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DDD Update

Daily news and top headlines for drug research professionals

FDA Approved Drug May Tackle Anemia Pain

May 13, 2011 11:04 am | News | Comments

A cancer drug already used to treat adults and school-age children with sickle cell anemia is safe and significantly reduces pain and other complications of the disease in children as young as 9 months.

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Alimera Resubmits Iluvien NDA

May 13, 2011 10:59 am | News | Comments

Alimera Sciences, Inc. resubmitted a New Drug Application for the investigational drug ILUVIEN for the treatment of diabetic macular edema (DME) to the U.S. Food and Drug Administration.

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FDA Weighs New Dosing Info

May 13, 2011 10:55 am | by Matthew Perrone | News | Comments

Federal health officials are considering adding dosing instructions for children younger than 2 years old to Children's Tylenol and similar products, a change favored by drugmakers and many doctors.

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Starch-based Pockets May Make Good Drug Carriers

May 13, 2011 8:38 am | News | Comments

Vitamins and medications may one day take rides on starch compounds, creating stable vitamin-enriched ingredients and cheaper controlled-release drugs, according to Penn State food scientists.

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NanoBio Trial Studies Nanoemulsion-based Treatment

May 13, 2011 8:35 am | News | Comments

NanoBio announced the initiation of two Phase 3 multicenter trials evaluating NB-001 as a topical treatment for cold sores, a step forward in their over-the-counter (OTC) licensing agreement with GlaxoSmithKline Consumer Healthcare (GSK CH).

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FDA Accepts Insys Therapeutics NDA for Fentanyl SL Spray

May 13, 2011 8:30 am | News | Comments

Insys Therapeutics, Inc. (formerly NeoPharm, Inc.) announced the Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Fentanyl SL Spray. The FDA will notify Insys of its PDUFA date in the 74-day letter, which is expected in the upcoming weeks.

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Adult Stem Cells Take Root in Livers and Repair Damage

May 13, 2011 8:27 am | News | Comments

Johns Hopkins researchers have demonstrated that human liver cells derived from adult cells coaxed into an embryonic state, can engraft and begin regenerating liver tissue in mice with chronic liver damage.

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Euthymics Bioscience Initiates MDD Trial

May 13, 2011 8:13 am | News | Comments

Euthymics Bioscience, Inc. announced the initiation of an advanced clinical study of product candidate, EB-1010, for the treatment of major depressive disorder (MDD.

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First-in-Human Dosing Commenced in Trial for Alzheimer’s Therapy

May 13, 2011 8:09 am | News | Comments

The first healthy human volunteers have been initially dosed in its Phase I clinical trial to evaluate ANAVEX 2-73, Anavex Life Sciences Corp.’s lead compound for Alzheimer’s disease.

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Brain Connectivity Changes During Development

May 13, 2011 8:03 am | News | Comments

Connected highways of nerve cells carry information to and from different areas of the brain and the rest of the nervous system. Scientists are trying to draw an atlas of these connections—sometimes referred to as the “connectome”—to gain better understanding of how the brain functions in health and disease.

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SpringLeaf Therapeutics Raises $15M Series B Financing

May 13, 2011 8:01 am | News | Comments

SpringLeaf Therapeutics has closed a $15 million Series B financing, in a round led by new investor SR One with participation from existing investors Flybridge Capital Partners and North Bridge Venture Partners.

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Translational Research Institute Creates Calorimeter Lab

May 13, 2011 7:58 am | News | Comments

The Translational Research Institute for Metabolism and Diabetes announced plans with MEI Research, Ltd. to create a state-of-the-art calorimeter laboratory.

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Patients Show Reduced Depression Rates After Locteron

May 13, 2011 7:56 am | News | Comments

Biolex Therapeutics announced results demonstrating reduced rates of depression from its SELECT-2 Phase 2b trial of Locteron for hepatitis C treatment at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL.

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Addex Trial Evaluates Parkinson’s Patients

May 13, 2011 7:49 am | News | Comments

Addex Pharmaceuticals announced the initiation of a Phase IIa clinical trial to evaluate dipraglurant in patients with Parkinson's disease levodopa-induced dyskinesia (PD-LID), a debilitating movement disorder caused by long-term treatment with levodopa.

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Fasting Pathway May Point to New Diabetes Drugs

May 13, 2011 5:44 am | News | Comments

Researchers at the Salk Institute for Biological Studies have uncovered a novel mechanism that turns up glucose production in the liver when blood sugar levels drop, pointing towards a new class of drugs for the treatment of metabolic disease.

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