Insomnia News and Research

Latest Insomnia News and Research

PGxHealth receives FDA approval for Viibryd tablets to treat major depressive disorder

The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

24 Jan 2011

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C.

20 Jan 2011

Transcept announces Intermezzo NDA resubmission for treatment of middle of the night awakenings

Transcept Pharmaceuticals, Inc. today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Intermezzo® for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

18 Jan 2011

Cadence launches OFIRMEV pain medication in the U.S.

Cadence Pharmaceuticals, Inc. today announced the launch of OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

18 Jan 2011

Sleep medications increase risk for nighttime falls and potential injury

Adults who take one of the world's most commonly prescribed sleep medications are significantly more at risk for nighttime falls and potential injury, according to a new study by the University of Colorado at Boulder.

14 Jan 2011

Exposure to room light prior to bedtime suppresses melatonin levels, increases cancer and diabetes risk: Study

According to a recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism, exposure to electrical light between dusk and bedtime strongly suppresses melatonin levels and may impact physiologic processes regulated by melatonin signaling, such as sleepiness, thermoregulation, blood pressure and glucose homeostasis.

13 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

New, paid prescriptions for Questcor's Acthar increase 66%

Questcor Pharmaceuticals, Inc. today reported a strong finish to 2010. The Company estimates that 353 new, paid Acthar prescriptions for the treatment of multiple sclerosis (MS) were filled and shipped during the quarter, up 66% from the year ago period and up 9% from the third quarter of 2010.

10 Jan 2011

NovaDel receives $500,000 milestone payment from Akrimax in connection with NitroMist agreement

NovaDel Pharma Inc. today announced that it has received a $500,000 milestone payment from Akrimax Pharmaceuticals. The milestone payment was received in connection with the license and distribution agreement, dated October 27, 2009, between NovaDel Pharma Inc. and Mist Acquisition, LLC, an affiliate of Akrimax Pharmaceuticals.

7 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

Metabolic cost of missing one night of sleep equivalent to walking two miles

In the first-ever quantification of energy expended by humans during sleep, a University of Colorado team has found that the metabolic cost of an adult missing one night of sleep is the equivalent of walking slightly less than two miles.

5 Jan 2011

BIOMICs oversees SGIker DNA Bank to know genetic heritage of Basque lineage

The BIOMICs Group, based at the Lucio Lascaray building in the álava/Araba campus of the University of the Basque Country, is specially known for overseeing the SGIker DNA Bank, not only undertaking this task, but also feeding data into the gene research bank and making good use of it for their own lines of research.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Antidepressants may have adverse effect on elders when prescribed for the first time

More than half of older Americans who were prescribed antidepressants for the first time were already taking a medication that could adversely interact with the antidepressant, according to a new study from Thomson Reuters.

17 Dec 2010

Zenobia, Lundbeck enter research collaboration for LRRK2 Parkinson's disease target

Zenobia Therapeutics, Inc. the leader in fragment-based lead discovery for CNS diseases, announced today a research collaboration with H. Lundbeck A/S utilizing Zenobia's expertise in protein expression and x-ray crystallography for the Parkinson's disease target, LRRK2. Under the agreement, Zenobia will continue to use its capabilities in fragment-based lead discovery (FBLD) to advance its internal LRRK2 drug discovery program independently of Lundbeck.

16 Dec 2010

Sound masking therapy is of uncertain benefit when used alone to treat tinnitus

Tinnitus — what many think of as "ringing in the ears" — is the perception of sound without any real acoustic stimulation. Sound masking therapy, a common component of tinnitus treatment, is of uncertain benefit when used on its own, a new evidence review finds.

10 Dec 2010

Study comparing subcutaneous, intravenous administration of VELCADE in relapsed MM patients presented at ASH

Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous administration of VELCADE (bortezomib) in patients with relapsed multiple myeloma. These data were presented at the 52nd annual meeting of the American Society of Hematology, held December 4-7 in Orlando, Florida.

8 Dec 2010

Sleep deprivation eliminates fear-associated memories

We commonly think of sleep as a healing process that melts away the stresses of the day, preparing us to deal with new challenges. Research has also shown that sleep plays a crucial role in the development of memories.

8 Dec 2010

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

Insomnia News and Research

Latest Insomnia News and Research

PGxHealth receives FDA approval for Viibryd tablets to treat major depressive disorder

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Transcept announces Intermezzo NDA resubmission for treatment of middle of the night awakenings

Cadence launches OFIRMEV pain medication in the U.S.

Sleep medications increase risk for nighttime falls and potential injury

Exposure to room light prior to bedtime suppresses melatonin levels, increases cancer and diabetes risk: Study

Shionogi brings KAPVAY ADHD drug to the U.S market

New, paid prescriptions for Questcor's Acthar increase 66%

NovaDel receives $500,000 milestone payment from Akrimax in connection with NitroMist agreement

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Metabolic cost of missing one night of sleep equivalent to walking two miles

BIOMICs oversees SGIker DNA Bank to know genetic heritage of Basque lineage

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Antidepressants may have adverse effect on elders when prescribed for the first time

Zenobia, Lundbeck enter research collaboration for LRRK2 Parkinson's disease target

Sound masking therapy is of uncertain benefit when used alone to treat tinnitus

Study comparing subcutaneous, intravenous administration of VELCADE in relapsed MM patients presented at ASH

Sleep deprivation eliminates fear-associated memories

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

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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