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Latest Hypnotics Stories

2011-09-13 21:23:00

POINT RICHMOND, Calif., Sept. 13, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) received notice today from the U.S. Food and Drug Administration (FDA) that it generally agrees with Transcept proposals to address concerns raised by the FDA in its July 2011 Intermezzo® Complete Response Letter. As previously announced, Transcept plans to meet with the FDA on September 14, 2011 to discuss the regulatory path forward for Intermezzo®,...

Insomnia Runs In The Family
2011-09-12 09:44:25

  A study presented today by Université Laval researchers at the 4th World Congress on Sleep Medicine currently underway in Quebec City revealed that the risk of insomnia is 67% higher in people from families in which at least one member is an insomniac. The research team, directed by Dr. Charles M. Morin of Université Laval's School of Psychology, came to these conclusions following a study involving 3,485 people. The participants were asked to answer a...

2011-09-09 08:38:00

BASEL, Switzerland and NUTLEY, N.J., Sept. 9, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of its first Phase 1 clinical trial to investigate the safety and tolerability of a molecule designed to address the cognitive and behavioral deficits associated with Down syndrome. "There is currently a large unmet medical need for the treatment of cognitive impairments in individuals suffering from Down syndrome," comments Luca Santarelli, Global Head of...

2011-09-06 08:25:00

EXTON, Pa., Sept. 6, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the European Commission has granted a Centralized Pediatric Use Marketing Authorization (PUMA) for Buccolam® (midazolam, oromucosal solution), for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age. This action by the European Commission represents the first product approval...

Insomnia Costs US Employers $63 Billion Per Year
2011-09-02 04:59:24

  Nearly one-in-four U.S workers are affected by insomnia, costing the nation $63.2 billion a year in lost productivity, according to a report from the American Academy of Sleep Medicine published Thursday in the journal Sleep. The study found that, on average, U.S. workers lose 11.3 days of productivity each year due to insomnia. "We were shocked by the enormous impact insomnia has on the average person's life," said Dr. Ronald Kessler, a psychiatric epidemiologist with the...

2011-08-02 00:00:28

Study Finds Prescription Drug Overdoses Eclipse Those from Heroin and Cocaine Beverly Hills, CA (PRWEB) August 01, 2011 According to a report from the Centers for Disease Control and Prevention (CDC) and reported by Bloomberg, the death rate of overdoses from prescription drugs in Florida have more than doubled in the past ten years. Dr. Michael Lowenstein, who specializes in the Waismann Method, an advanced procedure for rapid opiate detoxification, indicates that according to surveys...

2011-07-28 15:05:00

SAN DIEGO, July 28, 2011 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced its financial results for the quarter ended June 30, 2011. For the second quarter of 2011, the Company reported net income of $2.0 million, or $0.04 per share, compared to a net loss of $5.2 million, or $0.09 loss per share, for the same period in 2010. For the six months ended June 30, 2011, the Company reported net income of $4.9 million, or $0.09 per share, as compared to a net loss of...

2011-07-15 19:02:00

POINT RICHMOND, Calif., July 15, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today plans to reduce operating expenses by eliminating approximately 45% of its workforce following notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet), the company's lead product candidate, cannot be approved in its present form....

2011-07-14 22:42:00

POINT RICHMOND, Calif., July 14, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). In the Complete Response Letter, the FDA confirmed that Transcept has adequately demonstrated that Intermezzo® is efficacious for use...

2011-07-12 19:02:00

POINT RICHMOND, Calif., July 12, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) on or before July 14, 2011, the PDUFA date assigned by the FDA for completion of the Intermezzo® NDA review. The FDA issues a...