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DDD Update

Daily news and top headlines for drug research professionals

EMA Accepts Ceftolozane/Tazobactam MAA for Review

August 22, 2014 10:54 am | News | Comments

Cubist Pharmaceuticals announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. Read more...

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Mutated Polio Virus Breaches Vaccine Protection

August 22, 2014 10:48 am | News | Comments

Scientists of the University of Bonn, together with colleagues from Gabon, are reporting alarming findings: a mutated polio virus that was able to resist the vaccine protection to a considerable extent was found in victims of an outbreak in the Congo in 2010. Read more...

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Bioethicists Say Ebola Drugs Must be Fairly Distributed, Tested Ethically

August 22, 2014 10:42 am | News | Comments

Researchers and health authorities need to ensure that experimental drugs to treat Ebola are distributed fairly, and in the context of randomized controlled trials in collaboration with local communities and other stakeholders, according to a new Viewpoint, published in The Lancet. Read more...

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The Case for Orphan Drugs

August 22, 2014 10:34 am | by Louise Rozik, Editor | Articles | Comments

Neglected by the pharmaceutical industry before the Orphan Drug Act of 1983, rare diseases are now front and center in pharma R&D, with approximately one-third of all new medicines approved by the FDA in the past 5 years having been developed for the treatment of diseases that affect fewer than 200,000 Americans. Read more...

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AstraZeneca, Illumina Partner on Gene Sequencing

August 21, 2014 4:12 pm | News | Comments

AstraZeneca announced that it has entered into a collaboration with gene sequencing company, Illumina Inc., to develop its next generation sequencing platform for companion diagnostic tests applicable across AstraZeneca’s oncology portfolio. Read more…

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FDA Clears Eliquis for New Use Against Blood Clots

August 21, 2014 3:28 pm | by The Associated Press | News | Comments

Bristol-Myers Squibb and Pfizer said Thursday that federal regulators have expanded approval of their blood thinner Eliquis to treat two types of dangerous blood clots. Read more...                    

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Amid ALS Mania, Possible Drug Target Spotted

August 21, 2014 3:02 pm | by Cynthia Fox, Science Editor | Articles | Comments

As, all around them, everyone from Derek Jeter to the Kennedy family was dousing themselves in ice water for the ALS “Ice Bucket Challenge,” Harvard researchers announced last week they may have found an ALS therapy. Read more...      

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New Hydrocodone Restrictions to Take Effect

August 21, 2014 1:00 pm | News | Comments

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S. Read more...            

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Botox Injections Slow Growth of Stomach Tumors

August 21, 2014 1:00 pm | News | Comments

New research shows that nerves may play a critical role in stomach cancer growth and that blocking nerve signals using Botox (onabotulinumtoxinA) could be an effective treatment for the disease. Read more...             

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Both American Ebola Patients Discharged from Hospital

August 21, 2014 1:00 pm | by Jeff Martin and Katie Foody | News | Comments

After nearly three weeks of treatment, the two American aid workers who were infected with the deadly Ebola virus in Africa have been discharged from an Atlanta hospital, officials said Thursday. Read more...            

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Emergent, MorphoSys Collaborate on Prostate Cancer Drug

August 21, 2014 11:39 am | News | Comments

Emergent BioSolutions and MorphoSys announced an agreement for the joint development and commercialization of Emergent’s preclinical bi-specific antibody, ES414, targeting prostate cancer, under the terms of which Emergent will receive an upfront payment of US$20 million and milestone payments of up to US$163 million. Read more...

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Eisai Submits EU Marketing Authorization for Anti-Epileptic

August 21, 2014 11:34 am | News | Comments

Eisai has submitted a Marketing Authorization Application to the European Commission for its first-in-class anti-epileptic drug (AED) Fycompa (perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC). Read more...

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FDA Approves GSK Asthma Drug

August 21, 2014 11:29 am | News | Comments

GlaxoSmithKline plc announced that the FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Read more...

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Psoriasis Drug Fares Well in Late-Stage Trial

August 21, 2014 11:25 am | News | Comments

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease and plans to submit the product, ixekizumab, to regulators in the first half of next year. Read more...

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Researchers Restore Protein in Muscular Dystrophy

August 21, 2014 11:19 am | News | Comments

For the first time, a research team has succeeded in restoring a missing repair protein in skeletal muscle of three patients with muscular dystrophy carrying a dysferlin mutation who received a single systemic dose of a proteasome inhibitor. Read more...

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