Chelsea Therapeutics Announces FDA Acceptance of NDA Filing; Avanir Announces EMA Acceptance of Application for NUEDEXTA Print E-mail
By Staff and Wire Reports   
Thursday, 17 November 2011 20:14
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 17, 2011.

Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP)
announced the FDA has accepted for filing the New Drug Application (NDA) for NORTHERA" (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

The FDA also granted Chelsea's request for Priority Review, and, under the Prescription Drug User Fee Act (PDUFA), the FDA's goal is to review and act on the NDA by March 28, 2012. The FDA grants priority review to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists.

In addition, the FDA has indicated its intent to discuss the Northera NDA at a February 2012 meeting of its Cardiovascular and Renal Drugs Advisory Committee.

Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

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Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
announced the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA). Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review.

NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.

The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA, plus data from the company's longer-term safety studies. The MAA acceptance triggers the initiation of EMA's scientific assessment and opinion review period.

Additionally the company received notification from the EMA that the Name Review Group and the Committee for Medicinal Products for Human Use had no objections to the proposed use of the trade name NUEDEXTA.



Also Thursday:



Affymetrix®, Inc. (NASDAQ:AFFX)
announced today at the Association of Molecular Pathology (AMP) conference that they have entered into an exclusive agreement with Genisphere®, LLC, to offer the company’s proprietary FlashTag™ Biotin HSR Reagents designed for Affymetrix.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
today announced that it has hired Jefferies & Company, Inc. as a strategic advisor.

AmpliPhi Biosciences Corporation (APHB.PK)
, the leader in the development of bacteriophage-based anti-bacterial therapies to treat drug resistant infections, has announced that is has closed on an initial amount of $2.7M in equity investment and convertible loan notes to support the further progress of the Company.

Array BioPharma Inc. (Nasdaq: ARRY)
today announced that its Chief Executive Officer, Robert E. Conway, will speak at the Piper Jaffray Health Care Conference in New York City. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

Aetna (NYSE: AET)
and the Center for Biomedical Informatics at Harvard Medical School today announced a research agreement aimed at analyzing health care data in new ways to further clinical research and improve the quality and affordability of health care.
Biocartis Completes EUR 71 Million (USD 100 Million) Series C Fund Raising

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX)
("Connectyx"), www.connectyx.com, manufacturer and distributor of the MedFlash®, a Personal Health and Wellness Management System (ePHM) designed for maintaining personal health records (PHR), filed its financial results for the nine months ended September 30, 2011 recording a revenue increase of 34% versus the YTD third quarter of last year.

Cord Blood America, Inc. (OTC Bulletin Board: CBAI)
, the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, today is pleased to announce that it has been notified by The Depository Trust & Clearing Corp. that the "chill" announced by the DTCC in December 2010 has been removed.

Coronado Biosciences, Inc. (OTCBB: CNDO)
, a company focused on novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, today announced that its common stock has been approved for quotation on the OTC Bulletin Board and has commenced trading under the ticker symbol CNDO.

Eli Lilly and Company (NYSE: LLY)
today announced that it is providing more than $4 million in additional funding to the Infectious Disease Research Institute.

Genesis Biopharma, Inc. (OTCBB: GNBP)
, a biotechnology company developing targeted cancer immunotherapies, today announced that Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the National Cancer Institute, has joined the Company's Scientific and Medical Advisory Board.  

iBio, Inc.(NYSE AMEX: IBIO)
today announced that it successfully used its proprietary iBioLaunch technology to produce full length as well as a modified form of C1 esterase inhibitor in green plants.

InspireMD, Inc. (OTC BB: NSPR
) ("Inspire" or the "Company"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology, today announced that Sol J. Barer, Ph.D., a current member of the Company's board of directors and the former Chairman, and CEO of Celgene Corporation, has been elected the Chairman of InspireMD's Board of Directors, effective immediately. InspireMD thanks Asher Holzer for his contributions as chairman and leading the Company to its current successful stage. Mr. Holzer will continue as President of the Company and a member of the Board of Directors.

Lpath (OTCBB: LPTN)
, a San Diego-based firm, whose shares currently trade just under $1 appears to be a potential acquisition target. The firm' therapeutics platform is showing strong data that their drug-discovery engine has a unique ability to bind to and inhibit bioactive lipids that contribute to various diseases.

Positron Corporation (OTCBB:POSC)
, a leading molecular imaging company specializing in the field of nuclear cardiology is pleased to announce that Manhattan Isotope Technology, with the support of Positron, has executed a Memorandum of Understanding with the ARRONAX Cyclotron Facility in Nantes, France. Manhattan Isotope and ARRONAX will collaborate on production of strontium-82 and other medical radionuclides.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX)
(“the Company” or “RegeneRx”) announced today that the Company has been notified that two cardiac-related patents will be allowed in Australia and Mexico.

SANUWAVE Health, Inc. (OTCBB: SNWV)
, an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the highly positive data from its Phase III clinical trial of dermaPACE® to treat diabetic foot ulcers was the subject of a Continuing Medical Education (CME) accredited presentation at Desert Foot 2011: The 8th Annual High Risk Diabetic Foot Conference, honoring Federal Service Healthcare Providers, which took place at the Arizona Grand Resort in Phoenix.

SafeguardScientifics, Inc. (NYSE: SFE)
, a holding company that builds value in growth-stage lifesciences and technology companies, today announced that it has led a $7 million Series A financing for Medivo, Inc., a New York-based healthcare IT company that provides data analytics and lab testing services that empower and enable patients and physicians to improve health.

SeraCare Life Sciences, Inc. (NASDAQ: SRLS)
, a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported financial results for its 2011 fiscal fourth quarter and year ended September 30, 2011.

Stevia Corp. (OTCBB: STEV)
("Stevia Corp." or the "Company"), a farm management company focused on the economic development of stevia, the fastest growing product in the alternative sweetener sector, is pleased to announce its entry into a Farm Management Agreement with Stevia Ventures Corporation ("SVC") of Hanoi.

VistaGen Therapeutics, Inc. (OTCBB: VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, and the University Health Network (UHN), one of Canada's largest research hospitals, have expanded their existing collaborative pluripotent stem cell research and development program, and extended it through September 2017.



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