Drugs and devices already on the market await FDA-ordered studies

• Health Secretary Robert F. Kennedy, Jr. and ARPA-H Director Alicia Jackson launched a project in Austin, Texas, to accelerate the clinical trial process. • The experimental program aims to reduce the total amount of time and money required to conduct medical trials.

• Health officials and a hospital director confirmed a new case of mpox in Bunia, a city in northeastern Congo. • The region is already managing an Ebola epidemic that has infected 7,890 people and caused 3,799 deaths since May 15.

• NanoViricides, Inc. filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026, with the Securities and Exchange Commission on September 28, 2026. • The company is currently conducting Phase II clinical trials for NV-387, a broad-spectrum antiviral designed to treat difficult viral infections.

• The FDA approved the first-ever therapies for four ultra-rare genetic and metabolic conditions, including Sanfilippo syndrome type A and Alexander disease, in September 2026. • These regulatory decisions also granted the first approved treatments for MCT8 deficiency and ataxia-telangiectasia.

• Regeneron and Sanofi expanded their antibody partnership to develop new treatments, with Sanofi paying $1 billion upfront. • The companies plan to move three specific antibodies into clinical studies by 2027, with future profits split 50:50.

• The Pan American Health Organization recognized five countries and territories in the Americas on September 29, 2026, for successfully eliminating specific diseases over the past year. • These achievements contribute to a broader regional target to eliminate more than 30 communicable diseases, which are illnesses that spread from one person to another, by 2030.

• Health authorities from the Americas approved a new regional strategy on September 30, 2026, to strengthen food safety systems and reduce foodborne diseases. • The strategy targets a crisis that affects an estimated 43.7 million people and causes approximately 78,000 deaths in the region every year.

• An international research group published a study in Nature yesterday finding that ecosystem fragmentation and climate-driven rainfall declines increase the risk of disease outbreaks. • The researchers analyzed more than 58,000 outbreaks of 32 different diseases across 169 countries.

• Health authorities from the Americas approved a new regional strategy on health security on September 30, 2026. • The Pan American Health Organization (PAHO) designed the plan to improve how countries prevent, prepare for, and respond to health emergencies.

• The author warns readers that observational studies often produce misleading results regarding the effectiveness of long-term drug therapies. • These studies frequently suffer from healthy user bias, where the people taking the drug are already healthier than those who are not.

• NanoViricides, Inc. filed its Annual Report on Form 10-K with the SEC, detailing the progress of its antiviral drug NV-387. • The company is conducting Phase II trials for NV-387 to treat Ebola and Mpox, noting that there is currently no approved drug for Mpox Clade I or Clade II.