The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint

• Zealand Pharma received a positive recommendation from the European Union's Committee for Medicinal Products for Human Use on Friday for its drug candidate Zeydovio. • The drug is designed to treat short bowel syndrome, a condition where the intestines are too short to absorb enough nutrients.

• Replimune received approval for Tudriqev, a medication delivered directly to tumors to treat cancer. • This localized delivery approach is also used by Amgen’s Imlygic to target therapeutics specifically at tumor sites.

• Cue Biopharma announced positive results from a Phase 2 clinical trial of its CUE-221 treatment for chronic spontaneous urticaria, a condition causing chronic hives. • The trial results demonstrated that the drug achieved significant efficacy and maintained a favorable safety profile for patients.

• Clinicians are raising alarms over the sale of direct-to-consumer emergency kits that contain prescription drugs and antibiotics. • These kits allow individuals to purchase potent medications without a doctor's oversight or a valid prescription.

• A survey of Alberta healthcare workers revealed that many staff members experienced coercion and moral injury resulting from COVID-19 vaccine mandates. • The findings highlight the psychological impact on medical professionals who felt forced to comply with mandates to maintain their employment.

• The World Health Organization recognized a historic achievement in the global effort to stop dog-transmitted rabies through vaccination and surveillance. • WHO Director General Tedros Adhanom Ghebreyesus credited the success to more than five decades of sustained investment in public health.

• Xenon Pharmaceuticals paused new patient enrollment in clinical trials for its experimental major and bipolar depression drug on Thursday. • The company halted the studies following reports of side effects related to the mental and nervous system.

• The World Health Organization reported on September 10 that the Democratic Republic of the Congo is experiencing the fastest-growing Ebola outbreak on record. • Health officials have confirmed more than 6,700 cases and more than 3,200 deaths during this current surge.

• Robert F. Kennedy Jr. is scheduled to speak at a conference hosted by the Children's Health Defense organization. • The event is part of a broader series of health news updates including research on protecting heart health in outer space.

• The FDA has allowed companies to sell drugs and devices while completing safety and efficacy studies, but many of these postmarket requirements are now overdue or behind schedule. • FDA leaders announced in February that the default requirement for agency approvals will shift to one clinical trial instead of two.

• The U.S. Food and Drug Administration approved this season's COVID vaccines nearly three weeks ago for general use. • Children with private insurance can currently access the shots, but those in the Vaccines for Children program must wait for Health and Human Services sign-off.

• Philadelphia health officials reported a potential measles exposure at the Children's Hospital of Philadelphia on September 11. • The exposure occurred in the neonatal intensive care unit and other locations at the hospital's 3401 Civic Center Blvd facility.