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Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Dendreon Corporation today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline.

7 Jan 2011

Substantial equivalence review requirement for new tobacco products announced

The U.S. Food and Drug Administration announced today that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is "substantially equivalent" to products commercially available on Feb. 15, 2007.

7 Jan 2011

News outlets examine potential implications of record high food price levels

Though world food prices "jumped to a record high" in the U.N. Food and Agriculture Organization's (FAO) latest index, the agency "is drawing comfort from the absence of widespread riots, usually the defining element of a food crisis," the Financial Times reports looking at the factors that have led some food prices to rise significantly without sparking international panic.

7 Jan 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

ZIOPHARM Oncology, a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector Technology.

7 Jan 2011

Opinions: Global health top foreign policy issue; Global food security; Opiate-substitution programs in Eastern Europe; Feed the future; Foreign aid lessons

In response to a story examining 2011's top foreign policy issues, Serra Sippel, president of the Center for Health and Gender Equity, writes in a letter to the editor, published in The Hill, that "[g]lobal health was disturbingly absent from" the story. "Global health policy is at a critical turning point right now with the impending implementation of President Obama's Global Health Initiative, which will change our fundamental approach to health programs and policy," according to Sippel.

7 Jan 2011

Athersys completes patient enrollment in MultiStem Phase I study for leukemia

Athersys, Inc. today announced that it has completed patient enrollment of the single dose arm of a clinical study involving administration of MultiStem to patients being treated for leukemia or other blood born cancers.

7 Jan 2011

Liver transplant recipients develop PTMS, face high risk of cardiovascular disease

Researchers from Israel have determined that more than half of liver transplant recipients develop post-transplantation metabolic syndrome, placing them at greater risk for cardiovascular disease.

7 Jan 2011

CeNeRx commences TriRima Phase II trial for treatment resistant depression

CeNeRx BioPharma, today reported that it has initiated a Phase II trial of its new formulation of TriRima, the company's novel antidepressant in development as monotherapy for treatment resistant depression.

7 Jan 2011

FDA introduces new Web resource that helps companies to save time, resources

The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency.

7 Jan 2011

Altheus Therapeutics announces completion of Zoenasa phase I trial for ulcerative colitis

Altheus Therapeutics, announced that it has completed a two dose, double-blind, active-controlled Phase I clinical trial of the safety and tolerability of Zoenasa Rectal Suspension in adult patients with left-sided, or distal, ulcerative colitis.

6 Jan 2011

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Colorectal cancer (CRC) is the third most common cancer in men and women in the USA, with a new diagnosis made every 3.5 minutes and an associated death every 9 minutes.

6 Jan 2011

Tomatoes contain nutrient which prevents vascular diseases

They are the most widely produced fruit in the world and now scientists in Japan have discovered that tomatoes contain a nutrient which could tackle the onset of vascular diseases. The research, published in the journal Molecular Nutrition & Food Research, reveals that an extracted compound, 9-oxo-octadecadienoic, has anti-dyslipidemic affects.

6 Jan 2011

Tobacco product regulations announced by FDA

This Wednesday the Food and Drug Administration (FDA) released guidelines regarding agency approval for certain types of new products to be obtained by tobacco-product makers. FDA announced that products such as cigarettes, roll-your-own tobacco and smokeless products that were introduced or changed after Feb. 15, 2007 must be reviewed by the agency to show that they are “substantially equivalent” to products commercially available on Feb. 15, 2007.

6 Jan 2011

Queensland’s flooded residents warned against insect bites

The Queensland Health authorities have issued warnings to residents and tourists in the Emerald region regarding mosquitoes, biting midges (commonly known as sand flies) and black flies in areas affected by flooding. The Council insect control programs are helping with reducing the number of insects, say authorities but people still need to protect themselves to reduce the risk of being bitten in the next few weeks.

6 Jan 2011

Lexicon Pharmaceuticals announces clinical trial, mechanistic study results of LX4211

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced data from a recently completed clinical trial and mechanistic study of a solid oral dose formulation for LX4211, a dual inhibitor of sodium-glucose co-transporters 1 and 2 (SGLT1 and SGLT2).

6 Jan 2011

VEREGEN Ointment added as new therapeutic option in 2010 CDC STD Treatment Guidelines

PharmaDerm, a division of Nycomed US Inc., announced today that VEREGEN (sinecatechins) Ointment, 15%, a topical medication for the treatment of external genital and perianal warts, has been added as a new therapeutic option in the 2010 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines.

6 Jan 2011

Research: Tomatoes can tackle onset of vascular diseases

They are the most widely produced fruit in the world and now scientists in Japan have discovered that tomatoes contain a nutrient which could tackle the onset of vascular diseases.

6 Jan 2011

Opexa completes meetings with FDA regarding planned development program for Tovaxin

Opexa Therapeutics, Inc., a leading cell therapy company developing Tovaxin for multiple sclerosis, today announced the successful completion of two separate meetings with the U.S. Food and Drug Administration regarding the Company's planned development program for Tovaxin.

6 Jan 2011

JMD publishes results of Tissue of Origin Test validation, reproducibility study

Pathwork Diagnostics, Inc., a privately held molecular diagnostics company focused on oncology, announced today that The Journal of Molecular Diagnostics has published the results of a significant Tissue of Origin Test validation and reproducibility study.

6 Jan 2011

Food News and Research

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Substantial equivalence review requirement for new tobacco products announced

News outlets examine potential implications of record high food price levels

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

Opinions: Global health top foreign policy issue; Global food security; Opiate-substitution programs in Eastern Europe; Feed the future; Foreign aid lessons

Athersys completes patient enrollment in MultiStem Phase I study for leukemia

Liver transplant recipients develop PTMS, face high risk of cardiovascular disease

CeNeRx commences TriRima Phase II trial for treatment resistant depression

FDA introduces new Web resource that helps companies to save time, resources

Altheus Therapeutics announces completion of Zoenasa phase I trial for ulcerative colitis

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Tomatoes contain nutrient which prevents vascular diseases

Tobacco product regulations announced by FDA

Queensland’s flooded residents warned against insect bites

Lexicon Pharmaceuticals announces clinical trial, mechanistic study results of LX4211

VEREGEN Ointment added as new therapeutic option in 2010 CDC STD Treatment Guidelines

Research: Tomatoes can tackle onset of vascular diseases

Opexa completes meetings with FDA regarding planned development program for Tovaxin

JMD publishes results of Tissue of Origin Test validation, reproducibility study

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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