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Drug Development - Springer Nature

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Last Updated: 13 June 2022

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A Review of the Unique Drug Development Strategy of Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate: A First-in-Class, Once-Daily, Single-Inhaler, Fixed-Dose Combination Treatment for Asthma

"The acceptance of IND/GLY/MF in the European Union also included an optional electronic sensor and smartphone app, making it the first 'u201cdigital companion'u201d that can be used with an asthma drug. " This paper examines the unique strategy used in the accelerated development of IND/GLY/MF and IND/MF, including individual components with demonstrated efficacy/safety, bridging doses to optimize IND/GLY/MF's effectiveness/safety, and submission for regulatory clearance before formal completion of the pivotal phase III studies. IND/GLY/MF, IND/MF, and IND/MF were integrated into a single-development strategy, involving four phase III studies: QUARTZ and PALLADIUM assessed IND/MF and IND/MF, while IRIDIUM and ARGON evaluated IND/GLY/MF. "In the pivotal IRIDIUM report u2014IND/MF as an internal comparator, and high-dose salmeterol xinafoate/fluticasone propionate as a marketed comparator" is included, according to the author.

Source link: https://doi.org/10.1007/s12325-021-02025-w


Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update

"The term Lewy body dementia refers to one of two related disorders: dementia with Lewy bodies and Parkinson's disease dementia. " The clinical care of Lewy body dementia is difficult. Cholinesterase inhibitors have been shown to be helpful in reducing cognitive deficits in Lewy body dementia. Donepezil was approved in Japan as a DLB treatment. In comparison to low-dose Levodopa, which aids with parkinsonism, Levodopa may be of little use in addressing motor complaints and zonisamide in comparison to low-dose levodopa. When determining the latest Lewy body dementia management options, it's impossible to completely distinguish PDD from DLB. The Phase II trial results for neflamapimod show promising results. "Lewy body dementia drug trials" need new biomarker technologies and improved definitions of outcome measures due to the heterogeneity of symptoms and underlying pathophysiology.

Source link: https://doi.org/10.1007/s40266-022-00939-w


The role of basket trials in drug development for neurodegenerative disorders

In the lawsuit, there were 59 basket trials evaluating the effects of therapy on more than one NDD. " Parkinson's disease was the most common disease found in basket trials of symptomatic agents, and Alzheimer's disease was the most common condition in basket trials of disease-modifying therapies. Pharmaceutical companies funded the majority of the basket trials testing DMTs in basket trials; in contrast, the biopharmaceutical industry sponsored the majority of the DMT trials. Conclusions Basket trials can help reduce redundancy in trial setup, increasing recruiting, sharing placebo groups, and using biomarkers that are relevant to the treatment's mechanism of action across NDDs can improve drug development's effectiveness. The use of the basket trial approach may have the ability to improve the effectiveness of agent development efforts to address NDDs. ".

Source link: https://doi.org/10.1186/s13195-022-01015-6


Applications of Quantitative Systems Pharmacology (QSP) in Drug Development for NAFLD and NASH and Its Regulatory Application

"As such, there is a lot of activity within the pharmaceutical industry to boost drug discovery in this area, improve the quality of life, and reduce mortality among NASH patients. " This mechanism-based mathematical modeling approach explores both the pathophysiology of a disease and how pharmaceutical interventions can influence pathophysiologic responses. Several QSP models have been designed to display NASH pathophysiology to varying degrees. Simulations were conducted to see if patient behaviors could help explain the relatively high rate of fibrosis stage declines in placebo cohorts. Simulated food intake and body mass fluctuated during change. Despite returning to baseline for liver fat, plasma ALT, and the NAFLD activity score, a relatively slow turnover of liver collagen resulted in steady declines in predicted fibrosis stage with steady declines in predicted fibrosis stage. Results obtained from QSP models such as this one can help expedite the design of safe and effective drugs for NASH patients. ".

Source link: https://doi.org/10.1007/s11095-022-03295-x


Health Equity in Pediatric Drug Development: Translating Aspiration into Operation

"The theory of health equityu2014The achievement of the highest possible health for all members of societyu2014requires equal access to all aspects of healthcare, including pediatric drug development. " We will include case studies on stakeholder and community involvement in clinical research for rare diseases and other areas of healthcare as an example of policies and practices for actively involving under-represented populations and encouraging their involvement in pediatric drug development programs in this issue.

Source link: https://doi.org/10.1007/s43441-022-00410-3


Selective Signal Capture from Multidimensional GPCR Outputs with Biased Agonists: Progress Towards Novel Drug Development

"G protein coupled receptors are a superfamily of transmembrane-spanning receptors that are stimulated by multiple endogenous ligands and are the most common target for agonist or antagonist therapeutics in a wide variety of disorders. " Some GPCRs that have been discontinued as drug targets have been abandoned as a result of the development of pathways that limit the performance of a primary pathway or promote unnecessary signals. For new indications, biased ligands could potentially increase the number of novel drugs targeting GPCRs. We show an example of how large libraries of compounds that are unbound to preconceived notions of agonist binding can be used to find pathway-specific agonists by utilizing the recent elucidation of a 243_2-adrenergic receptor agonist that is biased in favour of Gs coupling over a u03b2_2-adrenergic receptor agonist, which is based on preconceived notions of agonist binding. In this case, an agonist that lacks tachyphylaxis for the treatment of obstructive lung disease was discovered, but with a design that was clearly different from other agonists. ".

Source link: https://doi.org/10.1007/s40291-022-00592-4

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions