Pfizer announces positive topline results from Phase 3 study of Hemophilia B gene therapy candidate

Enhertu to demonstrate a significant survival benefit vs. chemotherapy

Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers

Positive opinions based on significant survival benefit

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints

WuXi STA launches parenteral formulation manufacturing line at Wuxi

This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers

Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.