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Eisai and Biogen Idec Collaborate to Develop and Commercial​ize Alzheimer'​s Disease TreatmentsEisai Co., Ltd and Biogen Idechave entered into a collaboration to develop and commercialise two of Eisai’s clinical candidates for Alzheimer’s disease (AD), E2609 and BAN2401. The agreement also prov2014/3/6
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GW Pharma obtains FDA orphan status for Epidiolex for treatment of Lennox syndromeBritish biopharmaceutical firm GW Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its Epidiolex as a treatment for Lennox-Gastaut syndrome (LGS)2014/3/5
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Ignyta files IND application with FDA for tumour drug RXDX-101Ignyta has filed an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for its RXDX-101, an oral tyrosine kinase inhibitor targeting solid tumour indications. T2014/3/5
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Cobra Biologics and BioCancell Announce Agreement to Manufactur​e Promising Cancer Therapy DrugCobra Biologics, a leading contract manufacturer of clinical and commercial-scale biologics and pharmaceuticals, and targeted cancer therapy company BioCancell have announced an agreement to manufactu2014/3/4
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The Medicines Company's MMA for oritavancin accepted by EMA for reviewThe European Medicines Agency (EMA) has accepted The Medicines Company's (MDCO) investigational intravenous antibiotic, oritavancin, for review of a marketing authorisation application (MAA). Oritava2014/3/4
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Galderma's Mirvaso receives European approval for treatment of RosaceaThe European Commission (EC) has granted marketing authorisation in Europe for Switzerland-based pharmaceutical firm Galderma's Mirvaso (brimonidine) 3mg/g gel for the treatment of facial redness, als2014/3/3
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EMA grants orphan drug status to ImmunoCellular's brain tumour treatmentThe European Medicines Agency (EMA) has granted orphan drug designation for ImmunoCellular Therapeutics' lead product candidate ICT-107 for treatment of patients with glioblastoma. EU orphan drug sta2014/3/3
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Iroko's lower dose pain drug Tivorbex obtains FDA approvalUS-based Iroko Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to use Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20mg and2014/2/28
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FDA accepts BioCryst’s NDA for intravenous anti-viral drug peramivirBioCryst Pharmaceuticals has announced that the new drug application (NDA) for its intravenous peramivir has been accepted for review by the US Food and Drug Administration (FDA). In December 2013, B2014/2/28
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AstraZeneca's orphan drug Myalept obtains FDA approval for treatment of leptin deficiencyThe US Food and Drug Administration (FDA) has approved AstraZeneca's Myalept (metreleptin for injection) as replacement therapy for the treatment of complications of leptin deficiency in patients with2014/2/27