2027 Regulations Vaccine 
Agency IQ
AUGUST 2, 2024
What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.
The Pharma Data
JUNE 7, 2022
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Agency IQ
OCTOBER 20, 2023
” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. By contrast, a biosimilar product is only “highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency.”
The Pharma Data
DECEMBER 14, 2020
A product called DENARASE, which is used in gene and cell therapy, but is also required for production of certain types of vaccines, was the biggest driver of growth in 2020. Therefore, significant momentum came from vaccine development and production in 2020. The kit can be used to detect DENARASE residues. About c-LEcta.
The Pharma Data
JUNE 9, 2025
WHO Maintains Global Health Emergency Status for Mpox Amid 2024 Surge, Issues Strengthened Recommendations In response to the continuing resurgence of mpox across several regions in 2024, the World Health Organization (WHO) convened the fourth meeting of the International Health Regulations (2005) Emergency Committee on 5 June 2025.
The Pharma Data
FEBRUARY 8, 2021
RE47,739 (‘739) by more than four years until March 5, 2027. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. 2,3 In the U.S.,
Agency IQ
NOVEMBER 20, 2023
During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes. DARWIN EU).
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