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Lilly Receives Fourth FDA Approval For ALIMTA(R) (pemetrexed For Injection)
Eli Lilly and Company (NYSE: LLY) announced it received a fourth approval from the U.S. Food and Drug Administration (FDA) for ALIMTA(R) (pemetrexed for injection). The latest approval is for ALIMTA as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.
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Potential Patient Safety Risks Among Methadone Maintenance Treatment Patients Identified By Researchers
Boston Medical Center (BMC) researchers have identified potential safety risks among methadone maintenance treatment (MMT) patients due to the quantity and accuracy of medical record documentation. Improved communication and coordination among substance use treatment and medical providers could mitigate and manage the potential adverse effects of methadone and interacting medications. The BMC study appears in the July issue of Journal of General Internal Medicine.
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UCB's Cimzia(R) Approved In The U.S. For Adult Patients Suffering From Moderate To Severe Rheumatoid Arthritis
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the U.S. Food and Drug Administration (FDA) has approved Cimzia®, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia® (certolizumab pegol), is a PEGylated anti-TNFa (Tumor Necrosis Factor alpha). The product is currently being developed by UCB. Cimzia is one of several products which utilize Enzon"s PEGylation technology, including PEG-INTRON®, Macugen®, and Pegasys®.
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Cellerant Therapeutics Announces Dosing Of First Patient In A Phase 1 Trial Of CLT-008 For Hematological Malignancies

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has dosed its first patient in a Phase 1 IND trial of CLT-008 for hematological malignancies. CLT-008 is an off-the-shelf cell-based biologic designed to rapidly produce mature neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation, or being treated for chemotherapy- or radiation-induced neutropenia among other applications. The Phase 1 study is an open-label, dose-escalation trial and will investigate the safety and tolerability of CLT-008 in 20 to 25 patients undergoing cord blood transplants. Dr. John Wagner, Professor of Pediatrics and Director of the Division of Hematology-Oncology and Blood and Marrow Transplantation at the University of Minnesota is the Principal Investigator for the study. Dr. Wagner is recognized internationally as an expert in the field of stem cells and use of unrelated cord blood hematopoietic stem cells in transplant settings. The trial is being conducted at the University of Minnesota. "I am very excited to be part of this clinical study," said Dr. John Wagner. "Cord blood has become the principal of blood forming stem cells in children and is increasingly becoming a main of allogeneic cells for stem cell transplantation in adults with leukemia and lymphoma. However, delayed engraftment and prolonged hospitalization have been the limiting factors to its effectiveness. CLT-008, a of blood forming progenitor cells has the potential of overcoming these obstacles, making cord blood transplants safer and more available for everyone regardless of age, size, or ethnic and racial background. CLT-008 has tremendous potential as an off-the-shelf product for patients with transient bone marrow failure whether after chemotherapy or accidental exposure to radiation." "The initiation of this trial represents an important milestone for Cellerant," said Dr. Ram Mandalam, President and CEO of Cellerant Therapeutics. "In preclinical testing CLT-008 was shown to provide hematopoetic support to enable long-term engraftment of blood-forming stem cells, which could lead to broader use of cord blood transplants as an effective therapy for multiple life-threatening blood diseases. CLT-008 addresses a number of unmet medical needs with significant markets and we are excited to further the clinical development of CLT-008 for other indications including neutropenia in the near future." About CLT-008 CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Myeloid Progenitor Cells derived from adult stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In pre-clinical models, CLT-008 has been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficiency. Cellerant is developing CLT-008 as an effective treatment for chemotherapy induced neutropenia, protection from exposure to acute radiation and facilitating cord blood transplantation. Cellerant Therapeutics


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