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FDA on Tuesday discovered remnants of the bird flu virus in samples of commercially available pasteurized milk, in today's bite-sized hospital and health industry news from Indiana, Maryland, and New York.
- Indiana: Elevance Health and private equity firm Clayton, Dubilier & Rice (CD&R) are partnering on primary care. The new company will combine parts of Elevance's Carelon Health division and CD&R's Millennium Physician Group and apree health. According to Elevance and CD&R, the goal of the new company is to build strong patient-provider relationships and provide clinical teams with support for critical data analytics, care coordination, and health coaching. "We know that when primary care providers are resourced and empowered, they guide consumers through some of life's most vulnerable moments, while helping people to take control of their own health," said Bryony Winn, president of health solutions at Elevance Health. "By bringing a new model of advanced primary care to markets across the country, our partnership with CD&R will create a win-win for consumers and care providers alike." The new company will help operate more than 200 primary care clinics, and there are plans to expand geographically in the future, an Elevance spokesperson said. (Minemyer, Fierce Healthcare, 4/15; DeSilva, Modern Healthcare, 4/16; Japsen, Forbes, 4/15)
- Maryland: FDA on Tuesday reported that samples of commercially available pasteurized milk tested positive for the bird flu virus that has infected dairy cows across the country. So far, the U.S. Department of Agriculture has confirmed the virus has infected cows on more than 30 farms across eight states. At least one person in Texas has also been infected with bird flu. According to FDA, it believes the viral particles identified in its highly sensitive lab tests are likely to be remnants of viruses killed during the pasteurization process. The agency also noted that "we have seen nothing that would change our assessment that the commercial milk supply is safe." Results from additional tests are expected within the next few days or weeks, FDA said. Michael Osterholm, director of the University of Minnesota's Center for Infectious Diseases Research and Policy, said the findings are "unsurprising" and that PCR testing could also identify evidence of other pathogens that were killed during the pasteurization process, such as salmonella and listeria. "I still believe that the risk is very low for any live virus activity in milk," Osterholm said. (Goodman, CNN, 4/23; Aleccia, Associated Press, 4/23; Branswell et al., STAT, 4/23)
- New York: Intra-Cellular Therapies recently reported positive results in a late-stage clinical trial that could allow the company to expand the use of its medication Caplyta to include patients with major depressive disorder. Currently, Caplyta is only approved to treat schizophrenia and bipolar depression. In the Phase 3 trial, around 500 patients with major depressive disorder randomly received either Caplyta or a placebo for six weeks in addition to their current medications. Overall, Caplyta reduced depressive symptoms by 4.9 points on the Montgomery-Asberg Depression Scale compared to the placebo. This result was statistically significant and achieved the study's primary goal. The medication also had a significant benefit on a patient-reported measure of depression symptom severity. "The positive Phase 3 results in major depressive disorder represent a significant step towards our goal of further establishing Caplyta as a first-choice treatment across mood disorders," said Intra-Cellular CEO Sharon Mates. According to the company, results from another Phase 3 study of the medication are expected to be released late in the second quarter of the year. (Feuerstein, STAT+, 4/16; Smith, Bloomberg, 4/16)
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