Strategic Outsourcing in Clinical Development

Made Scientific's new 85,000-sq.-ft. facility, with 145 prior GMP batches, adds clinical- to commercial-scale cell therapy capacity.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.

NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.

Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.

Guselkumab eased spinal pain, stiffness, and MRI-confirmed spinal inflammation in a 411-patient trial of psoriatic arthritis with axial involvement.

Dr Stephen Wilson, CEO of the Botnar Institute of Immune Engineering, describes Basel's collaborative ecosystem and a 3-year roadmap linking research to global clinical partners.

BIIE CEO Dr Stephen Wilson outlines rapid growth plans and a multidisciplinary technology stack targeting global clinical translation.