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Janssen's Rezolsta Receives Positive Opinion from CHMP

September 29, 2014 | 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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DDD Update

Daily news and top headlines for drug research professionals

Array's Melanoma Drug Promising in Phase 2

September 29, 2014 3:46 pm | Comments

Final results from a Phase 2 trial of binimetinib in patients with advanced NRAS mutant melanoma were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain. Invented by Array BioPharma Inc. and licensed to Novartis in 2010, binimetinib is a small molecule selective inhibitor of the kinases MEK1 and MEK2. Read more...

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Tonix Fibromyalgia Pain Drug Misses Endpoint in Phase 2b

September 29, 2014 3:28 pm | Comments

Tonix Pharmaceuticals announced results of the Phase 2b BESTFIT study of TNX-102 SL as a chronic bedtime treatment for fibromyalgia. The study did not achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12. Read more...

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Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation

September 29, 2014 3:23 pm | 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 | 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 | 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 | 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 | 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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Cancer Research UK Increases Drug Development Investment

September 29, 2014 10:21 am | 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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WHO: 1000s of Ebola Vaccine Doses in Coming Months

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