Mitsubishi Gas Chemical Company and GlycoNex have begun a Phase I trial in Japan for their SPD8 denosumab biosimilar. The partners are also “actively pursuing global development plans” for the rival to Prolia and Xgeva.
Mitsubishi Gas Chemical Company and GlycoNex have taken a step forward in their joint plans to bring a Prolia/Xgeva (denosumab) rival to the Japanese market, revealing that the country’s Pharmaceuticals and Medical Devices Agency has given them the go-ahead to begin a Phase I trial for their SPD8 candidate.
The enrolment of the first patient in the Phase I trial marked “a significant milestone in the development of SPD8,”...
Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.
As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.
Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.
