Cempra's CEM-101 Wins Qualified Infectious Disease Product Designation from FDA; Atossa Shares Move Higher Following News Co. to Demonstrate ForCYTE Test Print E-mail
By Staff and Wire Reports   
Friday, 06 September 2013 19:00

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 6, 2013.

Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated oral Solithromycin (CEM-101), as a Qualified Infectious Disease Product (QIDP) for the indication of community-acquired bacterial pneumonia. The QIDP designation is expected to enable Cempra to benefit from certain incentives for the development of new antibiotics, including priority review, and a five year extension of new chemical entity (NCE) exclusivity. An oral formulation of solithromycin is currently being evaluated in a Phase 3 trial for the treatment of community-acquired bacterial pneumonia (CABP). Cempra is planning to initiate an intravenous-to-oral Phase 3 step-down Phase 3 trial during the second half of 2013.

 



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Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company(TM), will display its ForeCYTE Breast Health Test at the 7th annual Breast Cancer Symposium from September 7 through September 9, 2013 in San Francisco. Atossa's exhibit will be located in Booth 33 at the San Francisco Marriott Marquis -- Golden Gate Hall.

The ForeCYTE Breast Health Test, developed and marketed by Atossa's subsidiary, The National Reference Laboratory for Breast Health, detects reversible precancerous conditions in the breast up to eight years before they become cancer. The test uses Atossa's hand-held, FDA Class II medical device that is quick, painless, and non-invasive and can be administered during an OB/GYN office visit. Unlike mammograms, which are commonly recommended for women starting at age 40 to 50, the ForeCYTE Breast Health Test is more age agnostic, uses no radiation and does not require invasive biopsy needles or surgical incisions. To view a video about the ForeCYTE Test, click here: https://vimeo.com/62365818.



Also Friday:
 

 

Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that management team members will not participate at three banking conferences at which the company had previously planned to present.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, will display its ForeCYTE Breast Health Test at the 7th annual Breast Cancer Symposium from September 7 through September 9, 2013 in San Francisco. Atossa's exhibit will be located in Booth 33 at the San Francisco Marriott Marquis -- Golden Gate Hall.

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced that it has entered into a settlement agreement with Wockhardt USA, LLC and Wockhardt Ltd. (collectively, "Wockhardt") to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.

Celgene Corporation (NASDAQ: CELG)
today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Landec Corporation (NASDAQ: LNDC)
, a materials science company that develops and markets innovative and patented products for healthy living applications in food and biomedical markets, has been invited to present at the 2013 Gateway Conference being held on Tuesday, September 10, 2013 at the Palace Hotel in San Francisco.

Mast Therapeutics, Inc. (NYSE MKT: MSTX)
today announced the 2nd Annual Sickle Cell Disease Therapeutics Conference will take place on September 19th, 2013 at the Four Seasons Hotel in New York City (Cosmopolitan Suite).

Saint Alphonsus Regional Medical Center, a 387-bed facility renowned for its use of pioneering technologies, and Masimo (NASDAQ: MASI) today announced that the hospital has installed Masimo Patient SafetyNet™ in patient rooms on orthopedic, general surgery, and neurology floors. Patient SafetyNet is a remote monitoring and clinician notification system clinically shown to keep patients safer by enabling remote continuous monitoring of the patient's physiology, including oxygenation and pulse rate, which has led to saved lives, reductions in rapid response activations and transfers to intensive care units.1

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce that the NuVasive Spine Foundation™ (NSF), a non-profit organization developed and managed by NuVasive,® raised more than $230,000 during the 6th Annual NSF San Diego Golf Tournament.

Oncothyreon Inc. (NASDAQ: ONTY)
today announced the appointment of Ted W. Love, M.D., to its board of directors.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the second quarter ended June 30, 2013.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
today announced that management will present a company overview at the Bank of America Merrill Lynch Global Healthcare Conference in London.

PharmAthene, Inc. (NYSE MKT: PIP)
announced today that new data from the Company's SparVax® next-generation anthrax vaccine program were presented in two separate oral presentations at the 2013 Bacillus – ACT international anthrax conference in Victoria, British Columbia, Canada.

Press Ventures Inc. (OTCQB: PVEN)
, is pleased to announce that the Company, through its wholly-owned subsidiary Biosafety Systems, Inc. ("Biosafety Systems"), is in the process of submitting applications for rigorous testing of its patented natural cedar oil based biosafety technology in the United States with the federal Environmental Protection Agency ("EPA").

Regado Biosciences, Inc. (Nasdaq: RGDO)
, today announced the exercise of the over-allotment option granted to the underwriters to purchase 921,500 additional shares of common stock, at a public offering price of $4.00 per share, in connection with its previously announced initial public offering of 10,750,000 shares of common stock, bringing the total gross proceeds from the offering to $46,686,000, before deducting the underwriting discounts and commissions and other offering expenses payable by Regado Biosciences.

SurgiCount Medical, the wholly-owned operating subsidiary of Patient Safety Technologies, Inc. (OTCBB: PSTX, OTCQB: PSTX) today announced it has been awarded an Innovative Technology agreement by Novation, the leading healthcare supply chain expertise, analytics and contracting company for the more than 65,000 members of VHA, UHC, Children's Hospital Association and Provista, LLC.

SK3 Group, Inc.'s (OTC Pink: SKTO)
Investor Relations firm, Rubicon Capital Advisors, on behalf of the Company advises its shareholders today that the planned investor conference call scheduled for the week of September 6, 2013 has been delayed due to the enormous response from shareholders and interested parties. Over 100 questions were presented to the Company's executive team and board of directors.

Trius Therapeutics, Inc. (Nasdaq:TSRX)
, a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious infections, announced today that results of clinical studies of its lead antibiotic candidate, tedizolid phosphate, will be presented this week at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Denver.




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