US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.
Lonza already manufacturers three out of five commercially available ADCs but is preparing for additional demand with a two-year expansion project at its Visp site.
Regeneron and Sanofi’s Libtayo is granted marketing authorization by the European Commission for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.
WuXi Biologics expands its biologics conjugation solution center to include space for commercial manufacturing of antibody-drug conjugates for the biopharma industry.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Harbour BioMed and an unnamed ‘leader’ in immunology enter license agreement to develop, discover, and commercialize biologic therapeutics using the former’s transgenic mouse platform.
Lonza will provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases from its Switzerland site, which is expected to be operational by mid-2020.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
