Ionsys (fentanyl) / Novartis - LARVOL DELTA

Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (clinicaltrials.gov) - P1 | N=73 | Completed | Sponsor: Albert Einstein College of Medicine

New P1 trial • Anesthesia

Systemic granulocyte-macrophage colony-stimulating factor (GM-CSF) treatment increases T cell receptor diversity in localized and metastatic prostate cancer patients (AACR 2017) - P1,P1/2; "...In a separate clinical trial (NCT00064129), the combination of systemic GM-CSF (250 μg/m2/day on days 1-14 of each cycle) with ipilimumab in metastatic castrate-resistant prostate cancer (mCRPC) patients also resulted in a significant decline in clonality from pre-treatment samples to the 2-week timepoint on treatment (p=0.002)...These results indicate increased repertoire turnover when GM-CSF is combined with checkpoint inhibition. Hence data from both localized and metastatic prostate cancer, and from monotherapy and combination therapy regimens, supports a role for GM-CSF in inducing early diversification of the TCR repertoire."

Checkpoint inhibition • Combination therapy • Biosimilar • Genito-urinary Cancer • Oncology • Prostate Cancer

Fentanyl Iontophoretic Transdermal System (IONSYS(®)) can be Safely used in the Hospital Environment with X-Rays, Computerized Tomography and Radiofrequency Identification Devices. (PubMed) - "The performance of the ITS system was unaffected by X-ray exposure levels well beyond those associated with diagnostic X-rays and CT scans, and by exposure to radiofrequency field strengths typically generated by RFID devices. These results provide added confidence to clinicians that the fentanyl ITS system does not need to be removed during diagnostic X-rays and CT scans and can also be utilized in close proximity to RFID devices."

Journal • Biosimilar • Pain

Systematic Renal Function Evaluation Using Iohexol or Inuline Clearance before Lung Transplantation in Adult Cystic Fibrosis Patients (KIDNEY WEEK 2016) - "For these 2 patients, GFR estimation using CKD EPI was unable to detect the moderate decline in kidney function (estimated GFR >90mL/min/1.73m²). Despite prolonged exposition to high dose of aminoglycoside associated with a high prevalence of diabetes mellitus, no major decline in GFR was observed in our cohort."

Clinical • Biosimilar • Chronic Kidney Disease • Diabetes • Fibrosis • Immunology • Renal Disease

Systemic Endothelial Function and its Relationship With Pulmonary Vasoreactivity in Patients With Pulmonary Hypertension (AHA 2017) - "Abstract embargoed at this time."

Clinical • Cardiovascular

SYSTEMATIC REVIEW OF THE ENDOSCOPIC TREATMENT OF HIGH-GRADE DYSPLASIA AND INTRAMUCOSAL CARCINOMA: RESECTION WITH RADIOFREQUENCY ABLATION VERSUS ISOLATED ABLATION (DDW 2017) - "Endoscopic resection associated withradiofrequency ablation (EMR + RFA) is a safe and efficient method in the treatment of high-grade dysplasia and intramucosal carcinoma, with higher rates of remission and without major complications in comparison to the treatment with isolated radiofrequency ablation."

Head-to-Head • Retrospective data • Review • Biosimilar • Esophageal Cancer • Gastrointestinal Cancer • Immunology • Oncology • Pain

Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Patients (clinicaltrials.gov) - P3; N=60; Recruiting; Sponsor: The Medicines Company; Trial primary completion date: Feb 2016 ➔ Sep 2016

Trial primary completion date • Biosimilar • Pain

Systems Analysis of Subpopulation Structure in Long-Term Cultures of Escherichia coli K-12 (ASM Microbe 2018) - "In order to bridge the genotype-phenotype gap we invoked a systems approach for our wild-type focus population—where mutation rate is low. Combining genomic, transcriptomic, epigenomic, and metabolomic analysis, we are able to present evidence for evolution of cooperation within the population through the over-production and utilization of lysine—an amino acid not utilized by the progenitor."

Biosimilar • Immunology

Systemic Lupus Erythematosus: Novel Treatments - How to Treat Systemic Lupus Erythematosus (ACR-ARHP 2017) - No abstract available.

Immunology • Lupus

Systematic elucidation and pharmacologic targeting of mechanistic tumor dependencies (EORTC-NCI-AACR 2017) - "The therapeutic strategies prioritized by the proposed framework, on an individual tumor basis, will be rapidly tested in PDX models (N of 1 methodology), leading to rapid identification of candidate drugs and combinations for potential follow-up clinical validation (e.g., in basket trials) (7), consistent with the translational track record of our CTD2 Center (6, 8). We will specifically target malignancies that are either rare and thus poorly characterized, such as atypical/anaplastic meningioma (MEN), or considered untreatable, such as metastatic bladder (BLCA), lung (LUAD), and colon (COAD) adenocarcinoma."

Biomarker • Clinical • Combination therapy • Oncology • Solid Tumor

SYSTEMATIC REVIEW OF THE ECONOMIC BURDEN OF COELIAC DISEASE (UEGW 2017) - "Most economic studies of CD have focused on the cost of screening and diagnosis, especially in Europe. Methods of screening generally are considered cost-effective when they combine diagnostic modalities, such as serology then biopsy, in people being evaluated for symptoms. Much of the cost to a payer of managing CD derives from outpatient care, especially for patients with poorly controlled disease."

Clinical • HEOR • Review • Immunology • Inflammation • Inflammatory Bowel Disease

Systematic approach to methylation biomarker development in chronic lymphocytic leukemia, breast and lung cancers (AACR 2017) - "Subsequently, we evaluated the clinical relevance of the most promising biomarker candidates in chronic lymphocytic leukaemia, breast and lung cancers, using these assays (3, 4). Overall, our workflow allows fast and efficient validation of not only already existing biomarker candidates but also discovery of new disease specific methylation changes that show promise for clinical implementation."

Biosimilar • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology

Systemic Therapy of Bronchopulmonary Typical and Atypical Carcinoids: Current Status and Perspectives (WCLC 2016) - No abstract available.

Biosimilar • Oncology

SYSTEMATIC GENETIC TESTING FOR PERSONALISED OVARIAN CANCER THERAPY (SIGNPOsT) - STUDY DESIGN (BGCS 2017) - "Cost-utility analysis will be undertaken and compared to the £30000/ QALY NICE threshold. Discussion This study will provide currently unavailable data on impact of germline panel and concomitant somatic BRCA1/BRCA2 testing in unselected EOC on psychological health, QoL and cost-effectiveness."

Biomarker • Clinical • HEOR • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Systematic review: trends in survival from alcoholic hepatitis (BSG 2017) - "This is not explained by changes in severity of disease. This emphasises the urgent need for effective treatments for this alcoholic hepatitis."

Clinical • Observational data • Review • Biosimilar • Immunology

SYSTEMATIC ANALYSIS OF SAFETY OF STEM CELL TRANSPLANT IN STROKE PATIENTS (ESTOC 2017) - "This systematic review finds low prevalence of serious adverse events with stem cell trials. The caveat is that some trials reported no serious adverse events"

Clinical • Serious adverse event • Biosimilar • Cardiovascular • CNS Disorders • Epilepsy • Immunology • Venous Thromboembolism

Filings in the second half could be transformative for the Medicines Co. (Health News Daily) - “The Medicines Co. is likely to submit Ionsys...for U.S. regulatory filing in the first quarter of 2014, and in EU in the second quarter of that year.”

Anticipated EU regulatory • Anticipated FDA event • Pain

SYSTEMATIC REVIEW AND META-ANALYSIS OF THE ENDOSCOPIC TREATMENT FOR WEIGHT REGAIN FOLLOWING ROUX-EN-Y GASTRIC BYPASS AND THE ROLE OF ARGON PLASMA COAGULATION PRIOR TO ENDOSCOPIC SUTURE (DDW 2017) - "Our results show an important weight loss at the initial follow-up, plateau reached at mid-term and sustained partially until long-term. Around 10kgs are lost in mid-term which corresponds to approximately 25% of Excess Weight Loss, which is the threshold established by ASGE/ASMBS Task Force as minimum for an intended Endoscopic Bariatric Therapy."

Retrospective data • Review • Biosimilar • Immunology

SYSTEMATIC REVIEW OF COHORT-LEVEL ECONOMIC MODELS FOR ANTIPSYCHOTICS IN SCHIZOPHRENIA (ISPOR-EU 2017) - "No significant difference was found between DTs and CLMMs for antipsychotics in schizophrenia, except that longer timeframes and cost-utility analysis were more used in CLMMs. Overall, these models considered simple structures to address specific research questions. It remains unclear whether these models can be generalized to address broader research questions from health technology assessment perspective: it is likely that use of microsimulations can provide estimations closer to expectations and requirements, and flexibility to approach real-life."

Clinical • HEOR • Review • Biosimilar • CNS Disorders • Schizophrenia

Systemic Administration of an Angiotensin Type-2 Receptor Agonist Decreases Renal Regulatory T Cells (ASHyp 2017) - "In conclusion, AT2R activation suppresses renal Tregs, and females are more sensitive than males. These data suggest a novel role for AT2R regulation in the kidney in hypertension."

Cardiovascular