Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression).
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Treatment with a gonadotropin-releasing hormone agonist may reduce the risk for chemotherapy-induced amenorrhea, research shows.
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Much of the research defining osteoporosis and fracture risk has focused on older adults, i.e. postmenopausal women and men over the age of 50. While older adults are at highest risk of osteoporosis and related fractures, the disease can also affect younger adults between 20 and 50 years of age. However, the diagnosis and management of osteoporosis in young adults is complicated by special challenges, including a complex pathophysiology and the related fact that there is no clear definition of osteoporosis, or of intervention thresholds, in this age group.
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Female athletes, particularly those involved in high level college sports at the NCAA Division I level, are particularly prone to a trio of medical issues called the "female athlete triad." A new study conducted by sports medicine researchers at the Medical College of Wisconsin found there are some possible shortfalls in the methods used to screen these athletes for the triad, and that could put athletes at risk for lifelong health problems.
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Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.
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Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).
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Novartis Pharmaceuticals Corporation announced today that the US Food and Drug Administration (FDA) approved Afinitor (everolimus) tablets for the treatment of adult patients with kidney tumors known as renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery.
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Watson Pharmaceuticals, Inc. today confirmed that Watson has launched an authorized generic version of PROMETRIUM (progesterone, USP) Capsules 100mg and 200mg, as part of an agreement with Abbott Laboratories.
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The researchers studied the immune response of 107 pregnant women after they were injected with a single dose of non-adjuvant H1N1 vaccine. They concluded that the influenza shot boosted the immune response in pregnant women and at the same time protected neuronatal babies via the antibodies that transferred through the placenta.
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Women still have hot flushes and night sweats years after the menopause finds a new study published today in BJOG: An International Journal of Obstetrics and Gynaecology.
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A Phase III study of Afinitor (everolimus) tablets in patients with non-cancerous kidney tumors, or angiomyolipomas, associated with tuberous sclerosis complex (TSC) met its primary endpoint of best overall angiomyolipoma response rate, which includes reduction in kidney tumor size and absence of new tumors.
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Current estimates of the impact of chemotherapy on women's reproductive health are too low, according to a University of California, San Francisco (UCSF) study.
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POF is not only associated with infertility but also with significantly increased morbidity and mortality, as well as a decreased quality of life equivalent to that of people with type 2 diabetes or rheumatoid arthritis, said Dr. Rumana Islam, from Imperial College, London, UK.
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Women who have higher levels of the appetite-controlling hormone leptin have fewer symptoms of depression, and this apparent inverse relationship is not related to body mass index (BMI), a new study finds.
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A test that shows how many eggs a woman has in her ovaries may help young women with breast cancer know what their reproductive function will be after chemotherapy, a new study finds. The results will be presented Sunday at The Endocrine Society's 93rd Annual Meeting in Boston.
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Young female athletes who have stopped menstruating have a weakening in the quality of their bone structure that may predispose them to breaking a bone, despite getting plenty of weight-bearing exercise, a new study finds. The results will be presented Sunday at The Endocrine Society's 93rd Annual Meeting in Boston.
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Watson Pharmaceuticals, Inc., today announced the U.S. commercial launch of Generess Fe 0.8 mg/25 mcg, a new low-dose oral contraceptive option that's highly effective at preventing pregnancy and proven to provide users with short, lighter, predictable periods.
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Obesity levels are at an all-time high among men, women, and children in the United States. The need for good nutrition and regular exercise is paramount for maintaining proper health and for keeping those extra pounds at bay, especially for women.
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Repros Therapeutics Inc. today announced it has commenced preparation for dosing the 3 mg cohort in the Company's low dose study of Proellex® following a safety review of data from women that have completed 8 weeks of treatment at a 1 mg dose. No signals of liver toxicity were detected to date in the 1 mg group. Unexpectedly, low levels of drug activity were detected in this first cohort. The Company plans to commence dosing of the second group, 3 mg Proellex, next week.
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Sunovion Pharmaceuticals Inc. today announced the results of the PEARL 3 study, the third phase 3 worldwide clinical trial of Latuda® (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with schizophrenia. In this six-week, placebo-controlled trial, both fixed doses of LATUDA 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures.
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