The first accelerated approval for a tumor-agnostic drug was granted by the FDA...
Paradigm Shift Regarding API and Formulation Components
This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limited functionality with the new paradigm, which suggests these components play a significant role in therapeutic stability, quality, potency, immunogenicity, and bioavailability.
August’s top news stories
Gradalis started a Phase lll clinical trial of Vigil in combination with irinotecan and temozolomide for the treatment of patients with Ewing’s sarcoma, and Impel NeuroPharma dosed the first subject in the Phase l Safety and Tolerability of Intranasal POD-olanzapine (SNAP 101) trial of INP105. Drugdevelopment-technology.com wraps up the key news stories from August 2018.
Characterising Liposomes using Multi-Angle DLS
Liposomes are nowadays frequently used as drug delivery systems, and as such requires that they are well characterised for manufacturing and batch release. This characterisation includes their size and size distribution.
Detecting the Presence of Trace Polymorphs and Impurities
In the pharmaceutical industry, the detection of polymorph traces is one of the most important applications of powder x-ray diffraction (PXRD).
July’s top news stories
The Kyoto University’s Centre for iPS Cell Research and Application (CiRA) in Japan is to start two clinical trials that will evaluate human induced pluripotent stem cells (iPS) to treat Parkinson’s disease, and Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), along with Parkinson’s UK, announced that the European Medicines Agency (EMA) issued a positive qualification opinion on biomarker as a tool to boost clinical trials on Parkinson’s. Drugdevelopment-technology.com wraps up the key news stories from July 2018.
Getting Acquainted with the Theory of XRF
This white paper provides a general introduction to X-ray Fluorescence (CRF) spectrometry and XRF analysis. It explains how a spectrometer works and how XRF analysis is achieved.
Genentech doses first patient in Perjeta and Herceptin Phase 3 study
Genentech has dosed the first patient in a Phase 3 study of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) for subcutaneous administration using US-based biotechnology firm Halozyme's proprietary Enhanze drug-delivery technology in combination with chemotherapy.
Pre-Clinical and Clinical Studies in Dermatology
Monasterium Laboratory's pre-clinical research philosophy is to operate as much as possible with intact human hair follicles and skin, which are then exposed to test agents ex vivo (organ culture) or in vivo (human skin xenotransplants on SCID mice).
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