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The rising impact of biomarkers in early clinical development

Drug Target Review

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD). Clinical Pharmacology and Therapeutics. Bagyinszky E, et al. 21(10):3517. Rodrigues AD.

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

She completed a PhD at Durham University which focused on investigating the mechanisms of cardiotoxicity of cancer therapies using clinically relevant in vitro human models of cardiac physiology paired with novel methodologies to evaluate structural and functional toxicities. Ther Innov Regul Sci. 2001 Sep;24(9):517–26.

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Pivotal phase III clinical trial IND submission of the original innovative anticancer drug Chiauranib for the treatment of small cell lung cancer was accepted by the Center of Drug Evaluation of the NMPA.

The Pharma Data

It is a highly-selective Aurora B, CSF1R, VEGFR/PDGFR/c-Kit inhibitor, which exerts a comprehensive anti-tumor effect by simultaneously inhibiting tumor angiogenesis, inhibiting tumor cell mitosis and regulating tumor microenvironment. Chiauranib has shown pharmacological activity superior to that of other similar drugs in animal studies.

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Navigating the Complex Regulatory CRO Landscape for Oncology Trials in the European Union

Conversations in Drug Development Trends

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

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Chipscreen and HISUN reach a strategic cooperation

The Pharma Data

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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ReWalk Robotics announces the Appointment of Randel E. Richner, BSN, MPH to its Board of Directors

The Pharma Data

Founded in 2001, ReWalk has headquarters in the United States, Israel and Germany. ReWalk’s mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. ReWalk® is a registered trademark of ReWalk Robotics Ltd.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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