Insmed's Arikace Receives Orphan Drug Designation; EDAP Receives FDA Filing Acceptance for HIFU Print
By Staff and Wire Reports   
Thursday, 28 March 2013 19:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 28, 2013.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases in orphan indications that are often life-threatening, announced ARIKACE(R) , the Company's Iiposomal amikacin for inhalation, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of infections caused by non-tuberculous mycobacteria (NTM). Orphan drug designation provides certain exclusivity benefits, tax credits for certain research and a waiver of the New Drug Application user fee.

According to a recent company-sponsored patient chart study conducted by Clarity Pharma Research, approximately 50,000 cases of NTM lung disease were treated by physicians in the U.S. during 2011. There is no current FDA-approved treatment for NTM lung infection. "The FDA's timely approval of our request for orphan drug designation for ARIKACE to treat non-tuberculous mycobacteria is a key milestone that supports our broader strategy for this potentially life-saving therapy," stated Will Lewis, President and Chief Executive Officer of Insmed. "NTM is a chronic, debilitating disease, and currently available treatments have shown limited efficacy and tolerability. We continue to enroll patients in our phase 2 clinical trial of ARIKACE to treat NTM patients in the U.S. and Canada and look forward to having top-line data by the end of this year."


======


EDAP TMS SA (Nasdaq: EDAP)
, the global leader in therapeutic ultrasound, announced today that the U.S. FDA has provided a positive Filing Review Notification on the Company's Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device for the treatment of low-risk, localized prostate cancer. The FDA conducted a filing review of EDAP's PMA, and found it to contain all of the information needed to proceed with the substantive review, in which the FDA will evaluate the safety and effectiveness of Ablatherm Integrated Imaging HIFU device, as well as EDAP's engineering, manufacturing and quality systems.

Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "Receiving FDA filing acceptance for our PMA in less than two months is both very timely and a major milestone. We are moving forward in the PMA Review Process as the agency commences its substantive review. We will continue to work closely with the FDA review team."



Also Thursday:




Atossa Genetics, Inc. (NASDAQ: ATOS)
, a healthcare company focused on the prevention of breast cancer, has entered into a $30 million stock purchase agreement with Aspire Capital, LLC.

Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY)
Regenerative medicine company Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY), sponsored the second annual Skin Regeneration Symposium held in Munich, Germany, 21-22 March 2013.

FONAR Corporation (NASDAQ: FONR)
, The Inventor of MR Scanning™, announces today an upcoming medical scientific conference of distinguished medical experts on Saturday, April 6 at the Millennium Broadway Hotel, New York City.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
today announced the appointment of Matt Posard to its Board of Directors.  Mr. Posard is currently Senior Vice President and General Manager of Translational & Consumer Genomics at Illumina, Inc.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that ARIKACE®, the Company's Iiposomal amikacin for inhalation, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of infections caused by non-tuberculous mycobacteria (NTM).

International Isotopes Inc. (OTC Bulletin Board: INIS)
announces the financial results for fiscal year ended December 31, 2012, and plans for a shareholder conference call to review these results and provide a general update on the business performance and plans of the Company in 2013.

Life Technologies Corporation (NASDAQ: LIFE)
today announces plans to invest $18 million in a multi-phase plan to expand its facility in Pleasanton, Calif., where it will implement Current Good Manufacturing Practice (cGMP) capabilities for its genetic analysis products.

Mast Therapeutics, Inc. (NYSE MKT: MSTX)
today announced that it has engaged ESC Advisors, a division of the investment banking firm KEMA Partners LLC, to serve as its exclusive financial advisor to identify potential partners for MST-188 and advise the Company in transaction discussions.

MGC Diagnostics Corporation (NASDAQ: MGCD)
, a global medical technology leader, announced that its Board of Directors has approved a special, one-time cash dividend of $0.45 per share on its outstanding common stock, payable on April 26, 2013 to shareholders of record as of April 12, 2013.

Omeros Corporation (NASDAQ: OMER)
today announced data from toxicology studies evaluating OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program.

Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY)
today announced that it has met the primary overall statistical endpoint in its U.S. Phase 2 single arm clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel in patients with metastatic stage IIIB, or stage IV, or recurrent SCCLC who are chemotherapy naïve for their metastatic or recurrent cancer (REO 021).

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President, Finance, will present a company overview at the 20th Annual Future Leaders in the Biotech Industry Conference on Friday, April 5, 2013 at 10:30 am EDT.

SpectraScience, Inc. (OTCQB: SCIE)
today announced that the Company will hold a conference call at 4:30 p.m. Eastern (1:30 p.m. Pacific) on April 5th to provide an update on its business.

Symantec Corp. (NASDAQ: SYMC)
today announced that The Cardiac and Vascular Institute (TCAVI) is entrusting the protection of their sensitive information to Symantec, utilizing Symantec Endpoint Protection Small Business Edition 2013 and Symantec Backup Exec.cloud.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
, an emerging leader in the vertical and Local search space, today communicates with its shareholders and to the market in general that the company has signed a term sheet to acquire a privately held Local search Company.

Varian Medical Systems (NYSE: VAR)
, the world leader in radiotherapy equipment and software, is highlighting its Calypso® System as a tool designed to help doctors reduce women's risk of developing heart disease years after treatment for breast cancer.



"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'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus