The EMA and European Commission (EC) will hold a workshop March 20 to identify and discuss potential improvements to the implementation of the EU’s Pediatric Regulation. Read More
Beigene Ltd., of Beijing, dosed the first patient in a phase III trial testing its anti-PD-1 antibody, tislelizumab, as a second-line treatment in approximately 450 patients with advanced unresectable or metastatic esophageal squamous cell carcinoma. Read More
Synedgen Inc., of Claremont, Calif., said research on the potential for glycans and their ion-specific behavior to treat diseases was published in Macromolecular Theory and Simulation. Read More
Palo Alto, Calif.-based Varian Medical Systems will acquire Sirtex Medical Ltd. for about A$1.6 billion (US$1.3 billion). Shares of the acquirer remained flat on the announcement, perhaps because the deal was viewed as somewhat predictable and expensive by investors. Read More
DUBLIN – Aicuris Anti-infective Cures GmbH banked a €30 million (US$37.3 million) milestone from partner Merck & Co Inc. following formal European approval of Prevymis (letermovir) for preventing reactivation of cytomegalovirus (CMV) infection in seropositive bone marrow transplant patients. Read More
Three U.S.-based phase I trials of Bellicum Pharmaceuticals Inc.’s lead candidate, an adjunct T-cell therapy for bone marrow transplant patients, are on an FDA-ordered clinical hold after the company reported three cases of encephalopathy possibly related to the treatment. Read More
