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Novo Nordisk manufacturing facility, and clients, hit by FDA action
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
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diabetic macular oedema
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Novel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
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Innovative biologic prefilled syringe approved in EU
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
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MHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
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First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
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Lonza and Kodiak open custom-built bioconjugation facility
The newly opened facility will support the rapid launch and commercial manufacturing of KSI-301, Kodiak’s investigational retinal disease therapeutic.
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How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
