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Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL

 
• By Jessica Merrill

FDA issued a complete response letter to Coherus' application for a biosimilar version of Amgen's Neulasta (pegfilgrastim), giving Amgen a reprieve, though Mylan has an application pending at the US agency.

FDA's complete response letter to Coherus BioSciences Inc.'s application for a biosimilar version of Amgen Inc.'s neutropenia blockbuster Neulasta (pegfilgrastim), announced June 12, likely delays the launch of a biosimilar rival to the brand until 2018 at the earliest.

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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?

 
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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

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