Archives for August 3, 2015

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.

Currency issues impacting API manufacturers’ bottom lines

API makers are looking for ways to slash costs and improve efficiencies to counter the impact currency fluctuations and other market challenges, earnings results from Lonza and BASF show.

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. 

FDA approves first 3D-printed drug

A private Pennsylvania company says it has made the first 3D-printed drug to be approved by the US FDA.

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...

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.