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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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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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