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01:56 EST 23rd February 2020 | BioPortfolio

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Showing "Evolution Approval Regulation Processes Drugs Explored" PubMed Articles 1–25 of 23,000+

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks.

FDA vs EMA: review times and clinical evidence on novel drugs at the time of approval.

The FDA and EMA now have expedited review procedures for new drugs. We compared the review times of medicines licensed by the two agencies and explored differences in the evidence submitted. In 2015-2017 the FDA licensed 113 drugs, 66 of which reached Europe. The median review time was longer at the EMA than FDA and was shorter for drugs undergoing FDA expedited programmes compared to the same drugs approved by the EMA through the standard procedure. We identified differences regarding the evidence submitte...

Did citizen petitions prolong the number of approval days of generic drugs?

To compare the numbers of approval days of the generic drugs with and without citizen petitions.

Neutral evolution of cellular phenotypes.

Eukaryotes exhibit a great diversity of cellular and subcellular morphologies, but their basic underlying architecture is fairly constant. All have a nucleus, Golgi, cytoskeleton, plasma membrane, vesicles, ribosomes, and all known lineages but one have mitochondrion-related organelles. Moreover, most eukaryotes undergo processes such as mitosis, meiosis, DNA recombination, and often perform feats such as phagocytosis, and amoeboid and flagellar movement. With all of these commonalities, it is obvious that ...

Ribose Selected as Precursor to Life.

The chemical or prebiotic evolution referred also to as pre-Darwinian evolution describes chemical reactions up to the origin of a self-replicating system that was capable of Darwinian evolution. These chemical processes took place on Earth between about 3.7 and 4.5 billion years ago when cellular life came into being. The pre-Darwinian chemical evolution usually assumes hereditary elements, but does not regard them as self-organizing processes. Physical and chemical self-organization led to uninterrupted p...

Lumateperone: First Approval.

Lumateperone (Caplyta) is a novel, orally available agent developed by Intra-Cellular Therapies (under a license from Bristol-Myers Squibb) for the treatment of schizophrenia and other neuropsychiatric and neurological disorders. Lumateperone is a first-in-class selective and simultaneous modulator of serotonin, dopamine and glutamate. In December 2019, lumateperone received its first global approval in the USA for the treatment of schizophrenia in adults. The drug is also under clinical development for bip...

Approval processes in evidence-based clinical practice guidelines sponsored by medical specialty societies.

To determine the approval processes for evidence-based Clinical Practice Guidelines sponsored by medical specialty societies in the United States.

The legal regulation of drugs and role of government: Perspectives from people who use drugs.

The legalization and regulation of currently illicit drugs has come to the forefront of drug policy debates in recent years, particularly in the context of cannabis legalization and the opioid crisis in North America. However, sufficient granularity on the various aspects of a legally regulated drug supply is missing from these debates. Further, the voices and opinions of people who use drugs have generally been absent from drug law reform deliberations. This study aimed to examine the views of people who u...

Access to Cancer Precision Medicines in Switzerland: A Comparative Analysis (USA and EU) and Health Policy Implications.

Social health insurance is mandatory in Switzerland and covers the costs of basic medical care. In general, with regard to medicines, the costs are only reimbursed if the drug is (1) approved by Swissmedic and (2) listed on the so-called Spezia-litätenliste (SL) by the Federal Office of Public Health (FOPH). However, the SL does not include all drugs. For non-SL drugs, cost coverage is only granted under exceptional circumstances. Absence of cost coverage by social health insurance is especially problemati...

Statistical considerations for rare diseases drug development.

One of the most challenges for rare disease clinical trials is probably the availability of a small patient population. It is then a great concern on how to conduct clinical trials with a small number of subjects available for obtaining substantial evidence regarding safety and effectiveness for approval of the rare disease drug product under investigation. FDA, however, does not have the intention to create a statutory standard for approval of orphan drugs that are different from the standard for approval ...

Darolutamide: First Approval.

Darolutamide (NUBEQA™) is a structurally distinct non-steroidal androgen receptor antagonist being developed by Orion and Bayer as a treatment for prostate cancer. Based on positive results in the phase III ARAMIS trial, darolutamide was recently approved in the USA for the treatment of men with non-metastatic castration-resistant prostate cancer. This article summarizes the milestones in the development of darolutamide leading to this first approval.

Flawed evidence underpins approval of new cancer drugs.

Response Rates and Durations of Response for Biomarker-Based Cancer Drugs in Nonrandomized Versus Randomized Trials.

Many new targeted cancer drugs have received FDA approval based on durable responses in nonrandomized controlled trials (non-RCTs). The goal of this study was to evaluate whether the response rates (RRs) and durations of response (DoRs) of targeted cancer drugs observed in non-RCTs are consistent when these drugs are tested in RCTs.

Allostery in Drug Development.

Allosteric regulation is a ubiquitous strategy employed in nature to control cellular processes by regulating the affinities of biomolecules. Allosteric modulators are able to tune the protein/substrate affinity in a highly predictable way, suggesting that such modulators may represent safe drugs. Tremendous advances have been made in the development of allosteric modulators and the characterization of their therapeutic targets. Here, we briefly introduce several representative allosteric modulators of impo...

Timing of pediatric drug approval and clinical evidence submitted to regulatory authorities: International comparison among Japan, the US, and the EU.

Many prescription drugs approved for adult use lack pediatric labeling information, resulting in their off-label use in children. Drug regulatory authorities have developed legal and regulatory frameworks to promote pediatric drug development. However, the current state of pediatric indication approval and quality of efficacy evidence, which forms the basis of regulatory approvals, are unknown. Here, we analyzed novel therapeutics approved in Japan, the United States (US), and European Union (EU) during 200...

Beyond Brownian Motion and the Ornstein-Uhlenbeck Process: Stochastic Diffusion Models for the Evolution of Quantitative Characters.

Gaussian processes, such as Brownian motion and the Ornstein-Uhlenbeck process, have been popular models for the evolution of quantitative traits and are widely used in phylogenetic comparative methods. However, they have drawbacks that limit their utility. Here we describe new, non-Gaussian stochastic differential equation (diffusion) models of quantitative trait evolution. We present general methods for deriving new diffusion models and develop new software for fitting non-Gaussian evolutionary models to ...

Duration and variation of the ethics approval process in Germany - an example from a non-interventional study with 44 participating centers.

The bureaucratic and administrative burden for obtaining the obligatory Institutional Review Board (IRB) approval, which confirms the ethical integrity of a scientific project, is high. In order to participate in multicenter studies, most participating centers in Germany require a local second approval. We investigated the variation in the time it took the participating centers of a non-interventional multicenter study to obtain this approval.

Areas for further improvement of legislative regulation of patients' rights in Ukraine.

Introduction: The article reviews issues of legal regulation of patients' rights in Ukraine, analyzes the patient-doctor relationship, proposes the legislative approval of new patients' rights and the need of adoption of a single legislation of these rights. The aim of this work is to conduct a detailed study of legal regulation of patients' rights in Ukraine and the EU countries, to identify the areas for further improvement of the legislative regulation of patients 'rights in Ukraine, ways of harmonizatio...

Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed to develop a machine learning algorithm (RESOLVED2) to predict drug development outcome, which could support early go/no-go decisions after P1CTs by better selection of drugs suitable for further development.

Correction to: Camrelizumab: First Global Approval.

Page 1355, Abstract, Inline table 'Camrelizumab (AiRuiKa™): Key Points', and Introduction.

Revealing new landscape of cardiovascular disease through circular RNA-miRNA-mRNA axis.

Non-coding RNA (ncRNA) is a kind of RNA, produced by genomic transcription and does not encode protein, but can regulate the function of genes, thus widely regulating pathological and physiological processes. The dynamic balance of the reticular structure between them is needed to regulate the homeostasis, the abnormal regulation of one of them may lead to the occurrence of the disease. CircRNA is mainly involved in the evolution of CVD through sponge-like regulation of miRNAs, subsequently regulating miRNA...

Digest: Species delimitation in the face of demographic processes.

Existing approaches to species delimitation use the extent of divergence between taxa. However, processes such as gene flow during divergence or secondary contact, as well as population expansion and migration, complicate this task. Smith and Carstens (2019) introduce the R package delimitR, which uses machine learning to integrate gene flow into species delimitation inference. This article is protected by copyright. All rights reserved.

Epigenetic effects mediated by antiepileptic drugs and their potential application.

An epigenetic effect mainly refers to a heritable modulation in gene expression in the short term but does not involve alterations in the DNA itself. Epigenetic molecular mechanisms include DNA methylation, histone modification, and untranslated RNA regulation. Antiepileptic drugs have drawn attention to biological and translational medicine because their impact on epigenetic mechanisms will lead to the identification of novel biomarkers and possible therapeutic strategies for the prevention and treatment o...

From patent to patient: analysing access to innovative cancer drugs.

Analysis of cancer drugs licensed through the European Medicines Agency (EMA) in 2000-2016 shows that the number of authorisations increased over that timeframe. The median number of licensed drugs each year rose from 6 for 2000-2008 to 13.5 for 2009-2016. Over 2000-2016, there were 64 drug authorisations for haematological, 15 for breast, and 12 for skin cancer, but none for oesophageal, brain, bladder, or uterine cancer. Only 6% of authorisations included a paediatric indication. The average time for a dr...

How do I want to feel? The link between emotion goals and difficulties in emotion regulation in borderline personality disorder.

Appropriate contextualized emotion goals (i.e., desired emotional endpoints that facilitate goal attainment) are fundamental to emotion regulation, as they may determine the direction of regulation efforts. Given that difficulties in emotion regulation are prevalent in borderline personality disorder (BPD), we explored whether BPD traits (Study 1) and BPD diagnosis (Study 2) presented specific contextualized emotion goals, and whether these emotion goals may be linked to difficulties in emotion regulation.

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