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FluMist Takes Flu Protection Home: FDA Approves Self-Administration

XTalks

However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine. The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations.

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Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical Technology

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

XTalks

The biosimilar injections, Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz), are approved as interchangeable biosimilars to Prolia and Xgeva, respectively. This means they can be substituted for the reference product at a pharmacy without the need for instruction from a prescriber.

Drugs 59
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How the UAE’s COVID-19 Vaccination Strategy Differs from North America’s and Why It Matters

XTalks

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. Viewpoints from UAE Residents Who Were Given the COVID-19 Vaccine.

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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

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Source: Regeneron. Posted: November 2020.

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Casirivimab and imdevimab injection is not FDA approved for any use. did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk.

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. “The investigational cocktail is now available to indicated high-risk U.S.