Wednesday, August 22, 2018 Daily Archives

Mustang to make ‘bubble boy’ candidate from newly opened cell therapy plant

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A gene therapy for children with X-linked severe combined immunodeficiency (X-SCID) will be made at Mustang Bio’s facility in Massachusetts, which opened in June. Biotech firm Mustang Bio has partnered with St. Jude Children’s Research Hospital to develop a lentiviral gene therapy for the rare disease, commonly known as bubble boy disease, caused by a lack of immune cells necessary to fight off viruses, bacteria and fungi. As the therapy progresses through early-phase clinical trials, Mustang will begin to manufacture…

August 22, 2018

US made biosimilars: Competitive advantage or marketing spin?

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Coherus says American healthcare providers and payers favor biosimilars made in the US over those made overseas. But an industry analyst has dismissed this saying location should not matter provided the facility is approved. Coherus’ second quarter 2018 contained several regulatory milestones relating to its candidate Udencya (pegfilgrastim-cbqv), a biosimilar candidate to Amgen’s Neulasta. A resubmission to the US Food and Drug Administration (FDA) was accepted in May, while in July Europe’s Committee for Medicinal Products for Human Use (CMPH)…

August 22, 2018

WuXi Biologics launches bispecific antibody tech

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WuXi Biologics says it can expedite the development of bispecific antibodies by up to 18 months compared to current offerings through its new ‘WuXiBody’ platform. The Chinese contract development and manufacturing organization (CDMO) WuXi Biologics announced the additional service offering during its 2018 interim results and said its proprietary tech can potentially transform the bispecific industry. “We can take any two sequences of the MAbs [monoclonal antibodies] and engineer into WuXiBody bispecific in two to three months. The resulting bispecifics…

August 22, 2018