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Latin American Pharma Market Witnesses Increasing Investment, with Companies Looking to Further Operations in the RegionApproximately $12.7 billion has been invested in Latin America’s (LATAM’s) pharmaceutical market through mergers and acquisitions (M&As) in recent years, and with untapped potential identified in2014/2/13
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Gilead submits NDA to US FDA for hepatitis C combination therapyGilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleo2014/2/12
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FDA accepts Spectrum Pharma's NDA filing for lymphoma drug BeleodaqThe US Food and Drug Administration (FDA) has accepted filing of Spectrum Pharmaceuticals' new drug application (NDA) for Beleodaq, a novel, pan-histone deacetylase (HDAC) inhibitor, intended for the2014/2/12
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Alcobra seeks FDA's IND approval for Metadoxine extended-release to treat ADHDIsraeli biopharmaceutical company Alcobra has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase III clinical trial with its proprietary2014/2/11
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Omeros' Huntington's drug OMS824 gets FDA fast-track statusOmeros has received fast-track designation from the US Food and Drug Administration (FDA) for its phosphodiesterase 10 (PDE10) inhibitor 'OMS824' to treat cognitive impairment in patients with Hunting2014/2/11
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NIH Study Finds Regular Aspirin use May Reduce Ovarian Cancer RiskWomen who take aspirin daily may reduce their risk of ovarian cancer by 20%, according to a study by scientists at the National Cancer Institute (NCI), part of theNational Institutes of Health. Howeve2014/2/10
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Rempex obtains $90m BARDA contract for development of gram-negative antibioticThe Medicines Company subsidiary Rempex Pharmaceuticals has received a contract worth $90m from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of Carbava2014/2/10
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FDA grants breakthrough therapy status to GSK's anaemia drug eltrombopagThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GlaxoSmithKline's (GSK) Promacta/Revolade (eltrombopag) for the treatment of cytopenias in patients with seve2014/2/8
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Biogen's multiple sclerosis drug Tecfidera obtains EU approvalUS-based Biogen Idec has received approval from the European Commission (EC) for its Tecfidera (dimethyl fumarate) as a first-line oral treatment for people with relapsing-remitting multiple scleros2014/2/8
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US FDA approves Vanda's sleep disorder drugThe US Food and Drug Administration (FDA) has approved Vanda Pharmaceuticals' HETLIOZ (tasimelteon) 20mg capsules for treatment of non-24-hour sleep-wake disorder (non-24). HETLIOZ is the first FDA a2014/2/7