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Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. The Company also announced that it is commencing shipment through Global Pharmaceuticals, Impax’s generic division.

3 Mar 2010

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Lux Biosciences, Inc. today announced that the European Medicines Agency has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

3 Mar 2010

Advanced Cell Technology’s MA09-hRPE cells for treatment of SMD: FDA grants orphan drug designation

Advanced Cell Technology, Inc., a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy (SMD). As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as seven years.

3 Mar 2010

Study shows cryoablation technique offers a potential treatment for breast cancer

Freezing a cancer kills it in its place, and also appears to generate an immune response that helps stop the cancer's spread, leading to improved survival rates over surgery, according to a new study in mice from researchers at the University of Michigan Comprehensive Cancer Center.

3 Mar 2010

Study: Patients with community-acquired pneumonia who develop AKI more likely to die after discharge

Patients hospitalized with even mild to moderate community-acquired pneumonia who develop acute kidney injury (AKI) are more likely to die after discharge than pneumonia patients whose kidneys remain healthy, according to a University of Pittsburgh School of Medicine study in the February issue of Kidney International.

3 Mar 2010

Drinking coffee may lower risk of hospitalization for heart rhythm disturbances

Coffee drinkers may be less likely to be hospitalized for heart rhythm disturbances, according to a new study by the Kaiser Permanente Division of Research in Oakland, Calif. The researchers, who note the findings may be surprising because patients frequently report palpitations after drinking coffee, are presenting the study at the American Heart Association's 50th Annual Conference on Cardiovascular Disease Epidemiology and Prevention in San Francisco on March 5, 2010.

3 Mar 2010

Combination of two targeted therapies effective against subset of gastric cancers: Study

A combination of two targeted therapies already shown to be effective in breast cancer packs an effective one-two punch against a subset of gastric cancers that have a specific genetic mutation, a study at UCLA's Jonsson Comprehensive Cancer Center has found.

3 Mar 2010

ImmunoCellular Therapeutics receives Notice of Allowance on ICT-69 monoclonal antibody

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today it received a Notice of Allowance on monoclonal antibody ICT-69 which targets multiple myeloma and ovarian cancers. The antibody has demonstrated high specificity to these cancers by targeting a novel cell surface antigen.

2 Mar 2010

Concerns about unnecessary scans and radiation risk prompt reviews by doctors

Business Week reports on a study that finds 1 in 4 MRI and CT scans are inappropriately recommended by doctors. The study appears in the March issue of the Journal of the American College of Radiology. The researchers analyzed 459 scans at Harborview Medical Center in Seattle.

2 Mar 2010

Antares Pharma completes enrollment in Phase 3 clinical trial of Anturol for OAB

Antares Pharma, Inc. announced today that it has completed enrollment in the double-blind portion of the Company’s Phase 3 clinical trial of Anturol™, its transdermal oxybutynin ATD™ gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), is expected in the third quarter of this year.

2 Mar 2010

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010.

2 Mar 2010

Critical follow-up evaluations provide opportunity to help physicians best evaluate their HF patients

Heart failure is by far the most prevalent chronic cardiac condition. Around 30 million people in Europe have heart failure and its incidence is still increasing: more cases are being identified, more people are living to an old age, and more are surviving a heart attack but with damage to the heart muscle.

2 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

Imaging technique combining ultrasound and microscopic bubbles help visualize tumor activity at molecular level

An imaging technique combining ultrasound and specially modified contrast agents may allow researchers to noninvasively detect cancer and show its progression, according to research published in the March issue of The Journal of Nuclear Medicine (JNM). The technique enables researchers to visualize tumor activity at the molecular level.

2 Mar 2010

Synta Pharmaceuticals receives FDA approval for resuming elesclomol clinical development

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported that the U.S. Food and Drug Administration (FDA) has approved resuming clinical development of elesclomol, the Company's first-in-class oxidative stress inducer.

2 Mar 2010

French investigation explores the outcome of physical functioning of coronary angioplasty

A French investigation published in the current issue of Psychotherapy and Psychosomatics has explored the outcome in terms of physical functioning of coronary angioplasty.

2 Mar 2010

Problems controlling common diseases could be hindering efforts to meet key child health goals

Problems controlling common diseases like HIV, heart disease and diabetes in poor countries could be hindering efforts to meet the world's key child health and tuberculosis goals, a new study published in PLoS Medicine has warned.

2 Mar 2010

California's dirty air costs more than $193M in hospital-based medical care, finds RAND study

California's dirty air caused more than $193 million in hospital-based medical care from 2005 to 2007 as people sought help for problems such as asthma and pneumonia that are triggered by elevated pollution levels, according to a new RAND Corporation study.

2 Mar 2010

Fluorescence method predicts the efficacy of PDT for Port Wine Stains: Study

It is known that fluctuations in the treatment outcome of photodynamic therapy (PDT) between patients are related to the concentration of photosensitizer in target tissue. The purpose of a study, by Wang et al, published in the February 2010 issue of Experimental Biology and Medicine was to establish a fluorescence method not only providing a semi-quantitative measurement of photosensitizer concentration but also predicting the efficacy of PDT for Port Wine Stains (PWS).

2 Mar 2010

Sea squirts help in fight against Alzheimer's disease

Alzheimer's disease affects an estimated 27 million people worldwide. It is the most common form of age-related dementia, possibly the most feared disease of old age. There is no cure, and the available drugs only help to relieve symptoms without slowing progression of the disease. One of the characteristic changes in the brains of Alzheimer's patients is the accumulation of plaques and tangles; currently, the best hope for curing or at least slowing the disease lies in developing drugs that target this buildup.

2 Mar 2010

Medical Condition News

Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Advanced Cell Technology’s MA09-hRPE cells for treatment of SMD: FDA grants orphan drug designation

Study shows cryoablation technique offers a potential treatment for breast cancer

Study: Patients with community-acquired pneumonia who develop AKI more likely to die after discharge

Drinking coffee may lower risk of hospitalization for heart rhythm disturbances

Combination of two targeted therapies effective against subset of gastric cancers: Study

ImmunoCellular Therapeutics receives Notice of Allowance on ICT-69 monoclonal antibody

Concerns about unnecessary scans and radiation risk prompt reviews by doctors

Antares Pharma completes enrollment in Phase 3 clinical trial of Anturol for OAB

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

Critical follow-up evaluations provide opportunity to help physicians best evaluate their HF patients

InterMune seeks European marketing approval for pirfenidone

Imaging technique combining ultrasound and microscopic bubbles help visualize tumor activity at molecular level

Synta Pharmaceuticals receives FDA approval for resuming elesclomol clinical development

French investigation explores the outcome of physical functioning of coronary angioplasty

Problems controlling common diseases could be hindering efforts to meet key child health goals

California's dirty air costs more than $193M in hospital-based medical care, finds RAND study

Fluorescence method predicts the efficacy of PDT for Port Wine Stains: Study

Sea squirts help in fight against Alzheimer's disease

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