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Genes behind aggregation of arsenic in plants

In many countries arsenic in food is a major problem. But researchers at the University of Skövde in Sweden have now identified two genes that may play a crucial role in how arsenic is stored in plants.

13 Sep 2010

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

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 diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

13 Sep 2010

Triclosan levels in treated biosolids

A study by U.S. Department of Agriculture (USDA) scientists and cooperators provides new details about how fertilizing soils with biosolids also introduces triclosan-an antibacterial agent in soaps and other cleaning supplies-into the environment.

13 Sep 2010

Dr. Siegal & Son introduces CalciOs cookies to relieve heartburn

Dr. Siegal & Son, LLC, a new Vienna, Virginia based company launched by renowned physician and author Sanford Siegal, D.O., M.D., and his son, Matthew Siegal, the duo behind the internationally popular Dr. Siegal's COOKIE DIET brand, has introduced CalciOs cookies, a snack food that's enriched with calcium carbonate, a common source of dietary calcium supplementation that also neutralizes stomach acid and relieves occasional heartburn. U.S. and international patents are pending.

13 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Covidien supports FDA labeling changes for gadolinium-based contrast agents

Covidien, a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

13 Sep 2010

IRIN reports on efforts to better address moderate acute malnutrition

Aid groups in West Africa are trying out new strategies and products for treating moderate acute malnutrition (MAM) as part of a U.N.-led effort to change 30 year old policies, IRIN reports.

13 Sep 2010

Lawmakers plot health overhaul tax provision change, other provisions under fire

Senate aides expect Republicans and Democrats to offer competing amendments to change a tax-reporting provision in the health law. "The provision requires businesses to report to the Internal Revenue Service purchases over the course of the year that exceed $600.

13 Sep 2010

Lantheus Medical Imaging supports FDA action to ensure appropriate use of gadolinium-based contrast agents

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, supports the U.S. Food and Drug Administration's (FDA) announcement requiring safety-related label changes for all gadolinium-based contrast agents to highlight the rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF).

10 Sep 2010

BPA detectable in saliva of children for up to three hours after completion of dental work

Researchers from Mount Sinai School of Medicine have found that bisphenol A (BPA) released from some plastic resins used in pediatric dentistry is detectable in the saliva after placement in children's mouths. BPA is a widely used synthetic chemical that has been associated with changes in behavior, prostate and urinary tract development, and early onset of puberty. The findings are published in the current issue of Pediatrics.

10 Sep 2010

K-V successfully completes FDA inspection for resumption of manufacturing and shipment of products

K-V Pharmaceutical Company announced today that it has received notice from the U.S. Food and Drug Administration ("FDA") of the successful completion of an inspection of the Company's facilities and approval to return its first product to market. Under the Company's Consent Decree, successful FDA inspections of the Company's quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products.

10 Sep 2010

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2010 fiscal year ended June 30, 2010.

10 Sep 2010

Aceto Corporation 2010 fourth quarter net sales increase to $105.8 million

Aceto Corporation, a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of pharmaceuticals, nutraceuticals, specialty chemicals and crop protection products, today announced results of operations for its fiscal 2010 fourth quarter and year ended June 30, 2010.

10 Sep 2010

InHealth continues support for Northwestern and Duke with follow-on grants of over $830,000

The Institute for Health Technology Studies (InHealth) has awarded two follow-on grants totaling more than $830,000 to research teams at Northwestern University and Duke University.

10 Sep 2010

395 new vaccines being developed for infectious diseases: PhRMA

Critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America's biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.

10 Sep 2010

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

We applaud the U.S. Food and Drug Administration for taking appropriate enforcement action today against five distributors of electronic cigarettes for various violations of the Federal Food, Drug and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma. The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 – the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status.

10 Sep 2010

Dow Jones Sustainability World Index renews inclusion of Bayer

Bayer stock has been included once again in the Dow Jones Sustainability World Index (DJSI World), providing renewed proof of the standing of the company as an international leader in sustainability. Bayer is thus one of very few companies headquartered in Germany to have been listed in the DJSI World without interruption since the establishment of the index in 1999.

10 Sep 2010

FDA issues warning letters to five electronic cigarette distributors

The U.S. Food and Drug Administration today issued warning letters to five distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

Food News and Research

Genes behind aggregation of arsenic in plants

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Triclosan levels in treated biosolids

Dr. Siegal & Son introduces CalciOs cookies to relieve heartburn

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

Covidien supports FDA labeling changes for gadolinium-based contrast agents

IRIN reports on efforts to better address moderate acute malnutrition

Lawmakers plot health overhaul tax provision change, other provisions under fire

Lantheus Medical Imaging supports FDA action to ensure appropriate use of gadolinium-based contrast agents

BPA detectable in saliva of children for up to three hours after completion of dental work

K-V successfully completes FDA inspection for resumption of manufacturing and shipment of products

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

Aceto Corporation 2010 fourth quarter net sales increase to $105.8 million

InHealth continues support for Northwestern and Duke with follow-on grants of over $830,000

395 new vaccines being developed for infectious diseases: PhRMA

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

Dow Jones Sustainability World Index renews inclusion of Bayer

FDA issues warning letters to five electronic cigarette distributors

Understanding cultivated meat and its global potential 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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