Clinical Trials

Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from...

I-Mab, a clinical stage biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a...

Regeneron Pharmaceuticals, Inc. and the University of Oxford today announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase...

Sorrento Therapeutics, Inc. announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients. As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro...

Pfizer Inc. and BioNTech SE announced that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which...

Takeda Pharmaceutical Company Limited announced results from the Phase 3 TOURMALINE-MM2 trial evaluating the addition of NINLARO™ (ixazomib) to lenalidomide and dexamethasone versus lenalidomide and dexamethasone plus placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem...

Analysis from Phesi shows the impact of COVID-19 on clinical development is continuing to mount, with many clinical trial sites unable to bounce back following suspension in March and April 2020. Phesi’s previous analysis in May 2020 found that...