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DDD Update

Daily news and top headlines for drug research professionals

Bristol-Myers Squibb Gets Positive Results for Nivoluma

September 29, 2014 2:58 pm | News | Comments

Bristol-Myers Squibb Co. announced positive results from CheckMate-037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma. Read more...

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Perrigo Acquires Women's Healthcare Products from Lumara

September 29, 2014 11:02 am | News | Comments

Perrigo Company plc announced that it has signed a definitive agreement to acquire a portfolio of women's healthcare products from Lumara Health, Inc., a privately-held, Chesterfield, Missouri-based specialty pharmaceutical company, for $82 million in cash. Read more...

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Janssen's Rezolsta Receives Positive Opinion from CHMP

September 29, 2014 10:49 am | News | Comments

Janssen announced that the CHMP of the European Medicines Agency has granted a Positive Opinion recommending Rezolsta (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adults aged 18 years or older. Read more...

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EMA Validates Marketing Authorization Application for Nivoluma

September 29, 2014 10:31 am | News | Comments

Bristol-Myers Squibb announced that the European Medicines Agency has validated for review the Marketing Authorization Application for nivolumab in non-small cell lung cancer– the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type. Read more...

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Cancer Research UK Increases Drug Development Investment

September 29, 2014 10:21 am | News | Comments

Cancer Research UK is to increase investment by nearly 50% over the next five years in its Drug Development Office, which is also changing its name to the Center for Drug Development (CDD). Read more...              

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Daiichi Sankyo to Acquire Ambit Bioscience

September 29, 2014 10:09 am | News | Comments

Daiichi Sankyo Co. Ltd. and Ambit Biosciences jointly announced that they have entered into a definitive merger agreement under which Daiichi Sankyo will acquire all of the outstanding common stock of Ambit Biosciences for approximately $315 million on a fully diluted basis. Read more...

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Genentech’s Perjeta Regimen Extended Lives

September 29, 2014 9:59 am | News | Comments

Genentech announced final survival results from the Phase 3 Cleopatra study, which showed that adding Perjeta to Herceptin and docetaxel chemotherapy extended the lives of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy. Read more...

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WHO: 1000s of Ebola Vaccine Doses in Coming Months

September 26, 2014 4:05 pm | News | Comments

Thousands of doses of experimental Ebola vaccines should be available in the coming months and could eventually be given to health care workers and other people at high risk of the deadly disease, according to the World Health Organization. Read more...

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MicroBiome Therapeutics' Drug May Limit Metformin Side Effects

September 26, 2014 3:47 pm | News | Comments

MicroBiome Therapeutics reported positive topline results from a proof-of-concept study testing whether its investigational drug, NM 505, can improve the tolerability of metformin, the first-line therapy for Type 2 diabetes worldwide. Read more...

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Researchers Engineer New Mouse Model to Study Disease

September 26, 2014 3:33 pm | News | Comments

Researchers from the Broad Institute and MIT have created a new mouse model to simplify application of the CRISPR-Cas9 system for genome-editing experiments in living animals. Read more...

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One in 10 Antibiotic Prescriptions Fail

September 26, 2014 3:09 pm | News | Comments

Over a 22-year period more than one in 10 of all antibiotic treatments in a primary care setting have failed. This rate has increased and continues to rise, according to a new study which analysed almost 11 million antibiotic prescriptions in the UK. Read more...

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NIH, FDA Win IP Award for Meningitis Vaccine

September 26, 2014 2:48 pm | News | Comments

The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. Read more...

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Pharm Startup Creates Prefabricated Drug Dosages

September 26, 2014 2:15 pm | News | Comments

Officials of a pharmaceutical startup based on a Purdue University innovation say their company is creating prefabricated drug dosages that could be used by compounding pharmacists to support patient-centered medicine. Read more...

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Ebola Shot Turned Down by WHO is Best Hope as Virus Rages

September 26, 2014 11:16 am | by Makiko Kitamura and Shannon Pettypiece | News | Comments

The calls started coming in August to the office of GlaxoSmithKline Plc from the head of the World Health Organization, Margaret Chan. The Ebola outbreak was raging out of control and Chan needed the drugmaker’s vaccine as quickly as possible. The sudden sense of urgency was an about face from a few months earlier when Glaxo contacted the WHO, asking whether its vaccine could help with the outbreak. Read more...

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Bausch + Lomb Receives Successful Results from Phase 3 Study

September 26, 2014 10:59 am | News | Comments

Bausch + Lomb announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3 study. Read more...

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