GPC Biotech To Cut 38 Percent Of Workforce

Latest action comes after the German drug maker announced a restructuring last year due to a Phase III setback with satraplatin.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Another Regeneron CRL Prompts Regulatory Operations Questions

 

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.