Saudi CDMO’s fill/finish plant to offer Big Biopharma access to local benefits
Saudi Biotech Manufacturing has selected Swedish engineering firm KeyPlants to design and build a fill/finish plant for biological APIs.
Archives for February 1, 2017
Pfizer resubmits US and EU application for withdrawn ADC Mylotarg
Pfizer has resubmitted its antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) for regulatory review almost seven years after withdrawing it from the market.
Sandoz withdraws Neulasta biosimilar application after EMA questions GMP status
Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.
Novo Nordisk Foundation grants $17m for pharma fermentation pilot plant
The Novo Nordisk Foundation has awarded a DKK118m ($17m) grant to fund development of a fermentation pilot plant for cell line scale up experiments at the Technical University of Denmark.