Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan designation in the E.U.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. TOKYO , Jan.

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Packaging Small Molecule Production FDA Approval 52

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026.

Government 52

Government Vaccine Production Science 52

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

JUNE 28, 2024

Under the law, beginning in January 2026, manufacturers who sell products in Minnesota with intentionally added PFAS must submit a significant amount of information regarding the product.

Production 40

Production Regulations Compliance Packaging 40

Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. Read the full list of documents on FDA’s Unified Agenda here.]

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026.

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Regulations Compliance Production Government 40