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Posts Tagged 'CELG'

FDA Grants Orphan Drug Designation to Nuvilex, Inc. for Pancreatic Cancer Treatment

SILVER SPRING, Md., Dec. 22, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Nuvilex orphan drug designation for its pancreatic cancer treatment. Nuvilex’s pancreatic cancer treatment combines Nuvilex’s patented and proprietary cellulose-based encapsulation technology, known as Cell-in-a-Box(R), with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form. These capsules are ...

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Nuvilex’s Cancer Treatment Obtaining FDA Orphan Drug Status Would Make Company Attractive Big Pharma Target

Written by Ι Stock Market Media Group Staff — October 14, 2014

New York, NY – Nuvilex, Inc. (OTCQB: NVLX) has officially introduced its advanced pancreatic cancer treatment to the U.S. Food and Drug Administration (FDA) in an application asking the agency to grant orphan drug status to its Cell-in-a-Box/ifosfamide combination for the rare disease.

The FDA’s orphan drug program designates a special status to drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 ...

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Nuvilex and TD2 Begin Preparations for US-Based Studies on Symptoms Associated With Pancreatic Cancer

SILVER SPRING, Md., May 21, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that, together with Translational Drug Development (TD2) in Scottsdale, Arizona, preparations have begun for US-based preclinical and then clinical studies on the unbearable pain and the accumulation of fluid in the abdominal cavity which are two commonly occurring symptoms associated with advanced pancreatic cancer.

TD2 will study the effectiveness of Nuvilex’s ...

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Nuvilex Adds World Renowned Oncologist and Gastroenterologist to Play Major Role in Late Phase Clinical Trial

SILVER SPRING, Md., May 1, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that world renowned oncologist and gastroenterologist Professor Dr. Matthias Lohr of the famed Karolinska Institute in Stockholm, Sweden, has agreed to play a major role in Nuvilex’s Phase 2b clinical trial in pancreatic cancer to be conducted in Australia, as well as other clinical studies and trials in which Nuvilex will be involved. Dr. ...

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Nuvilex, Inc. Applying for Orphan Drug Status to Market Pancreatic Cancer Treatment without Competition

Nuvilex, Inc. Applying for Orphan Drug Status to Market Pancreatic Cancer Treatment without Competition

Written by ι Stock Market Media Group — April 22, 2014

When Nuvilex, Inc. (OTCQB: NVLX) named Clinical Network Services (CNS) as the Contract Research Organization (CRO) for its late phase clinical trials in advanced pancreatic cancer, the company also stated it will apply for “Orphan Drug” status.  This is a designation that will allow Nuvilex to exclusively market its pancreatic cancer treatment using the Cell-in-a-Box® technology combined with the anticancer drug ifosfamide.

Treatments for pancreatic cancer engender an Orphan Drug designation in most ...

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Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b Clinical Trial

Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b Clinical Trial

Written by ι Stock Market Media Group Staff — April 17, 2014

Nuvilex, Inc. (OTCQB: NVLX) has once again delivered a major announcement as it advances its pancreatic cancer treatment toward late phase clinical trials. Nuvilex continues to put forth what is turning into a well thought out game plan for the future of treating advanced pancreatic cancer. It’s a game plan that could include obtaining accelerated FDA approval of its pancreatic cancer treatment if it can produce the same strong results in an announced ...

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