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Courts, Not FDA Panel, Likely Bigger Hurdle For Amgen's Humira Biosimilar

 
• By Donna Young

Amgen Inc. appears to have a smooth path to FDA approval of its biosimilar of AbbVie Inc.'s tumor necrosis factor Humira (adalimumab) based on documents released ahead of a July 12 advisory committee meeting. But don't expect AbbVie to just sit back and take it.

Amgen Inc. has been eyeing the $14bn in cash rival AbbVie Inc. has been hauling in with its blockbuster Humira (adalimumab) – in fact the world's top-selling drug – and the FDA doesn't appear it will stand in the way.

Indeed, in briefing documents released ahead of a July 12 meeting of the FDA's Arthritis Advisory Committee, regulators all but...

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• By Anju Ghangurde

Glenmark signals thrust on high margin products, while exiting tail end brands as part of efforts to emerge as a branded company. In-licensed assets like Brukinsa and Tevimbra are seen as pivotal to driving growth alongside.

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• By Joseph Haas

Analysts lauded the 13-week weight-reduction rates Viking’s oral dual GLP-1/GIP agonist showed in Phase II, but the firm’s stock tumbled 42% due to high discontinuation rates.

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Interest In PTC’s Sephience Launch Overshadows FDA’s Vatiquinone Rejection

 
• By Alaric DeArment

PTC said it got a complete response letter for the Friedreich’s ataxia drug, with the agency asking for an additional clinical trial.

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Egetis Eyes Swift US Submission For Emcitate

 
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The Sweden-based firm is set for talks with the FDA on the regulatory path for its MCT8 deficiency candidate.