Roche

(IN BRIEF) BioNTech and Duality Biologics have announced the commencement of a pivotal Phase 3 trial for BNT323/DB-1303, a next-generation antibody-drug conjugate (ADC) targeting the Human Epidermal Growth Factor Receptor 2 (HER2) in metastatic breast cancer. The trial will enroll … Read the full press release →

(IN BRIEF) The SEA Fund for the transition of territories, backed by LISEA and MESEA, subsidiaries of VINCI Railways, has chosen 26 projects to support the agro-ecological transformation of regions affected by the South Europe Atlantic high-speed line (SEA HSL). … Read the full press release →

(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release →

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release →

(IN BRIEF) BioNTech has achieved a significant milestone in expanding mRNA vaccine manufacturing in Africa with the inauguration of its Kigali site, which includes the first manufacturing unit known as BioNTainer. This move is part of BioNTech’s broader efforts to … Read the full press release →