Volume 8.28 | Jul 23

Volume 8.28, July 23, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Genzyme Announces Positive Results from Carticel(R) Study at Major Sports Medicine Meeting: This landmark study demonstrated that autologous chondrocyte implantation provided sustained and clinically meaningful improvements in knee function and reductions in knee pain in this patient population with significant limitations and knee pain at baseline.
Article

Science

Human Stem Cells May be Produced Without Embryos ‘Within months’
Japan’s leading genetics researcher could be “a matter of months” from reaching the Holy Grail of biotechnology – producing an “ethical” human stem cell without using a human embryo, he has said.
Article

Columbia Scientists Peer Into Stem Cells in Live Brain
Columbia University Medical Center scientists report they have observed the detailed sub-cellular behavior of neuronal precursor cells in living rat brain tissue.
Article

South Dakota State University Research May Yield New Therapy for Cancer
Associate professor Marek Malecki’s “suicide gene therapy” recognizes cancer cells and specifically introduces genetic material to make those cells die by apoptosis.
Article

Scientists Invent Novel Hydrogels for Repairing, Regenerating Human Tissue
University of Delaware scientists have invented a novel biomaterial with surprising antibacterial properties that can be injected as a low-viscosity gel into a wound where it rigidifies nearly on contact – opening the door to the possibility of delivering a targeted payload of cells to repair the damaged tissue.
Article

Can Heart Tissue be Regenerated?
Mature heart cells, given the right environment, can replicate .
Article

Novel Adult Stem Cell Growth Method May Help Treat Cornea Disorders
Ophthalmologists at the University Clinic of the University of Navarra have confirmed the efficacy of a self-designed, novel method of adult stem cell growth for its capacity to grow cornea stem cells in animal studies.
Article

Genzyme Announces Phase 3 Trial of Mozobil in non-Hodgkin’s Lymphoma Meets Primary Endpoint
Genzyme Corp. has announced that it has successfully completed its phase 3 trial of MozobilTM in non-Hodgkin’s lymphoma, and that the trial has robustly met its primary and secondary endpoints.
Article

FDA Grants Fast Track Designation to Cardium’s Phase 3 Angiogenic Gene Therapy for Heart Disease
Cardium Therapeutics announced that the U.S. Food and Drug Administration has granted fast track designation to the Company’s lead product candidate, Generx(TM) for the potential treatment of myocardial ischemia.
Article

Stem Cell Eye Trials ‘Too Risky’
Thailand doctors are shocked that the National Research Council is to conduct clinical trials on state-hospital patients to replace cornea tissue with stem cell therapy.
Article

U.S. Couple Sets Up Bone Marrow Registry in India
The aim is to create the world’s largest registry of South Asian bone marrow and stem cell donors.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

RNAi-mediated Knockdown of Target Genes: A Promising Strategy for Pancreatic Cancer Research
This review provides a brief introduction to recent developments of RNAi applications in pancreatic cancer studies and suggestions for further exploration. It substantially demonstrates that RNAi holds a promising therapeutic potential as a future treatment for pancreatic cancer.
Abstract

Policy

German Ethics Body Recommends Easing Stem Cell Law
A body that advises the German government on medical ethics has recommended changing the law to make stem cell research easier, a view that could boost the chances of new legislation.
Article

Ethics Group Adopts Opinion on Human Embryonic Stem Cell Use in FP7 Projects
The European Group on Ethics in Science and New Technologies has issued an opinion setting out guidelines for use during the ethics review of EU-funded research projects involving human embryonic stem cells.
Article

Governor Deval Patrick Pitches Biotech Plan
Governor Deval Patrick has provided a blueprint for his proposed $1 billion investment in biotechnology, introducing sweeping legislation that would finance cutting-edge research, create the nation’s largest stem cell bank, and provide expanded tax credits to life science companies.
Article

United Kingdom Medical Groups Back Donor Call
A call for everyone in the country to be entered onto the organ donor register unless they specifically opt out has been applauded by the medical establishment.
Article

Business

Thermo Fisher Scientific Launches New Line of Cell Culture Products to Advance Stem Cell Research
Thermo Fisher Scientific Inc. has announced the launch of its Thermo Scientific HyClone AdvanceSTEM(TM) product Line.
Article

GE Healthcare Financial Services Closes $3.3 Million Deal with BioStorage Technologies
GE Healthcare Financial Services has provided a $3.3 million lease line of credit to BioStorage Technologies (BST).
Article

Alnylam Grants Hayashi Kasei License to Kreutzer-Limmer Patents for the RNA Interference (RNAi) Research Products Market
Alnylam Pharmaceuticals, Inc. and Hayashi Kasei have announced that Alnylam has granted Hayashi Kasei a non-exclusive license to provide RNAi research products and services under the Kreutzer-Limmer patent family.
Article

LCT Launches American Depositary Receipt (ADR) Program
Living Cell Technologies Limited has announced that it is capitalizing on growing US investor interest in the Company through the establishment of a Level 1 American Depositary Receipt Program sponsored by the Bank of New York.
Article

Proximagen Wins Grant for its R&D on Novel Gene Therapy to Treat Parkinson’s
Proximagen Neuroscience PLC said it has won a Novel Approaches to Drug Discovery for Parkinson’s disease grant by the Michael J Fox Foundation to pursue research to develop a gene therapy for the treatment of the disease.
Article

Introgen Obtains Exclusive US Patent for Development of Adenoviral Vector Based Gene Therapies
Introgen Therapeutics, Inc. has announced that a patent has been awarded titled “Diminishing Viral Gene Expression by Promoter Replacement” by the U.S. Patent and Trademark Office focusing on adenoviral vector development, which is the most commercially important type of viral vector used in the field of gene therapy.
Article

Canada Lags in Setting up National Cord Blood Bank
A national panel of organ transplant specialists has released recommendations for the creation of a national cord blood bank.
Article

NIH

Announcing 2008 NIH Regional Seminars in Program Funding and Grants Administration (NOT-OD-07-076)
Link

Tools and Techniques for Elucidating and Manipulating Neural Circuit Development (R21) (RFA-MH-08-060)
Link

CBER

Blood Products Advisory Committee Meeting
Link

Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts
Link

Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Link

Regulatory

FOOD AND DRUG ADMINISTRATION (Untited States of America)

FDA Bonuses Spending to Draw Scrutiny
The Food and Drug Administration is giving workers more than $8 million in bonuses to keep them from defecting to pharmaceutical and other regulated industries, at the same time the agency is being pressed to spend more on food and drug safety.
Article

AUSTRALIA NEW ZEALAND THERAPEUTIC PRODUCTS AUTHORITY (Australia and New Zealand)

Therapeutics Products and Medicines Bill on Hold
The Government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products, State Services Minister Annette King announced.
Article

CENTERS FOR MEDICARE AND MEDICAID SERVICES (United States of America)

Decision Memo for Clinical Trial Policy (CAG-00071R)
Link

ISCT

7th Annual Somatic Cell Therapy Symposium
September 26-28, 2007
Hyatt Regency Bethesda, Maryland

Registration now open!  Click here to register.

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
Link

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