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UN: Ebola Cases Could Reach 20,000

August 28, 2014 | by John Heilprin and Krista Larson | Comments

The Ebola outbreak in West Africa eventually could exceed 20,000 cases, more than six times as many as are now known, the World Health Organization said Thursday. Read more...                      

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DDD Update

Daily news and top headlines for drug research professionals

FDA Fast Tracks Pfizer's C.diff Vaccine

August 29, 2014 2:00 pm | Comments

Pfizer Inc. has announced  that the FDA has granted Fast Track designation to the company’s investigational Clostridium difficile vaccine candidate (PF-06425090). Read more...                 

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Amgen Submits BLA for Cholesterol-Lowering Pill

August 29, 2014 2:00 pm | Comments

Amgen has announced the submission of a Biologics License Application (BLA) to the FDA for evolocumab seeking approval for the treatment of high cholesterol. Read more...                       

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Isis Initiates Phase 3 Study of FCS Drug

August 29, 2014 2:00 pm | Comments

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 3 study evaluating ISIS-APOCIIIRx in patients with familial chylomicronemia syndrome (FCS). FCS is a rare orphan disease, characterized by extremely high triglyceride levels, that affects an estimated 3,000 to 5,000 patients worldwide. Read more...

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Drug-Delivery Vehicle Could Limit Spread of HIV, AIDS

August 29, 2014 2:00 pm | Comments

A unique method for delivering compounds that could positively impact the global battle against HIV and AIDS may be possible, according to new research. Read more...                         

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Synthesis Produces New Antibiotic

August 29, 2014 2:00 pm | Comments

A  collaboration at Rice University has led to the total synthesis of a recently discovered natural antibiotic. The laboratory recreation of a fungus-derived antibiotic, viridicatumtoxin B, may someday help bolster the fight against bacteria that evolve resistance to treatments in hospitals and clinics around the world. Read more...

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Amgen's Cholesterol-Lowering Drug Meets Co-Primary Endpoints

August 29, 2014 8:30 am | Comments

Amgen announced that the Phase 3 YUKAWA-2 study evaluating evolocumab in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol met its co-primary endpoints. Read more...       

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An End to Drug Errors?

August 29, 2014 8:30 am | Comments

MIT alumni have devised the MedEye, a bedside medication-scanning system that uses computer vision to identify pills and check them against medication records, to ensure that a patient gets the right drug and dosage. Read more...       

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Synthetic Biologics Improves Enzyme for C.diff Prevention

August 29, 2014 8:30 am | Comments

Synthetic Biologics, Inc. and FUJIFILM Diosynth Biotechnologies UK Limited have announced confirmation of exceptional results from the initial phase of cGMP manufacturing of SYN-004, Synthetic Biologics' proprietary oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infections. Read more...

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GSK-NIH Ebola Vaccine to Enter Safety Testing

August 28, 2014 2:00 pm | by Seth Borenstein, AP Science Writer | Comments

Federal researchers next week will start testing humans with an experimental vaccine to prevent the deadly Ebola virus. The NIH announced today that it is launching the safety trial on a vaccine developed by the agency's National Institute of Allergy and Infectious Diseases and GSK. Read more...

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New Drug Ups OS in Stage III Colon Cancer

August 28, 2014 2:00 pm | Comments

A subset of patients with Stage III colon cancer had improved survival rates when treated with irinotecan-based therapy, according to a new study. Read more...                          

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Compound Promises Relief for Inflammatory Pain

August 28, 2014 2:00 pm | Comments

Researchers have discovered that a compound they developed could potentially serve as a painkiller, with particular utility for East Asians with an alcohol-metabolizing enzyme mutation. Read more...                

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HIV Drug Dosage May Be Ineffective for African-Americans

August 28, 2014 2:00 pm | Comments

Many African-Americans may not be getting effective doses of the HIV drug maraviroc, a new study suggests. The initial dosing studies, completed before the drug was licensed in 2007, included mostly European-Americans, who generally lack a protein that is key to removing maraviroc from the body. Read more...

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Researchers Investigating New MS Treatment

August 28, 2014 2:00 pm | Comments

A new treatment under investigation for multiple sclerosis (MS) is safe and tolerable in Phase 1 clinical trials, according to a new study. The Phase 1 studies were the first to test the drug candidate in humans. Read more...     

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Two-Drug Combo Speeds Wound Healing, Reduces Scar Tissue

August 28, 2014 9:53 am | Comments

A combination of two drugs already approved by the U.S. Food and Drug Administration for different applications reduces wound healing time by one-quarter and significantly decreases scar tissue in mice and rats, researchers report. Read more...     

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FDA Approves Generic Megace from TWi

August 28, 2014 9:45 am | Comments

TWi Pharmaceuticals Inc. announced that it has received final approval from the FDA on its Abbreviated New Drug Application for megestrol acetate 125mg/ml oral suspension, the generic equivalent to Par Pharmaceutical's Megace ES. Read more...   

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