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Legal access to medications: a threat to Brazil's public health system?

BackgroundIn Brazil, health is fundamental human right guaranteed by the Constitution of 1988, which created the Brazilian Universal Health System (Sistema Único de Saúde - SUS). The SUS provides medications for outpatient care via policy of pharmaceutical assistance (PA) programmes. Despite the advances in PA policies which include the improvement in access to medications, there has been a significant increase in lawsuits related to health products and services. This study aimed to characterize the medication processes filed between 2010 and 2014 against the Secretary of State for Health of S

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… syndrome Phenylketonuria Alzheimer’s disease Haemangioma Polycystic ovary syndrome and Amyotrophic lateral sclerosis Heart and lung transplantation Primary adrenal insufficiency - Addison’s disease Anaemia in chronic renal failure Heart transplant Primary immunodeficiency Ankylosing spondylitis Hereditary angioedema … Phenylketonuria Alzheimer’s disease | Haemangioma | Polycystic ovary syndrome and Amyotrophic lateral sclerosis | Heart and lung transplantation | Primary adrenal insufficiency - Addison’s disease Anaemia in chronic renal failure | Heart transplant | Primary immunodeficiency Ankylosing spondylitis | Hereditary angioedema …

Revolutionizing in vivo therapy with CRISPR/Cas genome editing: breakthroughs, opportunities and challenges.

Genome editing using the CRISPR/Cas system has revolutionized the field of genetic engineering, offering unprecedented opportunities for therapeutic applications in vivo. Despite the numerous ongoing clinical trials focusing on ex vivo genome editing, recent studies emphasize the therapeutic promise of in vivo gene editing using CRISPR/Cas technology. However, it is worth noting that the complete attainment of the inherent capabilities of in vivo therapy in humans is yet to be accomplished. Before the full realization of in vivo therapeutic potential, it is crucial to achieve enhanced specific

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… malignancies in children | Phase 1 | United Kingdom NCT05143307 | Gene disruption of three undisclosed genomic sites in the HIV DNA | HIV-1-infection | Long-term follow-up study of HIV-1-infected adults who received EBT-101 | Phase 1 | United States NCT05120830 | Inactivate kallikrein B1 (KLKB1) | Hereditary angioedema … Intellia Therapeutics has undertaken another pivotal investigation involving the development of NTLA-2002 ( Seitzer, 2021 ) ( ClinicalTrials.gov number NCT05120830 ), a therapeutic intervention aimed at treating hereditary angioedema (HAE), a genetic disorder characterized by recurrent episodes of localized …

Precision medicine and monoclonal antibodies: breach of promise?

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… 2018 | prevention of inhalational anthrax Ocrelizumab | 2018 | multiple sclerosis Emicizumab | 2018 | hemophilia A Benralizumab | 2018 | asthma Burosumab | 2018 | X-linked hypophosphatemia Erenumab | 2018 | migraine prevention Galcanezumab | 2018 | migraine prevention Lanadelumab | 2018 | hereditary angioedema …

Esid 2014 oral presentations.

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Skin manifestations associated with systemic diseases - Part II.

The skin, by reflecting internal processes, externalizes what happens inside the body in many diseases. Thus, the skin, as an organ, extrapolates its functions of protection, barrier and signals the existence of systemic diseases, expanding the importance of the dermatologist beyond the skin surface. Thus, the dermatologist investigates diagnostic hypotheses for conditions related to all systems and refers patients to the appropriate specialty. Combined with examination by a trained eye, the skin, due to its easy access, is still the ideal place for performing biopsies, which often clarify the

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… Complications of antidiabetic therapy a) Skin reactions caused by insulin: systemic allergic reactions include angioedema, generalized urticaria or anaphylaxis, flush, palmar-plantar or disseminated pruritus. … In mastocytosis: refractory, with the presence of urticaria, angioedema, intolerance to heat, and pulmonary, gastrointestinal, or cardiac alterations. In hypothyroidism: less frequent and closely related to xerosis; associated signs: alopecia, periorbital edema, macroglossia, weight gain, fatigue. …

Diagnosis, treatment, and follow-up of patients with hypophosphatasia.

INTRODUCTION: Hypophosphatasia is a rare inherited systemic metabolic disorder, with an estimated prevalence in the severe forms of the disease of 1/100.000-1/300.000, that affects the typical architecture of bone, leading to defective mineralization during growth and remodeling. It is characterized by loss-of-function variants in the ALPL gene, resulting in low activity of tissue-nonspecific alkaline phosphatase. In severe cases, it can be fatal. OBJECTIVE: To generate recommendations on the diagnosis, treatment, and follow-up of patients with hypophosphatasia based on available evidence. M

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… Table 10 ERT Adverse events and management Adverse event Characteristics recommendations Allergic reactions Anaphylaxis: respiratory distress, nausea, angioedema, rash Hypersensitivity reaction: Fever, vomiting, skin rash, headache, irritability, chills, general or localized pruritus, oral hypoesthesia … Table 10 ERT Adverse events and management Source: adapted from [ 19 ] Adverse event | Characteristics | recommendations Allergic reactions | Anaphylaxis: respiratory distress, nausea, angioedema, rash Hypersensitivity reaction: Fever, vomiting, skin rash, headache, irritability, chills, general or localized …

Chemistry and Pharmacology of Fluorinated Drugs Approved by the FDA (2016-2022).

Fluorine is characterized by high electronegativity and small atomic size, which provide this molecule with the unique property of augmenting the potency, selectivity, metabolic stability, and pharmacokinetics of drugs. Fluorine (F) substitution has been extensively explored in drug research as a means of improving biological activity and enhancing chemical or metabolic stability. Selective F substitution onto a therapeutic or diagnostic drug candidate can enhance several pharmacokinetic and physicochemical properties such as metabolic stability and membrane permeation. The increased binding a

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… Berotralstat Approved by the FDA in December 2020, berotralstat is recommended for the prevention of attacks of hereditary angioedema (HAE) ( Table 7 ). This uncommon genetic condition causes significant swelling of the skin and upper airways. … Name | Structure | Therapeutic Uses Berotralstat | | Prevention of attacks of hereditary angioedema (HAE) Elexacaftor | | Treatment of cystic fibrosis Eravacycline | | Antibiotic Pretomanid | | Treatment of pulmonary tuberculosis Telotristat Ethyl | | Treatment of diarrhea caused by carcinoid syndrome …

Oral and Maxillo-Facial Manifestations of Systemic Diseases: An Overview.

Many systemic (infective, genetic, autoimmune, neoplastic) diseases may involve the oral cavity and, more generally, the soft and hard tissues of the head and neck as primary or secondary localization. Primary onset in the oral cavity of both pediatric and adult diseases usually represents a true challenge for clinicians; their precocious detection is often difficult and requires a wide knowledge but surely results in the early diagnosis and therapy onset with an overall better prognosis and clinical outcomes. In the current paper, as for the topic of the current Special Issue, the authors pre

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… and palate may be present, and diffuse erythema of the gingiva unresponsive to medical/instrumental treatments. ( Figure 12 b,c) The diagnosis is generally achieved by clinical sign detection and histological examination of the involved tissue, the latter useful for the differential diagnosis with angioedema … The differential diagnosis includes angioedema, Crohn’s disease, other granulomatosis, amyloidosis, NHL (mostly NK type) and oral squamous cell carcinoma too [ 112 ]. …

Livedoid vasculopathy: A multidisciplinary clinical approach to diagnosis and management.

Livedoid vasculopathy (LV) is a rare, chronic, and occlusive disease of the veins supplying the upper parts of the skin. The pathogenesis of the disease is not precisely understood, and its attacks are often unpredictable but tend to worsen during the summer. LV affects women more often. This increased risk for LV in women might be related to sex-specific physiological conditions, such as pregnancy, or a higher incidence of LV-associated conditions, such as connective tissue diseases, hypercoagulable states, and venous stasis in women. The typical clinical appearance of LV consists of three ma

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… ., 2020 ; Lee et al., 2003 ; Okada et al., 2008 ) Cyclooxygenase inhibitor; suppresses thromboxane A2 and prostaglandin I2; promotes vasodilation; prevents platelet aggregation and thrombus formation; improves ulcer healing 75–325 mg, higher doses (up to 325 mg, 3 × 1 daily) offering better results Angioedema … 2020 ; Lee et al., 2003 ; Okada et al., 2008 ) | Cyclooxygenase inhibitor; suppresses thromboxane A2 and prostaglandin I2; promotes vasodilation; prevents platelet aggregation and thrombus formation; improves ulcer healing | 75–325 mg, higher doses (up to 325 mg, 3 × 1 daily) offering better results | Angioedema …

Pyrotinib combined with thalidomide in advanced non-small-cell lung cancer patients harboring HER2 exon 20 insertions (PRIDE): protocol of an open-label, single-arm phase II trial.

BACKGROUND: Standard therapy for human epidermal growth factor receptor 2 (HER2)-mutant non-small-cell lung cancer (NSCLC) is lacking. The clinical benefits with pan-HER inhibitors (afatinib, neratinib, and dacomitinib), anti-HER2 antibody drug conjugate (ADC) trastuzumab emtansine, and an emerging irreversible tyrosine kinase inhibitor (TKI) poziotinib were modest. Another new ADC trastuzumab deruxtecan showed encouraging outcomes, but only phase I study was completed. Pyrotinib, another emerging irreversible epidermal growth factor receptor (EGFR)/HER2 dual TKI, has been approved in HER2-pos

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… of 240 mg Thalidomide Constipation, somnolence, or peripheral neuropathy | Consider interrupting thalidomide | Dose can be reduced as per investigator’s discretion Grade 3–4 AEs or clinically significant symptoms | Consider interrupting or discontinuing thalidomide | Dose reduction can be considered Angioedema …

In vitro расширила человека CD4+CD25+ регуляционные T клетки, подавляющие распространение Т клеток.

Регулирующие Т клетки (Tregs) оказались критически важными в балансе между автоиммунизацией и терпимостью и были связаны с несколькими аутоиммунными заболеваниями человека. Однако небольшое число трегов в периферии крови ограничивает их терапевтический потенциал. Поэтому мы разработали протокол, который позволит расширить "Трегз" при сохранении их подавляющей активности. Мы изолировали клетки CD4+CD25 hi от человеческой периферической крови и расширили их in vitro в присутствии anti-CD3 и anti-CD28 Магнитные кситы и высокие концентрации внешнего интерлейкина (IL) -2. Траги были эффективно расш

Selected Abstracts from the 13th Annual Meeting of the Clinical Immunology Society: 2022 Annual Meeting: Immune Deficiency and Dysregulation North American Conference

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Pharmacological treatment options for mast cell activation disease.

Mast cell activation disease (MCAD) is a term referring to a heterogeneous group of disorders characterized by aberrant release of variable subsets of mast cell (MC) mediators together with accumulation of either morphologically altered and immunohistochemically identifiable mutated MCs due to MC proliferation (systemic mastocytosis [SM] and MC leukemia [MCL]) or morphologically ordinary MCs due to decreased apoptosis (MC activation syndrome [MCAS] and well-differentiated SM). Clinical signs and symptoms in MCAD vary depending on disease subtype and result from excessive mediator release by MC

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… e.g. ondansetron); incremental doses of acetylsalicylic acid (50–350 mg/day; extreme caution because of the possibility to induce mast cell degranulation); in steps test each drug for 5 days until improvement of diarrhea Colicky abdominal pain due to distinct meteorism ⇒ metamizole; butylscopolamine Angioedema … e.g. ondansetron); incremental doses of acetylsalicylic acid (50–350 mg/day; extreme caution because of the possibility to induce mast cell degranulation); in steps test each drug for 5 days until improvement of diarrhea Colicky abdominal pain due to distinct meteorism ⇒ metamizole; butylscopolamine Angioedema …

When to investigate for secondary hyperhidrosis: data from a retrospective cohort of all causes of recurrent sweating.

Background: Identification of underlying diseases is crucial for secondary hyperhidrosis management, but data are lacking to guide appropriate investigation.Objective: To describe aetiologies of recurrent sweating in a hospital setting and the diagnostic performance parameters of their respective clinical/biological features.Patients and Methods: We performed a monocentric evaluative study in a tertiary care centre. Patients with recurrent generalised sweating were selected via the Clinical Data Warehouse (CDW) by screening all electronic hospital documents from the year 2018 using a keyword-b

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… Autoinflammatory) | Microscopic polyangiitis | 1 | Polyarteritis nodosa | 1 | Not specified | 1 | Lupus | 3 | Sarcoidosis | 3 | Autoinflammatory disease (unspecified) | 3 | Still’s disease | 2 | Familial Mediterranean fever | 1 | Erythema nodosum | 1 | IgA deficiency | 1 | Non-allergic histaminic angioedema …

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System.

This study reviews and evaluates the national drug formulary system used to improve patient access to new drugs by making reimbursement decisions for new drugs as part of the South Korean national health insurance system. The national health insurance utilizes three methods for improving patient access to costly drugs: risk-sharing agreements, designation of essential drugs, and a waiver of cost-effectiveness analysis. Patients want reimbursement for new drugs to be processed quickly to improve their access to these drugs, whereas payers are careful about listing them given the associated fina

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… The risk-sharing agreement application should be expanded to include medications that do not have alternatives or diseases such as acute attacks of hereditary angioedema, moderate to severe asthma, systemic lupus erythematosus, and cryopyrin-associated periodic syndromes. …

Selected Abstracts from the 12th Annual Meeting of the Clinical Immunology Society: 2021 Virtual Annual Meeting: Immune Deficiency and Dysregulation North American Conference.

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AGA Clinical Practice Update on GI Manifestations and Autonomic or Immune Dysfunction in Hypermobile Ehlers-Danlos Syndrome: Expert Review.

DESCRIPTION: The purpose of this Clinical Practice Update Expert Review is to describe key principles in the evaluation and management of pa … ralized mast cell disorder (eg, visceral and somatic pain, pruritus, flushing, sweating, urticaria, angioedema, wheezing, tachycardia, abdominal cramping, vomiting, nausea, diarrhea, urogynecological and neurological complaints) involving 2 or more physiological systems (eg, cutaneous, GI, cardiac, respiratory, and neuropsychiatric), but current data do not …

Клинические характеристики, диагноз, лечение и прогноз заболевания сывороткой ритуксимаба: ретроспективный анализ 39 Количество зарегистрированных случаев.

Заболевание сывороткой, вызванное ритуксимабом (РИСС), представляет собой необычайно запоздалую гиперчувствительность, характеризующуюся неполной клиническими характеристиками и управлением. Мы намеревались обобщить опубликованные доклады/серии с целью определения клинических моделей, терапевтических стратегий и результатов. МЕТОДЫ: PubMed, EMBASE, Web of Science, WanFang Data и China National Knowledge Infrastructure (CNKI) были найдены отчеты о болезни сыворотки, выпущенные до ноября 31, 2025, используя ключевые слова и свободные текстовые термины (например, "Rituximab", "Serum Bealth", "Ser

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… Serum sickness and severe angioedema following rituximab therapy in ra. Int J Rheum Dis. (2012) 15:e6–7. doi: 10.1111/j.1756-185X.2011.01645.x. PMID: 33. Catuogno M, Rezai S, Priori R, Magrini L, Valesini G. …

Shortage of plasma-derived medicinal products: what is next? narrative literature review on its causes and counteracting policies in Italy.

Introduction: This paper describes the peculiarities of the plasma-derived medicinal product (PDMP) market and illustrates the results of a review of the literature on policies aimed at counteracting the shortage of PDMPs. Characteristics of PDMPs: Plasma is primarily used for the industrial production of blood products (80%). The demand for PDMPs, particularly immunoglobulins (IGs), is increasing. However, the production of PDMPs is complex, long (7-12 months), and expensive, accounting, according to US estimates, for 57% of the total costs of PDMPs compared to 14% for small molecules. PDMP m

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… ➢ C1-esterase inhibitor, which is used to treat the clinical manifestations of hereditary angioedema. The use of IGs deserves particular attention ( Prevot and Jolles, 2020 ). As discussed below, there has been a consistent increase in their use. …

Antiphospholipid Antibodies and Lipids in Hematological Malignancies.

One of the main groups of lipids is phospholipids, which are mainly involved in forming cell membranes. Neoplastic processes such as cell replication have increased lipid synthesis, making tumor cells dependent on this synthesis to maintain their requirements. Antiphospholipid antibodies attack phospholipids in the cell membranes. Three main types of antiphospholipid antibodies are recognized: anti-β2 glycoprotein I (anti-β2GP-I), anticardiolipin (aCL), and lupus anticoagulant (LA). These types of antibodies have been proven to be present in hematological neoplasms, particularly in LH and NHL.

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… Case report presenting the diagnostic challenges in a patient with recurrent acquired angioedema, antiphospholipid antibodies and undetectable C2 levels. Allergy Asthma Clin. Immunol. 2018;14:24. doi: 10.1186/s13223-018-0246-9. 73. Liang H., Ba M., Li C., Li H., Guo Z., He P., Lin C. …