Itamar Medical : Watch-PAT to be included as an accepted ambulatory device for Medicare and Medicaid beneficiaries

March 15 , 2008 - Itamar Medical Inc. is pleased to report that the Centers for Medicare and Medicaid Services (CMS) has released (March 14^th, 2008) its final National Coverage Decision (NCD) where it has decided to cover the Watch-PAT for home diagnosis of obstructive sleep apnea. This decision will make the Watch-PAT available to Medicare beneficiaries nationwide.
The CMS Final Decision Memorandum discussed the Watch-PAT and the clinical evidence supporting its efficacy in very positive detail. Of particular note is CMS’s response to comments that asserted that the Watch-PAT is a useful diagnostic tool and should not be required to provide additional data under Coverage with Evidence Development... Itamar Medical's Press Release -

SleepEx : Agreement with the Atlanta School of Sleep Medicine and Technology for Online Physician Education!

March 6, 2008 - New management and product development pays off early as SleepEx signs a development and marketing agreement with the Atlanta School of Sleep Medicine and Technology; the premier sleep medicine school in the country. SleepEx, a leading provider of Sleep lab management software and data solutions founded in 2002 has developed a proprietary browser based product intended for the secure online review of sleep studies by sleep specialists and technologists.
This software product, the SleepXML Browser (developed as part of a Small Business Innovative Research grant funded by the NIH), has been selected by the Atlanta School and Director Russell Rosenberg, PhD. for incorporation into their curriculum to provide an interactive e-Learning portal for physicians for pre-board exam PSG and MSLT review and training... SleepEx's Press Release with Video -

SOMAXON PHARMACEUTICALS : NEW DRUG APPLICATION FOR SILENOR FOR THE TREATMENT OF INSOMNIA

January 31, 2008 - – Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR™ (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR™ for the treatment of insomnia... [PDF] Somaxon's Press release -

Graymark Healthcare : Letter of Intent to Acquire Nocturna Sleep, LLC

March 25, 2008—Graymark Healthcare, Inc. (OTCBB: GRMK), through its wholly owned subsidiary SDC Holdings LLC, is pleased to announce it has signed a letter of intent to acquire Nocturna Sleep, LLC located in Las Vegas, Nevada. Nocturna performs over 3000 sleep studies a year in the Las Vegas market, which is one of the fastest growing cities in the United States.

"The Letter of Intent to acquire Nocturna is another substantial addition to our sleep diagnostic business... Graymark Healthcare's Press Release -

Jazz Pharmaceuticals, Inc. : Development Pipeline Progress

March 13, 2008 - Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) provided a comprehensive update on its commercial activities and near-term product development pipeline, and provided 2008 financial guidance, for investors and analysts at its Investor Day meeting in New York City...
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...Jazz Pharmaceuticals' sales representatives currently promote XYREM(R) (sodium oxybate) for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy to sleep specialists, neurologists and psychiatrists. XYREM net sales increased by 34 percent, from $29 million in 2006 to $39 million in 2007. XYREM net sales are expected to be in the range of $45 million to $55 million during 2008....
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... Jazz Pharmaceuticals announced that JZP-7, a proprietary transdermal gel formulation of ropinirole, is designed to provide an effective, once-a-day treatment of moderate to severe restless legs syndrome. JZP-7 has been successfully evaluated in one pharmacokinetic (PK) study, and a second PK study is near completion. Available results from both studies demonstrate that the product is well tolerated. Jazz Pharmaceuticals is currently planning to initiate a Phase III clinical trial in the fourth quarter of 2008. Restless legs syndrome affects up to 10 percent of the U.S. population... Jazz Pharmaceuticals' Press Release -

Philips : completion of Respironics acquisition

March 17, 2008 - — Royal Philips Electronics (NYSE:PHG, AEX:PHI) (“Philips”) and Respironics, Inc. (NASDAQ:RESP) (“Respironics”) announced that Philips has completed the acquisition of Respironics through the merger of its indirect wholly owned subsidiary with and into Respironics. As a result of the merger, Respironics has become an indirect wholly owned subsidiary of Philips... Philips' Press Release -

Takeda, New Drug Application for Ramelteon in Japan for

February 29, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan.
Ramelteon works by selectively targeting two melatonin receptors in the brain, MT₁ and MT₂. These receptors are located in suprachiasmatic nucleus, a body’s ‘master clock’, which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, body’s sleep-wake cycle is regulated and physiological sleep is promoted... Takeda's Press Release -