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Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Celldex Therapeutics, Inc. today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

5 Oct 2010

NIH awards contract to develop nanotechnology tools for atherosclerosis treatment

Georgia Tech and Emory University have received a five-year $14.6 million contract from the National Institutes of Health (NIH) to continue the development of nanotechnology and biomolecular engineering tools and methodologies for detecting and treating atherosclerosis.

5 Oct 2010

Terminal metastatic cancer effectively treated in mice

Terminal metastatic cancer - the presently untreatable cause of the great majority of all cancer deaths - has now been effectively treated in three common fatal cancers in mice, announced Genomic Systems, citing research published online today in the Proceedings of the National Academy of Science (PNAS).

5 Oct 2010

NIEHS awards grant to study environmental impact on genetic information

The National Institute of Environmental Health Sciences has awarded $2.27 million to Indiana University researcher Joseph Shaw for a five-year study of how the environment alters genetic information through mutation and natural selection.

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Autism coal link study unable to move forward

There have been studies in the United States that have shown that there is a higher rate of autism among children living close to power stations. An Australian researcher following up on the possible link between coal-fired power stations and autism claims to have been denied access to data.

4 Oct 2010

Second pathway to brain’s memory function uncovered

Australian and US scientists have successfully identified a new mechanism by which the brain learns and stores memories. This could spell hope for brain injuries and diseases like Alzheimer’s disease.

4 Oct 2010

Depression treatment guidelines updated

There has been an update in the treatment of clinical depression. This includes suggestions on the use of medication, talk therapy, exercise, and alternative treatments and puts more emphasis on tailor made treatments for patients.

4 Oct 2010

NY Times: DEA crackdown means delays for some patients in need of pain meds

The New York Times: Increased scrutiny by the Drug Enforcement Administration may be causing painful delays for patients who need narcotic drugs. "Roland Lorenz has surgical screws in his back and neck and a pin in his upper leg, and when his pain reared up one recent weekend, he knew he needed something strong.

4 Oct 2010

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Enzo Biochem, Inc., announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI).

4 Oct 2010

Decision Resources: NSCLC drug market to grow from $4 billion in 2009 to over $6.5 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues finds that the non-small-cell lung cancer (NSCLC) drug market will increase from approximately $4 billion in 2009 to more than $6.5 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

4 Oct 2010

Titan Spine to release new Endoskeleton TC system in first-quarter 2011

Titan Spine announced that it will begin full commercial release of its new Endoskeleton® TC system first quarter of 2011. The Endoskeleton® TC is an interbody fusion device for the cervical spine. The product received 510(k) clearance in July of this year and has been in limited market release since early August. The device has an acid etched titanium surface and is biomechanically designed to promote spinal fusion.

4 Oct 2010

New equation to calculate energy requirement for underweight COPD patients

Malnutrition often goes hand in hand with COPD and is difficult to treat. In a recent study researchers at the University of Gothenburg, have come up with a new equation to calculate the energy requirement for underweight COPD patients. It is hoped that this will lead to better treatment results and, ultimately, better quality of life for these patients.

4 Oct 2010

FDA clears DFine's new percutaneous radiofrequency ablation device for metastatic spinal lesions

DFine, Inc., developer of minimally invasive solutions for the treatment of vertebral pathologies, announced today the 510(k) clearance of a new platform extension indicated for the palliative treatment of cancer patients. The product, a percutaneous radiofrequency ablation (RFA) device, provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort.

4 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Mylan subsidiary receives FDA approval for Fludarabine Phosphate Injection ANDA

Mylan Inc. today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).

4 Oct 2010

Nicotine reduction strategy should be an urgent research priority

After a major review of scientific information, six leading tobacco research and policy experts have concluded that a nicotine reduction strategy should be an urgent research priority because of its potential to profoundly reduce the death and disease from tobacco use. Their findings were published today in the journal Tobacco Control.

4 Oct 2010

IRSF awards $1.5M in research grants for Rett syndrome treatment

The International Rett Syndrome Foundation (IRSF) announced today that it will award an additional $1.5M in research grants, bringing the 2010 total to $2.15 million for innovative basic and translational research that moves treatments for Rett syndrome a step closer to the clinic.

4 Oct 2010