Sanofi Announces FDA Panel Recommends Approval of Nasacort; Integra Receives FDA Clearance for Titan(TM) Print E-mail
By Staff and Wire Reports   
Wednesday, 31 July 2013 19:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 31, 2013.

Sanofi (NYSE: SNY) announced the U.S. FDA Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with 2 abstentions, recommending approval of Nasacort® AQ Nasal Spray (triamcinolone acetonide) for over-the-counter use in the U.S.

"Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," said Charles Hugh-Jones, MD, MRCP, Chief Medical Officer, Sanofi US. "We appreciate the feedback from the Committee and look forward to working with FDA in completing its review."

If approved by the FDA, Nasacort AQ would be first-in-class as an OTC medicine and marketed by Sanofi's consumer healthcare division, Chattem, Inc. The proposed OTC indication is temporary relief of nasal symptoms of hay fever or other upper respiratory allergies (allergic rhinitis) in adults and children 2 years of age and older.

"The OTC availability of Nasacort would continue to build on Chattem's highly successful OTC launch of Allegra and further expand our consumer healthcare offering," said Anne Whitaker, President, North America Pharmaceuticals, Sanofi.

Among prescription and OTC allergy products, Nasacort AQ and other nasal sprays in the same medication class are considered the most effective treatment for hay fever and other upper respiratory allergies.

The NDAC panel's recommendation will be considered by the FDA in its review of the Supplemental New Drug Application (sNDA) for Nasacort AQ as an OTC treatment. The FDA's decision will also be based on data submitted from 13 placebo-controlled efficacy studies, and safety information from 43 clinical studies, as well as information from 16 years of post-marketing surveillance data.

Prescription Indication Nasacort AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.


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Integra LifeSciences Holdings Corporation (Nasdaq: IART) announced that the Integra® Titan™ Reverse Shoulder System has received 510k clearance from the U.S. Food and Drug Administration (FDA). Integra expects to begin a limited market release in the United States in the third quarter of 2013, and upon CE Mark clearance in Europe, begin a full global commercial launch.

The Reverse Shoulder System is built on a unique platform stem. This platform stem simplifies the conversion of a primary total shoulder, or hemi for fracture, to a reverse shoulder, without the need to remove a stem that is well-fixed in the patient's bone. The system offers fully interchangeable components, which allow all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems. This flexibility provides surgeons with minimally invasive intraoperative options, and the ability to offer continued care for the lifetime of the patient.

William Geissler, M.D., Professor of Orthopaedic Surgery, University of Mississippi Medical Center, said that, "The versatility of the Integra Titan Reverse Shoulder System will allow me to custom fit the prosthesis intraoperatively to the unique anatomy of each of my patients. Additionally, it builds off the same platform-based press-fit stem as the Titan Total Shoulder, which allows for easier conversion, if ever required."

"The Reverse Shoulder System is an exciting addition to Integra's shoulder portfolio, which includes the Total Shoulder System and the Humeral Resurfacing Arthroplasty System" said Robert Paltridge, Integra's President, Extremity Reconstruction. "The patient and surgeon benefits built into our new platform-based system are a true testimony to our continued investment in advancing cost-effective technology in shoulder surgery."

The global shoulder replacement market is estimated to reach approximately $865 million in 2014 and $1.3 billion by 2017. With the addition of the Titan Reverse Shoulder System, which addresses both the press-fit and cemented reverse shoulder market, Integra is well positioned to gain a key foothold in this rapidly growing market.

Integra will offer surgeons hands-on training on the Titan Reverse Shoulder System at the "Clinical Concepts in Shoulder Arthroplasty Course" being held at the Pacific American Life Science Learning Center on August 10, 2013 in San Diego, CA.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.



Also Wednesday:



Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) announced that the first patient has been recruited and dosed for the Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.

Atrion Corporation (NASDAQ: ATRI)
today announced that for the second quarter of 2013 diluted earnings per share were up 7% and revenues were up 6% compared to the results for the second quarter of 2012.

Astro-Med, Inc. (NASDAQ: ALOT) announced it has been awarded the flight deck printer contract for the Transavia Airlines fleet of Boeing 737-700 and 737-800 aircraft.

Baxter International Inc. (NYSE:BAX) and JW Holdings today announced that they have entered into an exclusive distribution and license agreement for parenteral nutritional products containing a novel formulation of omega 3 lipids.

Dyadic International, Inc. (OTC Pink: DYAI)
, a global biotechnology company, today announced that it will report its financial results for the second quarter ended June 30, 2013 after market close on Thursday, August 8, 2013 and will host a conference call that day at 5:00 p.m. Eastern Time to discuss those results.

EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced financial results for the three and six months ended June 30, 2013.

EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it has entered into an "at-the-market" (ATM) equity distribution agreement with Canaccord Genuity Inc. acting as sole agent.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that, subject to closing conditions, it has entered into a securities purchase agreement for up to $93 million with Oracle Investment Management, leading medical device executive Jack W. Schuler, certain members of the Company's Board of Directors, and other existing and new shareholders, including several former healthcare executives.

Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine, will announce results for its second quarter ended June 30, 2013 before market trading hours on Thursday, August 1, 2013.

Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today reported results for the second quarter ended June 30, 2013.

IDS Industries, Inc. (OTCQB: IDST) announced today the successful completion of testing of its patent-pending integrated battery management and charge controller system.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that the Company will report its financial results for the three and six months ended June 30, 2013, before the opening of the stock market on Tuesday, August 6, 2013.

Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the Canaccord Genuity 33rd Annual Growth Conference at the InterContinental Boston.

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced today the closing of its previously announced underwritten public offering of 1,500,000 units of common shares and warrants at a price of US$2.05 per unit for gross proceeds of approximately US$3.1 million.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced its results for the second quarter ended June 30, 2013.

Life Technologies Corporation (NASDAQ: LIFE) today announced that the company has signed a long-term supply and exclusive licensing agreement  with Novartis for immunotherapeutics involving T cells modified to express chimeric antigen receptors for the treatment of cancer.

Masimo (NASDAQ: MASI) today announced that Masimo SET® pulse oximetry is now being used hospital-wide in eight of the top10 hospitals on the current U.S. News & World Report Best Hospitals Honor Roll (2013-2014).

Masimo (NASDAQ: MASI) today announced its financial results for the second quarter ended June 29, 2013.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced today that it has obtained on July 25, 2013 an interim order from the Superior Court of Québec (the "Interim Order") authorizing, among other things, Medicago to hold a special meeting (the "Meeting") of shareholders of Medicago (the "Shareholders") relating to the previously announced plan of arrangement involving Mitsubishi Tanabe Pharma Corporation ("MTPC").

Medistem, Inc. (PINKSHEETS: MEDS)
, announced today it's President and Chief Scientific Officer, Thomas E. Ichim, Ph.D., presented at the CRYO 2013 Conference held in Bethesda, Maryland on Monday July 29th.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced record revenues of $109.9 million for the quarter ended June 30, 2013, an increase of 9% over revenues of $100.5 million for the quarter ended June 30, 2012.

MiMedx Group, Inc.  (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its results for the quarter ended June 30, 2013.

NeoGenomics, Inc. (NASDAQ: NEO)
, a leading provider of cancer-focused genetic testing services today reported its results for the second quarter of 2013.

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY), a clinical-stage biotechnology company focused on the topical, anti-infective market, today announced that Thomas J. Paulson, Chief Financial Officer of NovaBay Pharmaceuticals, will present a corporate and clinical update at the Southern California Investor Conference, held on August 8, 2013 in Newport Beach, CA.

Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes that considering the success of some of the programs in Israel in treating cancer patients with cannabis, Nuvilex Inc.'s (OTCQB: NVLX) subsidiary, Medical Marijuana Sciences, Inc. may elect to emulate some of that country's initiatives.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it will report financial results for the second quarter 2013 ended June 30, 2013 after the market closes on Thursday, August 8, 2013.

The Radiant Creation Group, Inc. (OTCBB: RCGP)
has developed a complete marketing and production process for sales and product distribution. Radiant achieved this by utilizing the combined key competencies of our partners, unmatched in the current online marketing environment for the wellness and health industry.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) today announced results of operations for the second quarter of 2013, a new pipeline agreement and reaffirmed its 2013 guidance.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
today announced the launch of Docetaxel Injection Concentrate, an antineoplastic agent, in three preservative-free vial presentations.

Sinovac Biotech Ltd. (Nasdaq: SVA)
, a leading provider of biopharmaceutical products in China, today announced that it will release its unaudited financial results for the second quarter ended June 30, 2013, after market closes on Tuesday, August 13, 2013 EDT.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
expects to announce its Q2 2013 financial results after market closes on Tuesday, August 13, 2013.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
an emerging leader in the Local search space, today announced a strategic partnership with CityGrid Media, a division of IAC.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that the Company is scheduled to present at the 33rd Annual Canaccord Genuity Growth Conference in Boston on Wednesday, August 14th at 8:30am (EDT).

Vermillion, Inc. (NASDAQ: VRML)
, a multivariate diagnostics company focused on gynecologic cancers and women's health, will hold a conference call on Wednesday, August 14, 2013, at 4:30 p.m. Eastern time to discuss results for the second quarter ended June 30, 2013.

ZELTIQ® (Nasdaq:ZLTQ)
, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced financial results for the second quarter 2013.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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