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Breaking News on Contract Research, Manufacturing & Clinical Trials

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Update

Baxter CMO business to decline 10% after loss of ‘major customer’

Baxter’s contract manufacturing business is expected to take a nearly 10% hit as one of its "major customers" has elected to self-manufacture products previously made by the CMO (contract manufacturing organization), Baxter CFO James Saccaro told investors last week.

News in brief

US FDA to review new drug application using Catalent softgel drug delivery tech

The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel technology as its delivery platform.

AMRI acquisitions driving up contract revenue in Q2

With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio , two Aptuit facilities and a UK aseptic facility pay off.

Australia looks to speed clinical trial start-up times

Australia’s National Health and Medical Research Council (NHMRC) is getting pragmatic with increasingly long clinical trial timelines and is now looking to streamline the research governance process in order to reduce delays in trial commencement.

TxCell: we’ll continue to use CMO even after we get back our GMP

French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.

News in brief

Novartis' Mereo selects Icon as exclusive provider of development services

Mereo BioPharma Group, a recently-formed specialty biopharma company, has selected CRO (contract research organization) Icon as its sole provider of clinical development services. 

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