Helus Pharma CEO to Join Sept. 11 Conference Chat

• The FDA has approved Oveporexton (brand name Orzeyful), developed by Takeda, for the treatment of narcolepsy type 1 in adults. • As the first drug to directly restore orexin signaling, the twice-daily tablet demonstrated improvements in daytime sleepiness, cataplexy, sleep paralysis, and hallucinations across two clinical trials.

• 60 Degrees Pharmaceuticals will release a public presentation on September 11 regarding its medicines for vector-borne diseases. • Following the presentation, company management will meet with institutional investors in New York from September 14-16.

• Updated COVID-19 vaccines are approved for the fall, with insurance coverage for the 2026-27 season depending on recommendations from the Advisory Committee on Immunization Practices (ACIP). • Under the Affordable Care Act, insurers must cover vaccines recommended by ACIP, but the panel has faced turmoil after HHS Secretary Robert F. Kennedy Jr. replaced all 17 members in June 2025.

• Researchers have developed a new hydrogel injection approach designed to keep osteoarthritis drugs effective within joints for several weeks. • The system utilizes a biocompatible polymer matrix and nanocarriers to act as a local reservoir, allowing for the delivery of hydrophobic therapeutic compounds.

• A Public Health Alerts report has identified over 6,000 cases of cyclosporiasis in Michigan through July 22, 2026, linked to contaminated iceberg lettuce. • This event marks the largest known outbreak of the diarrheal illness in U.S. history, highlighting significant risks in the produce supply chain.

• Leading U.S. medical groups issued updated guidelines on Wednesday urging the public to receive updated flu and COVID-19 vaccinations this fall. • The initiative aims to clear up public confusion regarding vaccination schedules and the science behind them, specifically addressing inconsistencies in previous administration advice.

• A recent Annenberg survey reveals a significant trust gap in U.S. healthcare, with 87% of Americans trusting their own doctors while confidence in the CDC, FDA, and NIH has dropped sharply. • This trend persists across various public health scenarios, including drug safety communications, food product recalls, and outbreak advisories.

• Public health debates have intensified following two "measles-associated" deaths in Pennsylvania and the FDA's approval of updated COVID-19 vaccines. • Critics are questioning the lack of direct randomized human efficacy trials for the new vaccine formulations and the transparency of the approval process.

• Researchers have discovered that a protein linked to cancer, specifically the BRAF pathway, may play a critical role in the development of chronic nerve pain. • The study suggests that existing cancer drugs targeting this biological pathway could potentially be repurposed to treat neuropathic pain by addressing pain amplification at its source.

• Health experts are warning of a potentially severe 2026 flu season in the US, driven primarily by the H3N2 strain. • A new flu vaccine has been developed specifically for adults over 50 to provide enhanced protection against the virus.

• 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.