Regulators and pharmaceutical companies across the world are intensifying efforts to get increasingly complex and innovative drugs to patients with high unmet medical need in the shortest possible time frame. This article reviews pathways to expedite drug development and approval available in member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Australia. It is concluded that the increasing availability of expedited regulatory pathways and associated modernisation of regulatory systems changes the current regulatory paradigm and requires sponsors to rethink drug development and regulatory strategy. A transformation of the current sequence of regulatory submissions, favouring those countries/collaborations that are best regulatory equipped to make innovative medical need drugs available to patients in the shortest time frame is imminent.
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http://dx.doi.org/10.1007/s43441-022-00480-3 | DOI Listing |
JMIR Ment Health
January 2025
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States.
Background: Evidence-based digital therapeutics represent a new treatment modality in mental health, potentially providing cost-efficient, accessible means of augmenting existing treatments for chronic mental illnesses. CT-155/BI 3972080 is a prescription digital therapeutic under development as an adjunct to standard of care treatments for patients 18 years of age and older with experiential negative symptoms (ENS) of schizophrenia. Individual components of CT-155/BI 3972080 are designed based on the underlying principles of face-to-face treatment.
View Article and Find Full Text PDFPLoS One
January 2025
Institute of Natural Antioxidants and Anti-Inflammation, Dali University, Dali, Yunnan, China.
Oxidative damage, oxidative inflammation, and a range of downstream diseases represent significant threats to human health. The application of natural antioxidants and anti-inflammatory agents can help prevent and mitigate these associated diseases. In this study, we aimed to investigate the effectiveness of walnut green husk (WNGH) as an antioxidant and anti-inflammatory agent in an in vitro setting.
View Article and Find Full Text PDFPLoS One
January 2025
Department of Infectious Diseases, NHO Nagoya Medical Center, Nagoya, Aichi, Japan.
No updated data on people living with HIV (PLHIV) in Japan have been available since 2015, leaving a critical gap in understanding the current status of care and treatment. Therefore, this study aimed to conduct a nationwide evaluation of the second and third goals of the "90-90-90 target" defined by UNAIDS between 2016 and 2020. The study utilized data from approximately 360 core hospitals through structured questionnaires and the National Database of Health Insurance Claims and Specific Health Checkups (NDB).
View Article and Find Full Text PDFPLoS One
January 2025
Laboratory of Developmental Biology, Department of Morphology and Genetics-Paulista Medicine School, Federal University of Sao Paulo (UNIFESP), Sao Paulo, SP, Brazil.
Melatonin is a pineal hormone synthesized exclusively at night, in several organisms. Its action on sperm is of particular interest, since they transfer genetic and epigenetic information to the offspring, including microRNAs, configuring a mechanism of paternal epigenetic inheritance. MicroRNAs are known to participate in a wide variety of mechanisms in basically all cells and tissues, including the brain and the sperm cells, which are known, respectively, to present 70% of all identified microRNAs and to transfer these molecules to the embryo.
View Article and Find Full Text PDFPLoS One
January 2025
School of Public Health, Anhui University of Science and Technology, Hefei, China.
A number of studies demonstrate the therapeutic effectiveness of Radix Bupleuri (RB) and Hedysarum Multijugum Maxim (HMM) in treating liver fibrosis, but the exact molecular mechanisms remain unclear. This study aims to explore the mechanism of RB-HMM drug pairs in treating liver fibrosis by using network pharmacology, bioinformatics, molecular docking, molecular dynamics simulation technology and in vitro experiments. Totally, 155 intersection targets between RB-HMM and liver fibrosis were identified.
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