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FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

XTalks

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

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Healthcare is about profits, not patients

World of DTC Marketing

“Every day, I wonder if I’m going to call into my manager’s office and offered a package because I earn so much,” she told me. Pharmacy schools are turning out thousands of pharmacists who earn a lot less than pharmacists who have to work at hospitals for years. It’s happening in pharma as well.

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Biden Outlines ‘Bold’ National Vaccine Effort

The Pharma Data

16, 2021 — President-elect Joe Biden described an ambitious national vaccination plan on Friday that will deliver coronavirus vaccines to far more people and invoke a wartime law to boost vaccine production. Even if Biden invokes the Korean War-era Defense Production Act, it may take some time to ease vaccine shortages.

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FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab

Pharmaceutical Technology

The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. that is not supported by the statute and applicable regulations.”

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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. . “COVID-19 continues to sicken hundreds of thousands of Americans every day and the people of Regeneron are committed to help,” said Leonard S. Schleifer , M.D., We are pleased to work with the U.S.

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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination.