NextVolume 13.06 February 20, 2012Previous

Lin28b Reprograms Adult Bone Marrow Hematopoietic Progenitors to Mediate Fetal-Like Lymphopoiesis
Researchers demonstrate that ectopic expression of Lin28 reprograms hematopoietic stem-progenitor cells from adult bone marrow, endowing them with the ability to mediate multilineage reconstitution that resembles fetal lymphopoiesis, including increased development of B-1a, marginal zone B, gamma/delta T cells, and natural killer T cells. [Science]
Abstract

Predictive Microfluidic Control of Regulatory Ligand Trajectories in Individual Pluripotent Cells
Experimental validation using functional activation of signal transducer and activator of transcription3 (STAT3) by secreted factors under microfluidic perfusion culture demonstrated that STAT3 activation and consequently mouse embryonic stem cell fate were manipulable by flow rate, position in the flow field, and local cell organization. [Proc Natl Acad Sci USA]
Abstract

PEGylated Polyplex with Optimized PEG Shielding Enhances Gene Introduction in Lungs by Minimizing Inflammatory Responses
Safe and effective gene introduction into the lungs was previously achieved using polyplexes from poly(ethyleneglycol) (PEG)-block-polycation [PEG-block-PAsp(DET)] and plasmid DNA. In the present study, researchers investigated the combined use of two polymers, PEG-block-PAsp(DET) and homo PAsp(DET) across a range of mixing ratios to construct polyplexes. [Mol Ther]
Abstract

Increased Erythropoiesis in Mice Injected with Submicrogram Quantities of Pseudouridine-Containing mRNA Encoding Erythropoietin
In cultured cells, researchers recently achieved high levels of translation with high-performance liquid chromatography-purified, in vitro-transcribed mRNAs containing the modified nucleoside pseudouridine. Importantly, pseudouridine rendered the mRNA non-immunogenic. Here, using erythropoietin-encoding mRNA complexed with TransIT-mRNA, researchers evaluated this new generation of mRNA in vivo. [Mol Ther]
Abstract

A New Therapeutic Approach Using a Schizophyllan-Based Drug Delivery System for Inflammatory Bowel Disease
A delivery system for antisense oligonucleotides (ODN) that enhances antisense stability, while maintaining the specificity of antisense for its target RNA or DNA is needed. Researchers have developed a delivery system for antisense ODN using schizophyllan, a polysaccharide that belongs to the beta-(1-3) glucan family. [Mol Ther]
Abstract

Cancer Immunotherapy Using a Membrane-Bound Interleukin-12 with B7-1 Transmembrane and Cytoplasmic Domains
In the present study, a new membrane-bound interleukin-12 (IL-12) containing murine single-chain IL-12 and B7-1 transmembrane and cytoplasmic domains was constructed and its efficacy in cancer treatment examined and its protective antitumor mechanism investigated. [Mol Ther]
Abstract

Transient Overexpression of Cyclin D2/CDK4/GLP1 Genes Induces Proliferation and Differentiation of Adult Pancreatic Progenitors and Mediates Islet Regeneration
Researchers hypothesized that gene therapy with cyclin D2/CDK4/GLP-1 plasmids targeted to the pancreas of STZ-treated rats by ultrasound-targeted microbubble destruction would force cell cycle re-entry of residual G0-phase islet cells into G1/S phase to regenerate beta cells. [Cell Cycle]
Abstract

Long-Term Gene Therapy Causes Transgene-Specific Changes in the Morphology of Regenerating Retinal Ganglion Cells
Gene therapy holds much promise for the treatment of neurotrauma and neurodegenerative diseases; however, neurotrophic factors are known to alter dendritic architecture, and thus researchers set out to determine whether such transgenes also change the morphology of transduced neurons. [PLoS One]
Abstract | Press Release

Pyrvinium, a Potent Small Molecule Wnt Inhibitor, Increases Engraftment and Inhibits Lineage Commitment of Mesenchymal Stem Cells (MSCs)
Using an in vivo model of granulation tissue formation, researchers demonstrated that pyrvinium enhanced long-term MSC engraftment. [Wound Repair Regen]
Abstract

A Human Stem Cell Model of Early Alzheimer’s Disease Pathology in Down Syndrome
Researchers report the development of Alzheimer’s disease pathologies in cortical neurons generated from human induced pluripotent stem cells derived from patients with Down syndrome. [Sci Transl Med]
Abstract | Press Release

Transcriptional Activation by Oct4 Is Sufficient for the Maintenance and Induction of Pluripotency
Here, researchers show that fusion proteins containing the coding sequence of Oct4 or Xlpou91 (the Xenopus homolog of Oct4) fused to activating regions, but not those fused to repressing regions, behave as Oct4, suppressing differentiation and promoting maintenance of undifferentiated phenotypes in vivo and in vitro. [Cell Rep]
Abstract | PressRelease

PRESS RELEASES

ARMC Stem Cell Clinical Trial Reveals Outstanding Results for Chronic Wounds
Physicians recently completed a clinical trial involving autologous stem cell therapy that showed outstanding success in the treatment of chronic wounds and pressure ulcers. [Arrowhead Regional Medical Center (ARMC)]
Press Release

ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from Embryonic Stem Cells
Advanced Cell Technology, Inc. (ACT) announced the dosing of third patient in its Phase I/II trial for Stargardt’s macular dystrophy using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. [Advanced Cell Technology, Inc.]
Press Release

Research Breakthrough Shows Promise in Offsetting Cornea Transplant Rejection
Scientists have determined a method, in pre-clinical trials, to genetically modify donor corneas so that they are less likely to be rejected by the host immune system. [National University of Ireland, Galway]
Press Release

OncoSec Initiates Phase II Merkel Cell Carcinoma Study and Doses Several Patients
OncoSec Medical Incorporated announced that physicians at the University of Washington and SeattleCancer Care Alliance in conjunction with the Fred Hutchinson Cancer Center,have treated several patients in an open-label Phase II clinical trial evaluating OncoSec's OMS ElectroImmunotherapy for the treatment of Merkel cell carcinoma. [OncoSec Medical Incorporated]
Press Release

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NSF Tops Research Agencies with a $340-Million Boost
President Barack Obama proposed a 4.8% increase in funding for the National Science Foundation (NSF) as part of his $3.8-trillion budget request for 2013. The $340-million boost is the largest absolute increase in spending for any federal research agency. [National Science Foundation, United States]
Press Release

Global Health Advocates Aren't Impressed with Budget Plan
The budget proposal unveiled by President Barack Obama is getting negative reviews from some public health advocates. In particular, the Global Health Initiative, which targets HIV/AIDS, tuberculosis, and neglected diseases, is slated for roughly a $300 million cut to about $8.5 billion. [Global Health Initiative]
Press Release

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Baxter Completes Acquisition of Synovis
Baxter International Inc. announced that the company has completed its planned acquisition of Synovis Life Technologies, Inc., following approval of the transaction by Synovis shareholders. The acquisition expands Baxter's regenerative medicine and BioSurgery franchise by adding biological and mechanical products from Synovis used for soft tissue repair and microsurgery in a variety of surgical procedures. [Baxter International Inc.]
Press Release

Medistem Initiates Collaboration with Chinese Conglomerate Aimed at Clinical Development of Endometrial Regenerative Cells for Critical Limb Ischemia
Medistem Inc. announced initiation of joint efforts with the Chinese conglomerate, Shanghai Jia Fu Medical Apparatus Inc, in developing the Endometrial Regenerative Cell “universal donor” stem cell product for the Chinese market. The initial focus of the collaboration will be treatment of critical limb ischemia. [Medistem Inc.]
Press Release

Queen's Soft Tissue Replacement Technology Gets a Funding Boost
A new process for transforming discarded human fat into a soft-tissue substitute for use in reconstructive surgery is laying the groundwork for creating an Ontario-based regenerative medicine initiative focused on developing products for reconstructive and cosmetic surgery. Further development of the technology is possible through $192,500 in funding from MaRS Innovation Medical Sciences Competitive Proof of Principle. [Queen's University]
Press Release

Organovo Announces $6.5 Million Private Placement to Advance 3D Bioprinting for Medical Applications
Organovo Holdings, Inc. announced the successful completion of a merger with Organovo, Inc.. Concurrent with the Merger, Organovo closed a private placement consisting of approximately 6.5 million units of its securities to qualified accredited investors, for total gross proceeds of $6.5 million. [Organovo Holdings, Inc.]
Press Release

UniSA’s New Nanomaterials Expert Wins Fellowship
Just one month into his appointment at the University of South Australia (UniSA) and Professor of Chemistry and Materials Science at the Mawson Institute, Dr Nico Voelcker, has won a prestigious Humboldt Research Fellowship to carry out a long-term research project in nanomaterials. [University of South Australia]
Press Release

U-M Human Embryonic Stem Cell Line Placed on National Registry
The University of Michigan’s (U-M's) first human embryonic stem cell line will be placed on the U.S. National Institutes of Health’s registry, making the cells available for federally-funded research. [University of Michigan Health System]
Press Release

Pathfinder Announces First European Patent Allowance for Pathfinder Cells
Pathfinder Cell Therapy, Inc. announced that the European Patent Office has communicated its intent to grant Pathfinder's first European Patent, which provides intellectual property protection for the Company's cell-based technology throughout this region. The patent covers the Company's proprietary Pathfinder Cells, which are a newly identified non-stem cell mammalian cell type that has demonstrated the ability to stimulate regeneration of local damaged tissue without being incorporated into the new tissue. [Reuters]
Press Release

UCLB Patented Technology Used to Develop a Potential New Treatment for Corneal Surface Disease
Researchers at University College London (UCL) have made a significant advance towards developing a treatment for Corneal Surface Disease, using RAFT^TM; a UCL Business (UCLB) patented technology licensed to Tap Biosystems. [University College London Business]
Press Release

bluebird bio Appoints David Davidson, M.D., as Chief Medical Officer
bluebird bio announced the appointment of David M. Davidson, M.D., to the role of chief medical officer. [bluebird bio]
Press Release

ACT Announces Approval of Wills Eye Institute as Additional Site for Stem Cell Clinical Trial for Stargardt’s Disease
Advanced Cell Technology, Inc. (ACT) announced that the Wills Eye Institute in Philadelphia has received institutional review board approval as a site for the company’s Phase I/II clinical trial for Stargardt’s Macular Dystrophy using human embryonic stem cell-derived retinal pigment epithelial cells. [Advanced Cell Technology, Inc.]
Press Release

Marina Biotech Announces Closure of Cambridge Site and Consolidation of R&D Operations in Bothell, WA
Marina Biotech, Inc. announced the closure of its Cambridge site and the consolidation of all research and development efforts at its headquarters in Bothell, WA. In addition, they announced dosing of the first patient in Cohort 2 in the Dose Escalation Phase of the START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) clinical trial with CEQ508. [Marina Biotech, Inc.]
Press Release

VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates
VistaGen Therapeutics, Inc. has identified its initial Top 10 drug rescue candidates and plans to launch two formal drug rescue programs by the end of next quarter. [VistaGen Therapeutics, Inc.]
Press Release

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A Flat Budget for NIH in 2013
There's little to cheer biomedical researchers in the president's budget proposal: the proposal would hold the National Institutes of Health's (NIH's) budget at the current level of $30.86 billion.
Press Release

Notice of Change of Participation of NIH Institutes and Centers in PA-11-335 “Lab to Marketplace: Tools for Biomedical and Behavioral Research (SBIR [R43/R44])” (NOT-OD-12-053)
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NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44) (RFA-HL-13-016)
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Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2012-3779)
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Center for Scientific Review: Notice of Closed Meetings (FR Doc No: 2012-3796)
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Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2012-3434)
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Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2012-3436)
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Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc No: 2012-3440)
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Office of the Director Notice of Establishment (FR Doc No: 2012-3572)
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Prospective Grant of Exclusive License: Photosensitizing Antibody-Fluorophore Conjugates for Photo-Immunotherapy (FR Doc No: 2012-3828)
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November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Webcast
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2012 Biological License Application Approvals
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Food and Drug Administration (United States)

FDA Stays the Course, But Asks Firms to Kick In More Fees
In the 2013 budget proposal, user fees would increase to $1.97 billion, from $1.33 billion in 2012, while the amount provided by the Administration would hold steady at $2.5 billion.
Press Release

FDA Seeks $4.5 Billion to Support Medical Product Development, Protect Patients and Ensure Safety of the Food Supply
The U.S. Food and Drug Administration (FDA) is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget - a 17 percent increase over the FDA enacted budget for FY 2012.
Press Release

Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols (FR Doc No: 2012-3743)
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Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications (FR Doc No: 2012-3548)
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Draft Guidance for Industry on Providing Submissions in Electronic Format - Standardized Study Data; Availability (FR Doc No: 2012-3956)
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Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability (FR Doc No: 2012-3549)
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Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Availability (FR Doc No: 2012-3552)
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Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability (FR Doc No: 2012-3957)
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Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice (FR Doc No: 2012-3553)
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Therapeutic Goods Administration (Australia)

Documents Released under Section 11C of the Freedom of Information Act 1982
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