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DDD Update

Daily news and top headlines for drug research professionals

Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation

September 29, 2014 3:23 pm | News | Comments

Insys Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioma. Read more...             

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Amag Pharma to Acquire Lumara Health for $675M

September 29, 2014 3:09 pm | News | Comments

Shares of anemia treatment maker Amag Pharmaceuticals soared Monday after it announced plans to buy Lumara Health in a cash-and-stock deal that eventually could be worth more than $1 billion. Read more...             

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Combo Treatment Ups PFS in Advanced Melanoma Patients

September 29, 2014 3:07 pm | News | Comments

Shares of Exelixis jumped Monday before markets opened and after the drugmaker said its treatment for a deadly form of skin cancer fared better than another drug in a late-stage clinical study. Read more...

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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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