The acquisition will give Zydus access to Assertio’s commercial infrastructure in the US specialty pharmaceutical market, particularly in oncology supportive care and pain management therapies.
The approval applies to adolescents and adults weighing at least 35 kilograms who have haemophilia A with factor VIII inhibitors or haemophilia B with factor IX inhibitors.
NICE recommended Imfinzi for adults whose stomach cancer has not spread extensively and can be removed through surgery, including gastric and gastro-oesophageal junction cancers that physicians frequently diagnose at advanced stages.
The acquisition includes MacroGenics’ biologics drug substance manufacturing facility in Rockville, Maryland, as well as a warehousing center in Frederick, Maryland, located about 30 miles away.
The next phase will focus on installing and validating fill-and-finish equipment, strengthening quality control systems, building specialized workforce capacity, and preparing for compliant vaccine manufacturing.
The pharmaceutical company submitted bids across several critical childhood immunisation categories, including the Pneumococcal Conjugate Vaccine (PCV10), Rotavirus vaccine, and paediatric Hepatitis B vaccine.
The financing consortium includes Proparco, the European Investment Bank through the Human Development Accelerator initiative, and the International Finance Corporation.
Hengrui will oversee the initial human clinical studies for the immunology assets licensed from BMS, a move intended to speed up proof-of-concept data generation.
The Denton facility will become Novartis’ first manufacturing site in Texas and its fifth radioligand therapy production site in the country.
The agreement excludes China, Hong Kong, Macau, and Taiwan, where SiranBio will retain rights.