GlaxoSmithKline announces start of two phase III studies in advanced/metastatic melanoma
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) announced the start of two global Phase III studies in advanced or metastatic melanoma patients with a BRAF V600 mutation. The studies will separately assess the efficacy and safety of two investigational agents, GSK2118436 and GSK1120212,
AstraZeneca Replies to FDA Complete Response Letter for BRILINTA
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- Category: AstraZeneca
AstraZeneca has replied to the US Food and Drug Administration's (FDA) Complete Response Letter (CRL) received for the ticagrelor (BRILINTA) New Drug Application (NDA) on 16 December 2010.
Genzyme to Build Additional Plant to Support Growth of Myozyme® and Lumizyme®
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- Category: Genzyme
Genzyme Corp. (NASDAQ: GENZ) announced that it will build an additional manufacturing plant in Geel, Belgium, to support the long-term growth of Myozyme® and Lumizyme® for Pompe disease. The company held a ceremony in Geel to mark the start of construction of the new €250 million plant,
The clinical phase III programme commenced on zicronapine
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- Category: Lundbeck
H. Lundbeck A/S (Lundbeck) announced the advancement of zicronapine into clinical phase III based on the positive clinical phase II data. The first study in the clinical phase III programme is expected to enrol some 160 patients with the aim to measure the efficacy of zicronapine and risperidone and their relative impact on key metabolic parameters.
Roche personalized investigational medicine shows survival benefit in advanced skin cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that BRIM3, a Phase III clinical study of RG7204 (PLX4032), met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.
Bayer and Regeneron start MYRROR Phase III Trial
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- Category: Bayer
Bayer HealthCare and Regeneron Pharmaceuticals announced initiation of a new Phase III clinical trial in collaboration with the Singapore Eye Research Institute (SERI) investigating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.
Boehringer Ingelheim to Purchase Amgen's Fremont (California) Facility
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- Category: Amgen
Amgen Inc. (Nasdaq: AMGN) and Boehringer Ingelheim have signed an agreement under which Boehringer Ingelheim will acquire Amgen's rights in and substantially all assets at Amgen's Fremont California development and manufacturing facility.
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