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Shire submits REPLAGAL BLA with the FDA

Shire plc , the global specialty biopharmaceutical company, today announced that it has submitted a BLA with the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease. REPLAGAL first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries.

22 Dec 2009

3rd Annual OneMedForum to highlight therapeutic and diagnostic products for cancers

ProActive Capital Resources Group, a company dedicated to the discovery and creation of value in the small and micro-cap marketplace, is proud to announce client presentations at the 3rd Annual OneMedForum held in San Francisco, January 12-13, 2010. ProActive clients presenting are: Access Pharmaceuticals, ImmunoCellular Therapeutics, DataTrak International, Quantum Immunologics, with Protox Therapeutic's presentation pending.

22 Dec 2009

A properly managed metabolic detoxification program can benefit

“Detox” programs have been in the spotlight recently, with a bevy of Hollywood celebrities citing their “detox” programs as the secret to looking great on the red carpet. But, what exactly is detoxification? Is it merely the latest health and beauty fad, or is it a true health therapy? And can anyone besides the Hollywood elite benefit from it?

22 Dec 2009

Genome-wide study of African and African-American ancestry released by scientists

People who identify as African-American may be as little as 1 percent West African or as much as 99 percent, just one finding of a large-scale, genome-wide study of African and African-American ancestry released today.

22 Dec 2009

Scientists identify role of epigenetic changes in SLE

Identical twins look the same and are nearly genetically identical, but environmental factors and the resulting cellular changes could cause disease in one sibling and not the other.

22 Dec 2009

Common variations in genes associated with microcephaly may explain differences in brain size

A group of Norwegian and American researchers have shown that common variations in genes associated with microcephaly - a neuro-developmental disorder in which brain size is dramatically reduced - may explain differences in brain size in healthy individuals as well as in patients with neurological and psychiatric disorders.

22 Dec 2009

Discovery suggests how toxin-filtering cells go awry

Researchers from Children's Hospital Boston and Brigham and Women's Hospital have identified an important genetic cause of a devastating kidney disease that is the second leading cause of kidney failure in children, according to The NephCure Foundation.

22 Dec 2009

Smoking, weight and skin cancer are associated with skin aging

Smoking, being heavier, not using sunscreen and having had skin cancer appear to be associated with sun damage and aging of skin on the face, according to report based on a study of twins in the December issue of Archives of Dermatology, one of the JAMA/Archives journals.

22 Dec 2009

SafeMinds disappointed with CDC's report on autism spectrum disorders

A study released Friday by the Centers for Disease Control (CDC) reported that autism prevalence has increased a staggering 57% from the 1994 rate of 1 in 150 to 1 in 110 for children born in 1996. SafeMinds is extremely dissatisfied with CDC's lack of commitment to researching environmental causes and the timing of their announcement.

22 Dec 2009

BUSM researchers discover new gene therapy for treating emphysema patients

Researchers from Boston University School of Medicine (BUSM) have discovered a new gene therapy that may prevent the progression of emphysema. The study, which appears on-line in the Journal of Clinical Investigation, describes a method to express therapeutic genes in lung tissue for a lifetime after only a single treatment.

22 Dec 2009

Findings may help develop new antiviral drugs for influenza

Investigators at Burnham Institute for Medical Research (Burnham), Mount Sinai School of Medicine (Mount Sinai), the Salk Institute for Biological Studies (Salk) and the Genomics Institute of the Novartis Research Foundation (GNF) have identified 295 human cell factors that influenza A strains must harness to infect a cell, including the currently circulating swine-origin H1N1.

22 Dec 2009

Effectiveness of VSEL stem cells in regenerative medicine demonstrated at the ASH meeting

NeoStem, Inc. (NYSE Amex: NBS), which is a leading provider of pre-disease adult stem cell collection, processing and long-term storage services, and holds the exclusive, worldwide license to VSEL(TM) technology that uses very small embryonic-like stem cells isolated from peripheral blood, announced today that five posters and two oral presentations at the prestigious American Society of Hematology (ASH) Annual Meeting in New Orleans in early December demonstrated the basic cellular mechanisms of very small embryonic-like stem cells.

21 Dec 2009

CSC completes a Series B financing round

California Stem Cell, Inc. (CSC), a leading stem cell company, announced that it has completed a Series B financing round with private investors. The financing will enable the company to support the advancement of its therapeutic products to human clinical trials, as well as the generation and distribution of its tools to aid in stem cell research and drug discovery.

21 Dec 2009

TessArae's RM-Flu test granted FDA EUA

TessArae, LLC, a privately held company, and Affymetrix Inc., (NASDAQ:AFFX) today announced that the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to TessArae for its TessArray® Resequencing Influenza A Microarray Detection Panel for the Detection of the 2009 H1N1 Influenza A Virus (TessArray RM-Flu test) for the duration of the declaration of emergency unless revoked earlier. The declaration of emergency will expire on April 26, 2010, unless terminated earlier or renewed.

21 Dec 2009

Preliminary results from Phase III study of afamelanotide in EPP announced

Clinuvel Pharmaceuticals Limited today announced that it has obtained promising 4-months results in testing afamelanotide in a multicentre randomised double-blind placebo controlled Phase III study in EPP (CUV017).

21 Dec 2009

Embryo biopsy does not adversely affect health of newborn singleton PGD/PGS children

The largest and longest running study of children born after preimplantation genetic diagnosis and screening has shown that embryo biopsy does not adversely affect the health of babies born as the result of a subsequent singleton pregnancy.

21 Dec 2009

Researchers determine structures of two enzymes that customize histones

Researchers at Emory University School of Medicine have determined the structures of two enzymes that customize histones, the spool-like proteins around which DNA coils inside the cell.

20 Dec 2009

Autism spectrum disorder dramatically increasing, early intervention crucial

In the wake of today's new report from the U.S. Centers for Disease Control (CDC) stating that autism now affects 1% or 1 in every 110 American children, Autism Speaks, North America's largest autism science and advocacy organization, called on the U.S. government to immediately step up its efforts - and dramatically increase funding - to address the growing global autism public health crisis.

19 Dec 2009

GE Global Ubiquitous Health Research and Development Center to be established

Incheon Free Economic Zone (IFEZ), GE Healthcare and Bio Research Complex (BRC) announced today the signing of a five year plan to invest in the establishment of the “GE Global Ubiquitous Health Research and Development Center” (GE Global u-Health R&D Center).

19 Dec 2009

Understanding the differences between skull bone and bones in limbs could prevent osteoporosis

Scientists at Queen Mary, University of London have uncovered fundamental differences between the bone which makes up the skull and the bones in our limbs, which they believe could hold the key to tackling bone weakness and fractures.

19 Dec 2009