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Roche receives FDA approval for Enspryng to treat NMOSD
pharmaceutical-technology
August 18, 2020
Roche has received approval from the US Food and Drug Administration (FDA) for Enspryng (satralizumab-mwge) to treat adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
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Celleron picks up discarded cancer drug from Roche
pharmatimes
August 14, 2020
Oxford, UK-based Celleron Therapeutics has signed a licensing agreement with Roche for exclusive rights to emactuzumab, a monoclonal antibody and tumour microenvironment modulator.
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FDA accepts application for self-administered Xolair use
pharmatimes
August 14, 2020
The US Food and Drug Administration (FDA) has accepted Roche’s application for a new self-administration option for Xolair (omalizumab) across all approved US indications.
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Celleron licenses cancer drug emactuzumab from Roche
pharmaceutical-technology
August 14, 2020
UK-based Celleron Therapeutics has entered an exclusive licensing agreement with Roche for global rights to the clinical development, manufacturing and commercialisation of cancer drug, emactuzumab.
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Roche gets US FDA approval for Evrysdi to treat spinal muscular atrophy
expresspharma
August 12, 2020
In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA.
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Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy
pharmaceutical-business-review
August 11, 2020
Roche has secured approval from the US Food and Drug Administration (FDA) for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in adults and children aged two months of age and older.
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Roche post mixed results for etrolizumab in ulcerative colitis
pharmatimes
August 11, 2020
Roche’s investigational medicine etrolizumab has demonstrated mixed results in phase III studies in patients with moderately to severely active ulcerative colitis.
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UCB Announces Alzheimer's Disease Treatment Coloration with Roche
americanpharmaceuticalreview
August 05, 2020
UCB announced an agreement to enter into a world-wide, exclusive license agreement with Roche and Genentech, a member of the Roche Group, for the global development and commercialization of UCB0107 in Alzheimer's Disease (AD).
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Rozlytrek from Roche gets EC approval to treat solid tumours and NSCLC
expresspharma
August 04, 2020
The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study.
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Roche gets US FDA approval for Tecentriq combo to treat advanced melanoma
expresspharma
August 03, 2020
The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without disease worsening or death.