at the University of Wisconsin have discovered that "different kids do best with different step-up treatments" once they find that their "regular steroid inhaler fails to prevent asthma attacks."
According to the paper in the New England Journal of Medicine, the "drugs with the best chance of success -- 45% -- are long-acting beta-agonists," however, "safety concerns limit the use of these agents." Investigators also discovered that approximately "30% of kids...do best either with a leukotriene-receptor antagonist, or by doubling the dose of the child's current inhaled steroid medication," but there is "no clear winner," and "there were few clues to predict which kids were most likely to do best on which step-up treatment."