• District of Columbia/Illinois: The American Hospital Association (AHA) and several federal agencies, including the FBI, HHS, and Cybersecurity and Infrastructure Security Agency, are warning hospitals and health systems about the ransomware group Akira, which has extorted over $244 million from victims. Although Akira has historically focused on Cisco environments, the group recently expanded its tactics and techniques. "Akira relies primarily on brute force attacks on virtual private networks without multifactor authentication enabled to gain initial access, and then they exploit known vulnerabilities in victim systems," said Scott Gee, AHA's deputy national advisor for cybersecurity and risk. "Hospitals should ensure that their VPNs are properly configured and that they are quickly addressing published common vulnerabilities and exposures." (Bruce, Becker's Health IT, 11/17)
• Georgia: According to a new study published in JAMA, increasing the uptake of lung cancer screenings to 100% among eligible patients could more than quadruple the number of lung cancer deaths prevented and life-years gained over a five-year period. Currently, only 18.7% of eligible adults are up to date on their lung cancer screenings, which prevents an estimated 24% of lung cancer deaths (roughly 14,970 deaths) and gains 190,030 life-years. However, if screening uptake was increased to 100%, the number of lung cancer deaths prevented could grow to an estimated 62,110. Life-years over five years would increase by 872,270. The researchers also found that if screening for ineligible ever-smoking individuals was 100%, an additional 29,690 deaths could be prevented and 482,410 life-years gained. "It's disappointing that lung cancer screening uptake remains this low," said Priti Bandi, one of the study's authors from the American Cancer Society. "More sobering is that this low uptake is translating into a real missed opportunity as ... more lung cancer deaths could be prevented, or lives saved, if everyone eligible were screened." (Bassett, MedPage Today, 11/19)
• Maryland: FDA has added a boxed warning and restricted the use of Elevidys, a gene therapy for Duchenne muscular dystrophy, after receiving reports of fatal liver injuries. Previously, the agency issued a safety communication about the drug after it received two reports of fatal acute liver failure in non-ambulatory boys. After the second patient died, the drug's manufacturer Sarepta Therapeutics suspended shipments of the treatment and paused dosing in its confirmatory trial for non-ambulatory patients. With the new change from FDA, Elevidys' prescribing information now warns that acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred while taking the drug. Patients with pre-existing liver impairment may also be at higher risk. The drug is also now limited to ambulatory patients with Duchenne muscular dystrophy who are ages four and older. (George, MedPage Today, 11/14)

Learn how cell and gene therapy developers can improve their partnerships with providers, particularly during contract negotiations and drug onboarding.