Serum Institute of India is an Indian private biotechnology and biopharmaceutical company based in Pune. It is recognized as the world’s largest vaccine manufacturer by volume.
WHO has launched the PARTNERS clinical trial testing MBP134 and remdesivir for Bundibugyo virus disease in the DRC. Advisers recommend limiting all candidate Ebola drugs to clinical trials. The outbreak has caused 1,792 confirmed cases and 625 deaths as of July 9.
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.