Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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The Pharma Data

JUNE 18, 2021

Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41). “We are encouraged by these results, which further support the efficacy of these two well-established therapies,” said Mohamed Zaki, M.D., IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

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Codon

JUNE 26, 2023

Since the last Codon Digest, I’ve published: Reasons to Be Grateful for Biotechnology (with Avadhoot Jadhav) AAV Foundations (Part I) An overview of AAV-based gene therapies, how they get made, and where they go wrong. Nevertheless, phage therapy did have a stint in the U.S. I’ll post an update soon. coli in mice.

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DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

Since the last Codon Digest, I’ve published: Reasons to Be Grateful for Biotechnology (with Avadhoot Jadhav) AAV Foundations (Part I) An overview of AAV-based gene therapies, how they get made, and where they go wrong. Nevertheless, phage therapy did have a stint in the U.S. I’ll post an update soon. coli in mice.

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DNA Therapies Engineering Clinical Trials 52

The Pharma Data

JUNE 18, 2021

The therapies were administered for a fixed duration of 12 months for VENCLYXTO/VENCLEXTA in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. with Ven-Obi versus 83.1% AbbVie Inc.

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Agency IQ

JANUARY 19, 2024

This process is more thoroughly covered in guidances on gene therapy and vaccine development, and in other guidelines, such as the ICH Q5B Guideline. a recombinant protein or gene therapy packaged via AAV virus) which has been produced by the cells, in addition to other debris such as the remaining media and the remnants of the cells.

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Agency IQ

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended.

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Agency IQ

JULY 28, 2023

September 30, 2023 PDUFA Sentinel: Pregnancy Hold a public workshop on post-market safety studies in pregnant women to facilitate determination of the ideal post-market study design(s), including industry experience and use of Sentinel Initiative and other real-world data resources. But despite the law’s age, it is not yet fully operational.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. CBER will not commit to reviewing packages greater than 250 pages.

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Therapies FDA Production Disease 59