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Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL

 
• By Alaric DeArment

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

Y-mAbs got a complete response letter for 131I-omburtamab in metastasis from neuroblastoma • Source: Shutterstock

With a complete response letter for its 131I-omburtamab, Y-mAbs Therapeutics Inc. seems ready to put the B7-H3-directed radiolabeled murine monoclonal antibody to the side and prioritize its development platform and already-approved neuroblastoma drug.

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More from New Products

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Vanrafia Approval Plays Into Novartis’s Multipronged IgAN Approach

 
• By Alaric DeArment and Andrew McConaghie

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.

Orphans Cling On To Growth Advantage As Market Share Heads Towards 20%

 
• By Alexandra Shimmings

It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.

Boehringer Still Sees Plenty Of Juice In Jardiance

 
• By Kevin Grogan

Strong sales growth for the German group’s SGLT2 inhibitor in 2024

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Executives On The Move: Nine CEOs, Six CMOs And Three CFOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Novo Nordisk and Takeda, plus Nxera Pharma nabs chief commercial officer from AstraZeneca.

Will China’s Retaliatory Tariffs Galvanize Manufacturing Onshoring?

 
• By Dexter Jie Yan

China’s imposed large retaliatory tariffs on US pharmaceuticals on 10 April, but some domestic firms with in-licensed, US-origin assets were already moving to localized manufacturing.

Compounding Unlikely To Solve GLP-1 Affordable Access Issues

 
• By Alaric DeArment

The end of semaglutide and tirzepatide shortages means large-scale compounding is declining, ICER noted. But compounded versions – and the demand for them – are likely here to stay.