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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
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Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog: Biosimilars

mL was approved on March 18, 2022. mL and 20 mg/0.4 mL for subcutaneous injection was approved on October 15, 2021; the supplement for 10 mg/0.2 Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively.

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Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

Drugs 52
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Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Agency IQ

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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MediWound Completes Enrollment Stage of its NexoBrid Phase 3 Pediatric StudyTop-line Data is Expected in the Second Half of 2021

The Pharma Data

The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022. patients during the review of the NexoBrid Biologics License Application (BLA).

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine?

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

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