Significant Changes Announced to 340B Drug Pricing Program Rules

• A retrospective review of FDA novel drug approvals from 2016 through 2024 reveals a trend of approvals being supported by a decreasing number of completed clinical studies. • Researchers analyzed FDA public records and the ClinicalTrials.gov database to evaluate trial counts, funding sources, and the timing of public result reporting.

• The FDA has approved updated COVID-19 vaccines specifically designed to target the XFG variant for the 2026-2027 season. • The new shots are rolling out to provide maximum protection against the evolving strain, with guidance available on eligibility and optimal timing for administration.

• The FDA approved a first-of-its-kind oral treatment from Roivant and Priovant Therapeutics for a rare disease affecting skin and muscles. • Following the announcement on Thursday, Roivant shares saw a 2% increase, closing at $37.58 in afternoon trading.

• A new study reveals that nearly 70% of new drugs approved by the FDA between 2016 and 2024 were granted approval based on a single clinical trial. • Researchers analyzed FDA records and the ClinicalTrials.gov database to track the number of supporting studies, funding sources, and the speed of public result releases.

• The White House is finalizing drug pricing agreements with pharmaceutical companies Bayer, Takeda, and CSL Behring. • These deals are part of a broader initiative by the U.S. government to secure more affordable medication costs through direct negotiations with drugmakers.

• NanoViricides, Inc. (NASDAQ:NNVC) has announced an update to its Measles Drug Treatment Program, introducing a new potential treatment candidate called NV-387. • The development of NV-387 comes in response to a global rise in measles cases, aiming to provide a viable therapeutic option for outbreaks.

• 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.

• On August 31, 2026, the FDA granted expedited approval to daraxonrasib (marketed as Rasonque), a first-of-its-kind daily oral medication. • The drug is specifically indicated for adults suffering from advanced metastatic pancreatic ductal adenocarcinoma.

• The FDA approved updated 2026-2027 COVID-19 vaccines targeting the XFG variant on August 27, with doses shipping immediately to pharmacies, hospitals, and clinics. • While the vaccines are now physically available across the country, federal eligibility guidance remains unsettled, leaving uncertainty regarding who qualifies for the shots.

• The FDA has approved new COVID-19 vaccines for the 2026-2027 season, specifically designed to target the XFG variant. • The vaccines are approved for adults aged 65 and older, with eligibility extended to younger individuals in high-risk groups depending on the specific shot.

• Researchers analyzed the impact of the 21st Century Cures Act, which allows the FDA to approve novel drugs based on a single pivotal trial rather than multiple studies. • Findings indicate that since 2016, the number of studies supporting new drug approvals in the US has steadily decreased.

• The US Food and Drug Administration (FDA) has granted expedited approval to daraxonrasib, a first-of-a-kind oral medication designed to treat the most common form of pancreatic cancer. • Developed by Revolution Medicines, the drug functions as a Ras multiselective inhibitor, targeting specific genetic drivers of the disease.