Articles By Estel Grace Masangkay
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EffRx Signs Agreement For Binosto Distribution In Russia And Africa
6/13/2014
Specialty pharmaceutical company EffRx Pharmaceuticals SA announced that it has signed into two new distribution agreements that will bring its osteoporosis drug Binosto to patients in Russia, Africa, and CIS countries.
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GSK And Theravance Announce Positive Phase 3 COPD Trial Results
6/12/2014
GlaxoSmithKline and Theravance announced positive data from two studies investigating Incruse Ellipta as part of a combination treatment in patients with chronic obstructive pulmonary disease (COPD).
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BioDelivery Sciences Receives FDA Approval For Opioid Addiction Drug
6/12/2014
BioDelivery Sciences International announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Bunavail (buprenorphine and naloxone) buccal film (CIII).
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Bayer Files For 4th Eyelea Indication In EU
6/12/2014
Bayer HealthCare has submitted a marketing authorization application to the European Medicines Agency (EMA) for Eyelea as treatment for visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO).
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FDA Publishes Draft Guidance On Identifying, Reporting Fake Drugs
6/12/2014
The U.S. Food and Drug Administration (FDA) has published its first draft guidance under the Drug Supply Chain Security Act. The FDA is asking for public opinion regarding its proposal on suspect drugs identification in the supply chain.
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FDA Grants Fast Track To GW Pharma's Dravet Syndrome Drug
6/11/2014
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GW Pharmaceuticals’ investigational cannabidiol (CBD) product Epidiolex for the treatment of Dravet syndrome.
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NIH Awards Scripps Research $13M Grant To Develop AIDS Vaccine
6/11/2014
A research team from the The Scripps Research Institute (TSRI) has been awarded a grant of over $13 million from the National Institute of Allergy and Infectious Disease of the National Institutes of Health to research antibodies that could lead to the development of a vaccine against human immunodeficiency virus (HIV).
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NORD Advises FDA On Biologics Naming Policy
6/10/2014
The U.S. Food and Drug Administration (FDA) received a letter from the National Organization for Rare Disorders (NORD) urging Commissioner Margaret Hamburg and the agency to consider the potential implications of its biologics naming policy on rare disease treatments.
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NIH Accepts BRAIN Initiative Challenge
6/10/2014
The National Institutes of Health Director Francis Collins accepted the $4.5 billion long term brain research vision, called Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which was presented by the Advisory Committee to the Director (ACD).
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Boehringer Ingelheim's IPF Drug Granted Accelerated EMA Review
6/10/2014
Boehringer Ingelheim announced that the European Medicines Agency (EMA) has granted accelerated review to its marketing authorization application (MAA) for nintedanib for treatment of idiopathic pulmonary fibrosis (IPF) in the EU.