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ThromboGenics And BioInvent Start Recruitment Of Second 100 Patient Cohort In Phase II DVT Prophylaxis Study With TB-402
ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have started recruitment of a second cohort of patients for their Phase II trial of TB-402. This follows completion of recruitment of the first cohort of 100 patients ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The decision to move ahead with the second cohort of this trial follows unanimous advice from the external efficacy and safety monitoring board to proceed using a higher dose of TB-402.

UQ Ipswich Campus 10th Anniversary And Launch Of Teaching Of Medicine, Australia
An event to mark the celebrate the 10th anniversary of the UQ Ipswich Campus and the launch of UQ"s teaching of Medicine at UQ Ipswich will be held today, Friday, July 24, 2009.
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U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial In Trauma Patients Remains On FDA Hold
Biopure Corporation (Nasdaq: BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure"s oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission, including the most recent, was placed on clinical hold.
Oncology

Joint Statement On Atypical Antipsychotic Use In Children

As advocates for people living with mental illnesses, we strongly urge the FDA to carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations. Access to safe and effective treatments, including more information about all treatment options, is crucial to treating these serious and complex conditions in children and adolescents. Bipolar disorder and schizophrenia are very real, life-threatening diseases which can appear in childhood and adolescence. For example, federally funded research (STEP-BD) found that, of 3,658 adult patients studied, 68% reported bipolar disease onset in childhood or adolescence. Patients with child onset had, on average, fewer days of euthymia (or neutral mood), greater impairment in functioning and poorer quality of life. Those with adolescent onset have better outcomes than those with child onset, but were still worse off than those who did not suffer from bipolar disorder until adulthood. These alarming statistics highlight the need for early recognition and treatment, which offers children and adolescents their best chance to achieve and maintain wellness. We encourage an open and transparent scientific discourse about all pharmacologic treatments that come before the Advisory Committee and urge the Committee to carefully weigh the available evidence regarding safety and efficacy. No one treatment option works for all children. In order for physicians and families to make informed treatment decisions they need access to a full range of medications and treatment options and to the research regarding the risks and benefits of these treatments. More long-term clinical research in children and adolescents is also needed to better understand the risks and benefits of these medications when used over an extended period. As we know, these medications can also have serious side effects, which is why it is crucial that parents and physicians have as much information as possible in order to make informed decisions and weigh the risk of side effects and adverse reactions against the risk of not treating these very serious diseases. Other treatments for grave childhood illnesses such as cancer can cause hair loss, nausea, compromised immune systems and even death. However, few people question the necessity of these aggressive forms of treatment. Like cancer, aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer. The best way to protect the health of our nation"s children and adolescents is to increase access to treatment options and communicate accurate, scientific information that helps parents and physicians cope with and properly treat these devastating illnesses. Our non-profit national mental health advocacy and medical professional organizations represent consumers, physicians, researchers and the top experts in the field of mental health and neuroscience. Mental Health America


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