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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

Mind-body intervention effective in treating persistent fatigue in breast cancer survivors

A group-based, holistic, mind-body intervention was equally effective in treating persistent fatigue and improving quality of life for breast cancer survivors, regardless of their race.

4 Oct 2010

Saturated fat intake has limited impact on CVD risk: Research

For the past three decades, saturated fat has been considered a major culprit of cardiovascular disease (CVD) and as a result dietary advice persists in recommending reduced consumption of this macronutrient. However, new evidence shows that saturated fat intake has only a very limited impact on CVD risk causing many to rethink the "saturated fat is bad" paradigm.

4 Oct 2010

Rate of chemotherapy administration for NSCLC more than twice that reported by SEER

For the first time to date, research published in the October edition of the Journal of Thoracic Oncology (JTO) sought to determine the use of chemotherapy in a contemporary, diverse non-small cell lung cancer (NSCLC) population encompassing all patient ages. Prior population-based studies have shown that only 20 to 30 percent of advanced lung cancer patients receive chemotherapy treatment.

4 Oct 2010

Study shows hypomethylation increases through progression of multiple myeloma

DNA methylation, a modification of DNA linked to gene regulation — is altered with increasing severity in a blood cancer called multiple myeloma, according to a study by Mayo Clinic and the Translational Genomics Research Institute (TGen).

4 Oct 2010

Neupro improves quality of life in Parkinson's disease patients

People with Parkinson's disease who used once-daily Neupro® (rotigotine) in the RECOVER trial achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms.

4 Oct 2010

Californian Hispanics at lower risk of developing melanoma, but develop the disease at younger age

Scientists at the Cancer Prevention Institute of California (CPIC), Stanford University, and the University of Southern California/Keck School of Medicine have found that while Hispanics have much lower risks of developing melanoma than non-Hispanic whites in California, they develop the disease at younger ages, develop thicker tumors, which are more difficult to treat, and experience a higher percentage of cases among people living in poorer neighborhoods.

4 Oct 2010

Cancer patients likely to experience memory impairment: Study

People with a history of cancer have a 40 percent greater likelihood of experiencing memory problems that interfere with daily functioning, compared with those who have not had cancer, according to results of a new, large study.

4 Oct 2010

New quantitative methods to detect small signs of tremor

Sensitive new quantitive methods could be used to detect small signs of increased tremor and impaired motor skills caused by exposure to certain metals, and to follow up the treatment of neurological disorders, reveals a thesis from the University of Gothenburg, Sweden.

4 Oct 2010