Volume 9.42 | Oct 27

Cell Therapy News 9.42, October 27, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Grow Mouse Prostate from a Single Cell: The four-person team at the Californian biotechnology firm Genentech said they achieved the feat after identifying a primitive, powerful cell called a stem cell in mouse prostates.


Salk Researchers Successfully Reprogram Keratinocytes Attached to a Single Hair
A team of researchers at the Salk Institute for Biological Studies, succeeded in boosting the reprogramming efficiency more than 100 fold, while cutting the time it takes in half over traditional methods.

Caltech Engineers Build First-Ever Multi-Input “Plug-and-Play” Synthetic RNA Device
Engineers from the California Institute of Technology have created a “plug-and-play” synthetic RNA device – a sort of eminently customizable biological computer – that is capable of taking in and responding to more than one biological or environmental signal at a time.

University of Michigan Researchers Uncover New Links between Stem Cells, Aging and Cancer
Four genes previously implicated in the control of cancer have been shown by University of Michigan scientists to play key roles in the aging process and stem-cell regulation.

Living Cell Technologies Receives Health Minister’s Approval to Start Leading Edge Live Cell Therapy Clinical Trial in New Zealand for Diabetics
Living Cell Technologies recently announced that the New Zealand Health Minister, has approved an application from the company to conduct in New Zealand a Phase I/IIa clinical trial of LCT’s lead product candidate for the treatment of insulin dependent (Type 1) diabetes.

Late Problems Seen after Hodgkin’s Disease Therapy
The chemotherapy, radiation, and stem cell therapy used to treat patients with relapsed or refractory Hodgkin’s disease are associated with significant long-term problems, including an increased risk of other cancers, according to a study in the Journal of Clinical Oncology.

Spinal Cord Stem Cell Trial could Start Soon, Report Says
A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin within three months thanks to a projected lifting of a Food and Drug Administration hold on the trial.


Promotion of Reprogramming to Ground State Pluripotency by Signal Inhibition
The researchers report that brain-derived neural stem cells acquire undifferentiated morphology rapidly and at high frequency after a single round of transduction with reprogramming factors.

Lentiviral-Mediated HoxB4 Expression in Human Embryonic Stem Cells Initiates Early Hematopoiesis in a Dose-Dependent Manner but does not Promote Myeloid Differentiation
In this study, hESCs ectopically expressing high and low levels of HoxB4 were quantified throughout differentiation revealing a steady increase in transcription levels of the constructs.


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Britain Widens Scope for Stem Cell Research
British plans to allow scientists to use hybrid animal-human embryos for stem cell research won final approval from lawmakers Wednesday in a sweeping overhaul of sensitive science laws.

The United Kingdom and California Announce International Collaboration to Advance Stem Cell Research toward Cures
The California Institute for Regenerative Medicine and the United Kingdom’s Medical Research Council announced recently an international collaboration on stem cell research.

Stem Cell Science Experts Release Letter Urging U.S. Commitment to all Avenues of Stem Cell Research
The International Society for Stem Cell Research joined with other leading scientists to issue an open letter to reiterate the urgent need for U.S. support for all types of stem cell research.

Many Voters Admit to not Knowing Much about Stem Cells
According to a report released recently, very few likely voters – 11 percent – feel that they know a lot about stem cell research. The good news: Voters do have an interest in learning more about stem cell research.


Cellartis, Novo Nordisk and Lund University Enter into a Collaboration to Develop Insulin-Producing Cells from Stem Cells for the Treatment of Diabetes
The collaboration aims to develop a cell therapy for the treatment of insulin-dependent diabetes and, in the longer term, a cure for diabetes.

Stem Cell Research to Benefit Horse Owners and Trainers
Melbourne scientists in collaboration with ViaGen Inc are hoping to develop equine embryonic stem cell lines, with the aim of creating a ‘bank’ of genetically matched stem cells preserved for individual horses.

Roche Confirms Genentech Bid
Swiss drug maker Roche Holding AG confirmed its commitment to a $43.7 billion bid for the rest of Genentech Inc.

Biovest Announces $1.6M in Federal Funding Appropriated for Groundbreaking Cancer Vaccine & Skin/Bone/Tissue Repair Research
Biovest International, Inc. recently announced that the U.S. Federal Government has approved the appropriation of $1.6 million in biomedical research funds for Fiscal Year 2009 for the Defense Department’s Cancer Immunotherapy and Cell Therapy Initiative.

Biotechs Confront Bankruptcy as Funding Evaporates
The biotechnology sector looks likely to be hit by a wave of bankruptcies and failures as small companies find themselves out of funding and out of options.


Cleared Biological 510(k) Device Applications – Update

Approved Biological Premarket Approval (PMA) Device Applications – Update

Approved Biological NDA and ANDA Applications – Update

Substantially Equivalent 510(k) Device Information: Atreus Whole Blood Processing System 

CBER Foreign Regulators Seminar



HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year
The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008.

Agency Information Collection Activities; Proposals, Submissions, and Approvals – Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format

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