Two teenage boys and a 51-year-old man have died after receiving different Sarepta gene therapies, raising safety concerns about the company's treatments for muscular dystrophy and related conditions, leading to market withdrawals and investigations.
Johnson & Johnson's experimental prostate cancer drug using actinium-225 showed significant tumor shrinkage in three patients but resulted in four patient deaths and five cases of interstitial lung disease, prompting plans for capped, flexible dosing.
A scathing U.S. Centers for Medicare & Medicaid Services report obtained by Asheville Watchdog details patient deaths and significant delays in care at Mission Hospital, leading to the hospital being placed in immediate jeopardy. The report highlights leadership failures, lack of available rooms, and deficiencies in care across various departments. Mission Hospital issued a plan of correction and faces the threat of losing its Medicare and Medicaid funding. Additionally, North Carolina Attorney General Josh Stein has filed a lawsuit against HCA Healthcare for alleged breaches of commitments made during the purchase of Mission Health.
Former Missouri respiratory therapist, Jennifer Hall, has been sentenced to 18 years in prison after pleading guilty to reduced first-degree involuntary manslaughter charges in connection with the deaths of two hospital patients. The deaths occurred in 2002 at Hedrick Medical Center in Chillicothe, where Hall worked. The case was revived after an analysis of tissue samples found unauthorized drugs in one patient's system. Hall had denied any involvement in the deaths, but some staff believed she was responsible due to her proximity to the patients and access to pharmaceuticals.
A former respiratory therapist in Missouri, Jennifer Hall, has been sentenced to 18 years in prison after pleading guilty to reduced first-degree involuntary manslaughter charges in connection with the deaths of two hospital patients. The deaths occurred in 2002 at Hedrick Medical Center in Chillicothe, and were described as "medically suspicious" events. Hall was also charged with attempted second-degree assault. The case was revived after an analysis of tissue samples found unauthorized drugs in one of the patients' systems.
Regeneron is reassessing its PSMA/CD28 bispecific antibody development in prostate cancer after two patient deaths occurred during a combination trial with Libtayo. The company has halted patient enrollment in the trial due to the emerging safety profile, including the deaths.
ADC Therapeutics has announced the discontinuation of a mid-stage study of Zynlonta, a treatment for large B cell lymphoma, in unfit or frail patients following seven patient deaths. The decision comes after the company voluntarily paused enrollment in the study, and the FDA issued a partial hold to stop further enrollment.
The chief medical superintendent of a government hospital in India was removed from their post after linking a large number of patient deaths to a scorching heat wave in the country. Nearly 170 people are reported to have died from conditions aggravated by the heat in the Indian states of Uttar Pradesh and Bihar. Authorities are investigating why so many of the deaths in Uttar Pradesh occurred in a single district—Ballia—despite surrounding areas experiencing similarly brutal heat and humidity. The facility’s medical chief, Dr. Divakar Singh, was transferred from his post after allegedly blaming the weather for the deaths. Investigators from the state government now say other factors may have played a role in the deaths—though it’s not yet clear what the factors might be.
A Pennsylvania nurse, Heather Pressdee, has been charged with two counts of homicide, one count of attempted murder, one count of aggravated assault, three counts of neglect of a care-dependent person, and three counts of reckless endangerment after allegedly killing two patients and seriously injuring a third by administering insulin to them. Pressdee had been disciplined or fired from a dozen places of employment over her career before she started working at Quality Life Services, a nursing facility in Butler County, Pennsylvania. Prosecutors say the incidents took place over a four-month period and were "deliberate and intentional."
The FDA has placed a partial clinical hold on Gossamer Bio's Phase Ib/II study of its BTK inhibitor for central nervous system lymphoma after two patient deaths occurred in the trial. The hold was placed due to serious adverse events, including atrial fibrillation, a sudden death event, and a fatal intracranial hemorrhage. Gossamer Bio had previously paused the trial due to a "benefit/risk profile."