HeartWare Wins FDA Approval in Destination Therapy Trial; Catalyst Pharma Reports Breakthrough Therapy Designation Print E-mail
By Staff and Wire Reports   
Tuesday, 27 August 2013 18:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 27, 2013.

HeartWare International, Inc. (Nasdaq: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the Company's pivotal, Destination Therapy clinical study.

In this supplemental cohort, HeartWare will enroll up to 286 patients receiving the HeartWare^® Ventricular Assist System, as well as up to an additional 143 control patients using a randomization scheme consistent with the ENDURANCE protocol.  Patients will be followed for 12 months after implant.  HeartWare intends to incorporate the data from both this new cohort and ENDURANCE into an anticipated Pre-Market Approval (PMA) Application seeking approval of the HeartWare System for the Destination Therapy indication.  

The protocol for this cohort is designed to confirm clinical observations that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events.  

Patient enrollment can commence at the 50 centers participating in the ENDURANCE clinical trial, following Institutional Review Board approvals at each of the centers.  

On November 20, 2012, FDA granted approval of the HeartWare System for the Bridge-to-Transplant indication.  Concurrent with approval, the Company commenced a post-approval study (PAS) to assess device performance in a real-world setting.  HeartWare's PAS is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database.  HeartWare expects enrollment for both arms of the PAS will be complete by year's end.


Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced that its investigational product Firdapse™ (amifampridine phosphate) has received "Breakthrough Therapy Designation" by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse™ is Catalyst's investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.

"We are very pleased to have received Breakthrough Therapy Designation for Firdapse™ and we are excited by the FDA's decision to place our product in a category that may enable expedited development and review for patients with LEMS," said Patrick McEnany, President and Chief Executive Officer of Catalyst. "With no approved or effective symptomatic treatment currently available for LEMS, Firdapse™ has the potential to be the first-line treatment option for patients with this rare condition."

Breakthrough Therapy Designation for Firdapse™ was based on clinical data from several previously published clinical trials of amifampridine (3,4-DAP) in patients with LEMS. Firdapse™ has the potential to provide significant relief of the often debilitating symptoms of the disease, including muscle weakness (e.g. difficulty walking), difficulty swallowing and talking, drooping of eyelids and facial weakness.

Also Tuesday:

AbbVie (NYSE: ABBV) will participate in the Morgan Stanley Global Healthcare Conference on Tuesday, Sept. 10, 2013.

Accuray Incorporated (Nasdaq: ARAY) announced today financial results for the fourth quarter and fiscal year ended June 30, 2013. Non-GAAP results are provided to enhance understanding of Accuray's ongoing core results of operations.

Agilent Technologies Inc. (NYSE: A) today announced that Dr. Emmanuel Barillot, director of Bioinformatics and Systems IT at the Institut Curie in Paris, has received an Agilent Thought Leader Award in recognition of his pioneering development of user-friendly, Web-based bioinformatics tools for systems toxicology.

Align Technology, Inc. (NASDAQ: ALGN) today announced that executives of Align Technology are scheduled to speak at upcoming financial conferences.

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 the publication of two new independent peer-reviewed publications on its patented biologic MANF.

Amgen (NASDAQ: AMGN) today announced that it will present new data on omecamtiv mecarbil, a small molecule cardiac myosin activator that is being studied for the treatment of heart failure in collaboration with Cytokinetics.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that its Chief Executive Officer, Kinneret Savitsky, Ph.D., and its Chief Financial and Operating Officer, Philip Serlin, will be presenting at the 2013 Stifel Nicolaus Healthcare Conference at the Four Seasons Hotel in Boston.

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, once again participated as a National Team for Tour de Cure and raised over $125,000 in the organization's cycling events that took place nationwide this year to benefit the American Diabetes Association.

Bovie Medical Corporation (NYSE MKT: BVX), a manufacturer and marketer of electrosurgical products, is pleased to announce that the submission of a video and paper presentation, by noted Gynecological surgeons, Dr. Warren K. Volker and Dr. Melissa Gutierrez, has been accepted for presentation at the AAGL Global Congress to be held in Washington, D.C., November 10-14, 2013.

EncounterCare Solutions, Inc. (PINKSHEETS: ECSL) today announced that its subsidiary CyberFuels, Inc. has signed a Representation Agreement with Western Petroleum World Traders LLC.

Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced that, effective today, Mr. Neal Moszkowski has retired from the Board of Directors. The Board has appointed Donald Morel as a Director of the Company.

Ira Shapiro, CEO of CodeSmart Holdings, Inc. (OTCQB:ITEN), has acquired 25,000 shares of common stock of CodeSmart from the public market in a transaction on August 27, 2013. The stock was purchased at the market value of $3.21 per share, which has a total value of $80,250.

Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, today announced that its Board of Directors has hired Jeffrey A. Duchemin, a veteran life science executive, as Harvard Bioscience's Chief Executive Officer.

LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced today that it will release financial results for its fourth quarter and full fiscal year ended June 30, 2013, after the market closes on Thursday, September 12, 2013.

The OTC Journal, the longest running electronic newsletter focused on the small cap and microcap sectors, suggests investors consider the agenda when reviewing the second Seeking Alpha article published on Nuvilex, Inc. (OTCQB: NVLX) in less than two weeks.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Rainier™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen (OGX-427) in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer.

OxySure Systems, Inc. (OTCQB: OXYS), a medical technology company that has pioneered an FDA-approved solution to produce medically pure oxygen from inert powders for emergency use, was reiterated with a Speculative Buy rating from analysts at Taglich Brothers.

Regado Biosciences, Inc. (Nasdaq: RGDO), today announced the closing of its previously announced initial public offering of 10,750,000 shares of common stock, at a public offering price of $4.00 per share, resulting in gross proceeds of $43,000,000, before deducting the underwriting discounts and commissions and other offering expenses payable by Regado Biosciences.

SK3 Group, Inc. (PINKSHEETS: SKTO) has announced that its licensed products are seeing wide distribution across California.

Sigma-Aldrich® Corporation (Nasdaq: SIAL)
today announced that Sigma®Life Science, its innovative biological products and services business, released Sigma CRISPRs, an inexpensive mammalian genome editing tool suitable for screening and exploratory studies.

announced today that it has successfully completed development of a functional prototype of its Single Port Orifice Robotic Technology (SPORT™) Surgical System.

Visualant, Inc. (OTCQB: VSUL)
, a leading provider of chromatic-based identification and diagnostic solutions, has been invited to present at the 2013 Gateway Conference being held on Tuesday, September 10, 2013 at the Palace Hotel in San Francisco.

"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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