Insomnia News and Research

Latest Insomnia News and Research

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

22 Jan 2010

Thomas S. Kilduff named a Fellow of the AAAS

SRI International, an independent nonprofit research and development institute, announced today that Thomas S. Kilduff, Ph.D., director of SRI International's Center for Neuroscience, has been named a Fellow of the American Association for the Advancement of Science (AAAS).

22 Jan 2010

Local physicians are currently recruiting PTSD patients for clinical research study

Researchers are currently recruiting patients with civilian post-traumatic stress disorder (PTSD) for a clinical research study called the COPE study. People who are having symptoms after experiencing a traumatic event or who have been diagnosed with PTSD may be eligible to participate in this study of a new investigational drug.

21 Jan 2010

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Depomed, Inc. announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes.

20 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

Animal experiments show old antidepressant may reverse heart failure

A team of Johns Hopkins and other researchers have found in animal experiments that an antidepressant developed over 40 years ago can blunt and even reverse the muscle enlargement and weakened pumping function associated with heart failure.

6 Jan 2010

VELCADE sNDA receives FDA approval

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

5 Jan 2010

Psychological stress at workplace can lower employees' productivity, says study

A new study shines a light on depression in the workplace, suggesting that psychological stress at the office — or wherever people earn their paychecks — can make it more difficult for depressed workers to perform their jobs and be productive.

31 Dec 2009

Eritoran well tolerated in Phase II trial for severe sepsis

The investigational compound, eritoran tetrasodium ("eritoran," also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.

22 Dec 2009

FDA extends action date for its review of Cephalon's sNDA for NUVIGIL Tablets

Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV].

22 Dec 2009

Intra-Cellular Therapies announces results of its ITI-007 antipsychotic drug Phase I study

Intra-Cellular Therapies, Inc. (ITI) announced at a recent conference on neuropsychiatric diseases the results from a recently completed Phase I clinical study demonstrating ITI-007, the Company's lead antipsychotic drug, interacts with important targets in the living human brain. These key targets are critical to drug action in many neuropsychiatric and related disorders.

21 Dec 2009

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

Celgene Corporation today announced the National Cancer Institute (NCI), a part of the National Institutes of Health, reported initial data from a Phase III, randomized, double-blind, multi-center clinical study led by the Cancer and Leukemia Group B (CALGB).

18 Dec 2009

Sepracor's LUNESTA receives patent term extension from USPTO

Sepracor Inc. today announced that the United States Patent and Trademark Office has determined that U.S. Patent No. 6,444,673, which is a composition of matter patent that covers the human drug product LUNESTA® (eszopiclone), received a patent term extension under 35 U.S.C. § 156.

18 Dec 2009

Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today stated that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

18 Dec 2009

HealthInsight and HealthMedia join to deliver Internet-based Digital Coaching solutions

HealthInsight, provider of the only value-based health care administration platform, today announced a partnership with HealthMedia, Inc., a Johnson & Johnson company, to deliver Internet-based Digital Coaching™ solutions focused on lifestyle and behavioral change.

16 Dec 2009

NovaDel receives Issue Notification from USPTO for oral spray

NovaDel Pharma Inc., today announced that it received an Issue Notification from the United States Patent and Trademark Office (USPTO) for a new U.S. Patent, No. 7632517, entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which covers a method of treating insomnia by administering zolpidem to humans utilizing NovaDel’s oral spray technology.

16 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

Study explores comorbidity of medical complaints and insomnia symptoms in school-aged children

A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine indicates that significant associations exist between parent-reported insomnia symptoms and medical complaints of gastrointestinal regurgitation and headaches in young school-aged children.

15 Dec 2009

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Insomnia News and Research

Latest Insomnia News and Research

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Thomas S. Kilduff named a Fellow of the AAAS

Local physicians are currently recruiting PTSD patients for clinical research study

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Animal experiments show old antidepressant may reverse heart failure

VELCADE sNDA receives FDA approval

Psychological stress at workplace can lower employees' productivity, says study

Eritoran well tolerated in Phase II trial for severe sepsis

FDA extends action date for its review of Cephalon's sNDA for NUVIGIL Tablets

Intra-Cellular Therapies announces results of its ITI-007 antipsychotic drug Phase I study

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

Sepracor's LUNESTA receives patent term extension from USPTO

Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

HealthInsight and HealthMedia join to deliver Internet-based Digital Coaching solutions

NovaDel receives Issue Notification from USPTO for oral spray

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Study explores comorbidity of medical complaints and insomnia symptoms in school-aged children

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

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Insomnia News and Research

Latest Insomnia News and Research

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Healthy Beginnings, Hopeful Futures: A Conversation with WHO’s Dr. Allotey

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