approval

OBJECTIVE: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of women of reproductive age and a complex endocrine condition, due to its heterogeneity and uncertainty about its etiology. However, PCOS is also associated with other metabolic abnormalities such as insulin resistance, impaired glucose tolerance, and diabetes. There are few medications that are approved for the most common symptoms of PCOS, leading to the off-label use of medications that were approved for other indications...

BACKGROUND AND OBJECTIVES: The use of community-based medical education as a method of learning primary care is now common worldwide. However, in many cases community participation remains passive. This study sought to explore the effects of introducing community members into medical education as active teachers. Medical education taught directly by community members might be a key to comprehensive community-based learning. METHODS: This study was conducted in Japan at two postgraduate programs in community hospitals...

Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho...

Head and neck squamous cell carcinoma (HNSCC) accounts for 3-5% of all tumor types and remains an unmet medical need with only two targeted therapies approved to date. ErbB3 (HER3), the kinase-impaired member of the EGFR/ErbB family, has been implicated as a disease driver in a number of solid tumors, including a subset of HNSCC. Here we show that the molecular components required for ErbB3 activation, including its ligand neuregulin-1 (NRG1), are highly prevalent in HNSCC and that HER2, but not EGFR, is the major activating ErbB3 kinase partner...

Noncompressible torso hemorrhage (NCTH) and shock is a leading cause of trauma-related mortality and evidence suggests that survival from this injury pattern has not improved in decades. As such, innovating new approaches and devices, including technologies which can be used by providers within a short of time after severe injury, is a priority for the military. Guided by wartime observations, and through partnerships with civilian academia and private investment, the military has led an effort to define resuscitative endovascular balloon occlusion of the aorta (REBOA) and assess its potential to address this problem...

BACKGROUND: Poly-(ADP-Ribose)-Polymerase (PARP) inhibitors are becoming important actors of anti-neoplasic agents landscape, with recent but narrow FDA's approvals for ovarian BRCA mutated cancers and prostatic cancer. Nevertheless, PARP inhibitors are also promising drugs for combined treatments particularly with radiotherapy. More than seven PARP inhibitors have been currently developed. Central Role of PARP in DNA repair, makes consider PARP inhibitor as potential radiosensitizers, especially for tumors with DNA repair defects, such as BRCA mutation, because of synthetic lethality...

Androgen receptor (AR) mediates initiation and progression of prostate cancer (PCa); AR-driven transcription is activated by binding of androgens to the ligand-binding domain (LBD) of AR. Androgen ablation therapy offers only a temporary relief of locally advanced and metastatic PCa, and the disease eventually recurs as a lethal castration-resistant PCa (CRPC) as there is no effective treatment for CRPC patients. Thus, it is critical to identify novel targeted and combinatorial regimens for clinical management of CRPC...

Several histone deacetylase inhibitors including Vorinostat have received FDA approval for the treatment of haematological malignancies. However, data from these trials indicate that Vorinostat has limited efficacy as a monotherapy, prompting the need for rational design of combination therapies. A number of epi-sensitised pathways, including sonic hedgehog (SHH), were identified in AML cells by integration of global patterns of histone H3 lysine 9 (H3K9) acetylation with transcriptomic analysis following Vorinostat-treatment...

CONTEXT: Unprecedented development of therapeutics for prostate cancer in recent years has left clinicians with the challenge of adequately sequencing therapeutic agents to optimise patient benefit. No clear guidelines exist on optimal treatment sequences. OBJECTIVE: To summarise the evidence on first-line activity, cross-resistance, and potential combinations of agents approved for metastatic castration-resistant prostate cancer (mCRPC). EVIDENCE ACQUISITION: A nonsystematic literature search of articles on agent sequencing in mCRPC in PubMed and relevant cancer conferences up to June 2016 was performed...

CONTEXT: Recent developments in the treatment of metastatic castration-resistant prostate cancer (mCRPC) have led to uncertainty about the optimal sequence of agents. OBJECTIVE: To review and assess treatment options and sequence in patients with mCRPC. EVIDENCE ACQUISITION: To identify data on the optimal use of approved treatments, we searched PubMed for studies on the use of recently approved agents for men with mCRPC published before March 2015...

CONTEXT: Human papillomavirus (HPV) is the commonest sexually transmitted pathogen in humans and is linked to the aetiopathogenesis for both benign and malignant disease in men. OBJECTIVE: To evaluate and summarise the evidence for HPV infection and vaccination in men. EVIDENCE ACQUISITION: A search of Medline, PubMed, and Scopus was performed to identify articles published in English within the last 10 yr addressing HPV epidemiology, the natural history of HPV infection and its long-term consequences, and vaccination in men...

Obese and type 2 diabetic (T2DM) patients have a high prevalence of nonalcoholic fatty liver disease (NAFLD). NAFLD is a continuum of chronic liver diseases ranging from benign hepatosteatosis to nonalcoholic steatohepatitis (NASH), cirrhosis and primary hepatocellular cancer (HCC). Because of its strong association with the obesity epidemic, NAFLD is rapidly becoming a major public health concern worldwide. Surprisingly, there are no FDA approved NAFLD therapies; and current therapies focus on the co-morbidities associated with NAFLD, namely, obesity, hyperglycemia, dyslipidemia, and hypertension...

For the past decade, advanced renal cell carcinoma (RCC) has been at the forefront of oncologic innovation. Our rapidly evolving understanding of the molecular and genetic basis of RCC has revolutionized the management of advanced RCC; 10 novel molecular targeted agents and immune checkpoint inhibitor have received U.S. Food and Drug Administration approval for treatment of advanced RCC in a little over a decade. Amid this progress, imaging has assumed a central role in metastatic surveillance and follow-up of advanced RCC...

BACKGROUND: Aware of the advantages of a project steering committee (SC) in terms of influencing the development of evidence-based health policies, the West African Health Organisation (WAHO) encouraged and supported the creation of such SCs around four research projects in four countries (Burkina Faso, Nigeria, Senegal and Sierra Leone). This study was conducted to describe the process that was used to establish these committees and its findings aim to assist other stakeholders in initiating this type of process...

PURPOSE: We aimed to determine whether there was a difference in post-operative symptomatic control and quality of life (QoL) between patients who were obese (BMI >30) and non-obese (BMI <30) pre-operatively. This information may inform the decision making of Physicians and patients whether to proceed to surgery for management of symptomatic lumbar disc prolapse. METHODS: We conducted a prospective questionnaire-based study of QoL and symptom control in 120 patients with postal follow-up at 3 and 12 months after lumbar disc surgery...

Organophosphate (OP) poisoning is a major global health issue; while compounds from this group have been used intensively over the last century, an effective antidote is still lacking. Oxime-type AChE reactivators are used to reactivate the OP inhibited AChE. Pralidoxime is the only US Food and Drug Administration, (FDA) approved oxime for therapeutic use but its efficacy has been disappointing. Two novel oximes (K378 and K727) were investigated in silico and in vitro and compared with an experimental oxime (kamiloxime; K-27) and pralidoxime...

AIMS: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. Our aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio® EP2006) with reference filgrastim (Neupogen(®)), pegfilgrastim (Neulasta(®)), and pegfilgrastim injection device (Neulasta Onpro(®); hereafter pegfilgrastim-injector) for CIN/FN prophylaxis...

Dermatophyte species identification often remains difficult because variation of isolates in the same species, overlapping characters in cultures and problems of nomenclature. DNA sequencing recently allowed the genus and species of these fungi to be reexamined. Species names were revised according to the new nomenclature convention adopted for fungi. The conclusions of this taxonomic study were approved by expert practitioners and searchers working with dermatophytes. Important points about species definition and nomenclature changes were summarized in the present communication...

Patients undergoing treatment with immunosuppressant drugs following solid organ or hematopoietic stem cell transplantation are at particular risk for development of serious infections such as invasive aspergillosis. Four triazole antifungal drugs, voriconazole, posaconazole, itraconazole, and isavuconazole, are approved to treat invasive aspergillosis either as first- or second-line therapy. All of these agents are inhibitors of cytochrome P450 3A4, which plays a key role in metabolizing immunosuppressant drugs such as cyclosporine, tacrolimus, and sirolimus...

GPR119 belongs to the G protein-coupled receptor family, and exhibits dual modes of action upon ligand-dependent activation: pancreatic secretion of insulin in a glucose-dependent manner, and intestinal secretion of incretins. Hence, GPR119 has emerged as a promising target for treating type 2 diabetes mellitus without causing hypoglycemia. However, despite continuous efforts by many major pharmaceutical companies, no synthetic GPR119 ligand has been approved as a new class of anti-diabetic agents thus far, nor has one passed beyond phase II clinical studies...