FDA Law Blog: Biosimilars

APRIL 7, 2025

Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. that it is effective on Day 1) and insinuating misleading comparative claims.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. covered insulin product or vaccine).

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The Pharma Data

JULY 29, 2021

100% Efficacy Observed in Phase 2b Trial of RSV Adult Vaccine Candidate; Provides New Data Updates on its COVID-19 Vaccine Booster and Oral COVID-19 Antiviral Programs As Part of a Broader Review of 8 Potentially First-in-Class Compounds NEW YORK, NY, Wednesday, July 28, 2021 – Pfizer Inc. Second-Quarter 2021 Revenues of $19.0

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The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Adjusted Income (2).

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The Pharma Data

FEBRUARY 8, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

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The Pharma Data

FEBRUARY 4, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

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Agency IQ

JULY 8, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Enzalutamide Viatris (enzalutamide)** Viatris Limited Positive August 2024 Nilotinib Accord (nilotinib)** Accord Healthcare S.L.U.

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