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What We're Reading: Vaccines in EUA Process; Alkermes Receives CRL; California Tightens Restrictions
The FDA will move rapidly to clear Pfizer's and Moderna’s coronavirus disease 2019 vaccines for emergency use; approval of Alkermes' ALKS 3831 is pending; California's governor is tightening restrictions for 94% of the state’s residents.
HHS Secretary Says FDA Will Rapidly Move to Clear Vaccine Candidates
Appearing yesterday on CNBC’s “Squawk Box,” HHS Secretary Alex Azar said the FDA will move as quickly as possible to clear Pfizer's and Moderna’s vaccine candidates against coronavirus disease 2019 (COVID-19) for emergency use. Azar’s statement comes amid interim results from Moderna, which announced yesterday that its COVID-19 vaccine was more than 94% effective in preventing the virus. Pfizer’s vaccine candidate was additionally shown to be 90% effective, with Azar noting that both authorization applications are currently being completed.
Alkermes Issued Complete Response Letter for Manufacturing of ALKS 3831
Today, Alkermes plc announced it received a Complete Response Letter from the FDA on its New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrennia and adults with bipolar I disorder. The FDA stated that approval of ALKS 3831 is pending resolution of certain conditions related to the tablet coating process at the company’s facility, which Alkermes noted has been resolved with sufficient data available to address these observations.
California Tightening COVID-19 Regulations Amid Record Surge in Cases
Yesterday, California Governor Gavin Newsom said that 41 of the state’s 58 counties will be put into the most restrictive “purple” tier due to widespread virus transmission, going into effect today, according to The Hill. Noting that California is pulling the “emergency brake” and tightening restrictions for 94% of the state’s residents, Newsom additionally stated that counties will be reassessed multiple times during the course of a week and will be unable to move forward until cases of infection improve and the state deems it safe.
Urticaria Diagnosis Challenged by Overlapping Pruritic Skin Conditions
April 23rd 2025Urticaria is complicated to diagnose by its symptomatic overlap with other skin conditions and the frequent misclassification in literature of distinct pathologies like vasculitic urticaria and bullous pemphigus.
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New Research Challenges Assumptions About Hospital-Physician Integration, Medicare Patient Mix
April 22nd 2025On this episode of Managed Care Cast, Brady Post, PhD, lead author of a study published in the April 2025 issue of The American Journal of Managed Care®, challenges the claim that hospital-employed physicians serve a more complex patient mix.
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Personalized Care Key as Tirzepatide Use Expands Rapidly
April 15th 2025Using commercial insurance claims data and the US launch of tirzepatide as their dividing point, John Ostrominski, MD, Harvard Medical School, and his team studied trends in the use of both glucose-lowering and weight-lowering medications, comparing outcomes between adults with and without type 2 diabetes.
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ACOs’ Focus on Rooting Out Fraud Aligns With CMS Vision Under Oz
April 23rd 2025Accountable care organizations (ACOs) are increasingly playing the role of data sleuths as they identify and report trends of anomalous billing in hopes of salvaging their shared savings. This mission dovetails with that of CMS, which under the new administration plans to prioritize rooting out fraud, waste, and abuse.
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