Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Roche revealed further information on how it would spend its multibillion-dollar manufacturing investment in the US, announcing on Monday that its subsidiary Genentech has started building a new site in Holly Springs, NC, worth $700 million. The new facility is expected to create more than 1,900 jobs and is scheduled to be operational in 2029, according to Roche. The FDA handed Telix Pharmaceuticals a complete response letter for its PET agent, codenamed TLX250-CDx, the company said Thursday. TLX250-CDx is being considered for the diagnosis and characterization of clear cell renal cell carcinoma. The agency cited issues in the company's chemistry, manufacturing and controls, and requested further information on the scaling-up process for TLX250-CDx’s commercial use. Further, the FDA filed two Form 483s for two of Telix’s third-party manufacturers. Telix’s stock sank almost 19% on the Australian stock exchange. Telix’s license partner, Heidelberg Pharma, was due to receive a $70 million milestone payment upon the asset's approval. Sandoz is spending CAD $220 million ($160 million) to “modernize”
its partner Delpharm’s facilities in Boucherville, Canada, with help from the Government of Quebec, according to a Thursday release. CAD $60 million ($43.6 million) is being invested by the provincial government, another CAD $60 million ($43.6 million) from the federal government and CAD $100 million ($72.6 million) from private investors. Sai Life Sciences has completed
the second phase of its so-called Production Block at its API manufactur |