Categories
Cardiovascular
Diagnostics
Endocrinology
Health Insurance
Medical Devices
Mental Health
Nutrition
Oncology
Public Health
Sexual Health
Popular Articles

New York Times Examines Debate Surrounding Use Of Experimental Treatments In Terminally Ill Patients
Some patient advocates are lobbying to legalize "compassionate use" of experimental drugs for people with terminal illnesses who have exhausted other treatments, prompting a debate about how and when to provide such patients with treatments that could prolong their lives, the New York Times reports. Most insurers do not cover unproven treatments, and physicians have concerns that using experimental treatment could give patients false hope and cause unnecessary pain. Drugmakers are concerned that if there are unfavorable outcomes from providing patients with an unproven treatment, it could hurt the drug"s chances of receiving FDA approval. At the same time, FDA does not want to grant drugs and their makers the opportunity to skip clinical trials. Currently, patients must individually apply to receive treatments through compassionate use (Harmon, New York Times, 5/17).
generic viagra online
Study: Benefit To Women Not Enough To Sway Men To Get HPV Vaccine
Informing men that a new vaccine to prevent human papillomavirus (HPV) would also help protect their female partners against developing cervical cancer from the sexually transmitted infection did not increase their interest in getting the vaccine, according to a new Florida State University study.
News of the day
House Democrats To Unveil Health Care Bill Details
"After a series of false starts, House Democrats are finally expected to unveil the details of a sweeping reform measure on Tuesday that would drastically revamp the country"s health care system," Politico reports. "Party leaders had initially planned to introduce legislation last week and start considering it in committees this week. But that timeline was scuttled when a parade of moderates threw up their arms last week at a draft of the bill offered weeks earlier by the three chairmen writing it." While the Democrats "know that the clock is ticking-that the slower the process goes, the more time opponents will have to plant doubts in the minds of voters," Republicans are "feeling giddy-free to stand back and watch as Democrats fight amongst themselves."
Cardiovascular

FDA Approves TYVASO (Treprostinil) Inhalation Solution For The Treatment Of Pulmonary Arterial Hypertension

United Therapeutics Corporation (Nasdaq: UTHR) announced that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories). TYVASO is indicated to increase walk distance in patients with NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. "We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition," said Martine Rothblatt, Ph.D., United Therapeutics" Chairman and Chief Executive Officer. "I want to specially recognize Drs. Werner Seeger of Germany and Lew Rubin of the United States for their critical pioneering efforts in making this new therapy possible. TYVASO epitomizes the hopes and dreams we had in forming this company." In connection with the TYVASO approval, United Therapeutics has agreed to Post-Marketing Commitments (PMC) to modify certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify expected dosing with the modified device. "We are well underway with the modifications to the TYVASO Inhalation System," said Roger Jeffs, Ph.D., United Therapeutics" President and Chief Operating Officer, "And we think these modifications will make the device more patient-friendly. In the meantime, patients will use the current version of the device." We have committed to complete the PMC no later than October 31, 2010. Additionally, United Therapeutics has agreed to a Post-Marketing Requirement (PMR) to conduct a long-term observational study to evaluate the risk of oropharyngeal and pulmonary toxicities among patients using TYVASO. "We welcome the opportunity to gather further information on TYVASO"s safety," continued Dr. Jeffs. We have committed to complete the PMR no later than December 15, 2013. In the TRIUMPH-1 randomized, double-blind, 12-week placebo-controlled clinical trial, patients taking TYVASO in four daily inhalation sessions achieved a 20-meter improvement in six-minute walk distance over those taking placebo (p= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain and diarrhea. United Therapeutics plans to launch TYVASO in conjunction with its wholly-owned subsidiary, Lung Rx, Inc., in the United States at the beginning of September 2009. About TYVASO TYVASO is an inhaled medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. TYVASO contains the same active ingredient (treprostinil) as REMODULIN (treprostinil sodium) Injection, which is also approved for the treatment of PAH. TYVASO is marketed by United Therapeutics and its wholly-owned subsidiary, Lung Rx, Inc. Nearly all clinical experience has been on a background of an endothelin receptor antagonist or a phosphodiesterase type 5 inhibitor. Important Safety Information for TYVASO TYVASO is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to increase walk distance. TYVASO is intended for oral inhalation only. TYVASO is approved for use only with the TYVASO Inhalation System. The safety and efficacy of TYVASO have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease). Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and any loss of drug effect. In patients with low systemic arterial pressure, TYVASO may cause symptomatic hypotension. TYVASO may also increase the risk of bleeding, particularly in patients receiving anticoagulants. The concomitant use of TYVASO with diuretics, antihypertensives or other vasodilators may increase the risk of systemic hypotension. Hepatic or renal insufficiency may increase exposure and decrease the tolerability of TYVASO. The most common side effects (>= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain and diarrhea. Please see the TYVASO full prescribing information or patient information for further details. About United Therapeutics United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer. Forward-looking Statements Statements included in this press release concerning, among others, the benefits of TYVASO for patients, our future activities to improve the TYVASO Inhalation System and its usability, our conducting a post-marketing usability analysis of the modified TYVASO Inhalation System device, the timing of completing the usability analysis, our conducting a post-marketing observational study of TYVASO, the timing of completing the observational study, and our plans to commercialize TYVASO in the United States are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and current reports on Form 8-K, which could cause actual results to differ materially from anticipated results. We are providing this information as of July 31, 2009, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthr-g] REMODULIN is a registered trademark of United Therapeutics Corporation. TYVASO is a trademark of United Therapeutics Corporation. Optineb is a registered trademark of NEBU-TEC GmbH. United Therapeutics Corporation


Add your comment:
Name:
Site address: http://
Your message:
Enter today\\\\'s date, 2 digits
(spam protection):

© Copyright 2009