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Launch Of Fund To Advance Scientific Discoveries Into Clinical Practice, UK
The Department of Health and the Wellcome Trust invited proposals from organisations and research groups seeking to draw on funding from the Health Innovation Challenge Fund to further the development of innovative healthcare products
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Treatable Hormonal Condition Sometimes Overlooked In Infertility Patients
A condition known as congenital adrenal hyperplasia, or CAH, is easily treatable but frequently overlooked or misdiagnosed, leading to infertility and other "perplexing symptoms," the New York Times reports. CAH is a hormone deficiency that leads to excess production of androgens, which can hinder ovulation in women and cause low sperm count in men. It also can cause short stature, body odor, acne, irregular menstruation and excessive hair growth. The condition can be diagnosed through a blood test and treated with small doses of the steroid dexamethasone, which can reverse symptoms in three months to two-and-one-half years.According to Maria New, a leading authority on CAH and a professor of pediatrics and human genetics at Mount Sinai School of Medicine, the disease occurs in one in every 100 people in the general population. It is more common among certain ethnic groups, occurring in one in 27 Ashkenazi Jews and one in 40 Hispanics. Not everyone with the condition has symptoms or needs to be treated. The most severe form of the disease, classic CAH, can result in ambiguous genitalia in girls, while the milder nonclassical form sometimes produce no symptoms, the Times reports.Many fertility clinics do not test for the disease or only test after attempting other treatments. Some obstetricians are unaware of CAH and its effect on fertility, according to Zev Rosenwaks, director of the Center for Reproductive Medicine at New York Presbyterian-Weill Cornell hospital. CAH also can be confused with polycystic ovarian syndrome -- which has some similar symptoms -- or early puberty in younger patients (Tarkan, New York Times, 7/7).
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Human Genome Sciences Announces Completion Of Enrollment In Phase 2b Monthly-Dosing Trial Of Albuferon(R)
Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that Novartis has completed enrollment and initial dosing in a Phase 2b clinical trial to evaluate the safety and efficacy of Albuferon(R) (albinterferon alfa-2b) administered monthly in combination with ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
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FDA Accepts Final Section Of NDA Filing For LUCASSIN(R)

Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN(R) (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1. The filing was completed on May 4, 2009, and LUCASSIN has been granted Priority Review as well as Orphan Drug status and Fast Track designation. HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months. In September 2008, Ikaria acquired the North American rights to LUCASSIN, including responsibility for manufacturing, distribution, marketing, sales, customer service and post-market development. Those rights will be transferred to Ikaria following marketing approval. LUCASSIN is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS. Terlipressin was recently approved in France, Ireland, Spain and South Korea for the treatment of patients with HRS Type 1. Terlipressin is not approved by the FDA for use in the U.S. About Orphan Therapeutics, LLC Orphan Therapeutics, LLC, is a privately held drug development company dedicated to developing treatments for rare and serious diseases. It was founded in 2003 with the initial purpose to develop and seek U.S. FDA approval for its first product, LUCASSIN(R) (terlipressin), for the treatment of hepatorenal syndrome (HRS) Type 1. About Ikaria Holdings, Inc. Ikaria Holdings, Inc. is a biotherapeutics company whose acute care products and therapies address the significant unmet needs of critically ill patients. The company"s lead product, INOmax(R) (nitric oxide) for inhalation, is the only FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns, and also is marketed in Canada, Europe, Latin America and Australia. INOmax is approved for marketing in Japan and Mexico. Ikaria is engaged in new and ongoing clinical development of INOmax, carbon monoxide for inhalation and hydrogen sulfide. Ikaria also acquired the North American rights to terlipressin, which currently is under review by the FDA for the treatment of hepatorenal syndrome Type 1. Ikaria is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI, and a manufacturing facility in Port Allen, LA. Ikaria Holdings Inc


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