- Author: Health Informer
- Filed under: Health News
- Date: Nov 11,2010
Legacy applauds HHS Secretary Kathleen Sebelius and the leadership at the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) for its bold new effort announced to dramatically reduce the number of American lives lost annually to tobacco-related disease. Still the number one preventable cause of death, tobacco continues to claim more than 400,000 lives each year in the United States.
The announcement included a proposed rule, Required Warnings for Cigarette Packages and Advertisements, requiring more prominent warnings to better communicate the deadly effects of tobacco. As Secretary Sebelius shared with us today, anyone who picks up a pack of cigarettes will soon clearly understand the risk that comes with smoking. Placing prominent color photos and warning statements will hopefully help young smokers make more informed decisions about lighting up, and give current smokers a renewed commitment to quit their addiction for good.
The proposed graphic warnings would significantly cover the front of cigarette packs, replacing the current warnings on the narrow side of cigarette packs, and would be required as part of the new proposed rule. The proposed warnings include images of tobacco-related cancers and even the corpse of an individual who has passed away from lung cancer. Read the rest of this entry »
If you're new here, you may want to subscribe to my RSS feed. Thanks for visiting!
- Author: Health Informer
- Filed under: Health News
- Date: Nov 10,2010
Key FDA Clinical Meeting Held; Company on Track to Initiate Phase 3 Trials for Menerba
Bionovo, a pharmaceutical company focused on the discovery and development of safe and effective treatments for women’s health and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s total clinical development plan for Menerba, the company’s drug candidate for menopausal hot flashes.
“We had a very positive meeting with the FDA on our clinical program for Menerba. As anticipated, they agreed with our overall clinical development plan which included the number of clinical trials, number of subjects and length of exposure as well as non-clinical studies necessary for New Drug Application (NDA) submission for a non-estrogen drug such as Menerba. They also provided useful suggestions for improving the clinical trial protocols,” said Mary Tagliaferri, M.D., Bionovo’s President and Chief Medical Officer. “While we are awaiting the formal minutes from the FDA meeting, we are moving forward to implement the agency’s suggestions and have forwarded the approved clinical trial design to our investigators and their investigational review boards, or IRBs.”
“Menerba is a first-in-class, unique drug candidate that is intended for a large medical need, for the safe and effective treatment of menopausal symptoms,” said Isaac Cohen, Bionovo’s Chairman and Chief Executive Officer. “We want to do everything necessary to bring Menerba to market for the treatment of hot flashes, while we also investigate its potential use in the treatment of breast cancer prevention. Now that we have agreements with the FDA and the EMA (the European Medicines Agency) on the overall development of Menerba, we have accelerated discussions with potential partners to successfully bringing Menerba to market.”
- Author: Health Informer
- Filed under: Health News
- Date: Nov 9,2010
While the vast majority of physicians recognize the contribution of genetic tests for improving medication response by guiding the prescribing and dosing of many widely-used medications, most doctors don’t feel they know enough about these tests to put them into practice.
However, new data from the Medco Research Institute — a research subsidiary of Medco Health Solutions — shows that when both physicians and patients are informed about choices regarding testing and the process is made convenient, the adoption of genetic tests is substantially increased – an advance that can lead to safer and more effective use of medications. The new data were presented this past weekend at the Annual Meeting of the American Society for Human Genetics.
The use of genetic testing in patients on the blood thinner warfarin and the breast cancer prevention drug tamoxifen has been low in routine practice. But according to the analysis, when a proactive pharmacy-based pharmacogenomic testing program was implemented, the incidence of testing in patients on warfarin was nearly 45-times higher, and was nearly 7-times higher among patients on tamoxifen as compared to the pre-program time period.
“It’s quite remarkable that we saw such a huge jump in the adoption of genetic testing following the proactive outreach to physicians and patients to inform them about the availability of the tests,” said Eric Stanek, PharmD, Medco’s senior director of personalized medicine research and the study’s lead researcher. ”It shows quite convincingly that physicians and patients can understand the value of these tests when choice, information, genetic testing, and results reporting are made accessible and convenient. This is a very important step in establishing a model that can substantially move the genetic testing needle forward and expedite its adoption in routine clinical care on a broad scale.” Read the rest of this entry »
- Author: Health Informer
- Filed under: Health News
- Date: Nov 9,2010
Arena Pharmaceuticals and Eisai Inc. reported that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes.
In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, as described below, lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.
The BLOOM-DM study evaluated 604 obese and overweight patients with type 2 diabetes. Patients were randomized to lorcaserin 10 mg BID (N=256), lorcaserin 10 mg dosed once daily (QD) (N=95) or placebo (N=253). To expedite enrollment, randomization to the lorcaserin 10 mg QD dose was discontinued after approximately 300 patients were enrolled in the trial.
The three primary efficacy endpoints at Week 52 were as follows: the proportion of patients who lose at least 5% of their baseline body weight; change from baseline in body weight; and the proportion of patients who lose at least 10% of their baseline body weight. Using Modified Intent-to-Treat Last Observation Carried Forward (MITT-LOCF) analysis, lorcaserin 10 mg BID met the three primary efficacy endpoints by producing statistically significant weight loss compared to placebo (p<0.0001). At Week 52, 37.5% of patients treated with lorcaserin 10 mg BID achieved at least 5% weight loss, more than double the 16.1% of patients taking placebo. Patients treated with lorcaserin 10 mg BID achieved mean weight loss of 4.5% (4.7 kg), compared to 1.5% (1.6 kg) for placebo. Also, at Week 52, 16.3% of lorcaserin 10 mg BID patients achieved at least 10% weight loss, compared to 4.4% of patients taking placebo. Read the rest of this entry »