Vanda Halted for FDA Advisory Committee to Review HETLIOZ NDA; ACADIA Announces Initiation of Phase II Trial with Pimavanserin Print E-mail
By Staff and Wire Reports   
Thursday, 14 November 2013 21:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 14, 2013.

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced that NASDAQ halted trading of Vanda common stock this morning.  

The Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) meets today to review Vanda's New Drug Application (NDA) for tasimelteon, proposed trade name HETLIOZ™, for the treatment of Non-24-Hour Disorder in the totally blind.  The Advisory Committee meeting is scheduled for 8:00 am ET.

Vanda's HETLIOZ™ NDA is currently under Priority Review by the FDA with an action target date under the Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014.  



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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD)
, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it has initiated a Phase II feasibility trial designed to examine the efficacy and safety of pimavanserin as a treatment for patients with Alzheimer’s disease psychosis (ADP). No drug is approved in the United States to treat ADP and the off-label use of current antipsychotics is linked to increased mortality, serious adverse events, and cognitive decline in elderly patients with dementia-related psychosis.

“The development of psychosis and related behavioral disturbances in patients with Alzheimer’s disease carries a poor prognosis and often has a devastating impact on both patients and their caregivers,” said Clive Ballard, M.D., Professor of Age Related Diseases at King’s College London. “Finding new therapies that can effectively treat ADP without compromising safety is an important priority for the neurology community and society as a whole. Pimavanserin’s attractive efficacy, tolerability and safety profile observed in a Phase III trial in patients with Parkinson’s disease psychosis suggests that it may offer the potential for an important new therapeutic advance for patients suffering from ADP.”

The Phase II feasibility trial, referred to as the -019 Study, is a randomized, double-blind, placebo-controlled study designed to examine the efficacy and safety of pimavanserin in about 200 patients with ADP. The study is being conducted through a large network of research care homes established as part of the National Institute for Health Research (NIHR) Maudsley Biomedical Research Unit. Following a screening period that includes brief psycho-social therapy, patients will be randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for 12 weeks. The -019 Study will assess several key efficacy endpoints, including use of the Neuropsychiatric Inventory - Nursing Home (NPI-NH) scale to measure psychosis (hallucinations and delusions), agitation/aggression, and sleep/nighttime behavior, as well as use of the Cohen-Mansfield Agitation Inventory - Short Form (CMAI-SF) scale and the Alzheimer’s Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale. Key efficacy endpoints will be based on the change at week six from baseline. The study will also assess additional exploratory endpoints, including the cognitive status of patients using the Mini-Mental State Examination (MMSE) scale, and the durability of response to pimavanserin through twelve weeks of therapy.

“We are delighted to pursue this clinical study in collaboration with Professor Ballard and King’s College London,” said Roger G. Mills, M.D., ACADIA’s Executive Vice President of Development and Chief Medical Officer. “We believe that their unique clinical research infrastructure and expertise will provide access to a pool of well-characterized ADP patients and enable the use of a small and geographically-focused group of highly trained raters, which we expect to enhance study precision.”



Also Thursday:



Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat debilitating and often fatal rare diseases, announced today that the company will participate in the Jefferies 2013 Global Healthcare Conference in London.

Allerayde SAB (OTCQB:ASAB)
today announced that the company has participated in a leading Pharmaceutical Industry marketing and networking event, CPhI Worldwide 2013, with a goal of identifying potential new development and distribution partners.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today reported financial results and development progress for the third quarter and nine-month periods ended September 30, 2013.

American CryoStem Corporation (OTCQB:CRYO)
, a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today announced the formation of Autogenesis Corporation ("Autogenesis") as part of its collaborative agreement to develop wound healing products and other cellular therapies with privately-held Protein Genomics (PGen).

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced its inclusion on Deloitte's Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences, and clean technology companies in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2008 to 2012.

Athersys, Inc. (Nasdaq:ATHX)
today announced its financial results for the three months ended September 30, 2013.

Authentidate Holding Corp. (Nasdaq:ADAT)
, a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced financial results for the three-month period ended September 30, 2013.

BG Medicine, Inc. (Nasdaq:BGMD)
, the developer of the BGM Galectin-3® Test, announced today that its Board of Directors has appointed Stephen P. Hall, as the company's Executive Vice President, Chief Financial Officer.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX)
, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today that the U.S. District Court for the District of Delaware has ruled in favor of Cadence in the company's patent infringement lawsuit against Exela Pharma Sciences, LLC.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today reported financial results for the quarter ended September 30, 2013.

Digirad Corporation (Nasdaq:DRAD)
, the leader in providing diagnostic imaging services and technology on an as needed, where needed, and when needed basis, today announced that it will present at the sixth annual LD MICRO conference.

Dyadic International, Inc. (OTC Pink: DYAI)
, a global leader in the commercial application of biotechnology for the discovery, development and production of enzymes and other proteins, today announced financial results for the quarter and nine months ended September 30, 2013.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today said that an appeals court in Germany has suspended the enforcement of an injunction against sales of Medtronic's transcatheter heart valves in Germany, pending the posting of a EUR 5 million bond by Medtronic.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
, a specialty pharmaceutical company dedicated to developing and commercializing oral sustained and controlled release product formulations and generics with high barriers to entry, announced today that management will host a conference call to provide a quarterly business update at 3:00 PM ET on Monday, November 18, 2013.

Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-functional lipid ingredients, announced today that Dr. Ariel Katz, the Company's President and Chief Executive Officer, will be presenting at the Jefferies 2013 Global Healthcare Conference to be held on November 20-21, 2013 in London, UK.

Epocrates, Inc., an athenahealth company (Nasdaq:ATHN), today announced a partnership with The Cochrane Library to bring selections of its internationally recognized evidence-based reviews, editorials and meta-analyses to the Epocrates Rx® application, further informing the clinical choices made by health care providers.

Gentium S.p.A. (Nasdaq:GENT)
and Link Healthcare today announced that Defibrotide has been designated as an Orphan Drug for the Treatment of Hepatic Veno-Occlusive Disease (VOD).

Intellect Neurosciences, Inc. (OTCBB:ILNS)
, a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic and diagnostic agents for the treatment of Alzheimer's and other neurological diseases, today announced it obtained a Notice of Allowance from the United States Patent and Trademark Office (USPTO).

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today reported financial results for its third quarter 2013, and provided an update on recent accomplishments.

Medistem Inc. (OTCQB:MEDS)
, today announced that its shares of common stock are now listed on the OTC Markets Group's OTCQB marketplace. The company's shares were previously listed on the Pinksheets.

MusclePharm Corporation (OTCQB: MSLP)
, a leading international, award-winning sports nutrition company, announced today its financial results for the third quarter ended September 30, 2013 ("Q3 2013").

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY)
, a clinical-stage biopharmaceutical company developing non-antibiotic antimicrobial products, today reported third quarter 2013 financial results and provided a clinical update.

Pacific Health Care Organization Inc., (OTCQB: PFHO)
today announced its financial results for the third quarter ended September 30, 2013.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, today announced that it has sold its interest in VeriTeQ Corporation ("VeriTeQ") for $750,000. In conjunction with the sale, PositiveID also entered into a letter agreement with VeriTeQ (the "Letter Agreement"), under which it will receive a warrant to purchase 300,000 shares of VeriTeQ common stock.

Premier, Inc. (Nasdaq:PINC
), a leading healthcare improvement company, has been granted a patent from the United States Patent and Trademark Office for its hospital supply expense methodology.

SmallCapVoice.com, Inc. announced today that a new audio interview with Fresh Start Private Management, Inc. (OTCQB:CEYY), a leader in alcohol treatment and rehabilitation programs, is now available.

StemCells, Inc. (Nasdaq:STEM)
, a leading stem cell company developing novel cell-based therapeutics for disorders of the central nervous system, today announced that Greg Schiffman will join its executive team as Chief Financial Officer and Executive Vice President of Finance, effective January 1, 2014.

Stemline Therapeutics, Inc. (Nasdaq:STML)
today announced five presentations at the 2013 American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 7-10, 2013, at the Ernest N. Morial Convention Center in New Orleans, LA.

Stereotaxis, Inc. (Nasdaq:STXS)
today reported financial results for the third quarter ended September 30, 2013. In light of the Company's current rights offering and preceding preliminary earnings release, the Company will not be holding a conference call in conjunction with this release, but refers stockholders to the results and comments contained herein along with Form 10-Q for the quarter ended September 30, 2013.

ThermoGenesis Corp. (Nasdaq:KOOL)
, a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today reported financial results for the first quarter of fiscal 2014.

Transcat, Inc. (Nasdaq:TRNS)
, a leading provider of accredited calibration, repair, inspection and compliance services and distributor of professional grade handheld test, measurement and control instrumentation, recently received new orders for calibration services valued at over $2.0 million over three years.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced today that trading of Tandem Diabetes Care, Inc. (Nasdaq:TNDM), a leading provider of insulin pump therapy, commenced on The NASDAQ Stock Market on November 14, 2013.



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