Antares Says FDA Approves OTREXUP Injection; Covidien Reports Postive Data from DURABILITY II Study Print E-mail
By Staff and Wire Reports   
Monday, 14 October 2013 17:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 14, 2013.

Antares Pharma, Inc. (NASDAQ: ATRS) announced the approval of OTREXUP™ (methotrexate) injection by the U.S. Food and Drug Administration (FDA). OTREXUP™ is the first FDA approved subcutaneous (SC) methotrexate (MTX) for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP™ is indicated for adults with severe active rheumatoid arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs), or children with active polyarticular juvenile idiopathic arthritis (pJIA). The FDA also approved adult use of OTREXUP™ for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.

In 2012, approximately six million prescriptions were written across all dosage forms of MTX in the U.S. to treat patients for RA, pJIA and psoriasis, the same indications for which OTREXUP™ has been approved. MTX treatment is usually initiated with oral tablets, however; many patients experience an inadequate response for reasons of efficacy or tolerability.



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Covidien (NYSE: COV)
, a leading global provider of healthcare products, has released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR trial at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas, NV. These studies demonstrate the safety and effectiveness of technologies used in the treatment of peripheral arterial disease (PAD). The DURABILITY II three-year results support the use of a single long EverFlex™ self-expanding stent. DEFINITIVE AR acute 30-day data shows early success with the combined use of directional atherectomy and a drug-coated balloon (DAART) in treating lower limb blockages in PAD patients.

“Covidien's extensive clinical research program in vascular therapies aims to provide rigorous evidence that physicians can use to make treatment decisions for conditions, such as peripheral arterial disease – a common vascular disease affecting over 200 million people worldwide,” said Mark Turco, M.D., Chief Medical Officer, Covidien Vascular Therapies. “Providing clinically relevant data – like the DURABILITY II and DEFINITIVE AR trials - to physicians is a must, and I'm proud of Covidien's work to drive this evidence.”

In DURABILITY II, the use of the EverFlex™ stent demonstrated a low need for repeat procedures (revascularization of treated lesions) as well as a low rate of stent breakage (fracture rate). Stent fracture is a known cause of artery reblockage leading to repeat procedures. Final results support the long-term safety and effectiveness of the EverFlex stent in a challenging PAD patient population.

In the DEFINITIVE AR randomized study, early results show that physicians are achieving better acute procedural success when treating patients with directional atherectomy plus anti-restenotic therapy (DAART) versus using a drug-coated balloon alone. The results also showed superior lumen gain with DAART treatment with fewer vessel tears (dissections) and no “bailout” stents required.



Also Monday:



Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced data from a Phase 2 proof-of-concept study of dalfampridine extended release tablets, 10 mg (dalfampridine-ER) in people with post-stroke deficits.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today the results from a series of preclinical studies that evaluated the mechanism of action of MG01CI.

AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG)
announced that a poster being presented today at the 2013 American College of Gastroenterology's (ACG) annual scientific meeting was recognized as a Presidential Poster Award recipient.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today announced positive analytical performance data for the LymPro Test®, the Company's flagship blood test for Alzheimer's disease.

Analogic Corporation (Nasdaq: ALOG)
, enabling the world's medical imaging and aviation security technology, is showcasing a new generation of the SonixHub™ software at the ACEP 2013 Conference being held in Seattle, Washington, October 14-16.

Antares Pharma, Inc. (NASDAQ: ATRS)
today announced the approval of OTREXUP™ (methotrexate) injection by the U.S. Food and Drug Administration (FDA). OTREXUP™ is the first FDA approved subcutaneous (SC) methotrexate (MTX) for once weekly self-administration with an easy-to-use, single dose, disposable auto injector.

Arrowhead Research Corporation (NASDAQ:ARWR)
, a biopharmaceutical company developing targeted RNAi therapeutics, today announced that on October 11, 2013 it closed a previously announced private offering of common and convertible preferred stock.

Atossa Genetics Inc. (NASDAQ: ATOS)
, The Breast Health Company™, announced today that Gregory L. Weaver has joined the Company's Board of Directors and has been appointed a member of the Audit Committee.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC)
today announced the addition of three leaders in the research and development of new treatments for blood-related cancers to CTI's recently formed Scientific Advisory Board (SAB):  Alan List, M.D., President and CEO of Moffitt Cancer Center; Ross Levine, M.D., Associate Attending Physician at Memorial Sloan-Kettering Cancer Center; and Brian Druker, M.D., Director of the Knight Cancer Institute at Oregon Health & Science University (OHSU).

Coronado Biosciences, Inc. (Nasdaq:CNDO)
, a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, today announced top-line results from TRUST-I, its Phase 2 clinical trial evaluating TSO (Trichuris suis ova or CNDO-201) in 250 patients with moderate-to-severe Crohn's disease.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of minimally invasive treatments for aortic disorders, announced today details relating to the release of its third quarter 2013 financial results, which will take place on Wednesday, October 30, 2013 after the close of the market.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, plans to announce its operating results for the quarter ended September 30, 2013 before the market opens on Monday, October 28, 2013 and will host a conference call at 10:00 a.m. ET that morning to discuss its results.

Given Imaging Ltd, (Nasdaq:GIVN)
, a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results from two new studies that provide new information about gastroparesis, constipation and small intestinal bacterial overgrowth when using its SmartPill product.

Illumina, Inc. (NASDAQ: ILMN)
today announced that Verinata Health, an Illumina company, will offer a new test option for its non-invasive verifi® prenatal test.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician group practice company, announced today that it has acquired the assets of three affiliated hospitalist entities in South Texas: THG The Hospitalist Group LP, The Hospitalist Management Group, LLC, and MD @ Home Ltd., (collectively known as THG). Headquartered in Mission, Texas, THG operates in acute care hospitals and post-acute care facilities throughout the Rio Grande Valley communities of Mission, Edinburg and McAllen.

IsoRay Inc. (NYSE MKT: ISR) (NYSE Amex: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the presentation of clinical findings by numerous medical centers of the successful treatment of cancers and tumors using IsoRay's patented Cesium-131 (Cs-131) seeds, sutured seeds and seed sutured mesh for internal radiation therapy.

Michael Thomas, chief executive officer of iSonea Ltd. (ASX: ISN)  (OTCQX: ISOAY) and mHealth expert, will speak at MobileCON(TM) 2013 powered by CTIA on the "Power of M2M" (machine to machine) and "Wearables: Beyond the Handset."

MannKind Corporation (Nasdaq: MNKD)
today announced the resubmission on October 13, 2013 of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA® (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes.

MELA Sciences, Inc. (Nasdaq:MELA)
, the medical device company that has developed and is commercializing MelaFind®, the first and only FDA approved optical diagnostic device for melanoma detection used by dermatologists in their fight against melanoma, today announced that it will release its 2013 third quarter financial results after the close of trading on Wednesday, November 6, 2013.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced that results from a verification study showed the Myriad myPath™ Melanoma test effectively differentiated malignant melanoma from benign skin lesions.

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP)
, a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced new findings from its STEPS 2 study supporting the long-term use of Gattex® (teduglutide [rDNA origin]) for injection in adult patients with Short Bowel Syndrome (SBS).

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today reported five abstracts had been accepted as poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 19-23, 2013 at the Hynes Convention Center in Boston, MA.

PLX Technology, Inc. (NASDAQ: PLXT)
, the global leader in PCI Express® (PCIe®) silicon and software connectivity enabling emerging data center architectures, today announced that Larry Chisvin, PLX® vice president of strategic initiatives, will lead a panel of industry experts addressing microservers, and Akber Kazmi, PLX senior marketing director, will present on PCIe's penetration in and disruption of the storage market, at the upcoming Open Server Summit.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today initial positive results from its phase I clinical trial of oral glucocerebrosidase (GCD), or Oral GCD (PRX-112), in patients with Gaucher disease.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced plans to invest more than $285 million for the expansion of its biologics manufacturing facilities in Vacaville and Oceanside, California.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP)
today announced the availability of Ulcerative Colitis For Dummies®, Special Edition. Authored by Boston Medical Center’s Clinical Director in Gastroenterology, Co-Director of the Center for Digestive Disorders, and Professor of Medicine at the Boston University School of Medicine Francis A. Farraye, M.D., M.Sc., this version of the popular Wiley brand reference series features patient-focused information on ulcerative colitis (UC).

Sigma-Aldrich Corporation's (NASDAQ: SIAL) custom manufacturing services business unit, SAFC® Commercial, is expanding two of its manufacturing facilities in the United States to support drug manufacturers in efficiently bringing new targeted and cytotoxic therapies to market.  

Speaking today from New York, SmartMetric, Inc. (OTCQB: SMME) President & CEO Chaya Hendrick said the company is very pleased with its early sales of its MedicalKeyring™ from its limited release in August.

St. Jude Medical, Inc. (NYSE:STJ)
, a global medical device company, today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers.

Tauriga Sciences, Inc. (OTCQB:TAUG)
, a diversified company focused on generating profitable revenues through license agreements and evaluating potentially lucrative acquisition targets in an industry agnostic manner, has today announced the retention of the international law firm Nixon Peabody LLP ("Nixon Peabody) to advise the Company on both the structuring future business transactions and the evaluation of intellectual property ("IP").

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
announces today that the U.S. Food and Drug Administration has granted approval of the generic equivalent to TOBI® (Tobramycin Inhalation Solution USP) in the United States. Pursuant to an agreement with Novartis on this product, Teva expects to launch this product in late November.

TotipotentRX Corporation and ThermoGenesis Corp. (Nasdaq:KOOL), reported yesterday at the annual meeting of the American Association of Blood Banks in Denver, Colorado, a study confirming TotipotentRX's ground-breaking acute myocardial infarction combination product utilizing ThermoGenesis' point-of-care cell processing technology for an autologous bone marrow derived stem cell therapy can be delivered safely in 60 minutes.

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health delivery system, today provided an update regarding its development of an acute care hospital in Alvin, Texas, a suburb of Houston.



"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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