Provides Full Year 2024 Financial Guidance PRINCETON, N.J.— 2024年2月29日– Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in biosimulation, today reported its financial results for the fourth quarter of fiscal year 2023. Fourth Quarter Highlights: “We are encouraged by our strong fourth quarter results, driven by improved execution across both software and services,” said William … Continued
The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation. It links in vitro data to in vivo absorption, distribution, metabolism, excretion and pharmacokinetic/pharmacodynamic outcomes to explore clinical scenarios and …
Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies. For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents. Tools that incorporate generative artificial intelligence (AI) can … Continued
Rare diseases are a public health priority. FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued
Authors: Govind Menon, Suruchi Bakshi, J. Krishnan It is well-established that misfolded alpha-synuclein (alpha-syn) is a histopathological marker of Parkinson’s disease. Given this, we focus on key pathways centered around alpha-syn to explore the pathogenesis of Parkinson’s disease. These are …
By Hugo Geerts, PhD, Piet van der Graaf, PharmD, PhD Over the past 20 years, less than a handful of completed Phase III Alzheimer disease (AD) clinical trials have been successful. Despite large investments of capital and research, more than 200 investigational programs have failed or …
In a long-awaited development, Italy’s Medicines Agency, AIFA, underwent transformative changes on January 30th, 2024. This has been a recurrent topic of discussion, with talks of merging the Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR). However, the COVID-19 pandemic delayed these plans, leading to a continuous extension of the current … Continued
