Tebipenem HBr, a potential first oral carbapenem antibiotic, will be submitted to the US FDA under a rolling NDA in the first quarter of 2021 for complicated urinary tract infection and acute pyelonephritis.

Companies developing antibiotics to get financial and technical support from more than 20 firms contributing to new AMR Action Fund. Initiative is also pushing for reimbursement reform and other policies to support commercial marketing.

Companies developing antibiotics to get financial and technical support from more than 20 firms contributing to new AMR Action Fund. Initiative is also pushing for reimbursement reform and other policies to support commercial marketing.

A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.