Insomnia News and Research

Latest Insomnia News and Research

FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

22 Nov 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Protein, not sugar, stimulates cells keeping us thin and awake

A new study has found that protein and not sugar activates the cells responsible for keeping us awake and burning calories. The research, published in the 17 November issue of the scientific journal Neuron, has implications for understanding obesity and sleep disorders.

17 Nov 2011

Genzyme's alemtuzumab Phase lll trial on MS meets co-primary endpoints

Genzyme, a Sanofi company, reports today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab as compared with Rebif.

14 Nov 2011

Sleep problems may increase risk of fibromyalgia among women

Researchers from Norway have uncovered an association between sleep problems and increased risk of fibromyalgia in women.

14 Nov 2011

SAMHSA: Drug-related intentional poisonings result in 14,720 ED visits during 2009

Intentional poisoning refers to attempts to physically harm someone or render that person defenseless against crimes by deliberately getting them to ingest, inhale or in some other way take in a potentially harmful substance without their knowledge.

11 Nov 2011

Positive results from Alkermes VIVITROL addiction study

Alkermes plc today presented positive results from a long-term study of VIVITROL (naltrexone for extended-release injectable suspension) at the 24th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas, NV.

10 Nov 2011

Human Genome Sciences to present abstracts regarding BENLYSTA, SLE at ACR/ARHP meeting

Human Genome Sciences, Inc. announced today that several abstracts related to BENLYSTA (belimumab) and systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011.

5 Nov 2011

Acorda third quarter GAAP net income increases to $18.9 million

Acorda Therapeutics, Inc. today announced its financial results for the third quarter ended September 30, 2011.

4 Nov 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

Drinking cherry juice improves quality and duration of sleep

Drinking cherry juice significantly improves both the quality and duration of sleep, according to new findings from Northumbria University.

2 Nov 2011

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

Lundbeck's ONFI receives FDA approval for treating seizures associated with Lennox-Gastaut syndrome

Lundbeck Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark, announced today that the U.S. Food and Drug Administration (FDA) has approved ONFI as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients two years and older.

24 Oct 2011

Positive top line results from Shire's LDX phase III study on ADHD

Shire plc, the global specialty biopharmaceutical company, today presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder.

22 Oct 2011

Takeda commences TAK-875 Phase 3 clinical trial program for type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiaries, Takeda Global Research & Development Center, Inc., and Takeda Global Research & Development Centre (Europe), Ltd., announced today the initiation of the Company's Phase 3 clinical trial program for TAK-875, an investigational therapy for type 2 diabetes.

18 Oct 2011

HHWC medical doctors provide insight into depression

A staggering 230 million antidepressant prescriptions are filled each year. Yet the face of depression does not always fit the mold: a successful career, loving spouse, wonderful children, seemingly good health and finances. From the outside life appears perfect, so why are Americans depressed?

15 Oct 2011

Merck announces results from ISENTRESS Phase III combination study on HIV-1

Merck, known as MSD outside the United States and Canada, today announced results of new exploratory pre-specified analyses from the ongoing STARTMRK Phase III study of its integrase inhibitor ISENTRESS (raltegravir) Tablets in combination therapy compared to efavirenz in combination therapy in previously untreated adult HIV-1-infected patients.

14 Oct 2011

FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

12 Oct 2011

Takeda, Affymax announce data from multiple studies of peginesatide on anemia

Affymax, Inc. and Takeda Pharmaceuticals Global Research & Development Center, Inc., U.S., today announced data from multiple studies of peginesatide have been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2011 taking place November 8-13, 2011 in Philadelphia, Pa.

11 Oct 2011

Discovery of ‘alarm-clock’ gene

Researchers led by Indian-American scientist, Satchidananda Panda at the Salk Institute for Biological Studies in La Jolla, Calif., said the gene is responsible for starting the body’s biological clock from its restful state every morning. They add that this may open avenues in research in insomnia or sleeplessness, aging and chronic illnesses.

3 Oct 2011