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Free drug samples may end up costing uninsured more

Free drug samples provided to physicians by pharmaceutical companies could actually be costing uninsured patients more in the long run, according to a study done by researchers at Wake Forest University Baptist Medical Center and colleagues.

7 Sep 2008

FDA forces manufacturers of TNF-blockers to highlight risk of fungal infections

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

5 Sep 2008

FDA approves DNA test to measure hepatitis B viral load

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

5 Sep 2008

$FDA approves Medtronic software update that will help detect fractures in cardiac defibrillator leads$

FDA approves Medtronic software update that will help detect fractures in cardiac defibrillator leads

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead.

4 Sep 2008

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

BioMS Medical Corp has announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

4 Sep 2008

FDA assigns priority review to ATryn from GTC Biotherapeutics

The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.'s Biologic License Application, or BLA, for ATryn.

4 Sep 2008

Celgene receives FDA 'fast track' for Amrubicin in small cell lung cancer after first-line chemotherapy

Celgene Corporation today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy.

4 Sep 2008

Zimbabwe lifts ban on aid groups; organizations still face difficulties providing assistance

Zimbabwe on Friday lifted an almost three-month ban on the work of aid groups in the country, which the government had imposed because it said some of the groups had supported the opposition to President Robert Mugabe, the New York Times reports (Dugger, New York Times, 8/30).

4 Sep 2008

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.

4 Sep 2008

Second phase 3 trial of Bronchitol in cystic fibrosis sufferers begins

Pharmaceutical company Pharmaxis today announced that it has enrolled the first subject into its second pivotal Phase 3 clinical trial evaluating Bronchitol in cystic fibrosis sufferers.

4 Sep 2008

Biovail files abbreviated new drug application for Fenofibrate tablets

Biovail Corporation today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories).

3 Sep 2008

National Toxicology Program finalizes report on Bisphenol A

Current human exposure to bisphenol A (BPA), a chemical used in many polycarbonate plastics and epoxy resins, is of "some concern" for effects on development of the prostate gland and brain and for behavioral effects in fetuses, infants and children, according to a final report released today by the National Toxicology Program (NTP).

3 Sep 2008

Further analysis from ATHENA study showed Multaq (Dronedarone) reduced risk of stroke in patients with atrial fibrillation

The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany.

3 Sep 2008

Why bypass surgery helps in diabetes

To manage obesity, various different surgical procedures can be performed on the stomach, including so-called bypass surgery in which, as well as reducing the size of the stomach, a bypass is created to send food directly into the distal gut (which, before the operation, is far from the stomach).

3 Sep 2008

Hurricane Katrina increased mental and physical health problems in New Orleans by up to three times

Half the residents of New Orleans were suffering from poor mental and physical health more than a year after their homes and community were devastated by Hurricane Katrina in August 2005, according to research published in the September issue of the UK-based Journal of Clinical Nursing.

3 Sep 2008

FDA authorizes INDA for recombinant human C1 inhibitor in kidney transplantation

Biotech company Pharming Group NV has announced that the US Food and Drug Administration (FDA) has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for the treatment of antibody-mediated rejection (AMR) in kidney transplantation. Dr. Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with rhC1INH under an Investigator IND from the FDA.

3 Sep 2008

Ondansetron helps reduce vomiting, hospital admissions in children with gastroenteritis

University of North Carolina at Chapel Hill researchers have demonstrated that a drug called ondansetron helps reduce vomiting, the need for intravenous fluids and hospital admissions in children with acute gastroenteritis.

3 Sep 2008

Spinifex secures major investment to develop pain drug

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured venture capital investment of A$12 million from GBS Venture Partners Limited, Brandon Capital Partners and Uniseed to fund the development of its pain management drug, EMA401.

2 Sep 2008

Advances in cell therapy bring cure for diabetes step closer

Affecting eight percent of America's population, diabetes can lead to blindness, kidney failure, strokes and heart disease. Thanks to Tel Aviv University researchers, a new cure -- based on advances in cell therapy -- may be within reach.

2 Sep 2008

The impact of soft drink availability in elementary schools on consumption

The consumption of soft drinks is generally considered to be a contributing factor in childhood obesity. Because children spend a substantial amount of time at school, the school food environment plays a central part in shaping eating behaviors.

2 Sep 2008

Food News and Research

Free drug samples may end up costing uninsured more

FDA forces manufacturers of TNF-blockers to highlight risk of fungal infections

FDA approves DNA test to measure hepatitis B viral load

FDA approves Medtronic software update that will help detect fractures in cardiac defibrillator leads

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

FDA assigns priority review to ATryn from GTC Biotherapeutics

Celgene receives FDA 'fast track' for Amrubicin in small cell lung cancer after first-line chemotherapy

Zimbabwe lifts ban on aid groups; organizations still face difficulties providing assistance

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Second phase 3 trial of Bronchitol in cystic fibrosis sufferers begins

Biovail files abbreviated new drug application for Fenofibrate tablets

National Toxicology Program finalizes report on Bisphenol A

Further analysis from ATHENA study showed Multaq (Dronedarone) reduced risk of stroke in patients with atrial fibrillation

Why bypass surgery helps in diabetes

Hurricane Katrina increased mental and physical health problems in New Orleans by up to three times

FDA authorizes INDA for recombinant human C1 inhibitor in kidney transplantation

Ondansetron helps reduce vomiting, hospital admissions in children with gastroenteritis

Spinifex secures major investment to develop pain drug

Advances in cell therapy bring cure for diabetes step closer

The impact of soft drink availability in elementary schools on consumption

Understanding cultivated meat and its global potential eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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