A March 9 draft guidance from the FDA proposes an allowance for biosimilar sponsors to use clinical data from outside the U.S. to seek the agency’s approval, which would reduce the requirement of at least one study in the approval process. Current FDA guidance requires drugmakers to conduct at least one pharmacokinetic study that directly […]
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Eight-year-old Jonah woke up one May morning with a swollen face and a toothache. He refused the pain medication that his mom, Geneva Reynolds, tried to give him. He didn’t sleep or eat and cried constantly. Within a few days, Reynolds became so desperate that she and her husband had to physically restrain Jonah, dumping […]
Continue ReadingThe first call came just before Thanksgiving last year. She didn’t recognize the phone number, but she answered anyway. “The person said he was an officer of the Department of Criminal Investigations looking into drug trafficking and money laundering,” the woman recalled. He seemed to know a lot about her: the states where she and […]
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Jonah, de 8 años, se despertó una mañana de mayo con la cara hinchada y dolor de muelas. Se negó a tomar el medicamento para el dolor que su mamá, Geneva Reynolds, trató de darle. No dormía ni comía y lloraba sin parar. En pocos días, Reynolds estaba tan desesperada que ella y su esposo […]
Continue ReadingStatista, a global data company that publishes insights for 170 industries, projects four cancer therapies will be among the top 10 best-selling pharmaceutical products in the U.S. this year. The company projects Merck’s cancer drug Keytruda will earn $12.7 billion in U.S. revenue in 2026 — nearly twice that of the second top-selling medication, according […]
Continue ReadingGaithersburg, Md.-based Adventist HealthCare has shared plans to close its Germantown (Md.) Emergency Center July 1, pending state approvals. All affected employees have been offered to stay at Adventist HealthCare to serve patients in Rockville, Md., or at the health system’s other locations, according to a March 9 news release shared with Becker’s. The freestanding […]
Continue ReadingAurora, Colo.-based UCHealth’s credit rating was upgraded to “AA+” from “AA” by Fitch. The upgrade reflects the health system’s very strong financial profile, benefiting from its market position in a growing service area and a long track record of robust operating margins, Fitch said in a March 9 report. UCHealth’s rating also reflects its position […]
Continue ReadingMemphis, Tenn.-based Regional One Health has received notice from the Tennessee Health Facilities Commission that its certificate of need was approved to build a $900 million hospital in Memphis. The CON request will be finalized March 24. The former Commercial Appeal building site will be transferred into the new hospital. “I am extremely pleased that […]
Continue ReadingDigital lifestyle nudges can help GLP-1 users focus on healthier habits, according to a study at Stanford (Calif.) Medicine. The researchers conducted an online randomized trial of over 5,000 adults using the weight-loss medications across the globe, finding that low-cost digital interventions increased their expectation that they would adopt healthy behaviors, with effects lasting up […]
Continue ReadingSecaucus, N.J.-based Hudson Regional Health has appointed chief hospital executives for two of its facilities, according to a March 9 health system news release shared with Becker’s. Michael Hochberg, MD, was promoted to chief hospital executive of Hoboken (N.J.) University Hospital, formerly Hoboken University Medical Center. Vijayant Singh, MD, was named chief hospital executive of […]
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