Germany’s BioNTech is acquiring Kite’s solid tumor neoantigen T-cell receptor (TCR) research-and-development platform and the Gilead company’s clinical manufacturing plant in Gaithersburg, Maryland.

Bristol Myers Squibb shared new details on the global biopharmaceutical firm’s Phase III research on a potential first-line treatment for people who have been diagnosed with recurrent or metastatic squamous cell carcinoma of the head and neck. 

Moderna Chief Executive Officer Stéphane Bancel sees significant growth opportunities for his company and messenger RNA-based vaccines.

Medable Inc., a leading cloud platform for patient-centered drug development, announced the first stage of the company’s European expansion plans with a new EMEA headquarters in Dublin.

Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The EC also approved Libtayo in advanced basal cell carcinoma (BCC).

Clinical Ink’s white paper discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations, and a Phase III case study.

Craig Lipset, a clinical trials industry innovator and leader, joined the MedVector team as a new board member and executive advisor.

The U.S. Food and Drug Administration approved Blueprint Medicines’ Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis.

Medable Inc., a leading cloud platform for patient-centered drug development, announced the hiring of Sanskriti Thakur as chief growth officer.

Topline results from the Phase III TULIP study show an antibody-drug conjugate (ADC) from the Netherlands-based Byondis B.V. significantly prolonged progression-free survival (PFS) in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).