Author: Willem van Lawick

  • BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

    SAN RAFAEL, Calif., April 27, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced completion of the rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for drisapersen, an investigational exon-skipping drug candidate for the treatment of the largest genetically defined subset of Duchenne muscular dystrophy (DMD). DMD is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3,500 live male births with about 20,000 new cases diagnosed globally each year. Drisapersen induces the skipping of dystrophin exon 51, potentially providing a therapeutic benefit to DMD patients for whom skipping of exon 51 restores the proper dystrophin reading frame, corresponding to approximately 13% of DMD patients. The company intends to also submit an application for registration in the European Union in summer 2015. (more…)

  • Pulsecath and Terumo Europe signed combining technologies and distribution agreements

    On April 20th 2015 both parties signed agreements that combine Terumo’s Solopath expandable sheath with Pulsecath’s iVAC 2L percutaneous short term pulsatile LVAD.
    The Solopath SR-19/35 expand and re-collapsible Sheath will be merged with iVAC 2L as 13.5 Fr. reliable and easy to use introducing system. This technologies combination will create an attractive full percutaneous short term pulsatile LVAD to use in CathLabs with high risk PCI and cardiogenic shock patients.
    As part of these agreements Terumo Europe will distribute, service and support the iVAC 2L in four European countries: Italy , Spain , Switzerland and France.
    Both companies are going to launch this corporation during the PCR congress, Paris May 2015.

  • Organ Assist: UMCG puts donor organ perfusion unit into use

    Groningen, The Netherlands, 13 February 2015 The ‘Organ Preservation & Resuscitation’ unit in the operation centre can preserve four donor organs in four perfusion machines at the same time. The unit implemented Organ Assist’s Kidney Assist, Liver Assist, lung Assist and ECOPS. The machines ensure that the organs are continually rinsed with oxygen-enriched fluid and nutrients for several hours before transplantation. The organs can also be kept warm. Years of research have shown that this method is the best way to preserve organs such as lungs, liver and kidneys, and even enhance the quality. (more…)

  • PulseCath iVac Receives Positive Reimbursement Decision For Hospitals Across Germany

    Arnhem, The Netherlands, January 30, 2015, the German Institute for the Hospital Remuneration System (InEK) today announced that the iVAC Intra-Aortic Catheter With Para-Corporal Pump for cardiac support of the left ventricle has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 4 approval across 14 leading hospitals in Germany, a decision from German regulators that may positively influence reimbursement from insurance companies for the costs of iVAC procedures (more…)

  • Organ Assist: The University of Pittsburgh and the UPMC have published their recent research with the Liver Assist

    Groningen, The Netherlands, 27 january 2015 – The University of Pittsburgh and the UPMC have published their recent research with the Liver Assist. Dr. Paulo Fontes has perfused livers at subnormothermia with an artifical oxygen carrier solution.
    The results of the pre-clinical research Dr. Fontes with the Liver Assist has performed has been published in the American Journal of Transplantation (Volume 15, Issue 2, Article first published online: 22 januari 2015). The project in Pittsburgh has been a cooperation of Organ Assist with Dr. Fontes.
    Paulo Fontes and his colleagues at the University of Pittsburgh School of Medicine, UPMC and Pitt’s McGowan Institute for Regenerative Medicine have developed machine-perfusion technology that preserves donor livers by pumping them with a form of cold artificial blood known as a “cell-free oxygen-carrier solution.” (more…)

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