Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. When such a situation is identified, it is noted in the product labeling.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. 8 IMBRUVICA U.S.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. 7 IMBRUVICA U.S.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

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Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Malaria mortality from 2000 (left) to 2019 (right). Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do?

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Vaccine DNA Virus Engineering 52

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Malaria mortality from 2000 (left) to 2019 (right). Stahl et al. on bioRxiv. If you want to edit a gene inside of a neuron, what do you do?

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Vaccine DNA Virus Engineering 52

Drug & Device Law

SEPTEMBER 12, 2022

Pfaff is a straggler from the In re Propecia (Finasteride) Products Liability Litigation MDL, most of which settled in 2019. As with practically all post- Albrecht successful preemption cases, the drug had an extensive FDA regulatory history regarding the risk at issue (suicide) and related risks (chiefly depression and suicidal ideation).

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