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FDA announces consent decree of permanent injunction against Deltex

The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.

19 Jan 2011

Antidepressant medication reduces frequency and severity of menopausal hot flashes

Women who were either in the transition to menopause or postmenopausal experienced a reduction in the frequency and severity of menopausal hot flashes with the use of the antidepressant medication escitalopram, compared to women who received placebo, according to a study in the January 19 issue of JAMA.

19 Jan 2011

Medtronic recieves conditional approval from FDA to modify CoreValve U.S. Pivotal Clinical Trial

Medtronic, today announced it has received conditional approval from the U.S. Food and Drug Administration to modify its CoreValve U.S. Pivotal Clinical Trial.

19 Jan 2011

FDA approves Natroba for treatment of head lice infestations

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

18 Jan 2011

Soy protein lowers total cholesterol and non-HDL: New study

Soy protein's ability to lower total and LDL cholesterol has been extensively studied, but the mechanism whereby soy protein lowers cholesterol remains unresolved. A new study published in the Journal of Clinical Lipidology last month shows that soy protein lowers total cholesterol and non-HDL cholesterol significantly more than milk protein in patients with moderately high cholesterol levels.

18 Jan 2011

FDA approves ParaPRO's Natroba for topical treatment of head lice

ParaPRO, LLC announced today that the U.S. Food and Drug Administration has approved Natroba Topical Suspension, 0.9% to eliminate head lice. Natroba received approval as a prescription medication and is indicated for the topical treatment of head lice infestations in patients four years of age and older.

18 Jan 2011

Organic milk best: Study

The latest research published by Newcastle University, UK has shown that organic milk contains less unhealthy fat, as well as a range of important healthy nutrients. It contains fewer chemicals and poses less risk for children to develop allergies and eczema. Organic milk is also rich in omega 3 fatty acids that re good for the heart. However it costs more. At least 60 per cent of the diet of organic cows has to be organically grown grass and its traditional derivatives — silage and hay.

18 Jan 2011

FDA approves Cook Medical's two Formula renal stents

Cook Medical has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Formula™ Balloon-Expandable Renal Stent System. The approval includes both the Formula 414RX Balloon Expandable Renal Stent and the Formula 418 Balloon Expandable Renal Stent.

18 Jan 2011

Harbor Biosciences signs development agreements for HE2000, HE3235 and HE3286 with CIPI

Harbor BioSciences, Inc., a leader in the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals, announced it has licensed the research and development and commercialization rights for three of its products, exclusively in the People's Republic of China and Hong Kong, to China State Institute of Pharmaceutical Industry (CIPI).

18 Jan 2011

FDA grants CASMED 510(k) clearance for expanded labeling of FORE-SIGHT Absolute Tissue Oximeter

CAS Medical Systems, Inc. today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded labeling of its FORE-SIGHT® Absolute Tissue Oximeter to monitor skeletal muscle of infants, children and adolescents weighing between 5 and 50 kg.

18 Jan 2011

Transcept announces Intermezzo NDA resubmission for treatment of middle of the night awakenings

Transcept Pharmaceuticals, Inc. today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Intermezzo® for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

18 Jan 2011

Cadence launches OFIRMEV pain medication in the U.S.

Cadence Pharmaceuticals, Inc. today announced the launch of OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

18 Jan 2011

PROLOR and Yeda enter definitive license agreement for Reversible PEGylation technology

PROLOR Biotech, Inc., today announced that it has entered into a definitive license agreement with Yeda Research and Development Company Ltd. for novel technology utilized in the development of long-acting therapeutic peptides and small molecules, termed Reversible PEGylation.

18 Jan 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

Mylan receives FDA approval for generic Precose Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose® Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

18 Jan 2011

Hotspur announces successful completion of GPSCath Catheter in peripheral angioplasty surgery

Hotspur Technologies, announced today that Dr. Greg Sampognaro, Interventional Cardiologist at P & S Surgical Hospital in Monroe, Louisiana, successfully completed the first use of the GPSCath Balloon Dilatation Catheter in an intervention to treat a blocked peripheral artery.

18 Jan 2011

Palomar Medical introduces Artisan Aesthetic System to provide laser skin resurfacing treatment

Palomar Medical Technologies, a leading researcher and developer of lasers and pulsed-light systems for aesthetic treatments, is pleased to announce that the Artisan Aesthetic System is now being shipped.

18 Jan 2011

Media look at what's ahead for South Sudan

"This week's independence referendum in southern Sudan marks an apparent victory for U.S. foreign policy in east Africa - one that has secured for Washington a deeper advisory role in what is expected to be the birth of a new, impoverished nation," according to a Wall Street Journal article looking at the issues facing the U.S. in south Sudan after voting concludes.

18 Jan 2011

Scientists create GM chicken that does not spread bird flu to other chickens

"Scientists have developed genetically modified [GM] chickens that don't transmit bird flu [H5N1] to other chickens," HealthDay News/Bloomberg Businessweek reports.

18 Jan 2011

Report recommends new approaches for fighting world hunger

A new report from the Worldwatch Institute, a research organization, recommends focusing on new approaches to address world hunger, Nature's blog "The Great Beyond" reports.

18 Jan 2011

Food News and Research

FDA announces consent decree of permanent injunction against Deltex

Antidepressant medication reduces frequency and severity of menopausal hot flashes

Medtronic recieves conditional approval from FDA to modify CoreValve U.S. Pivotal Clinical Trial

FDA approves Natroba for treatment of head lice infestations

Soy protein lowers total cholesterol and non-HDL: New study

FDA approves ParaPRO's Natroba for topical treatment of head lice

Organic milk best: Study

FDA approves Cook Medical's two Formula renal stents

Harbor Biosciences signs development agreements for HE2000, HE3235 and HE3286 with CIPI

FDA grants CASMED 510(k) clearance for expanded labeling of FORE-SIGHT Absolute Tissue Oximeter

Transcept announces Intermezzo NDA resubmission for treatment of middle of the night awakenings

Cadence launches OFIRMEV pain medication in the U.S.

PROLOR and Yeda enter definitive license agreement for Reversible PEGylation technology

Alexza completes FDA review for AZ-004 NDA

Mylan receives FDA approval for generic Precose Tablets ANDA

Hotspur announces successful completion of GPSCath Catheter in peripheral angioplasty surgery

Palomar Medical introduces Artisan Aesthetic System to provide laser skin resurfacing treatment

Media look at what's ahead for South Sudan

Scientists create GM chicken that does not spread bird flu to other chickens

Report recommends new approaches for fighting world hunger

The future is bioengineered: Synthetic biology and global sustainability eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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