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FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept Tablets, which are used to treat dementia associated with Alzheimer's disease.

8 Jun 2011

Thermo Fisher Scientific launches new triple quadrupole gas chromatography-mass spectrometry system

Thermo Fisher Scientific Inc. has announced the launch of its new triple quadrupole gas chromatography-mass spectrometry (GC-MS/MS) system designed to offer best-in-class selectivity, analytical performance and productivity. The Thermo Scientific TSQ Quantum XLS Ultra delivers the increased matrix selectivity needed for challenging applications that require lower levels of quantitation in extremely complex matrix extracts. With its exceptional sensitivity, easy detection and reliable peak integration, the system provides superior performance for the most difficult of matrix challenges.

From Thermo Fisher Scientific Inc. 7 Jun 2011

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for the use of ivermectin topical cream as a treatment for head lice infestations in children and adults.

7 Jun 2011

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Acorda Therapeutics, Inc. today announced an analysis of pooled clinical trial results showed patients who were responders to AMPYRA (dalfampridine) Extended Release Tablets, 10 mg demonstrated clinically relevant improvements in walking ability as measured by patient self-report on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12), regardless of either their baseline Expanded Disability Status Scale (EDSS) score or baseline walking speed.

7 Jun 2011

Unique clinical trial addresses important questions about treating AIDS-related cancers

As the world marks the 30-year anniversary of the first reporting of HIV/AIDS, now comes the realization of a new challenge for people with the incurable disease. For reasons not yet clear, people with HIV face a higher rate of cancers not usually associated with HIV. This increasing rate of "non-AIDS defining cancers" includes lung, head and neck, liver, kidney, and anal cancers, among others.

7 Jun 2011

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc.,, today announced the presentation of detailed results from the Phase III SUCCEED clinical trial. SUCCEED evaluated oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

7 Jun 2011

Consumption of high-fat food causes more insulin to be released by the pancreas and leads to obesity

Fat-rich food makes you fat. Behind this simple equation lie complex signalling pathways, through which the neurotransmitters in the brain control the body's energy balance.

7 Jun 2011

Agilent Technologies introduces mass spectrometry systems at ASMS 2011

Agilent Technologies Inc. today introduced mass spectrometry systems raising performance standards for biology and analytical chemistry analyses at the annual conference of the American Society of Mass Spectrometry.

7 Jun 2011

Sprouts suspected as possible source of German E. coli outbreak

German officials on Sunday said an E. coli strain that has sickened more than 2,000 people and killed 22 may have originated in a batch of sprouts produced at an organic farm in the north of the country, the New York Times reports.

7 Jun 2011

APP to commence marketing Letrozole Tablets for breast cancer in the U.S.

Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that APP Pharmaceuticals will immediately begin marketing Letrozole Tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited.

7 Jun 2011

Moderate consumption of desserts with low glycemic index and glycemic load may help treat pediatric obesity

Overweight girls lose more weight and can better stay on a healthy diet if they eat sugar-free, low-fat desserts several times weekly, as opposed to any dessert once a week, a new study finds. The results will be reported Monday at The Endocrine Society's 93rd Annual Meeting in Boston.

7 Jun 2011

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Lannett Company, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011 for the company's 505(b)(2) New Drug Application for Morphine Sulfate Oral Solution

7 Jun 2011

Thermo Fisher Scientific unveils three new mass spectrometry products at 59th Annual ASMS Conference

Thermo Fisher Scientific Inc., the world leader in serving science, introduced three breakthrough instruments that take mass spectrometry (MS) analysis to new levels of performance in resolution, speed, sensitivity and accuracy. The new instruments were unveiled at the 59th Annual ASMS Conference on Mass Spectrometry and Allied Topics, being held June 5-9 at the Colorado Convention Center.

From Thermo Fisher Scientific Inc. 7 Jun 2011

Actavis receives final FDA approval for Zolpidem ER Tablets

Actavis, an international generic pharmaceuticals company, today announced that it has received final approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV. Distribution of the product has commenced.

7 Jun 2011

ITI receives FDA clearance for new Q fever assay kit

This week the U.S. Food and Drug Administration cleared the first nucleic acid amplification In vitro diagnostic (IVD) test that detects Coxiella burnetii, the bacteria that causes Q fever.

7 Jun 2011

Gleevec shows significant overall survival benefit for patients w/ GIST after 3 years of adjuvant treatment vs. 1 year

Novartis announced new data today showing a significant improvement in both recurrence-free survival and overall survival for patients taking Gleevec® (imatinib mesylate)* tablets for three years after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) compared to one year of treatment. These data will be presented at the 47th American Society of Clinical Oncology (ASCO) plenary session on Sunday, June 5.

6 Jun 2011

Waters introduces SYNAPT G2-S at 59th ASMS Conference on Mass Spectrometry

Waters Corporation today introduced the SYNAPT® G2-S High Definition Mass Spectrometer, representing a significant step forward in performance for High Definition Mass Spectrometry. The SYNAPT G2-S incorporates both high-sensitivity Waters StepWave™ ion transfer optics and Triwave® ion mobility technologies along with a suite of new informatics tools to take qualitative and quantitative high resolution performance to a new level.

6 Jun 2011

Life Technologies develops qPCR-based accurate test to detect E. coli

Life Technologies Corporation today announced that it has developed a custom test (assay) to accurately detect the E. coli bacterium that has killed at least 22 people and affected more than 2,100 worldwide, including four new cases reported in the United States. Shipments of the TaqMan® E. coli 0104 Detection Kit to test foods thought to be associated with the outbreak are now in Europe.

6 Jun 2011

Consumption of moderately reduced carbohydrate diet can help reduce total body fat

A modest reduction in consumption of carbohydrate foods may promote loss of deep belly fat, even with little or no change in weight, a new study finds. Presentation of the study results will be Sunday at The Endocrine Society's 93rd Annual Meeting in Boston.

6 Jun 2011

Dr. Reddy’s launches generic ARICEPT, EFFEXOR XR and FEMARA in the US

Dr. Reddy's Laboratories today announced that it has launched three products in the US market.

6 Jun 2011

Food News and Research

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Thermo Fisher Scientific launches new triple quadrupole gas chromatography-mass spectrometry system

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Unique clinical trial addresses important questions about treating AIDS-related cancers

Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Consumption of high-fat food causes more insulin to be released by the pancreas and leads to obesity

Agilent Technologies introduces mass spectrometry systems at ASMS 2011

Sprouts suspected as possible source of German E. coli outbreak

APP to commence marketing Letrozole Tablets for breast cancer in the U.S.

Moderate consumption of desserts with low glycemic index and glycemic load may help treat pediatric obesity

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Thermo Fisher Scientific unveils three new mass spectrometry products at 59th Annual ASMS Conference

Actavis receives final FDA approval for Zolpidem ER Tablets

ITI receives FDA clearance for new Q fever assay kit

Gleevec shows significant overall survival benefit for patients w/ GIST after 3 years of adjuvant treatment vs. 1 year

Waters introduces SYNAPT G2-S at 59th ASMS Conference on Mass Spectrometry

Life Technologies develops qPCR-based accurate test to detect E. coli

Consumption of moderately reduced carbohydrate diet can help reduce total body fat

Dr. Reddy’s launches generic ARICEPT, EFFEXOR XR and FEMARA in the US

Enhancing confidence in chemical ionization spectrometry data eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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