Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Imipenem,Cilastatin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), in the primary and key secondary endpoints of the study.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 05, 2020
Lead Product(s) : Imipenem,Cilastatin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Imipenem,Cilastatin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : FDA has approved sNDA for RECARBRIO (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
May 06, 2020
Lead Product(s) : Imipenem,Cilastatin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Imipenem
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts Review Supplemental New Drug Application for RECARBRIO
Details : The submission is based on the results of the pivotal Phase 3 RESTORE-IMI 2 trial in adult patients with HABP/VABP.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 02, 2020
Lead Product(s) : Imipenem
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable