Clinical Trials

• NanoViricides, Inc. (NYSE American: NNVC) announced on August 31, 2026, that it is preparing for clinical trials of its broad-spectrum drug candidate, NV-387. • The drug utilizes host-mimetic nanomedicine technology designed to treat measles, a disease currently seeing a rise in cases both within the USA and globally. • This development is significant as it aims to provide a revolutionary antiviral treatment that viruses cannot easily escape, addressing a critical gap in measles management.

• New clinical trials have been launched in the Democratic Republic of Congo to evaluate the efficacy of two drugs, MBP-134 and remdesivir, against the Bundibugyo Ebola virus. • These trials are critical because the Bundibugyo species currently lacks any approved vaccines or therapies to mitigate its spread. • The outbreak has already resulted in over 1,561 confirmed cases and more than 500 deaths, according to the CDC.

• Genmab's epcoritamab showed successful results in treating diffuse large B-cell lymphoma (DLBCL), while BRUKINSA achieved a win in treating mantle cell lymphoma (MCL). • The FDA approved Tregzi for the treatment of graft-versus-host disease (GVHD), providing a critical new tool for patients undergoing allogeneic stem cell transplantation. • These developments highlight a trend of incremental progress in B-cell malignancies and transplant medicine, contrasting with the continued unpredictability of neuropsychiatric drug development.

• Paradigm Health formally submitted its response to the U.S. Food and Drug Administration's (FDA) Request for Information (RFI) regarding the Real-Time Clinical Trial (RTCT) Initiative on June 30, 2026. • As the sole technology provider currently operationalizing the FDA's RTCT proof-of-concept studies, Paradigm Health based its submission on insights from biopharma sponsors and healthcare providers. • This move is critical for refining the framework of real-time clinical trials, aiming to accelerate drug development and improve the efficiency of regulatory oversight.

• The U.S. Department of Health and Human Services (HHS) and the FDA have launched an "unprecedented" initiative to restore American leadership in clinical trials and counter competition from China. • A key component of the plan is an expedited investigational new drug pilot program designed to reduce early trial timelines by as much as 12 months. • Health Secretary Robert F. Califf stated the effort aims to reverse the trend of clinical research moving overseas by making the U.S. the premier location for medicine development.

• The U.S. Department of Health and Human Services (HHS) has launched a coordinated, department-wide initiative to restore American leadership in clinical research. • The ONC is working to integrate clinical trial notifications into electronic health records to connect eligible patients with research opportunities during routine care. • ARPA-H is implementing modernization programs, including THRIVE and CATALYST, which utilize AI and machine learning to optimize dosing and predict safety before patient enrollment.

• A federal grand jury in the Southern District of Florida charged a medical doctor and two staff members for falsifying data during clinical drug trials. • Starting around 2019, the defendants allegedly fabricated testing records to falsely indicate that human subjects had taken medications and undergone required protocol testing. • The scheme targeted trials sponsored by a pharmaceutical development company intended to evaluate the safety and efficacy of new drugs for FDA approval.

• HHS through the National Cancer Institute announced a $200 million public-private partnership to fund clinical trials for cancer vaccines targeting high-risk recurrence patients. • The initiative supports mRNA and other vaccine types, aiming to accelerate development with private sector involvement including venture capital. • 'Nothing of this scale has been attempted in cancer vaccines before,' said Stacey Adam, VP of science partnerships for the Foundation for the National Institutes of Health.