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. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. provides a 10-year market exclusivity period. Orphan designation in the E.U. countries examined between 2010 and 2017. member states.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

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

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.

Packaging 52

Packaging Small Molecule Production FDA Approval 52

Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. and the E.C.

Regulations 40

Regulations FDA Science Production 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.

Regulations 40

Regulations Compliance Production Government 40