Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tirabrutinib Hydrochloride
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ONO PHARMA Completes Enrollment for PROSPECT Study On Tirabrutinib
Details : ONO-4059 (tirabrutinib) is a highly selective irreversible Bruton's tyrosine kinase inhibitor. It is being evaluated for patients with relapsed or refractory primary central nervous system lymphoma.
Product Name : Velexbru
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 25, 2024
Lead Product(s) : Tirabrutinib Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tirabrutinib Hydrochloride
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Velexbru (tirabrutinib hydrochloride) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor. It has received orphan drug designation from the FDA for the treatment of primary central nervous system lymphoma.
Product Name : Velexbru
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 22, 2023
Lead Product(s) : Tirabrutinib Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nivolumab,Cisplatin,Gemcitabine
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Opdivo (nivolumab) is a PD-1 immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. It is been approved for treating resectable non-small cell lung cancer in Taiwan.
Product Name : Opdivo
Product Type : Antibody
Upfront Cash : Inapplicable
February 24, 2023
Lead Product(s) : Nivolumab,Cisplatin,Gemcitabine
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Encorafenib,Cetuximab
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In this study, BRAFTOVI and cetuximab combination treatment group demonstrated a statistically significant extension in overall survival (OS), versus the control group (irinotecan and cetuximab based combination treatment).
Product Name : Braftovi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 20, 2021
Lead Product(s) : Encorafenib,Cetuximab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nivolumab,Ipilimumab
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Bristol Myers Squibb
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Opdivo®, a human PD-1 monoclonal antibody, and Yervoy® Injection, a human monoclonal antibody against CTLA-4, in combination therapy for the first-line treatment of unresectable advanced or recurrent malignant pleural mesothelioma.
Product Name : Opdivo
Product Type : Antibody
Upfront Cash : Inapplicable
May 27, 2021
Lead Product(s) : Nivolumab,Ipilimumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Bristol Myers Squibb
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : This application is based on the result from an investigator-initiated clinical study (NivoCUP study), conducted under the initiative of Kindai University Hospital, evaluating Opdivo in patients with cancer of unknown primary (CUP).
Product Name : Opdivo
Product Type : Antibody
Upfront Cash : Inapplicable
April 14, 2021
Lead Product(s) : Anamorelin HCl
Therapeutic Area : Nutrition and Weight Loss
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Marketing approval of Adlumiz® (generic name: anamorelin hydrochloride) Tablet 50mg (“Adlumiz”) is mainly based on the results from the ONO-7643-04 and ONO-7643-05 studies conducted in Japan in patients with cancer cachexia.
Product Name : Adlumiz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 22, 2021
Lead Product(s) : Anamorelin HCl
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Etelcalcetide
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Parsabiv IV Injection Syringe Launched in Japan for Dialysis Patients
Details : Parsabiv (etelcalcetide HCl) is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Product Name : Parsabiv
Product Type : Peptide
Upfront Cash : Inapplicable
December 21, 2020
Lead Product(s) : Etelcalcetide
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nivolumab,Oxaliplatin,Tegafur
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The supplemental application for approval for Opdivo® has been filed based on the data from the following 2 clinical studies: CheckMate -649 study (ONO-4538-44) and ATTRACTION-4 study (ONO-4538-37.
Product Name : Opdivo
Product Type : Antibody
Upfront Cash : Inapplicable
October 12, 2020
Lead Product(s) : Nivolumab,Oxaliplatin,Tegafur
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nivolumab,Ipilimumab
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Bristol Myers Squibb
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : This approval is mainly based on the result from the Opdivo and Yervoy combination therapy cohort of a multicenter, open-label Phase II clinical study conducted by Bristol Myers Squibb in patients with MSI-High or deficient mismatch repair (dMMR).
Product Name : Opdivo
Product Type : Antibody
Upfront Cash : Inapplicable
September 25, 2020
Lead Product(s) : Nivolumab,Ipilimumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Bristol Myers Squibb
Deal Size : Inapplicable
Deal Type : Inapplicable