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Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

Spectranetics Corporation today initiated a voluntary recall of specific lots of its thrombus extraction catheter (product number 60090-01) manufactured by Spectranetics since October 2009. The Food and Drug Administration has been informed of this action and communication to various Competent Authorities outside of the United States has begun. While Spectranetics has received and confirmed customer complaints on this issue, no adverse events have been reported to the Company.

2 Jul 2010

OTA reminds consumers to choose organic foods over synthetic dye foods

In response to a call from the Center for Science in the Public Interest (CSPI) to ban synthetic dyes to color foods, the Organic Trade Association (OTA) today reminded consumers that they can already avoid such dyes in the marketplace by choosing to purchase organic foods.

2 Jul 2010

Frenotomy procedure can help babies to breastfeed effectively

Doctors advise new mothers to breastfeed for at least the first six months of a baby's life, but a simple yet often untreated problem can sabotage their efforts, University of Florida researchers say.

2 Jul 2010

Medicare weighs cost, benefit of covering Dendreon's Provenge for prostate cancer

The announcement that the Centers for Medicare and Medicaid Services would do this analysis "was the latest hurdle in Dendreon's push to get its Provenge treatment used. If the Centers for Medicare and Medicaid Services covers Provenge, that would increase the number of patients eligible and likely force private insurers to do the same.

2 Jul 2010

House Subcommittee approves $52.7B FY11 Foreign Ops appropriations bill

The Appropriations Subcommittee on State, Foreign Operations, and Related Programs approved a $52.7 billion FY 2011 spending bill on Wednesday that withheld $3.9 billion in aid for Afghanistan over concerns about corruption in the country, CongressDaily reports. The bill "already cut $4 billion from President Obama's request to fund the State Department, U.S. Agency for International Development and dozens of foreign assistance and cooperation programs," the publication writes.

2 Jul 2010

Adding nutrients could improve efficiency of deep sea biological pump

Adding nutrients to the sea could decrease viral infection rates among phytoplankton and enhance the efficiency of the biological pump, a means by which carbon is transferred from the atmosphere to the deep ocean, according to a new mathematical modelling study. The findings, published in the Journal of Theoretical Biology, have implications for ocean geo-engineering schemes proposed for tackling global warming.

2 Jul 2010

Draft Guidance on judicious use of antimicrobials in food-producing animals

The U.S. Food and Drug Administration today issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food-producing animals.

2 Jul 2010

Haitian President rejects U.S. Senate's recommendations for upcoming elections

A day after Haitian President Rene Preval signed a decree authorizing a date for November elections, he rebuffed other recommendations issued by the U.S. Senate, which include "holding an election for his successor, brushing off criticism that the current process will leave the shattered country without a credible leader," the Associated Press reports.

2 Jul 2010

FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Butrans™ (buprenorphine) Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is an analgesic product that delivers continuous release of medication for seven days.

2 Jul 2010

Caraco Pharmaceutical Laboratories commences marketing of rivastigmine tartrate capsules

Caraco Pharmaceutical Laboratories, Ltd. has started shipping rivastigmine tartrate capsules. These products, approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA), are therapeutically equivalent to Exelon® capsules from Novartis.

2 Jul 2010

DARA BioSciences suspends $10M underwritten public offering

On May 17, 2010, DARA BioSciences, Inc. issued a press release announcing that it had commenced an underwritten public offering of $10 million of units comprised of shares of common stock and warrants. DARA has decided to indefinitely suspend the offering, effective immediately. Several important factors have influenced this decision.

2 Jul 2010

Lupin's Famotidine for Oral Suspension receives FDA approval

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval from the US Food and Drug Administration (FDA) for its Famotidine for Oral Suspension (40 mg / 5 mL). Commercial shipments of the product have already commenced.

2 Jul 2010

Diagnostic Hybrids receives Chinese SFDA approval for D3 Ultra DFA Respiratory Virus Screening and ID Kit

Diagnostic Hybrids, a Quidel Company, received approval from the People's Republic of China's State Food and Drug Administration (SFDA) for its D3 Ultra DFA Respiratory Virus Screening and ID Kit. The D3 Ultra DFA Respiratory Virus Screening and ID Kit is a direct fluorescence assay (DFA) that provides rapid, sensitive and specific screening and identification of Influenza A, Influenza B, Parainfluenza 1, 2, & 3, Respiratory Syncytial Virus and Adenovirus.

1 Jul 2010

Hospira subsidiary completes tender offer for Javelin's outstanding shares of common stock

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, today announced the successful completion of the tender offer by Discus Acquisition Corporation, a wholly owned Hospira subsidiary, to purchase all outstanding shares of the common stock of Javelin Pharmaceuticals, Inc..

1 Jul 2010

Watson commences shipment of generic Exelon

Watson Pharmaceuticals, Inc. announced today that, under a settlement with Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively "Novartis"), Watson has commenced shipment of a generic version of Exelon® (rivastigmine tartrate) 1.5mg, 3mg, 4.5mg and 6mg capsules. Exelon® is used to treat dementia in people with Alzheimer's disease.

1 Jul 2010

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Diagnostics Division submitted on June 30, 2010, a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its iChem®Velocity™ Automated Urine Chemistry Analyzer and iRICELL® Urinalysis Workstation.

1 Jul 2010

FDA grants Cyclacel's sapacitabine orphan drug designation for AML and MDS

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's sapacitabine (CYC682) product candidate for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

1 Jul 2010

Investment report on BioElectronics

MicroStockProfit.com announces an investment report featuring BioElectronics Corp. The report includes financial, comparative and investment analyses, and recent company news that you need to know to make an educated investment decision.

1 Jul 2010

AMP comments on array-based cytogenetic tests at FDA's public meeting

Today, the Association for Molecular Pathology presented comments at the US Food & Drug Administration's public meeting on array-based cytogenetic tests. The FDA convened the meeting to seek answers to more than a dozen questions they had on how to evaluate the performance, interpret results and report findings of array-based cytogenetic tests for copy number variation.

1 Jul 2010

Individual variants of environmental toxins can affect body's hormone systems: Research

Marianne Kraugerud's doctoral research has led to the discovery that individual variants of the environmental pollutants PCB and PFC can affect several of the body's hormone systems in a more complex way than previously supposed. Humans and animals are constantly exposed to these toxins through the food they eat and the air they breathe. Kraugerud concludes that the impact of these pollutants should be taken into account when carrying out risk appraisals of PCB and PFC.

1 Jul 2010

Food News and Research

Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

OTA reminds consumers to choose organic foods over synthetic dye foods

Frenotomy procedure can help babies to breastfeed effectively

Medicare weighs cost, benefit of covering Dendreon's Provenge for prostate cancer

House Subcommittee approves $52.7B FY11 Foreign Ops appropriations bill

Adding nutrients could improve efficiency of deep sea biological pump

Draft Guidance on judicious use of antimicrobials in food-producing animals

Haitian President rejects U.S. Senate's recommendations for upcoming elections

FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

Caraco Pharmaceutical Laboratories commences marketing of rivastigmine tartrate capsules

DARA BioSciences suspends $10M underwritten public offering

Lupin's Famotidine for Oral Suspension receives FDA approval

Diagnostic Hybrids receives Chinese SFDA approval for D3 Ultra DFA Respiratory Virus Screening and ID Kit

Hospira subsidiary completes tender offer for Javelin's outstanding shares of common stock

Watson commences shipment of generic Exelon

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

FDA grants Cyclacel's sapacitabine orphan drug designation for AML and MDS

Investment report on BioElectronics

AMP comments on array-based cytogenetic tests at FDA's public meeting

Individual variants of environmental toxins can affect body's hormone systems: Research

Enhancing confidence in chemical ionization spectrometry data 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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