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Bayer’s BlueRock Moves Parkinson’s Cell Therapy into Phase III

 
• By Kevin Grogan

Productive talks with the US FDA after securing Regenerative Medicine Advanced Therapy designation haves speeded up development of bemdaneprocel, which is about to go into a registrational trial to see if it can slow down or even stop progression of the neurodegenerative disease.

Deep brain stimulation surgery for Parkinson's disease
• Source: Alamy

Founded eight years ago, Bayer subsidiary BlueRock Therapeutics is now putting the final touches to the late-stage program for bemdaneprocel, its closely watched investigational cell therapy for Parkinson’s disease.

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Japan Market Entry: Consortium’s One-Stop Shop To Support Foreign Entrants

 
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Japanese CDMO Bushu talks about a consortium designed to provide a broad range of development services to smaller foreign firms looking to bring high-need drugs to the Japanese market.

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The company said the main reason for expanding its manufacturing capacity was its growing US commercial portfolio and clinical pipeline.

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In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

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