Bone Marrow News and Research

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Bone Marrow is the soft, sponge-like tissue in the center of most bones. It produces white blood cells, red blood cells, and platelets.

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

Protalix BioTherapeutics, Inc. announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists.

13 Jul 2010

New approach in treating heart attack, cardiomyopathy using stem cells

Presenting at the UK National Stem Cell Network annual science conference today (13 July), Professor Michael Schneider describes a new approach to treating heart attack and cardiomyopathy using stem cells.

13 Jul 2010

Asuragen, Life Technologies announce European launch of BCR/ABL1 Quant Test

Asuragen, Inc. and Life Technologies Corporation announced today that they have achieved CE-marking and commercial launch in Europe of the BCR/ABL1 Quant™ Test, Asuragen's clinically validated and cGMP manufactured test intended to aid clinicians in the monitoring and treatment of individuals afflicted with chronic myeloid leukemia (CML). Asuragen manufacturers the monitoring test, which is exclusively distributed by Life Technologies and runs on the company's Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument™.

13 Jul 2010

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

12 Jul 2010

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Protalix BioTherapeutics, Inc., announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

12 Jul 2010

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Australian regenerative medicine company, Mesoblast Limited, today announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration to discuss a proposed Phase 3 clinical trial program.

12 Jul 2010

Musashi 2 protein predicts progression of AML and CML, identify researchers

Researchers at Whitehead Institute and Children's Hospital Boston have identified a protein, called Musashi 2, that is predictive of prognosis in acute myeloid leukemia and chronic myeloid leukemia patients.

9 Jul 2010

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR™ in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in this study.

8 Jul 2010

Amniocentesis and non-embryonic stem cells among list of "Huge Medical Breakthroughs"

Two key focus areas of Biocell Center, the nation's first amniotic fluid stem cell bank, have been recently mentioned among the most important medical discoveries of the last century. Amniocentesis and non-embryonic stem cells were among the list of "Huge Medical Breakthroughs" presented in an article by Althea Chang on Mainstreet.com, produced by TheStreet.com on June 29, 2010.

8 Jul 2010

Study identifies factors that control production of HSCs

A team of researchers from the Institute for Research in Immunology and Cancer of the University of Montreal have made significant progress in the understanding of blood-producing (hematopoietic) stem cells. The study led by IRIC Chief Executive Officer and Scientific Director, Dr. Guy Sauvageau, identifies factors that control the production of hematopoietic stem cells.

7 Jul 2010

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the company will pursue a Phase 3 clinical program for its autologous cell therapy for the treatment of critical limb ischemia (CLI) through the U.S. Food and Drug Administration's special protocol assessment (SPA) process. Aastrom is currently completing a Phase 2b clinical trial of its cell therapy in patients with CLI and recently met with FDA officials to discuss plans for the Phase 3 program.

7 Jul 2010

Preclinical efficacy data of Sangamo's ZFN based human stem cell therapy for HIV published

Sangamo BioSciences, Inc. announced the publication of data demonstrating the preclinical efficacy of a human stem cell therapy for human immunodeficiency virus (HIV) based on its proprietary zinc finger DNA-binding protein nuclease (ZFN) technology.

6 Jul 2010

Pennsylvania Department of Health announces new study on blood disorder Polycythemia vera

The Pennsylvania Department of Health today announced a new, federally-funded study on the blood disorder Polycythemia vera, or PV, in Bedford, Blair, Cambria and Somerset counties.

3 Jul 2010

Heart patients treated for lymphoma at increased risk of cardiac problems

Older patients with Hodgkin lymphoma (HL) and a history of heart disease face a high risk of hospitalization for cardiac complications after completing treatment, according to research published online today in Blood, the journal of the American Society of Hematology. HL is a form of cancer of arising in the lymph nodes, and approximately 8,500 people were diagnosed with the disease in 2009, according to the American Cancer Society.

3 Jul 2010

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease. The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

2 Jul 2010

Children's Hospital Boston researchers reprogram adult blood cells into iPS cells

In findings likely to make it easier and faster for stem cell biologists to generate patient-specific embryonic-like stem cells, researchers at Children's Hospital Boston have reprogrammed adult blood cells into induced pluripotent stem (iPS) cells.

2 Jul 2010

HL patients with heart disease at increased risk of hospitalization for cardiac complications after treatment

2 Jul 2010

Allogeneic stem cell transplant holds promise for treatment-resistant chronic lymphocytic leukemia

Allogeneic (donor-derived) stem cell transplant (alloSCT) may be a promising option for patients with treatment-resistant chronic lymphocytic leukemia (CLL), regardless of the patient's underlying genetic abnormalities, according to the results of a study published online today in Blood, the journal of the American Society of Hematology.

2 Jul 2010

Commonly used type of bone marrow stem cell may help treat sepsis, new study suggests

A new study from researchers in Ottawa and Toronto suggests that a commonly used type of bone marrow stem cell may be able to help treat sepsis, a deadly condition that can occur when an infection spreads throughout the body. The study, published in the American Journal of Respiratory and Critical Care Medicine, shows that these cells can triple survival rates in an experimental model of sepsis.

1 Jul 2010

New guide to get pregnant

Infertility affects about 7 million Americans -- that's about one in six couples during their childbearing years. There are many reasons for infertility, with equal chances it's his medical issue as it is hers. A new book, "A Baby at Last!: The Couples' Complete Guide to Getting Pregnant" (Fireside Books, Simon and Schuster), points the way for couples to get past the emotionally wrenching obstacle of infertility and finally bring home their bundle of joy.

1 Jul 2010

Bone Marrow News and Research

Further Reading

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

New approach in treating heart attack, cardiomyopathy using stem cells

Asuragen, Life Technologies announce European launch of BCR/ABL1 Quant Test

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Musashi 2 protein predicts progression of AML and CML, identify researchers

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Amniocentesis and non-embryonic stem cells among list of "Huge Medical Breakthroughs"

Study identifies factors that control production of HSCs

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Preclinical efficacy data of Sangamo's ZFN based human stem cell therapy for HIV published

Pennsylvania Department of Health announces new study on blood disorder Polycythemia vera

Heart patients treated for lymphoma at increased risk of cardiac problems

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Children's Hospital Boston researchers reprogram adult blood cells into iPS cells

HL patients with heart disease at increased risk of hospitalization for cardiac complications after treatment

Allogeneic stem cell transplant holds promise for treatment-resistant chronic lymphocytic leukemia

Commonly used type of bone marrow stem cell may help treat sepsis, new study suggests

New guide to get pregnant

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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