Medical Tidbits, Solving Organ Shortage Announces Strategic Research Goals to Regenerate or Bioengineer a Kidney

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AUSTIN, Texas–(EON: Enhanced Online News)–Solving Organ Shortage today announced the Phase One Strategic Research Goals identified by its Whole Kidney Research Community, a multidisciplinary group of senior academic investigators collaborating to develop techniques and technologies to regenerate failing kidneys or engineer replacement organs for use in transplantation. By identifying which challenges to tackle first, SOS hopes to focus the field and accelerate progress toward solving the worldwide shortage of donor kidneys that is expected to worsen in the coming decade as the population in industrialized countries ages. read more

EISAI RECEIVES ADDITIONAL APPROVAL IN JAPAN FOR VASCULAR EMBOLIZATION DEVICE DC BEAD® AS TREATMENT OF HYPERVASCULAR TUMORS AND ARTERIOVENOUS MALFORMATIONS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received additional approval for the vascular embolization device DC Bead® (specially controlled medical device, “DC Bead”) to be used for the treatment of hypervascular tumors and arteriovenous malformations (AVM) in Japan. The product will be able to be reimbursed for this newly approved purpose once procedures are completed for insurance reimbursement listing as a specially controlled medical device (the original purpose for treatment of hepatocellular carcinoma is already eligible for reimbursement).  read more

Sarepta Therapeutics Announces USPTO Decision in Patent Interference Case with BioMarin Pharmaceutical

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sep. 30, 2015– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has issued a decision in the patent interference proceeding (Interference No. 106,013) concerning methods for treating Duchenne muscular dystrophy with certain exon 51 skipping oligonucleotides claimed in BioMarin’s pending U.S. Patent Application No. 14/198,992 and Sarepta’s granted U.S. Patent No. 8,486,907. The PTAB has not yet issued a decision in the two pending composition of matter patent interference proceedings relating to (i) the exon 51 skipping oligonucleotides underlying the methods that are the subject of this decision (Interference No. 106,008) or (ii) the exon 53 skipping oligonucleotides (Interference No.  read more

New Global Partnership, RHD Action, Calls on World Leaders to End Rheumatic Heart Disease

New York – September 29, 2015 – RHD Action, a new global movement to end rheumatic heart disease (RHD), launched today on the occasion of the United Nations General Assembly in New York.  Global health experts, healthcare providers, people living with RHD and others called for new action against this easily preventable but neglected disease, which is a major cause of serious illness and death among women, children and adolescents in developing countries. read more

OncoGenex Announces Completion of Patient Enrollment in Borealis-2(TM) Clinical Trial Evaluating Apatorsen in Relapsed or Refractory Metastatic Bladder Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, Sept. 30, 2015 /CNW/ — OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that Borealis-2™, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States.  read more

United Therapeutics Announces Settlement of Patent Litigation with Sandoz Inc.

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2015 /PRNewswire/ — United Therapeutics Corporation (NASDAQ: UTHR) announced today that it has entered into a Settlement Agreement with Sandoz Inc. (“Sandoz”) relating to ongoing litigation concerning certain patents relating to United Therapeutics’ product, Remodulin® (treprostinil) Injection, and Sandoz’s Abbreviated New Drug Application (“ANDA”) seeking approval by the U.S. Food and Drug Administration to market a generic version of Remodulin. read more

DaVita to Establish Operations in Brazil  

SÃO PAULO, Sept. 30, 2015 /PRNewswire/ — DaVita HealthCare Partners Inc. (NYSE: DVA), a leading global provider of kidney care services and a leading independent medical group in the United States, today announced plans to begin operations in Brazil. The company, which operates in 11 countries serving more than 1.5 million patients, aims to bring its global expertise and leading clinical outcomes to the country.   read more

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