Sagent Pharma Reports Reintroduction of Amiodarone HCL Injection; Quidel Wins FDA Clearance for Sofia(R) hCG FIA Print E-mail
By Staff and Wire Reports   
Monday, 05 August 2013 19:22

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 5, 2013.

Sagent Pharmaceuticals, Inc. (Nasdaq: SGNT) announced the reintroduction of Amiodarone HCl Injection, an antiarrhythmic agent, now in an improved prefilled plastic syringe that is compatible with most standard I.V. pumps. According to IMS, for the 12 months ending June 2013, the US market for Amiodarone HCl Injection approximated $16 million.

As with all products in Sagent's portfolio, Amiodarone features Sagent's PreventIV MeasuresSM packaging and labeling, designed to help reduce medication errors.

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Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia(R) hCG fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. Sofia is the brand name for Quidel's next-generation, immunoassay system.

The Sofia Analyzer and Sofia hCG FIA with proprietary Kinetic Check(TM) Technology combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within three (3) minutes of application of the patient's specimen.


Also Monday:

Atossa Genetics, Inc.(NASDAQ: ATOS), The Breast Health Company™, said that the new ASCO clinical practice guideline for the use of pharmacologic interventions for breast cancer risk reduction, published on July 8, 2013, by the American Society for Clinical Oncology (ASCO), is an important step forward in the fight to prevent breast cancer.

Jason Napodano, Senior Biotechnology Analyst at Zacks Investment Research, stated in an interview with George Mack of The Life Sciences Report, "Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) has a regenerative medicine device product called ReCell® Spray-On Skin® (autologous cell suspension), a treatment for severe skin defects, burns, scalds, scars, vitiligo (discoloration of the skin when melanin is lost), acne scarring and what I call the holy grail of indications, chronic wounds.

BioLineRx (NASDAQ: BLRX; TASE: BLRX)
, a biopharmaceutical development company, announced today that BL-8040 has been shown in pre-clinical trials to be effective for the treatment of thrombocytopenia, or reduced platelet production.

The Cooper Companies, Inc. (NYSE:COO)
today announced that it will release third quarter 2013 financial results on Thursday, September 5, 2013 at 4:00 PM ET.

Cutera, Inc. (Nasdaq: CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, today reported financial results for the second quarter ended June 30, 2013.

Jason Napodano, Senior Biotechnology Analyst at Zacks Investment Research, stated in an interview with George Mack of The Life Sciences Report, "Cynapsus Therapeutics Inc. (OTCQX: CYNAF) (TSX VENTURE: CTH) is a small Canadian company developing a sublingual formulation of a drug called apomorphine, which is a rescue medication for Parkinson's disease patients who experience something called 'off time,' a rigid or frozen state that occurs when their levodopa + carbidopa medication has worn off.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards SAPIEN 3 transcatheter aortic heart valve and accessories.

Enzo Biochem Inc. (NYSE:ENZ) reported today that a Federal Court Judge in New Haven, CT, has upheld the jury verdict issued in November 2012 which awarded Enzo $48.6 million in direct infringement damages as a result of Applera Corp., now Life Technologies, Inc. (NASDAQ:LIFE) having infringed Enzo’s patent covering pioneering technologies relating to compounds used in DNA sequencing systems to read the genetic code.

EPIC Corporation (PINKSHEETS: EPOR)
, and Ronald S. Tucker, EPIC's president, announced that "EPIC's earnings, for nine months, are $1,827,877 or $0.17 per undiluted share."

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that the first patients have been successfully enrolled in the new study design of its ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of Hansen Medical's Artisan® family of Control Catheters with its Sensei® X Robotic Catheter System for treatment of Atrial Fibrillation (AF), the most common cardiac arrhythmia.

iSatori, Inc. (OTCQB: IFIT)
today announced Rick J. Anderson has joined the Company's executive management team as Vice President of Sales.

Life Technologies Corporation (NASDAQ: LIFE)
and RainTree Oncology Services today announced they have entered into a collaboration agreement designed to further the advancement of personalized care for cancer patients.

Lightlake Therapeutics Inc., (OTC BB: LLTP)
, a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that it has retained KCSA Strategic Communications ("KCSA"), a leading New York-based communications firm, to direct the Company's investor and public relations programs.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
today announced the retirement of Jeffrey H. Cooper, the company's Chief Financial Officer, effective as of December 31, 2013.

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 that it will present at the 33rd Annual Canaccord Genuity Growth Conference in Boston.

Oncologix Tech Inc. (OTCQB: OCLG)
, announced today the Company has purchased 100% of the common stock of Angels of Mercy, Inc., a leader in the Personal Care Attendant (PCA) healthcare services industry.

Parametric Sound Corporation (NASDAQ: PAMT)
, a leading innovator of audio products and solutions, and Turtle Beach, the market leader in video game audio, today announced that the companies have reached a Definitive Agreement to merge in a stock for stock transaction.

PDI, Inc. (Nasdaq: PDII)
, today reported financial and operational results for the second quarter ended June 30, 2013.

PharmAthene, Inc. (NYSE MKT: PIP)
, a biodefense company developing medical countermeasures against biological and chemical threats,  today announced that its financial and operating results for the second quarter of 2013 will be released on Wednesday, August 7, 2013.

PTC Therapeutics, Inc. (NASDAQ: PTCT)
today announced that the company will report financial results for the second quarter ended June 30, 2013 following the close of market on Monday, August 12, 2013.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia® hCG fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy.

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, announces the launch of a newly formatted website featuring an interactive, secure physician web portal customized for ordering molecular diagnostic testing services, enhanced and readily accessible information for investors, improved navigation and an easier communication portal with the Company.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
today announced the reintroduction of Amiodarone HCl Injection, an antiarrhythmic agent, now in an improved prefilled plastic syringe that is compatible with most standard I.V. pumps.

Sorrento Therapeutics, Inc. (OTCQB: SRNE; SRNED; Sorrento) and IGDRASOL announced today that IGDRASOL has received official meeting minutes from an End-of-Phase 2 meeting for Cynviloq™ (or IG-001) with the US Food and Drug Administration (FDA). Cynviloq™ (paclitaxel polymeric micelle) is initially under development for the treatment of metastatic breast cancer (MBC) and non-small cell lung cancer (NSCLC) in the US.




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