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Common diabetes drug metformin works in gut, not the bloodstream

Although metformin was introduced as a treatment for type 2 diabetes nearly 60 years ago and is now the recommended first-line treatment for newly diagnosed patients, researchers still debate precisely how the drug works.

19 Aug 2015

Palatin applauds FDA's approval of flibanserin for women living with hypoactive sexual desire disorder

Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential. Palatin's lead product under development is bremelanotide for the treatment of female sexual dysfunction (FSD).

19 Aug 2015

Liraglutide drug combined with diet and exercise promotes weight loss in diabetic patients

Among overweight and obese patients with type 2 diabetes, daily injection of the diabetes drug liraglutide with a modified insulin pen device, in addition to diet and exercise, resulted in greater weight loss over 56 weeks compared with placebo, according to a study in the August 18 issue of JAMA.

19 Aug 2015

Study shows alcohol intoxication does not affect accuracy of sexual assault testimonies

People are often concerned about the accuracy of testimony given by victims who were intoxicated during a sexual assault- but a new study by University of Leicester researchers has found that while alcohol intoxicated participants report fewer pieces of information about an assault, the information that they do provide is just as accurate as sober participants.

19 Aug 2015

Intarcia Therapeutics announces positive top-line results from ITCA 650 Phase 3 FREEDOM-2 clinical trial

Intarcia Therapeutics, Inc. today announced positive top-line results from its 52-week Phase 3 FREEDOM-2 clinical trial to determine the comparative efficacy of the company's late-stage investigational candidate ITCA 650 to Merck's Januvia in reducing HbA1c in patients with type 2 diabetes following a year of treatment.

18 Aug 2015

Omeros reports additional positive data from OMS721 Phase 2 trial for treatment of thrombotic microangiopathies

Omeros Corporation today announced additional positive data in the company's Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) – aggregations of platelets – in the microcirculation of the body's organs, most commonly the kidney and brain.

18 Aug 2015

Intoxicated victims of sexual violence could accurately retain information from events

18 Aug 2015

Researchers examine how GABA supplementation enhances planning, controls different actions

People show an enhanced ability of prioritizing planned actions after the ingestion of the food supplement GABA. Psychologists Laura Steenbergen and Lorenza Colzato, with their colleagues at the Leiden Institute of Brain and Cognition and fellow researchers from the Technical University of Dresden, published their findings in Scientific Reports.

18 Aug 2015

Vitamin D supplements may help reduce risk of falls in homebound elderly

Every year falls affect approximately one in three older adults living at home, with approximately one in 10 falls resulting in serious injury. Even if an injury does not occur, the fear of falling can lead to reduced activity and a loss of independence.

18 Aug 2015

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD

17 Aug 2015

Omeros plans to file patent infringement lawsuit against Par

Omeros Corporation today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

17 Aug 2015

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

Neurocrine Biosciences, Inc. announced today that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Mono-Amine Transporter 2 (VMAT2) compound NBI-98854 in tardive dyskinesia patients.

13 Aug 2015

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

ImmunoCellular Therapeutics, Ltd. announced today that it has reached agreement with the US Food and Drug Administration on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma.

13 Aug 2015

Researchers analyze inclusion/exclusion criteria used in antidepressant efficacy studies

Mark Zimmerman, M.D., a clinical researcher at Rhode Island Hospital, and his team analyzed the criteria used in antidepressant efficacy studies (AETs) and learned that the inclusion/exclusion criteria for AETs have narrowed over the past five years so that the most patients are excluded. The research was published today in Mayo Clinic Proceedings.

13 Aug 2015

Ardelyx reports net income of $9.0 million for second quarter 2015

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on gastrointestinal and cardio-renal diseases, today announced financial results for the second quarter ended June 30, 2015.

12 Aug 2015

Testosterone administration not associated with atherosclerosis progression among older men

Among older men with low testosterone levels, testosterone administration for 3 years compared with placebo did not result in a significant difference in the rates of change in atherosclerosis (thickening and hardening of artery walls), nor was it associated with improved overall sexual function or health-related quality of life, according to a study in the August 11 issue of JAMA.

12 Aug 2015

TEAAM trial finds that testosterone has no effect on atherosclerosis progression

Testosterone sales have grown rapidly over the last decade, but few studies have examined the long-term effects of taking testosterone on cardiovascular health and other important outcomes. This week, investigators from Brigham and Women's Hospital report the results of the Testosterone's Effects on Atherosclerosis Progression in Aging Men (TEAAM) trial in the Journal of the American Medical Association.

12 Aug 2015

IQWiG dossier assessment finds no added benefit for vortioxetine in depression

Vortioxetine (trade name: Brintellix) has been approved since December 2013 for the treatment of depression in adults, but did not become actually available before May 2015. The German Institute for Quality and Efficiency in Health Care examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier because it contained no data evaluable for the assessment.

12 Aug 2015

Mount Sinai launches clinical trial to test effectiveness of ticagrelor drug in treating coronary stent patients

The Icahn School of Medicine at Mount Sinai has launched an international clinical trial called TWILIGHT to test the safety and effectiveness of treating coronary stent patients with the anti-clotting medication ticagrelor alone, instead of combining it with aspirin, which is the current standard of care. Researchers will analyze the potential benefits of administering ticagrelor to reduce clotting while at the same time reducing the risk of bleeding associated with the use of both medications.

12 Aug 2015

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label.

11 Aug 2015

Placebo News and Research

Common diabetes drug metformin works in gut, not the bloodstream

Palatin applauds FDA's approval of flibanserin for women living with hypoactive sexual desire disorder

Liraglutide drug combined with diet and exercise promotes weight loss in diabetic patients

Study shows alcohol intoxication does not affect accuracy of sexual assault testimonies

Intarcia Therapeutics announces positive top-line results from ITCA 650 Phase 3 FREEDOM-2 clinical trial

Omeros reports additional positive data from OMS721 Phase 2 trial for treatment of thrombotic microangiopathies

Intoxicated victims of sexual violence could accurately retain information from events

Researchers examine how GABA supplementation enhances planning, controls different actions

Vitamin D supplements may help reduce risk of falls in homebound elderly

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Omeros plans to file patent infringement lawsuit against Par

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

Researchers analyze inclusion/exclusion criteria used in antidepressant efficacy studies

Ardelyx reports net income of $9.0 million for second quarter 2015

Testosterone administration not associated with atherosclerosis progression among older men

TEAAM trial finds that testosterone has no effect on atherosclerosis progression

IQWiG dossier assessment finds no added benefit for vortioxetine in depression

Mount Sinai launches clinical trial to test effectiveness of ticagrelor drug in treating coronary stent patients

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

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