Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. They are required for orphan drugs but not for biosimilars.

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Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. Other significant challenges include: 1.

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The Pharma Data

NOVEMBER 6, 2020

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. is a leading global pharmaceutical company headquartered in Japan. About Alzheimer’s Disease. About Eisai Co.,

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drug development industry is undoubtedly in a season of change.

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Clinical Trials Drug Development Trials Biosimilars 52

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. 4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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