Remove 2025 Remove Biosimilars Remove Vaccine
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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

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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Sanofi to acquire vaccine biotech in billion-dollar deal

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 headquarters in Bridgewater, New Jersey.

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Apples to apples: Stelara biosimilars and the fight for market share

BioPharma Drive: Drug Pricing

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). What is the impact of vertical integration, the IRA and other factors on biosimilar adoption?

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

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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And We’re Off: FDA Announces That the Commissioner’s National Priority Voucher Program is Open for Applications

FDA Law Blog: Drug Discovery

On July 22, 2025, FDA announced some of these additional details and opened the CNPV program for applications. Example : A universal flu vaccine. Tobolowsky & Michelle L. Butler — We blogged recently about the new Commissioner’s National Priority Voucher (“CNPV”) program, noting that we were eagerly awaiting additional details.

FDA
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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L.

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Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1