MHRA clarifies position on off-label Avastin
Roche’s drug has been used for years to treat wet AMD, an indication for which it is not specifically licensed
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Tag: Lucentis
Novartis to file Lucentis for rare sight condition in premature babies
Novartis has revealed its intent to file anti-VEGF therapy Lucentis for retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness.
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High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin
Bayer and Novartis have lost a landmark case in the UK seeking to prevent the off-label use of Roche’s Avastin to treat wet AMD, a leading cause of sight loss in the elderly.
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Allergan, Molecular Partners’ AMD drug non-inferior to Lucentis
Allergan, Molecular Partners’ abicipar has shown non-inferiority to Novartis’ Lucentis but with fewer injections in late-stage trials involving patients with neovascular age-related macular degeneration.
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NICE backs Bayer’s Eylea, Novartis’ Lucentis for sight condition
Cost regulators for NHS-funded therapies in England and Wales have issued updated guidelines for the treatment of wet AMD, which continue to back use of both Bayer’s Eylea and Novartis’ Lucentis, but the GMC says doctors should not fear prescribing Roche’s Avastin off-label if they believe it is clinically appropriate and in the patient’s best interest.
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Roche’s bags new US approvals for Tecentriq, Lucentis
The US Food and Drug Administration has expanded the approval of Roche’s Tecentriq so that it can be used to treat a wider range of patients with bladder cancer.
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US clears fifths indication for Roche eye drug
Roche group Genentech’s application to use Lucentis for the treatment of myopic choroidal neovascularization (mCNV) has been approved by the US Food and Drug Administration, giving patients the chance to access the first anti-vascular endothelial growth factor (VEGF) therapy for the condition.
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Novartis/Ophthotech eye drug fails in nAMD trials
Novartis’ plans to develop a combination of Lucentis with pegpleranib to treat patients with neovascular age-related macular degeneration (nAMD) have suffered a setback after it failed to induce better outcomes than Lucentis alone in late-stage studies.
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EU expands use of Novartis’ eye drug Lucentis
The treatment scope of Novartis’ Lucentis has been expanded in Europe to include patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM).
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Priority review for Genentech’s eye drug Lucentis
US regulators are undertaking a speedy review of Genentech’s eye drug Lucentis for the treatment of myopic choroidal neovascularisation (mCNV), a complication of severe near-sightedness that can lead to blindness.
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