FDA Grants Priority Review for Genzyme's Cerdelga™; athenahealth Initiates Guidance for Fiscal Year 2014 Print
By Staff and Wire Reports   
Wednesday, 11 December 2013 21:50

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 11, 2013. Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced the FDA has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1. As previously announced, the European Medicines Agency in late October validated Genzyme's marketing authorization application (MAA) for eliglustat in the EU.

Genzyme is developing eliglustat, a capsule to be taken twice daily, to provide an effective oral treatment alternative for adult patients with Gaucher disease type 1, and to provide a broader range of treatment options for Gaucher patients and physicians. Genzyme's clinical development program for eliglustat represents the largest clinical program ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries.

“The acceptance of our applications for Cerdelga represents another important milestone in our commitment to understand and respond to the needs in the Gaucher community, providing more choice for the treatment of patients,” said Genzyme's President and CEO David Meeker, M.D.

The marketing applications for Cerdelga are based on two positive Phase 3 studies for eliglustat, ENGAGE, which included patients new to therapy, and ENCORE which included patients switching from enzyme replacement therapy. The submissions also include four years of safety and efficacy data from the eliglustat Phase 2 study.



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athenahealth, Inc. (ATHN) (the "Company"), a leading provider of cloud-based electronic health record (EHR), practice management, and care coordination services to medical groups and health systems, today reaffirmed financial guidance for fiscal year 2013 and announced financial guidance for fiscal year 2014. The Company will host its Sixth Annual Investor Summit tomorrow, Thursday, December 12, 2013, starting at 8:30 a.m. Eastern Time to provide an update on the Company's business and share management's outlook for future financial and operational performance.

The Company's fiscal year 2013 and 2014 guidance is presented below:

For the Fiscal Year Ending:



"We are very excited about our growth opportunities and are pleased to present an ambitious financial plan for fiscal year 2014. We expect a year of continued investment as we broaden our service portfolio and deepen our capabilities to transform and support the full continuum of care," said Tim Adams, the Company's Chief Financial Officer. "We are highly confident that our strategic investments are expanding our addressable market and our portfolio of services while strengthening our position to achieve the ultimate goal of becoming this nation's health information backbone."



Also Wednesday:



Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today announced that Mike Levitz, senior vice president and CFO, will be presenting at the Imperial Capital Security Investor Conference on Thursday, December 12, at 2:15 p.m. ET.

AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the appointment of John Soto as Chief Commercial Officer, a newly created position overseeing the Company's global sales and marketing initiatives.

Apricus Biosciences, Inc. (Nasdaq:APRI), announced that Kleanthis G. Xanthopoulos, Ph.D. has been elected as Chairman of the Company's Board of Directors.

athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based electronic health record (EHR), practice management, and care coordination services to medical groups and health systems, today reaffirmed financial guidance for fiscal year 2013 and announced financial guidance for fiscal year 2014.

Cerner Corp. (Nasdaq:CERN) today announced that it is offering KidsHealth pediatric-specific discharge and after-care instructions to Cerner clients. The KidsHealth Instructions, created exclusively for pediatrics, is available in the current Cerner Millennium® Patient Education Content in English and Spanish. KidsHealth, the largest licensor of online pediatric health information, provides medical expertise from a physician-directed, professional editorial staff that makes complex and sensitive medical topics understandable.

Coastal.com (Nasdaq:COA) (TSX:COA), the leading online provider of eyewear, announced today that it has launched a partnership with Overstock to market Coastal.com's industry leading eyewear offering to Overstock's large and growing customer base.

CollabRx, Inc. (Nasdaq:CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, and Cynvenio Biosystems, Inc., a cancer diagnostics company, today announced a multi-year agreement to access CollabRx technology and content resources in support of the clinical interpretation of genetic sequencing-based tests provided by Cynvenio.

Gentium S.p.A. (Nasdaq:GENT)
today announced that additional data on Defibrotide were presented this week at the 55th Annual Meeting and Exposition of the American Society of Hematology at the Ernst N. Morial Convention Center in New Orleans, LA, December 7-10, 2013.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced that the underwriters for its initial public offering of common stock have fully exercised their option to purchase an additional 1,020,000 shares of common stock at the public offering price of $16.00 per share, less underwriting discounts.

MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced the online publication of data on the isolation of cancer stem-like cells (CSLCs) from human adenosquamous carcinoma (ASC) of the lung in the journal PLOS ONE.

Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. – has entered the anti-aging products market. HempMedsPX™ is unveiling the world's first cannabidiol (CBD)-rich hemp oil anti-aging product line, Cannabis Beauty DEFINED™, at the American Academy of Anti-Aging Medicine (A4M) in Las Vegas, December 12-15.

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY), a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced that it received ISO (International Organization for Standardization) 13485 certification from the notified body DEKRA, for its quality management system.

Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that its contractor, Inno Biologics Sdn. Bhd., is using the Clone-Pix™ technology for the isolation and selection of clones preparatory to obtaining the large numbers of cells for Nuvilex's future clinical trials in advanced, inoperable pancreatic cancer.

Ocera Therapeutics (Nasdaq:OCRX) today announced that David S. Moore, its chief business officer, will be leaving Ocera to pursue other opportunities. Mr. Moore was a former member of the management team at Tranzyme and continued his employment with Ocera following the merger of Ocera and Tranzyme, which closed in July 2013.

Roche (SIX:RO) (SIX:ROG) (OTCQX:RHHBY)
and Prothena Corporation plc (Nasdaq:PRTA), announced today that they have entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody for the treatment of Parkinson's disease, which is currently in preclinical development and is expected to enter Phase 1 clinical trials in patients with Parkinson's disease in 2014.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that two of its products, the GuideLiner guide extension catheter and the SuperCross FT microcatheter, have received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).

Wellness Center USA, Inc. (OTCQB:WCUI)
, today announced that wholly-owned subsidiary Psoria-Shield's Mexican Distributors, Smart Company S.A de C.V., have received their clearance to sell Psoria-Light® systems in Mexico.




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