GlaxoSmithKline Receives FDA Approval For Arnuity Ellipta; Hospira Granted Temporary Restraining Order Against FDA Print
By Staff and Wire Reports   
Wednesday, 20 August 2014 18:29
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 20, 2014.
GlaxoSmithKline plc (NYSE:GSK) announced that the FDA has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.

The approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients."

The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma.

Full US Prescribing Information, including Patient Information Leaflet, will be available soon at: us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Inquiries" section at the end of this document.

Arnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.



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Shares of Hospira (NYSE: HSP)
are trading higher after the company was granted a temporary restraining order against the U.S. Food and Drug Administration over the agency's approval of generic versions of the company's top-selling drug, Precedex.

Precedex is a sedative that accounts for nearly 11 percent of Hospira's total revenue.

Shares of Hospira are up 2.23 percent At $55.12.



Also Wednesday:



ActiveCare Inc. (OTCQB:ACAR)
, a leader in diabetes monitoring and wellness services for self-insured employers nationwide, today reported financial results for the third fiscal quarter ended June 30, 2014.

Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced positive 18-month data from its second Phase 3 study (Study 012) of the oral small molecule chaperone migalastat HCl in Fabry patients with amenable mutations.

BioReference Laboratories, Inc. (Nasdaq:BRLI)
announced today it plans to issue earnings results for the third quarter 2014 before the open of market trading on Wednesday, August 27, 2014.

Cellectar Biosciences, Inc. (Nasdaq:CLRB)
, a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced the closing of an underwritten public offering of 3,333,333 shares of its common stock at a per share price of $3.75 and warrants to purchase up to the same number of shares of common stock at a per warrant price of $0.01; plus the issuance of approximately an additional 1,110,000 shares and warrants in consideration of the cancellation of $4,000,000 principal amount of convertible debentures plus accrued interest.

Cloud Medical Doctor Software Corporation (OTCQB:NSCT)
, a leading provider of cloud-based services for the healthcare market announced today that its Cloud-MD V4.1 EHR Module has been certified as a Complete Ambulatory 2014 Meaningful Use both Stage 1 and Stage 2 EMR under the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body (ONC-ACB) program.

Cytomedix (OTC:CMXI)
, a pioneer in biodynamic therapies, today announced that it has partnered with Net Health to develop functionality in Net Health's WoundExpert software that enables collection of patient data for the Company's Coverage with Evidence Development program.

iKang Healthcare Group, Inc. (Nasdaq:KANG)
, the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, announced today it will attend the J.P. Morgan Asia Pacific Equity Conference to be held on September 3rd to 4th at Ritz-Carlton Hotel in Boston.

Lion Biotechnologies, Inc. (OTCBB:LBIO)
, a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), today announced that it has hired Elma Hawkins, PhD, MBA, to serve as president and chief operating officer. Her appointment is effective immediately.

Nanosphere, Inc. (Nasdaq:NSPH)
, a company enhancing medicine through targeted molecular diagnostics, today announced the appointment of Kristopher Wood to its board of directors.

Neogen Corporation (Nasdaq:NEOG)
, an international company that provides products and services to improve the quantity, quality and safety of the world's food supply, will visit the NASDAQ MarketSite in Times Square.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that Dr. Hans Keirstead, President, NeoStem Oncology, will give a company presentation at the Swedish-American Life Science Summit 2014 in Stockholm where the conference's theme is 'The Future of Medicine.'

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that studies are underway at Translational Drug Development's (TD2) facilities in Scottsdale, Arizona, to determine if Nuvilex's unique cancer treatment can slow the accumulation of fluid, known as "malignant ascites," in the abdomen that is characteristic of the growth of many abdominal tumors.

The Spectranetics Corporation (Nasdaq:SPNC)
today announced that its management will be participating in two upcoming investor conferences.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced the publication of data in a peer-reviewed scientific journal which highlights positive results in an animal model of Marburg virus infection enabled by Tekmira's lipid nanoparticle (LNP) technology.



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