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DDD Update

Daily news and top headlines for drug research professionals

Intercept Liver Drug Excels in Trial

August 12, 2014 9:21 am | News | Comments

Shares of Intercept Pharmaceuticals Inc. soared in premarket trading Tuesday, a day after the drug developer said its most advanced candidate performed better than a placebo in a mid-stage study of patients with a form of chronic liver disease. Read more...

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Mirati Lymphoma Drug Designated Orphan Drug

August 11, 2014 3:03 pm | News | Comments

Mirati Therapeutics Inc. announced that the U.S. FDA has granted Orphan Drug Designation - which provides seven years of market exclusivity - to mocetinostat, a spectrum selective HDAC inhibitor, for diffuse large B-cell lymphoma (DLBCL). Read more...

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European Commission Approves Macular Edema Drug

August 11, 2014 2:54 pm | News | Comments

Regeneron Pharmaceuticals Inc. announced that Eylea (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema, the leading cause of vision loss in working-age adults in much of the developed world. Read more...

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Regulators Approve Glioblastoma Study Enhancements

August 11, 2014 2:46 pm | News | Comments

Northwest Biotherapeutics announced that, following a 9-month process of regulatory submissions and reviews by regulators in the US, UK and Germany, it has obtained regulatory approvals to make certain enhancements to its ongoing Phase 3 clinical trial of DCVax-L Glioblastoma multiforme (GBM) brain cancer. Read more...

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Discovery May Provide Key to Treating CHF

August 11, 2014 2:38 pm | News | Comments

Researchers have discovered a previously unknown cardiac molecule -- a long non-coding RNA called myosin heavy-chain-associated RNA transcript or Myheart  -- that could provide a key to treating, and preventing, heart failure. Read more...

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First US Ebola Outbreak Stopped 25 Years Ago

August 11, 2014 2:24 pm | by Matthew Barakat, Associated Press | News | Comments

It had all the makings of a public-health horror story: an outbreak of a wildly deadly virus on the doorstep of the nation's capital, with dozens of lab monkeys dead, multiple people testing positive, and no precedent in this country on how to contain it. Read more...

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AIDS Activist Now Fights for FDA

August 11, 2014 2:08 pm | by Matthew Perrone, AP Health Writer | News | Comments

As an AIDS activist in the early 1990s, Gregg Gonsalves traveled to Washington to challenge the Food and Drug Administration, but now he worries that growing anti-regulatory sentiment will roll back safety and effectiveness standards for all types of drugs. Read more...

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TPM/Oxymorphone Patch Demonstrates Reproducibility

August 11, 2014 10:53 am | News | Comments

Australian drug delivery company, Phosphagenics Ltd. announced that the first of its additional studies designed to further characterize the TPM/Oxymorphone patch, in support of an Investigational New Drug (IND) application with the FDA has been completed. Read more...

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Avillion Doses First Patients in Leukemia Drug Trial

August 11, 2014 10:49 am | News | Comments

Avillion LLP announced that the first patients have been dosed in the United States in a global Phase 3 clinical trial called "BFORE," which is designed to assess the effectiveness and safety of Bosulif as a first-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia. Read more...

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Stiffness Matters in Stem Cell Differentiation

August 11, 2014 10:41 am | News | Comments

Bioengineers at the University of California, San Diego have proven that when it comes to guiding stem cells into a specific cell type, the stiffness of the extracellular matrix used to culture them really does matter and also found that a protein binding the stem cell to the hydrogel is not a factor in the differentiation of the stem cell as previously suggested. Read more...

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MannKind, Sanofi Enter Deal Worth $925M

August 11, 2014 10:32 am | News | Comments

MannKind Corp. is teaming up with the French pharmaceutical giant Sanofi to help develop and sell its first product to hit the market, the inhaled insulin Afrezza, an insulin powder that comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. Read more...

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Venom Gets Good Buzz as Potential Cancer Drug

August 11, 2014 10:16 am | News | Comments

Bee, snake or scorpion venom could form the basis of a new generation of cancer-fighting drugs, reported scientists who have devised a method for targeting venom proteins specifically to malignant cells while sparing healthy ones. Read more...

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Ethical Questions Emerge Over Who Gets Ebola Drug

August 11, 2014 10:00 am | by Ciaran Giles, Maria Cheng, Associated Press | News | Comments

In a development that raises a host of ethical issues, Spain announced it had obtained a scarce U.S.-made experimental Ebola drug to treat a Spanish missionary priest infected with the killer virus, despite the U.S. Centers for Disease Control and Prevention having said there were virtually no doses available of the drug. Read more...

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Results Show Anthrax Vaccine is Potent with Rapid Onset

August 8, 2014 3:25 pm | News | Comments

Soligenix Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced results demonstrating the improved immunogenicity and rapid action of its anthrax vaccine, VeloThrax. Read more...

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Genentech Submits sBLA for Diabetic Retinopathy Drug

August 8, 2014 3:21 pm | News | Comments

Genentech, a member of the Roche Group, announced that the company has submitted a supplemental Biologics License Application for Lucentis (ranibizumab injection) to the U.S. Food and Drug Administration for the treatment of diabetic retinopathy. Read more...

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