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DDD Update

Daily news and top headlines for drug research professionals

Newly Approved Kidney Drug Gets Unexpected Safety Warning

September 5, 2014 2:34 pm | News | Comments

Keryx Biopharmaceuticals received approval Friday for a pill to treat complications of kidney disease in dialysis patients, but the company's stock fell as investors reacted to an unexpected safety warning in the drug's prescribing label. Read more...

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NeuroDerm Starts Phase 2a Study of Parkinson’s Drug

September 5, 2014 11:11 am | News | Comments

NeuroDerm Ltd. announced that the first patients with severe Parkinson’s disease have been enrolled and dosed in a Phase 2a trial of ND0612H, a high-dose form of NeuroDerm’s proprietary liquid levodopa/carbidopa (LD/CD) drug formulation. Read more...

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Antisense Acromegaly Drug Shows Efficacy in Phase 2

September 5, 2014 11:04 am | News | Comments

Antisense Therapeutics Ltd. reported the primary efficacy results from its Phase 2 clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. Read more...               

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Flu Vaccine Protects Mothers, Babies

September 5, 2014 10:53 am | News | Comments

A new study shows that the influenza vaccination of pregnant HIV-uninfected and HIV-infected women is safe and protects the women against confirmed influenza illness. Read more...                     

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Actavis Antibiotic NDA Accepted, Deemed QIDP

September 5, 2014 10:27 am | News | Comments

Actavis plc confirmed that the FDA has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary Tract Infections and Complicated Intra-Abdominal Infections. Read more...

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U.S. to Give $75M to Expand Ebola Care Centers

September 5, 2014 10:19 am | by Jonathan Paye-Layleh and Sarah DiLorenzo | News | Comments

The American aid agency announced Thursday it would donate $75 million to fund 1,000 more beds in Ebola treatment centers in Liberia and buy 130,000 more protective suits for health care workers. Read more...            

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FDA OKs Merck Cancer Drug, 1st in New Class

September 5, 2014 8:29 am | by Linda A. Johnson, AP Business Writer | News | Comments

Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments. Read more...                       

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FDA Puts Merck's Relebactam on Fast Track as QIDP

September 4, 2014 2:57 pm | News | Comments

Merck announced that the FDA has designated relebactam, the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. Read more...            

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Mallinckrodt's Pain Drug Shows Efficacy in Phase 3

September 4, 2014 2:52 pm | News | Comments

Mallinckrodt reported that a Phase 3 efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy. Read more...            

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HIV Antibody Binds to Novel Target on Virus

September 4, 2014 2:46 pm | News | Comments

A team of scientists has discovered a new vulnerability in the armor of HIV that a vaccine, other preventive regimen or treatment, could exploit. Read more...                           

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J&J to Accelerate Ebola Vaccine Development

September 4, 2014 2:40 pm | News | Comments

J&J announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak. Read more...

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Google's Health Startup Forges Venture with AbbVie

September 4, 2014 2:34 pm | News | Comments

Google's ambitious health startup is teaming up with biotechnology drugmaker AbbVie in a $500 million joint venture that will try to develop new ways to treat cancer and other diseases such as Alzheimer's. Read more...          

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Lilly's Insulin Fares Well in Late-Stage Tests

September 4, 2014 11:31 am | News | Comments

Eli Lilly and Co. plans to seek approval early next year for a new insulin it developed after the diabetes treatment fared better than the competition in two late-stage clinical studies. Read more...               

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Flexion Advances OA Drug Development Plan by One Year

September 4, 2014 11:16 am | News | Comments

Based on a recent meeting with the U.S. Food and Drug Administration (FDA) to review the clinical development program for Flexion’s lead drug candidate FX006, the company announced it will initiate a Phase 3 clinical trial for FX006 in late 2014. Read more...

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Bayer Submits App in Japan for New Eylea Indication

September 4, 2014 11:05 am | News | Comments

Bayer HealthCare announced that Bayer Yakuhin Ltd. has submitted an application for marketing authorization for aflibercept solution for injection into the eye for patients with macular edema secondary to branch retinal vein occlusion (BRVO). Read more...

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