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As Viatris seeks growth in eye care, its Ocuphire-partnered dilation drop Ryzumvi wins FDA nod

Fierce Pharma

The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028. | The partners plan to make Ryzumvi available in the U.S.

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Viatris, Ocuphire Pharma Receive FDA Approval on Ryzumvi

PharmExec

Eye drop treatment indicated for pharmacologically induced mydriasis.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Top-10 ways for Pharma to leverage AI according to…AI

Impetus Digital

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported.

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Nuvectis Pharma receives IND approval from FDA for NXP900

Pharmaceutical Technology

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. The approval also includes clearance for a Phase I clinical trial protocol of NXP900.

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Novartis drops presbyopia drug acquired with Encore Vision

pharmaphorum

At the time of the Encore Vision takeover, there were pharmacological therapies for presbyopia, but that changed last year when AbbVie secured FDA approval for Vuity , a once-daily eyedrop formulation of pilocarpine, as the first drug for the common eye condition. Image by Oscar Aznar from Pixabay .

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Abliva’s NV354 receives ODD from US FDA

Pharma Leaders

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. FDA is a validation of the quality of the NV354 pre-clinical program and another important milestone for Abliva.

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