pharmaphorum

JUNE 6, 2022

Repotrectinib has picked up three breakthrough designations from the FDA, including most recently for ROS1-positive metastatic NSCLC patients who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

AUGUST 9, 2022

The data provide proof-of-principle for the use of MET-targeting drugs to offset Tagrisso resistance, and charts a way forward towards regulatory approvals of the combination as an alternative to chemotherapy for these patients. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

Chemotherapy 52

Chemotherapy Labelling 52

Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. Here are some of the top regulatory developments from 2024.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

LifeProNow

FEBRUARY 3, 2025

January 28, 2025: “Pfizer will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California. Detailed results from the Phase 3 CREST trial will be presented at an upcoming congress.

Chemotherapy 130

Chemotherapy Labelling 130