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DDD Update

Daily news and top headlines for drug research professionals

Onconova And FDA Agree on Phase 3 Trial Design

October 5, 2010 8:05 am | News | Comments

Onconova Therapeutics, Inc. announced agreement with the FDA regarding an SPA for the design of a pivotal Phase 3 trial for Estybon as monotherapy in patients with myelodysplastic syndromes, diseases affecting the production of healthy blood cells.

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PROLOR Receives Orphan Drug Designation

October 5, 2010 7:55 am | News | Comments

PROLOR Biotech, Inc. announced that the FDA has granted orphan drug designation to hGH-CTP, PROLOR’s longer-acting version of human growth hormone for the treatment of growth hormone deficiency. hGH-CTP is currently in a Phase 2 clinical trial.

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X-Rays Linked to Childhood Leukemia

October 5, 2010 7:40 am | News | Comments

Researchers have discovered that children with acute lymphoid leukemia had almost twice the chance of having been exposed to three or more X-rays compared with children who did not have leukemia.

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Possible Biomarker for Seizure-related Stress

October 5, 2010 7:36 am | News | Comments

New research has found that reduced levels of brain-derived neurotrophic factor, a protein in the brain that encourages growth of neurons, may be a trait marker for individuals with seizures that are psychological in origin.

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Promising Start for New Osteoporosis Drug

October 5, 2010 7:31 am | News | Comments

Researchers have discovered a group of substances in the body that play a key role in controlling bone density, and on this basis they have begun development of a drug for prevention and treatment of osteoporosis and other bone disorders.

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Inflammation Helps Heal Wounds

October 5, 2010 7:28 am | News | Comments

A new research study may change how sports injuries involving muscle tissue are treated, as well as how much patient monitoring is necessary when potent anti-inflammatory drugs are prescribed for a long time.

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Brain Cancer Vaccine Extends Survival

October 5, 2010 7:24 am | News | Comments

A new vaccine added to standard therapy appears to offer a survival advantage for patients suffering from glioblastoma, the most deadly form of brain cancer. The vaccine knocks out a growth factor that characterizes the most aggressive form of the disease.

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Norian Paying Maximum Fine for Unapproved Trials

October 5, 2010 7:09 am | by Maryclaire Dale | News | Comments

A Pennsylvania medical devices company will pay the maximum $23 million fine for illegally testing bone cement on about 200 spinal patients, three of whom died during surgery.

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Tris Pharma Marketing Generic Tussionex

October 5, 2010 7:05 am | News | Comments

Tris Pharma, Inc., has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for a generic version of UCB's Tussionex, which is used for relief of cough and upper respiratory symptoms associated with allergy or a cold.

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Breakdown of Sanofi-Genzyme Deal

October 5, 2010 7:01 am | News | Comments

Here's how French pharmaceutical giant Sanofi-Aventis SA, which has initiated a hostile takeover attempt for Genzyme Corp. of Cambridge, Mass., describes how the proposed $18.5 billion deal would benefit the two companies and their shareholders.

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Merck Wants Fosamax Verdict Overturned

October 5, 2010 6:56 am | News | Comments

Merck & Co. says it will seek a new trial or even a ruling in its favor after a federal judge slashed the jury verdict against the drugmaker in the case of a woman alleging Merck's osteoporosis drug severely damaged her jaw.

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Gamma Radio HPLC Detector

October 4, 2010 8:24 am | Product Releases | Comments

LabLogic’s innovative Flow-RAM is a gamma radio HPLC detector specifically developed for PET and SPECT applications – the company’s response to five years’ feedback from customers in PET centres and nuclear medicine departments.

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Reference Dye

October 4, 2010 8:12 am | Product Releases | Comments

SsoFast EvaGreen Supermix with low ROX, now available from Bio-Rad Laboratories, Inc., enhances the speed, reliability, and sensitivity of qPCR experiments performed on instruments requiring ROX reference dye.

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Pharmatek Expands Manufacturing Capabilities

October 4, 2010 7:59 am | News | Comments

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities.

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Mallinckrodt Has Become Avantor

October 4, 2010 7:54 am | News | Comments

Mallinckrodt Baker will now be known as Avantor Performance Materials, company officials announced as they unveiled a new name and identity following the recent acquisition by an affiliate of New Mountain Capital.

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