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CV Therapeutics, Inc.

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Latest From CV Therapeutics, Inc.

Could US Drug Shortages Worsen After Aurobindo’s Eugia Plant Setbacks?

FDA’s observations at Aurobindo subsidiary Eugia's plant in India and a new one in New Jersey could lead to more drug shortages in the US, particularly injectables, though the company aims to streamline production by end-March. Meanwhile, it will capitalize on the “sizable opportunity” from the EU's list of critical medicines while launching a Herceptin biosimilar in India

Commercial Clinical Trials

Intas’ Response To Second Data Integrity Inspection Still Did Not Go Far Enough, US FDA Says

Intas – the the troubled Indian firm at the center of the cisplatin shortage – may have punished workers for their visual-inspection subterfuge, but it also should have gone after managers, the FDA asserted in a second data integrity warning letter in four months.

Manufacturing Quality

Intas And mAbxience Strike Global Etanercept Deal

Intas and mAbxience have announced an exclusive licensing agreement covering mAbxience’s etanercept biosimilar candidate in more than 150 countries worldwide, including Europe and the US.

Deals Biosimilars

Indian Leaders Climb Into Generics And Biosimilars Top 10

In a year that has seen significant changes throughout the generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders. Meanwhile, companies lower down our ranking have enjoyed mixed fortunes, leading to a number of significant movements in this year’s Generics Bulletin Top 50.

Outlook 2024 Biosimilars
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