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The FDA has approved several new therapies this week, including a new two-component Pompe therapy, an extended-release drug for major depression without sexual side effects, and an eye drop for drug-induced dilation. Additionally, the agency has set review dates for several products, including odronextamab for blood cancers, sotatercept for pulmonary arterial hypertension, and Dupixent in young children with eosinophilic esophagitis.


FDA Updates for the Week of Sept. 25, 2023

Senior Vice President of Risk Adjustment Solutions for PopHealthCare and Emcara Health.

Jeremy Berk, senior vice president of Risk Adjustment Solutions for PopHealthCare and Emcara Health, shares how plans must conduct a detailed analysis of how changes to risk adjustment models impact your plan in order to set an effective go-forward strategy.

CMS Has Changed the Game for Medicare Advantage Reimbursement. Here’s How Plans Can Respond Effectively.

Study links inflammatory bowel disease diagnosis to increased gout risk, with Crohns disease and ulcerative colitis linked to 68% and 38% increases in likelihood of developing gout, respectively, relative to counterparts without IBD.



Chances of Developing Gout Are Higher for Patients With IBD

Laura is the vice president of content of Managed Healthcare Executive

 (MHE) and all its brands, including Formulary Watch

. She has been working on MHE since 2019 and has been with MHE's parent company, MJH Life Sciences

, since 2011. She has an MA in business and economic reporting from New York University.

Two posters presented at the European Respiratory Society International Congress found use of Dupixent improved lung function by 12 weeks with sustained responses.

Children With Asthma Experience Improved Lung Function With Dupixent Initiation

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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Authors

More than 4 million annual provider visits, including visits to the ER, can be attributed to adverse drug events

FDA prioritizes drug safety, expects industry to be proactive

Craig Coleman

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