| |OCTOBER 20248TAKEDA SECURES JAPANESE APPROVAL TO MANUFACTURE FRUZAQLAPCI PHARMA SERVICES FUNNELS OVER $365 MILLION FOR ADVANCED DRUG DELIVERYTakeda has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) to produce and sell Fruzaqla capsules 1mg/5mg (fruquintinib), an oral inhibitor of VEGFR-1, -2, and -3, for advanced or recurring colorectal cancer treatment that has failed chemotherapy and cannot be cured or removed.The endorsement is primarily supported by the findings of the FRESCO-2 study, an international phase 3 clinical trial carried out in the United States, Europe, Japan, and Australia. The study evaluated the effectiveness of Fruzaqla combined with best supportive care (BSC) versus a placebo combined with BSC in patients who had already received treatment for metastatic colorectal cancer (mCRC). The FRESCO-2 study achieved success in meeting all main and important secondary effectiveness measures and showed uniform advantages in individuals treated with Fruzaqla, regardless of their prior therapies.Dr. Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said, "Although the mortality rate of colorectal cancer has been going down in recent years due to early screening and advances in treatment, the 5-year survival rate for metastatic colorectal cancer remains low and new treatment options are much in need. The approval of Fruzaqla in Japan offers new hope for patients and families of patients with metastatic colorectal cancer, as well as for healthcare personnel involved in colorectal cancer treatment. I feel that it is of great clinical significance." POPCI Pharma Services, a top CDMO specializing in complex biopharma therapies, is dedicating over $365 million to enhance infrastructure for assembling and packaging drug-device combination products with advanced drug delivery systems, particularly focusing on injectable formats. Consisting of enhanced facilities in Europe and North America, this initiative is a key component of PCI's worldwide investment strategy, backed by new business revenue, and aimed at supporting future expansion.PCI's investments in biologics leverage over two decades of expertise, solidifying its leadership in the field, notably through its top-tier Biotech Center of Excellence in Philadelphia. That site utilizes precise handling machinery for pre-filled syringes, syringe assembly and labeling, vial labeling and cartoning, and autoinjector assembly. Recently, PCI made significant investments in cutting-edge, automated advanced drug delivery technologies to improve capabilities and capacities at this facility, ensuring it stays ahead in innovation.Together, the new initiatives enhance PCI's capability to oversee the entire life cycle of these products, from developing and producing sterile drugs to supplying clinical trials, launching products, and commercializing them.In Rockford, Illinois, PCI in the US has ambitious plans for a 545,000-square-foot expansion on its campus, focused on advanced drug delivery and drug-device combination assembly and packaging. Emphasizing the step-by-step approach is a large project spanning 475,000 square feet, with 345,000 dedicated to advanced drug delivery injectable packaging and 130,000 allocated for extra warehousing of products at various development stages. POTOP STORIES
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