Insomnia News and Research

Latest Insomnia News and Research

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

Researchers develop new drugs to prevent post-traumatic stress syndrome

Post-traumatic stress syndrome - when a severely stressful event triggers exaggerated and chronic fear - affects nearly 8 million people in the United States and is hard to treat. In a preclinical study, Northwestern Medicine scientists have for the first time identified the molecular cause of the debilitating condition and prevented it from occurring by injecting calming drugs into the brain within five hours of a traumatic event.

7 Dec 2010

Amgen announces final study results of Nplate in adults with chronic ITP

Amgen Inc. today announced the final results from a 5-year open-label extension study investigating the long-term efficacy and safety of Nplate (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura. Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events.

6 Dec 2010

Lundbeck reports positive phase III study data of clobazam in treating seizures associated with LGS

Today, Lundbeck Inc. presented positive data from its pivotal phase III study to determine the efficacy and safety profiles of the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome.

6 Dec 2010

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa (zoledronic acid) significantly improved overall survival and progression-free survival in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

4 Dec 2010

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

Sleep plays a crucial role in post-infarction remission

The heart and the brain appear to be even more closely connected than previously imagined. The damaging effects of myocardial infarction are apparently not confined to the heart, but also affect the brain.

2 Dec 2010

Clinicians should assess sleep-wake disturbances to understand physiology of Parkinson's disease

Nearly three-quarters of patients with Parkinson's disease experience fatigue or excessive daytime sleepiness (EDS), but clinicians should assess both problems separately in order to improve the profession's understanding of their distinct, but overlapping, physiology. That is the key finding of a study published in the December issue of the European Journal of Neurology.

1 Dec 2010

Common sleep complaints predict development of metabolic syndrome: Study

A study in the Dec. 1 issue of the journal SLEEP found that loud snoring and two common insomnia symptoms difficulty falling asleep and unrefreshing sleep each significantly predicted the development of the metabolic syndrome. The study emphasizes the importance of screening for common sleep complaints in routine clinical practice.

1 Dec 2010

New brain imaging technique can trace effects of SYN115 drug in Parkinson's disease

Neuroscientists using a new brain imaging technique could see an investigational drug for Parkinson's disease get into a patient's brain and affect blood flow in several key structures, an indicator the drug may be effective.

1 Dec 2010

Prescription rates for controlled medications double for teens, young adults

Adolescents and young adults are most likely to abuse prescription medications. Yet prescription rates for controlled medications, or drugs the Drug Enforcement Administration deems as having the potential for abuse, have nearly doubled for those age groups in the past 14 years, according to a recent study published in Pediatrics. Overall, a controlled medication was prescribed for young adults at approximately one out of every six visits and for young adult by adolescents one out of every nine encounters.

30 Nov 2010

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.

29 Nov 2010

Affymax, Takeda to regulate peginesatide drug for treating anemia in CRF patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited , today announced that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.

29 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

Neurocrine Biosciences, Inc. today announced results from the open-label portion of the six month Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

22 Nov 2010

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

On November 20 at the American Society of Nephrology 43rd Annual Meeting, interim results presented from an ongoing, randomized prospective study conducted independently by James A. Tumlin, MD, at the University of Tennessee College of Medicine Chattanooga indicated that 9 of 15 patients (60%) with advanced diabetic nephropathy who are currently enrolled in the study and have completed or are still undergoing a six month course of treatment with H.P. Acthar ® Gel have exhibited a clinically significant decrease in proteinuria and achieved stabilized renal function.

22 Nov 2010

Acthar Gel may be a viable treatment option for resistant nephrotic syndrome

On November 20 at the American Society of Nephrology 43rd Annual Meeting, Columbia University Assistant Professor of Clinical Medicine Andrew Bomback, MD, presented results from a patient case series assessing the potential therapeutic value of H.P. Acthar Gel (repository corticotropin injection) as a treatment for patients with nephrotic syndrome, a kidney disorder characterized by excessive loss of urinary protein.

22 Nov 2010

New study links high prevalence of insomnia and poor quality of life in software engineers

Insomnia is bad news for software engineers' quality of life and deserves greater recognition and attention, according to new research by Sara Sarrafi Zadeh and Khyrunnisa Begum from the University of Mysore in India. Their work shows that poor sleep has a bearing on quality of life - affecting physical and mental health in particular - in this group with high levels of job-related stress. Their paper is published online in Springer's journal Applied Research in Quality of Life.

22 Nov 2010

Insomnia News and Research

Latest Insomnia News and Research

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Contrave, new weight loss pill gets FDA panel nod

Researchers develop new drugs to prevent post-traumatic stress syndrome

Amgen announces final study results of Nplate in adults with chronic ITP

Lundbeck reports positive phase III study data of clobazam in treating seizures associated with LGS

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Sleep plays a crucial role in post-infarction remission

Clinicians should assess sleep-wake disturbances to understand physiology of Parkinson's disease

Common sleep complaints predict development of metabolic syndrome: Study

New brain imaging technique can trace effects of SYN115 drug in Parkinson's disease

Prescription rates for controlled medications double for teens, young adults

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Affymax, Takeda to regulate peginesatide drug for treating anemia in CRF patients

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Vertex submits NDA for telaprevir for treating hepatitis C

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

Acthar Gel may be a viable treatment option for resistant nephrotic syndrome

New study links high prevalence of insomnia and poor quality of life in software engineers

Clue's CEO Rhiannon White on the Future of Femtech and PCOS

Freezing Point Osmometry in Life Science Applications

Precision in every drop: Inside Hamilton’s syringe technology

Insomnia News and Research

Latest Insomnia News and Research

Clue's CEO Rhiannon White on the Future of Femtech and PCOS

Freezing Point Osmometry in Life Science Applications

Precision in every drop: Inside Hamilton’s syringe technology

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