Drug Discovery World

JULY 25, 2023

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. This article will summarise these five guidelines, with a specific focus on modelling and simulation when it is discussed.

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The Pharma Data

DECEMBER 13, 2020

Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). The drug is an anti-CD20 antibody.

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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. In all, around 130 clinical trials are ongoing for oligonucleotides.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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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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Disease FDA Clinical Trials Licensing 40

Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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Biosimilars Science Clinical Pharmacology FDA 40

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. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

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