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The Lead

Rating U.S. Drug Development Programs

August 20, 2014 11:10 am | by Chris Plaford, CFA, Chief Executive Officer, Claravant Analytics LLC | Articles | Comments

According to industry estimates, the majority of drugs in development will never make it to FDA approval. While a lack of efficacy is often a key factor, many clinical programs are derailed due to avoidable setbacks that can cause delays and significantly increase costs. Read more...

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DDD Update

Daily news and top headlines for drug research professionals

Novan’s Topical Treatment Shows Efficacy Against Drug-resistant Bugs

August 20, 2014 2:29 pm | News | Comments

Novan Therapeutics announced that the company’s Nitricil platform technology has been shown to be efficacious against several of the most multi-drug resistant pathogens plaguing civilian and military health care providers across the globe. Read more...

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New Vaccine Promising Weapon Against TB, Leprosy

August 20, 2014 2:09 pm | News | Comments

The currently available century-old vaccine Bacille Calmette-Guerin, or BCG, provides only partial protection against both tuberculosis and leprosy. Now, researchers may have found a stronger weapon against both diseases. Read more...     

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CEL-SCI Expands Head, Neck Cancer Trial in North America

August 20, 2014 10:47 am | News | Comments

CEL-SCI Corporation announced its Phase 3 Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine has added Centre Hospitalier Universitaire de Québec’s L’Hotel Dieu de Quebec to its growing number of clinical sites in North America. Read more...

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Oramed Snags Oral Insulin Patent in Spain

August 20, 2014 10:40 am | News | Comments

Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that the Intellectual Property Department of Spain has granted the company's patent for its invention, titled "Methods and Compositions for Oral Administrations of Proteins." Read more...

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AstraZeneca, Mitsubishi Tanabe Collaborate in Diabetic Nephropathy

August 20, 2014 10:30 am | News | Comments

AstraZeneca and Mitsubishi Tanabe Pharma Corp. announced a three-year research collaboration in the area of diabetic nephropathy, which aims to leverage complementary strengths, expertise and assets to validate and progress novel research targets and molecules into clinical development. Read more...

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Stemedica Posts Alzheimer’s Stem Cell Data

August 20, 2014 10:24 am | News | Comments

Stemedica International, a Stemedica Cell Technologies subsidiary developing stem cell therapies for Alzheimer’s disease and dementia, revealed the first results of an intravenous administration of allogeneic, human, ischemia-tolerant mesenchymal stem cells in a pre-clinical animal model of Alzheimer’s disease. Read more...

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Roche, Garvan Partner on Genomics Technologies

August 20, 2014 10:18 am | News | Comments

Roche and the Garvan Institute of Medical Research announced a collaboration to develop new technologies for targeted epigenomic analysis using DNA sequencing, bringing together the genomics expertise and infrastructure at the Garvan Institute and target enrichment products from Roche NimbleGen. Read more...

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Liberia Seals Slum to Halt Ebola

August 20, 2014 10:09 am | by Jonathan Paye-Layleh, Abbas Dulleh, Associated Press | News | Comments

Security forces blocked off a seaside slum in Liberia's capital Wednesday, stepping up the government's fight to stop the spread of Ebola, unnerving residents and reportedly sparking a protest by disgruntled youths opposed to the quarantine. Read more...

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NIH Launches Three Integrated Precision Medicine Trials

August 19, 2014 4:01 pm | News | Comments

The NIH's Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) was launched Monday to identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival. Read more...

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Amgen's Thyroid Drug Hits Key Phase 3 Endpoints

August 19, 2014 3:52 pm | News | Comments

Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. Read more...

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FDA Accepts NDA for BI’s COPD Combo

August 19, 2014 3:45 pm | News | Comments

Boehringer Ingelheim announced that the FDA accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat inhaler. Read more...           

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New Vaccines Can Cut Meningitis Spread by 39%

August 19, 2014 3:35 pm | News | Comments

Investigators have discovered that two new vaccines can prevent the transmission of meningitis bacteria from person to person. The vaccines do this by reducing "carriage" of the responsible bacteria in the nose and throats of the population. Read more...

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DOJ Closes Probe into AstraZeneca Trial

August 19, 2014 3:26 pm | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action. Read more...               

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Liberian Ebola Patients Receiving ZMapp Improving

August 19, 2014 3:05 pm | by Jonathan Paye-Layleh and John Heilprin | News | Comments

Three Liberian health workers receiving an experimental drug for Ebola are showing signs of recovery, officials said Tuesday, though medical experts caution it is not certain if the drug is effective. Read more...           

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Gamida Cell, Novartis Sign Option Agreement

August 19, 2014 11:56 am | News | Comments

Gamida Cell, a world leader in stem cell expansion technologies and therapeutic products, announced that it has signed an investment and option agreement with Novartis Pharma AG, under which Novartis will invest $35 million in Gamida Cell. Read more...

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