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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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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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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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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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Where is the promise for plant-based medicines? Part 2: Psilocybin 

Drug Discovery World

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. The next question of interest is where the potential is for psilocybin, and what research is being undertaken to advance it? million in seed funding, bringing the total to date up to £2.5

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role.

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

The Pharma Data

develops, manufactures and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke. 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.