EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
The proposed approach demonstrates benefit for real-world application, establishing more robust, adaptive, and economical process systems, the research suggests.
As part of the agreement with Novo Nordisk, Lexicon Pharmaceuticals is eligible for total of $1 billion in upfront and potential milestone payments, alongside royalties.
31 March 2025 | By
Learn how Medtronic processes and quantifies their xC/UV/MS data using the quantitation workflow in MS Workbook Suite.
EPR's latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
Addressing key challenges in the pharmaceutical and biotechnology environmental monitoring market, such as high technology costs, while leveraging key market drivers is critical for the sector to thrive, analysis suggests.
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
26 March 2025 | By Thermo Fisher Scientific Pharma Services
This webinar explores oral drug product development and how to address critical challenges such as complex formulations and regulatory hurdles.
The new license agreement will support development of a potential additional treatment option for patients at risk of atherosclerosis.
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
The proposed technique outperformed traditional controllers, supporting improved air quality control in cleanrooms, according to the study.
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
The new data shows potential of the psilocybin treatment to provide durable, longer-term antidepressant effects in patients with treatment-resistant depression (TRD).
The company now has ABPI membership after a two-year suspension involving concerns relating to its compliance with the industry body’s code of conduct.
The company’s new acquisition, valued up to $1 billion, supports development of in vivo cancer treatments and the future of cell therapy.