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McNeil Consumer Healthcare implements voluntary recall of infant and children's liquid products

Working in consultation with the United States Food and Drug Administration, McNeil Consumer Healthcare is implementing a voluntary recall of infant and children's liquid products due to manufacturing deficiencies which may affect quality, purity or potency.

3 May 2010

Pfizer to maintain top spot in prescription sales through mergers and acquisitions

The rheumatoid arthritis treatment Humira will replace Lipitor as the world's biggest-selling drug in 2016, but a familiar name, Pfizer, will still be the biggest seller of medicines after the patent cliff according to the World Preview 2016 report published today by EvaluatePharma, the premier provider of pharma and biotech analysis.

3 May 2010

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

Results of a new study found that the investigational triple combination therapy of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) demonstrated significantly greater mean reductions at week 12 in blood pressure (37.1/21.8 mm Hg versus 27.5 to 30.0/15.1-18.0 mm Hg LS Mean Reductions, P< 0.0001), as compared to corresponding dual combination therapy (dual components).

3 May 2010

DSM Biologics partners with Australian Governments to build cGMP mammalian CMO

DSM Biologics is pleased to announce the signing of preliminary agreements to enter a partnership with the Australian Governments (Queensland State Government and the Commonwealth of Australia) to design, build and operate the first major Australia-based mammalian biopharmaceutical manufacturing facility, which will be located in Brisbane.

3 May 2010

Celgene seeks court declaration over claims of romidepsin injection usage for T-cell lymphomas

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 it received a complaint filed by Celgene Corporation seeking a declaration from the court that four Cyclacel-owned patents, which claim the use of romidepsin injection in T-cell lymphomas, are not infringed by Celgene's products and are invalid.

3 May 2010

Promising results from combination therapy of pemetrexed concurrent with radiation in lung cancer

The first trial of an important new combination therapy of treatment with the chemotherapy drug pemetrexed concurrent with radiation in lung cancer has delivered promising results, French researchers report at the 2nd European Lung Cancer Conference.

3 May 2010

AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Zenvia™ (dextromethorphan/quinidine) for the treatment of pseudobulbar affect (PBA). AVANIR expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth calendar quarter of 2010.

3 May 2010

Taking vitamin D supplements during pregnancy safe for mother, baby: Study

Taking vitamin D supplements during pregnancy is not only safe for mother and baby, but also can prevent preterm labor/births and infections, according to results of a randomized controlled study to be presented at the Pediatric Academic Societies annual meeting in Vancouver, British Columbia, Canada.

3 May 2010

Watson Pharmaceuticals sued in connection with filing ANDA for generic equivalent of Trilipix

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with the filing of Watson's Abbreviated New Drug Application for choline fenofibrate delayed-release capsules in the 45 mg and 135 mg strengths.

3 May 2010

Nearly 85% of adolescents at risk of overdosing on acetaminophen: Study

The majority of teens say they have never heard of acetaminophen - or what the appropriate dosing of it is even with access to the label instructions - despite having taken the medication recently, according to a new University of Rochester Medical Center Study assessing teens' health literacy. More than 60 percent of the teens in the study had never before heard of acetaminophen despite 21 percent of them having taken it within the previous month.

3 May 2010

FDA oks 'vaccine' to treat prostate cancer

Provenge, developed by Dendreon Corporation, is the first approved "treatment that uses a so-called cancer vaccine, a drug that trains the body's own immune system to fight the disease," The New York Times reports.

3 May 2010

Probiotic supplementation helps ELBW infants gain weight: Study

Extremely low birthweight infants who received feedings supplemented with probiotics had better weight gain than infants who were not given the supplements, according to a randomized, controlled, double-blind study to be presented Saturday, May 1 at the Pediatric Academic Societies annual meeting in Vancouver, British Columbia, Canada.

3 May 2010

Eating more olive oil could help prevent ulcerative colitis: UEA study

Eating more olive oil could help prevent ulcerative colitis, according to a new study co-ordinated by medical researchers at the University of East Anglia.

3 May 2010

Preclinical safety data reports Natural S-equol has little effect on 2 reproductive hormones

Natural S-equol, a novel soy germ-based compound, is very likely the primary ingredient for reducing hot flushes in the dietary supplement SE5-OH, which is under development for reduction of menopause symptoms, according to pre-clinical efficacy data from studies using an animal model presented at the Experimental Biology 2010 annual meeting.

3 May 2010

Vita Breath may contain hazardous levels of lead, warns FDA

The U.S. Food and Drug Administration is advising consumers not to purchase nor consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif., and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead.

3 May 2010

SGB procedure holds potential promise for PTSD treatment

Walter Reed Army Medical Center in Bethesda, MD, has published case reports detailing the successful treatment of combat-related post-traumatic stress disorder with a stellate ganglion block.

3 May 2010

FDA issues complete response letter for Bristol-Myers Squibb's belatacept

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.

3 May 2010

DHA supplements during lactation increases DHA status in preterm infants

Docosahexaenoic acid (DHA), an omega-3 fatty acid, is essential for the growth and development of infants' brains. Very premature infants may be deficient in DHA because they miss out on the third trimester in utero when the fatty acid accumulates in tissues. In addition, their gastrointestinal system is immature, and health problems often increase the risk of malnutrition.

3 May 2010

VIMOVO delayed-release tablets receive FDA approval

AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

3 May 2010

Vitamin E effective in treating NASH: Study

Vitamin E has been shown effective in treating nonalcoholic steatohepatitis, an obesity-associated chronic liver disease that can lead to cirrhosis, liver cancer, and death. NASH also is related to or a part of type 2 diabetes, lipid disorders and cardiovascular disease.

3 May 2010

Pharmaceutical News

McNeil Consumer Healthcare implements voluntary recall of infant and children's liquid products

Pfizer to maintain top spot in prescription sales through mergers and acquisitions

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

DSM Biologics partners with Australian Governments to build cGMP mammalian CMO

Celgene seeks court declaration over claims of romidepsin injection usage for T-cell lymphomas

Promising results from combination therapy of pemetrexed concurrent with radiation in lung cancer

AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

Taking vitamin D supplements during pregnancy safe for mother, baby: Study

Watson Pharmaceuticals sued in connection with filing ANDA for generic equivalent of Trilipix

Nearly 85% of adolescents at risk of overdosing on acetaminophen: Study

FDA oks 'vaccine' to treat prostate cancer

Probiotic supplementation helps ELBW infants gain weight: Study

Eating more olive oil could help prevent ulcerative colitis: UEA study

Preclinical safety data reports Natural S-equol has little effect on 2 reproductive hormones

Vita Breath may contain hazardous levels of lead, warns FDA

SGB procedure holds potential promise for PTSD treatment

FDA issues complete response letter for Bristol-Myers Squibb's belatacept

DHA supplements during lactation increases DHA status in preterm infants

VIMOVO delayed-release tablets receive FDA approval

Vitamin E effective in treating NASH: Study

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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