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Outlook Eyes Blockbuster-Sized Sales For An Old Eye Drug In Wet-AMD

 
• By Jessica Merrill

The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.

eye
Outlook refiled a BLA for bevacizumab for wet-AMD • Source: Shutterstock

Outlook Therapeutics, Inc. believes it has a straightforward commercial opportunity on its hands if it can become the first to win US Food and Drug Administration approval for an ophthalmic formulation of bevacizumab, even though the VEGF inhibitor has long seen off-label use to treat wet age-related macular degeneration (AMD) and other retinal diseases, and the market is already highly competitive.

The company announced on 30 August that it has re-filed a biologics license application (BLA) for its bevacizumab formula ONS-5010,...

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• By Manas Mishra

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• By Sushmita Panda

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In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
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Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By Kevin Grogan

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

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AstraZeneca Launches At-Home Flu Vaccine Amid Industry DTC Push

 
• By Alaric DeArment

The drugmaker announced the launch of an at-home version of its nasal FluMist vaccine, as more companies are looking into direct-to-patient drug sales in response to Trump’s most favored nation pricing proposals.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

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Schrödinger Drops CDC7 Inhibitor SGR-2921 After Two Patient Deaths

 
• By Alaric DeArment

The drug is one of multiple candidates in the class that have been pulled from development, though it is not the company’s lead candidate.