Volume 8.15 | Apr 23

Volume 8.15, April 23, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Studies Confirm Proof-of-Principle for Geron’s Human Embryonic Stem Cell (hESC) Derived Hepatocytes: Geron Corporation has announced that it has developed standardized hepatocytes from human embryonic stem cells (hESCs) that can model human hepatic drug metabolism.


Gene Plays Key Role in Embryonic, Adult Stem Cells
One gene directs both embryonic and adult stem cells to perform the self-renewal function that is crucial in their potential broad use in medical treatments.

Adult Stem Cells May Have Smarts to Guard Against Cancer
Some bewildering behavior seen in the stem cells of muscles has led researchers at the Stanford University School of Medicine to an unexpected discovery that could explain why cancer isn’t more common.

Gelatin-Based Nanoparticle Effective in Gene Therapy for Breast Cancer
Northeastern University professor Mansoor Amiji and graduate student Sushma Kommareddy have published a new paper that examines the potential of engineered gelatin-based nanoparticles to deliver therapeutic genes to human breast cancer tumors implanted in mice.

Liver Regeneration May Be Simpler Than Previously Thought
The way the liver renews itself may be simpler than what scientists had been assuming. A new study provides new information on the inner workings of cells from regenerating livers that could significantly affect the way physicians make livers regrow in patients with liver diseases such as cirrhosis, hepatitis, or cancer.

Introgen’s Intravenous Nanoparticle Gene Therapy Shows Activity in Stage IV Lung Cancer Patients
A cancer-suppressing gene has been successfully delivered into the tumors of stage IV lung cancer patients via Introgen Therapeutics, Inc.’s intravenously administered lipid nanoparticle product candidate INGN 401.

Living Cell’s Diabetes Drug to Trial
Biotechnology company Living Cell Technologies has been granted New Zealand regulatory approval to proceed to Phase I and IIa trials of its diabetes drug, DiabeCell.

Cell Genesys Reports GVAX Immunotherapy for Prostate Cancer Induces a Broad, Patient-Specific Antibody Response
Evaluation of antibody responses in patients with advanced prostate cancer from these studies shows that the GVAX cell-based immunotherapy induces antibody responses to a broad array of prostate cancer- associated antigens, including some not previously known to be associated with prostate cancer.

Sports Medicine Miracles?
Designer “spare parts” for ruptured tendons and torn ligaments. Stem cell injections to heal and build muscle. Medical therapeutics that would allow star athletes to extend their careers by years, if not decades.


Direct Differentiation of Human Embryonic Stem Cells to Hepatocyte-like Cells Exhibiting Functional Activities
This study discusses a differentiation system that shows that hESCs can be differentiated to hepatocyte-like cells capable of executing a range of hepatocyte functions.


EU May Miss Boat on Stem Cells
Europe may miss the boat on promising new stem cell and other advanced therapies unless a deadlock over regulation is broken.

UK Launches National Stem Cell Network
The UK has launched a new network to coordinate and promote the country’s stem cell research effort.

Stem Cell Agency President Resigns
The president of California’s $3 billion stem cell agency said that he would resign at month’s end rather than in June as previously announced.

Texas House Panel Votes To Ban Funds For Embryonic Stem Cell Research
A Texas House committee has voted to bar state funding for embryonic stem cell research.

Stem Cell Debate Rekindles in Michigan
A coalition including some advocacy groups and Democratic state lawmakers is reviving efforts to remove barriers on embryonic stem cell research in Michigan.


Baxter Moves from Drips to Stem Cell Research
Baxter International Inc. is quietly entering the complex, but promising field of stem cell research.

GE Healthcare Acquires Wave Biotech LLC, Broadening Capabilities in Growing Biopharmaceutical Manufacture Segment
GE Healthcare, a unit of General Electric Company has announced it has acquired Wave Biotech LLC, a supplier of innovative disposable manufacturing technologies for the biopharmaceutical industry.

Thrombogenics Announces License Agreement With Millipore for Commercialization of Stem Cell Medium Technology
ThromboGenics NV has announced that it has completed a global license agreement with Millipore Corporation under which ThromboGenics will exclusively license its technology for production of the proprietary stem cell culture medium marketed by Millipore as RESGRO(TM)(x).

Lonza Splashes Out On Biomanufacturing Expansion
Swiss contract manufacturer Lonza has announced it will invest around $300m (€220m) in the expansion of its US biomanufacturing plant, just two weeks after kicking off the construction of a similar facility in Singapore.

Texas Institute for Genomic Medicine Now Selling Mouse Embryonic Stem Cell Clones for Research
The Texas Institute for Genomic Medicine has expanded its product offering to include sales of mouse embryonic stem cell clones from the world’s largest collection of C57BL/6 and 129SvEv mouse lines. These mouse stem cell clones will be made available to scientists on a case by case basis.

ReNeuron Receives Notice of European Patent Grant Covering Key Neural Stem Cell Lines
ReNeuron Group plc has announced that it has received a notification of grant from the European Patent Office concerning a patent application covering the composition, manufacture and use of three key human neural stem cell lines.


Career Enhancement Award for Stem Cell Research (K18) (PA-07-359)

Updated NHLBI Contact Names for PA-06-243, “New Approaches to Non-Viral Systems for Gene Transfer Applications for Heart, Lung, and Blood Diseases” (NOT-HL-07-110)

Addendum to NOT-HG-07-011 Administrative Supplements for Making Knockout Mice (NOT-HL-07-111)


Vaccines and Related Biological Products Advisory Committee

Draft Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting – Improving Human Subject Protection

SOPP 8413: Postmarketing Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting – Updated

All new CBER information can be reached from the What’s New page at What’s New Page


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting


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