Tags : Project Orbis

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Approval for Chronic

Shots: The US FDA in collaboration with TGA and Health Canada granted supplemental approval to AstraZeneca’s Calquence to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as the part of Project Orbis and Real-Time Oncology Review (RTOR) pilot program   The approval is based on two P-III studies, ELEVATE-TN & ASCEND assessing […]Read More

PharmaShots Weekly Snapshot (September 16– 20, 2019)

1.Boehringer Ingelheim Enters into an Agreement with Inflammasome Therapeutics to Co-Develop Therapies for Retinal Diseases Published: Sept 20, 2019 | Tags: Boehringer Ingelheim, Agreement, Inflammasome Therapeutics, Co-Develop, Therapies, Retinal Disease 2. Astellas and FibroGen’s Evrenzo (roxadustat) Receives MHLW’s Approval for Anemia Associated with Chronic Kidney Disease in Dialysis Patients Published: Sept 20, 2019 | Tags: Astellas, FibroGen, […]Read More

Merck’s Keytruda (pembrolizumab) + Eisai’s Lenvima (lenvatinib) Receives FDA’s Approval

Shots: The approval is based on P-II KEYNOTE-146/Study 111 assessing Keytruda (200mg, IV, q3w) + Lenvima (20mg, PO, qd) in 108 patients with metastatic endometrial carcinoma that is not microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) with diseases progression following prior systemic therapy and are not candidates for curative surgery or radiation The P-II KEYNOTE-146/Study 111 […]Read More

The US FDA Initiates its First Step Towards Project Orbis

Shots: The US FDA announces Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) providing a framework concurrent submission and review of oncology therapies in collaboration with TGA and Health Canada, allowing for simultaneous decisions in all three countries The collaboration allows cancer patients to receive earlier access to products in other […]Read More