Boston Scientific Receives CE Mark Approval for Direxion Torqueable Microcatheter; BioMarin Confirms FDA Panel Recommends Approval of Vimizim Print E-mail
By Staff and Wire Reports   
Tuesday, 19 November 2013 20:17
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 19, 2013.

Further bolstering its market-leading portfolio of peripheral embolization technologies, Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration clearance and CE Mark approval for its Direxion™ Torqueable Microcatheter.

Peripheral embolization is a technique used primarily by interventional radiologists to treat liver cancer, uterine fibroids and other challenging conditions.  It involves deliberately blocking a blood vessel to prevent blood flow to an area of the body, which can effectively shrink a tumor or block an aneurysm.

"The Direxion Microcatheter's unique handling characteristics are intended to enable physicians to efficiently access difficult to navigate vessels across many types of peripheral embolization procedures," said Riad Salem, M.D., MBA, professor of Radiology and director of Interventional Oncology at Northwestern Memorial Hospital.

"Combined with a range of tip shape offerings and selection of pre-loaded systems, the Direxion Microcatheter offers an attractive portfolio that opens up a whole new dimension in microcatheter technology," said Robert Lewandowski, M.D., associate professor of Radiology at Northwestern Memorial Hospital.

Salem and Lewandowski were the first users of this platform worldwide.

The Direxion Torqueable Microcatheter is designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic



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BioMarin Pharmaceutical Inc. (Nasdaq: BMRN)
announced the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA voted in favor of approval of Vimizim for the treatment of Morquio A syndrome, also called Mucopolysaccharidosis Type IVA (MPS IVA). Of the 21 panel members, 19 voted in favor of approval of Vimizim for use in all MPS IVA patients, 1 voted in favor of approval for a subgroup of MPS IVA patients, and one panel member voted to not recommend approval.

Vimizim is an investigational enzyme replacement therapy for the treatment of patients with the lysosomal storage disorder Morquio A syndrome.  Morquio A syndrome is an ultra-rare, severely debilitating disease that affects an estimated 3,000 patients in the developed world.  

"We are thrilled to have achieved this important milestone in our mission to bring the first approved therapy to treat Morquio A patients," said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "I am very pleased with the outcome of today's panel vote and look forward to continuing to work with the FDA to bring this much-needed therapy to these patients."

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2014, for completion of its review of the Biologics License Application (BLA) for Vimizim. The EMDAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the EMDAC's recommendation, but will consider the committee's recommendation as the FDA completes its review of the Vimizim BLA.



Also Tuesday:



Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, today announced it will present at the 2013 Piper Jaffray Healthcare Conference on Wednesday, December 4, 2013 at 3:00 PM Eastern Time at the New York Palace Hotel.

Amgen (NASDAQ: AMGN)
today announced results from the Open Label Study of Long TERm Evaluation Against LDL-C (OSLER) trial, a long-term controlled 52-week safety and efficacy study, that showed monthly treatment with evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood1, was not associated with a major increase in adverse events (AEs) versus standard of care (SOC) and produced mean LDL-C reductions of 52 percent in combination with SOC in patients with high cholesterol.

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT)
and its subsidiaries announced today its results for the quarter ended September 30, 2013.

BG Medicine, Inc. (Nasdaq:BGMD)
announced today the publication of results of an independent multicenter clinical research trial in Europe that enrolled 419 heart failure patients and demonstrated that elevated levels of galectin-3 in blood, as measured using the BGM Galectin-3® Test, were significantly predictive of unplanned hospital readmissions and fatal events during the 12 month follow-up period of the trial.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
announced today that NASDAQ has halted trading of the company's stock. The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) is meeting today to review BioMarin's Biologics License Application (BLA) for Vimizim, an enzyme replacement therapy being developed for the treatment of patients with the lysosomal storage disorder Morquio A syndrome.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A syndrome, also called Mucopolysaccharidosis Type IVA (MPS IVA).

Biota Pharmaceuticals Inc. (Nasdaq:BOTA)
announced today that it has commenced dosing in two Phase 1 clinical trials of laninamivir octanoate, its long-acting neuraminidase inhibitor being developed for the treatment of influenza.

Capstone Therapeutics' (OTCQB:CAPS)
joint venture, LipimetiX Development, LLC, today announced the presentation of pre-clinical data demonstrating the sustained benefit effect of their apolipoprotein E mimetic peptide (AEM-28) on established atherosclerotic lesions in Apo E null mice at the American Heart Association Scientific Sessions meeting, November 16 – 20, 2013, in Dallas, TX.

Gentium S.p.A. (Nasdaq:GENT)
announced today that the European Commission ("EC") has granted Orphan Drug Designation to Defibrotide for the prevention of Graft versus Host Disease ("GvHD").

Hemispherx Biopharma (NYSE MKT:HEB)
announced its sponsorship of the Conference on "Diagnosis, Treatments and New Developments in ME and CFS" ("Myalgic Encephalomyelitis" and "Chronic Fatigue Syndrome") which will be held on November 20th beginning at 11 AM (EST) at the New York Academy of Medicine, 1215 Fifth Avenue/103rd Street, New York, NY.

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 David Phelps has accepted a role as global Chief Sales Officer for the company.

MRI Interventions, Inc. (OTCQB:MRIC)
today announced that Veterans Affairs Medical Center (VAMC) in San Francisco, California, has become the first VA hospital to offer MRI-guided asleep deep brain stimulation (DBS) surgery to veterans suffering from Parkinson's disease.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
today announced financial results for the second quarter of fiscal year 2014, ended September 30, 2013.

The Spectranetics Corporation (Nasdaq:SPNC)
today announced that its management will be presenting at the Piper Jaffray 25th Annual Healthcare Conference on December 4th, 2013 in New York.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that clinical trial results of SL-701, a Phase 2 therapeutic entering registration-directed studies in high-grade glioma (HGG), in an additional indication, low-grade glioma (LGG), will be presented by investigators from the University of Pittsburgh at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) being held in conjunction with the 18th Annual Society for Neuro-Oncology (SNO) meeting in San Francisco, California on November 21-24, 2013.

At the request of IIROC, Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) wishes to confirm that the Company's management is unaware of any material change in the Company's operations that would account for the recent increase in market activity.



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