Tuesday, June 19, 2018 Daily Archives

Patheon On Keeping Up With Biologics Demand

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  Patheon is doubling its biomanufacturing capacity through a $50 million investment in Missouri. We spoke with the CDMO about the continued demand for biologics services and its relationship with owner Thermo Fisher. In April, contract development and manufacturing organization (CDMO) Patheon announced plans to add 16,000 L of single-use capacity at its St Louis, Missouri facility. The US$50 million (€43 million) expansion effectively doubles the firm’s global biomanufacturing capacity. According to David Kenyon, senior director of Global Scientific and Technical…

June 19, 2018

Sanofi: ‘Ablynx Nanobody Tech Will Fuel Innovation’

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Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

June 19, 2018

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

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Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter​ sent to the firm in January highlighting “multiple poor aseptic practicesâ€Â at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

June 19, 2018