FDA Approval Immune Response Licensing Sales 
Pharmaceutical Technology
OCTOBER 28, 2022
What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. VAX-24 has forecasted sales of $21 million in the same year. billion and $812 million in 2028.
XTalks
MAY 2, 2024
In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.
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XTalks
MAY 1, 2023
Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. At its peak sales, Qalsody is expected to generate around $300 million for Biogen. The recommended dosage of Qalsody is 100 mg (15 mL) per administration. What is SOD1 -ALS?
pharmaphorum
JUNE 2, 2021
The 50 mcg dose was put through its paces in a study reported last month which found that it was able to generate an encouraging immune response against some key SARS-CoV-2 variants, including the Brazil and South Africa strain – when administered as a booter to previously vaccinated individuals.
The Pharma Data
DECEMBER 29, 2020
The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. Casirivimab and imdevimab injection is not FDA approved for any use.
The Pharma Data
OCTOBER 28, 2020
“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.
The Pharma Data
DECEMBER 17, 2020
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.
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