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Data and Corporate Governance in Pharma and Digital Health: A Necessary Regulatory Convergence.
Research on effectiveness of DAA is limited. Existing researches explore impact of DAA only on relationship between drug manufacturers and consumers. However, in reality, pharma marketing revolves around three major stakeholders: the pharmaceutical companies, physicians and consumers. Pharmaceutical professionals on behalf of drug manufacturers have last mile connectivity with end users and they are an important stakeholder in this entire marketing relationship network. So, it is important for marketers to ...
Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration ("FDA"). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authorit...
According to the Treaty on the Eurasian Economic Union, a common pharmaceutical market was supposed to become operational on January 1, 2016. Nevertheless, the responsible parties did not meet the deadline. Although a majority of the draft guidelines regulating this process were already known in 2014 and 2015, the anticipated process itself caused anxiety among representatives of the foreign pharma industry, who tried to prepare for coming challenges. Among other possible issues, the ambiguity of transition...
Prostaglandin (PG) D, a prostanoid known to have hypotensive effect, can evoke increased in vitro prepartum myometrial contraction resulting from up-regulation of the F prostanoid (FP) receptor. The present study further determined postpartum rat uterine responses to PGD to evaluate the possibility of the prostanoid becoming a therapeutic for postpartum uterine atony, a major cause of postpartum hemorrhage that can lead to maternal morbidity. In vitro and in vivo postpartum uterine responses to PGD were det...
Sounds evoke color sensations in sound-color synesthesia. Recently, we showed that pitch classes (do, re, mi, etc.) have rainbow hues and that colors are linked to the names of pitch classes rather than to their sounds in 15 subjects who had "pitch class-color synesthesia." However, all synesthetes in our previous study had high levels of absolute pitch (AP); therefore the effects of AP on the condition remained unclear. The present study investigated 18 additional pitch class-color synesthetes who had no o...
The alternative payment model (APM) is a nontraditional financial arrangement that rewards health care providers who deliver cost-effective, high-quality care. Now we are facing the possibility that pharmaceutical manufacturers and insurers will embrace APMs as a payment mechanism in some situations.
There is no evidence that Hippocrates, although being credited for it, ever literally stated 'let thy food be thy medicine and thy medicine be thy food'. However, yet in line with Hippocrates' philosophy, we are currently witnessing a reappraisal of the complementarity of nutrition and pharmacology. Recent studies not only underline the therapeutic potential of lifestyle interventions, but are also generating valuable insights in the complex and dynamic transition from health to disease. Next to this, nutri...
Photodynamic diagnosis using the optical imaging agent hexaminolevulinate (HAL, Hexvix®, Ipsen Pharma GmbH, Ettlingen, Germany) as an adjunct to white light cystoscopy (WLC) during the initial transurethral resection of bladder tumours (TURB) improves the detection rate of bladder cancer and leads to fewer recurrences.
Strategies are needed to increase gastrointestinal transit without systemic pharmacologic agents. We investigated whether optogenetics, focal application of light to control enteric nervous system excitability, could be used to evoke propagating contractions and increase colonic transit in mice.
Parent-child interactions are likely influenced by the personality characteristics of both the parent and the child. However, questions remain concerning the bidirectional nature of these effects (e.g., does a child's personality evoke changes in his or her parent's behavior?). Furthermore, the existing literature is based primarily on European American children and generally relies on questionnaire measures of parent-child interactions rather than assessing behavior during observed interactions. To address...
We have previously shown that albuminuria and renal levels of advanced glycation end products (AGEs), receptor for AGEs (RAGE), and oxidative stress are suppressed in dipeptidyl peptidase-4 (DPP-4)-deficient diabetic rats, thus suggesting the crosstalk between AGE-RAGE axis and DPP-4 in experimental diabetic nephropathy. Therefore, we examined here the role of DPP-4 in AGE-evoked inflammatory reactions in human proximal tubular cells. Proteins were extracted from proximal tubular cells, and conditioned medi...
Nociceptin/orphanin FQ (N/OFQ) is the endogenous ligand of a Gi protein-coupled receptor named NOP. Both N/OFQ and NOP receptor are widely expressed in brain areas involved in the control of emotional processes. Clinical and preclinical studies support antidepressant effects due to the blockade of NOP receptor signaling. By contrast, NOP receptor activation did not evoke any change in behavioral despair tests.
Compared to other arthropods, such as crustaceans or insects, the term 'chelicerate' often does not evoke a similar sense of recognition or familiarity. Yet the subphylum Chelicerata has been encountered by every living person today, frequently to the effect of fear, awe, or outright revulsion. Chelicerates include such familiar groups as spiders, scorpions, mites, and ticks, as well as an array of bizarre and unfamiliar forms, such as vinegaroons, camel spiders, and hooded tick spiders (Figure 1).
Chronic pain is often accompanied by comorbidities like anxiety and depression. The temporal correlations, as well as the underlying mechanisms of these reciprocal correlations, are unclear. Moreover, preclinical studies examining emotional behaviour are very controversial and a chronological analysis of anxiety-like behaviour in mouse pain models considering both genders has not been performed so far.
Considering its strong symbolic connotations and its rich history, syphilis could be regarded as the perfect example of venerian disease. It could also be seen as a representative disease of the whole medical history and the evolution of both medical ways of thinking and curing. In this work we will briefly discuss the history of the syphilitic disease and try to show how this condition has affected the life and works of some of the most famous artists of the 19th century. Moreover, we shall try to evoke th...
Nocturnal insects have evolved ultrasound-sensitive hearing in response to predation pressures from echolocating insectivorous bats. Flying tympanate moths take various evasive actions when they detect bat cries, including turning away, performing a steering/zigzagging flight and ceasing flight. In general, infrequent ultrasonic pulses with low sound intensities that are emitted by distant bats evoke slight turns, whereas frequent and loud ultrasonic pulses of nearby bats evoke erratic or rapid unpredictabl...
This study assessed the ability of endothelin-1 (ET-1) to evoke heat hyperalgesia when injected directly into the trigeminal ganglia (TG) of mice and determined the receptors implicated in this effect. The effects of TG ETand ETreceptor blockade on alleviation of heat hyperalgesia in a model of trigeminal neuropathic pain induced by infraorbital nerve constriction (CION) were also examined.
To determine if standardized palpation of the masseter muscle can evoke referred pain and/or sensations in healthy individuals and to compare the mechanical sensitivities in response to three different levels of palpation force.
Skull base surgery involves the microdissection and intraoperative monitoring of cranial nerves, including cranial nerve XI (CN XI). Manipulation of CN XI can evoke brisk trapezius contraction, which in turn may disturb the surgical procedure and risk patient safety. Here we describe a method for temporarily silencing CN XI via direct intraoperative application of 1% lidocaine.
A delayed or absent swallow reflex is common in dysphagia and can have a significant impact on swallow safety. Recent clinical practice survey data have supported the fact that clinicians continue to use thermo-tactile stimulation (TTS) as a strategy to stimulate key nerve pathways and evoke a swallow reflex for patients with a delayed or absent swallow reflex.
Sub-anesthetic doses of the non-competitive N-methyl-d-aspartate receptor (NMDA-R) antagonist ketamine evoke transient psychotomimetic effects, followed by persistent antidepressant effects in treatment-resistant depressed patients and rodents through still poorly understood mechanisms. Since phencyclidine (PCP) disinhibits thalamo-cortical networks by blocking NMDA-Rs on GABAergic neurons of the reticular thalamic nucleus (RtN), we examined ketamine's actions in the same areas.
Recent years have seen a number of regulatory approvals for immune oncology or immunotherapies based on their ability to enhance anti-tumor immune responses. Nevertheless, the majority of the patients remain refractory to these treatments; hence, new therapies that augment current immunotherapies are required. Innate immune receptors that recognize nucleic acid are potent activators of subsequent T cell responses and, as a result, can evoke potent anti-tumor immune responses. Here, we present a novel compou...
Neurons process and convey information by transforming barrages of synaptic inputs into spiking activity. Synaptic inhibition typically suppresses the output firing activity of a neuron, and is commonly classified as having a subtractive or divisive effect on a neuron's output firing activity. Subtractive inhibition can narrow the range of inputs that evoke spiking activity by eliminating responses to non-preferred inputs. Divisive inhibition is a form of gain control: it modifies firing rates while preserv...