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Enzon to commence EZN-4176 Phase 1a/1b study in castration-resistant prostate cancer

Enzon Pharmaceuticals, Inc. today announced the Investigational New Drug (IND) approval by the US Food and Drug Administration (FDA) and plan to commence enrollment into a Phase 1a/1b study shortly. The study will evaluate the safety and tolerability of EZN-4176, the company's novel androgen receptor (AR) mRNA antagonist, for the treatment of patients with castration-resistant prostate cancer (CRPC).

10 Jan 2011

Watson receives FDA approval for generic Fentora

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora ® tablets.

10 Jan 2011

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011.

10 Jan 2011

Food price rise will affect 'millions,' FAO economist says

Abdolreza Abbassian, an economist with the U.N. Food and Agriculture Organization (FAO), on Friday "warned of a 'worrying rise' in food prices which will affect millions of people following unexpected shortfalls in major cereals owing to bad weather in 2010," Agence France-Presse reports.

10 Jan 2011

Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for its new formulation of OPANA® ER designed to be crush resistant.

10 Jan 2011

Quality of life measures most useful for clinical decision-making in trials with QOL as primary outcome

Quality of life measures tend to be most useful for clinical decision-making in trials in which quality of life is the primary outcome, according to a recent study published online January 7 in The Journal of the National Cancer Institute.

10 Jan 2011

Researchers demystify death of brain cells in Parkinson's patients

Just 5 percent of Parkinson's disease cases can be explained by genetic mutation, while the rest have no known cause. But a new discovery by researchers at The University of Texas Health Science Center San Antonio may begin to explain why the vast majority of Parkinson's patients develop the progressive neurodegenerative disease.

10 Jan 2011

FDA warns public about extortion scam

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued international extortion scam.

10 Jan 2011

FDA warns retailers for illegal sale of tobacco products to minors

The U.S. Food and Drug Administration today announced it is issuing its first warning letters to retailers for the illegal sale of tobacco products to minors in violation of the 2009 Family Smoking Prevention and Tobacco Control Act.

10 Jan 2011

FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

Orexo AB announces today that its partner ProStrakan Group plc has received approval from the US Food and Drug Administration for Abstral. Abstral is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain.

10 Jan 2011

FDA, EMA accept boceprevir for expedited review

Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.

10 Jan 2011

CMI, TriReme Medical sign agreement to distribute peripheral and coronary balloon dilatation catheters

TriReme Medical, today announced that it has signed an exclusive distribution and sales agreement for TriReme's complete line of advanced peripheral and coronary balloon dilatation catheters with Century Medical, a leading independent device distributor for the important Japanese market.

10 Jan 2011

Specific silicon microdevices may provide new way to screen metastatic breast cancer cells

Research by engineers and cancer biologists at Virginia Tech indicate that using specific silicon microdevices might provide a new way to screen breast cancer cells' ability to metastasize.

9 Jan 2011

FDA grants marketing clearance for diaDexus's PLAC Test

diaDexus, a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced that the U.S. Food and Drug Administration has cleared for marketing the automated version of its proprietary PLAC® Test.

9 Jan 2011

Abstral transmucosal tablets receive FDA approval, may help manage pain in cancer patients

The U.S. Food and Drug Administration today approved Abstral transmucosal tablets to manage breakthrough pain for adults with cancer.

9 Jan 2011

Green tea may help in Alzheimer’s disease: Study

A new study finds that a cup of green tea may protect against Alzheimer’s disease and other forms of dementia. The researchers looked at the effects of a concentrated green tea extract that had been treated in the laboratory to mimic the effects of normal digestion.

9 Jan 2011

Sniffing women's tears reduces sexual arousal in men

Emotional crying is a universal, uniquely human behavior. When we cry, we clearly send all sorts of emotional signals. In a paper published online today in Science Express, scientists at the Weizmann Institute have demonstrated that some of these signals are chemically encoded in the tears themselves. Specifically, they found that merely sniffing a woman's tears - even when the crying woman is not present -- reduces sexual arousal in men.

7 Jan 2011

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Iroko Pharmaceuticals, LLC today reported the results of the Phase I clinical study of its unique formulation of naproxen, a widely used pain medication, using proprietary, patent protected nanotechnology.

7 Jan 2011

Chimerix initiates enrollment in CMX001 clinical study for life-threatening conditions caused by dsDNA viruses

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that patient enrollment has begun in a multicenter, open-label clinical study of CMX001 (the CMX001-350 study) for the treatment of life-threatening or serious conditions caused by double-stranded DNA (dsDNA) viruses.

7 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

Food News and Research

Enzon to commence EZN-4176 Phase 1a/1b study in castration-resistant prostate cancer

Watson receives FDA approval for generic Fentora

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Food price rise will affect 'millions,' FAO economist says

Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

Quality of life measures most useful for clinical decision-making in trials with QOL as primary outcome

Researchers demystify death of brain cells in Parkinson's patients

FDA warns public about extortion scam

FDA warns retailers for illegal sale of tobacco products to minors

FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

FDA, EMA accept boceprevir for expedited review

CMI, TriReme Medical sign agreement to distribute peripheral and coronary balloon dilatation catheters

Specific silicon microdevices may provide new way to screen metastatic breast cancer cells

FDA grants marketing clearance for diaDexus's PLAC Test

Abstral transmucosal tablets receive FDA approval, may help manage pain in cancer patients

Green tea may help in Alzheimer’s disease: Study

Sniffing women's tears reduces sexual arousal in men

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Chimerix initiates enrollment in CMX001 clinical study for life-threatening conditions caused by dsDNA viruses

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Enhancing confidence in chemical ionization spectrometry data 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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