Trends

BE/BA, FDA, bioRASI, GDUFA

BE/BA sites must be logged with US FDA under GDUFA

By Gareth Macdonald

CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.

Aurobindo sets eyes on pharmaceutical API CRAMS biz

Aurobindo sets eyes on API CRAMS biz

By Natalie Morrison

Aurobindo has announced long term plans to steer away from its generics making business in a bid to focus on long term API manufacturing partnerships.

M&A, partnerships and new services in pharma outsourcing

New pharma services from M&A and partnerships: round-up

By Natalie Morrison

Outsourcing-Pharma.com presents the low down on new services forged by partnerships and M&A (mergers and acquisitions), including a molecular biology offering for Quotient, Onyx’s added purification and separation capabilities, and Accenture’s new...

BioFocus: new HTS compound portfolio management system

BioFocus gives itself room to update compound library

By Natalie Morrison

BioFocus has taken on Titian’s sample management software in a bid to pump more resources into “refreshing” its 900,000 strong high-throughput screening (HTS) compound portfolio.

DPT Renaissance acquisition Confab CDMO

No cuts at DPT Labs says new owner Renaissance Pharma

By Gareth Macdonald

No job losses, facility divestitures or strategic changes are planned at DPT Laboratories according to new owner Renaissance Pharma, which bought the CDMO in an out-of-the-blue deal last week. 

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