Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 275

Posts Tagged ‘treatment’

First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain

Posted by fidest press agency su martedì, 20 agosto 2019

Basel. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. These approvals are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/II STARTRK-NG study. In the integrated analysis, Rozlytrek was studied in several solid tumour types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers. In ROS1-positive, metastatic NSCLC, Rozlytrek shrank tumours in 78% of people with the disease (overall response rate [ORR]; N=51) and the duration of response (DoR) ranged from 1.8 to 36.8+ months (N=40 out of 51).1 Rozlytrek also shrank tumours in more than half of people with NTRK gene fusion-positive, locally advanced or metastatic solid tumours (ORR=57%; N=54), and objective responses were observed across 10 tumour types (DoR ranged from 2.8 to 26.0+ months; N=31 out of 54).1 Objective responses to Rozlytrek were seen in people with central nervous system (CNS) metastases at baseline.
The most common adverse reactions (≥20 percent) with Rozlytrek were fatigue, constipation, altered sense of taste (dysgeusia), swelling (oedema), dizziness, diarrhoea, nausea, nervous system disorders (dysaesthesia), shortness of breath (dyspnoea), muscle pain (myalgia), cognitive impairment, increased weight, cough, vomiting, fever (pyrexia), joint pain (arthralgia) and vision disorders. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.2 The accelerated approval for NTRK gene fusion-positive solid tumors is based on tumour response rate and durability of response, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.Biomarker testing for ROS1 in NSCLC and NTRK gene fusions across all solid tumours is the only way to identify people who are eligible for treatment with Rozlytrek. Roche is leveraging its expertise in developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine, to help identify people with ROS1 and NTRK gene fusions. Foundation Medicine will submit FoundationOne®CDx to the FDA for approval as a companion diagnostic for Rozlytrek. An FDA-approved companion diagnostic for Rozlytrek is not available at this time.

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Treatment of Irritable Bowel Syndrome with Constipation

Posted by fidest press agency su lunedì, 19 agosto 2019

Alfasigma USA, Inc. today announced that ZELNORM™ (tegaserod) is now available in the United States as a prescription pharmaceutical treatment for irritable bowel syndrome with constipation (IBS-C) in adult women less than 65 years of age. Alfasigma USA acquired ZELNORM from Sloan Pharma S.à r.l., a subsidiary of US WorldMeds Holdings, LLC, in July 2019.“We are pleased to inform U.S. physicians and pharmacists about the reintroduction of ZELNORM and how Alfasigma USA is supporting the availability, access to, and appropriate use of this important medicine for the many patients who cope daily with an urgent need for new treatment options,” said Bryan Downey, president and chief executive officer at Alfasigma USA. “Our growing U.S. organization and national sales force is excited to lead the return of ZELNORM and committed to making a positive difference in the lives of patients.”
Originally approved in 2002 as the first prescription medication for IBS-C, ZELNORM was voluntarily withdrawn from the market in 2007 due to concerns regarding possible cardiovascular risk. In March 2019, ZELNORM was approved for reintroduction in the U.S. for use in adult women under 65 years of age with IBS-C, following a thorough safety review by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The evaluation consisted of a review of clinical data from 29 placebo-controlled trials and post-marketing treatment outcome data.
ZELNORM is the only serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. It targets the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation, and decrease pain signaling.

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Strategic Alliance in FDC for Cancer Treatment

Posted by fidest press agency su domenica, 4 agosto 2019

Biotechnology company Antikor Biopharma Ltd is pleased to announce that it has entered into an Investment Agreement for up to US$3,100,000 with Essex Bio-Investment, a wholly-owned subsidiary of Essex Bio-Technology Ltd (”EssexBio”), which will enable Antikor to consolidate and expand its position as a leading innovator in smaller-format conjugate therapies for solid tumours.Mahendra Deonarain, Antikor’s CEO and visiting Reader in Antibody Technology at Imperial College London where Antikor has its roots, commented: “We believe we have a platform that is tailored to make an impact in an area of major unmet medical need, and with EssexBio’s considerable commercial and clinical expertise, we now have the opportunity for translating the promised advantages of Antikor’s proprietary products into clinical benefit.”“We are excited to have established a strong alliance with Antikor”, said Malcolm Ngiam, President of Essex Bio-Investment, “Fragment-Drug Conjugate is an innovative approach with the potential to overcome many of the challenges faced by current treatment methods. The research and commercial partnership with Antikor is an important step towards developing first-in-class treatment for cancer.” Antikor’s novel technology platform will enrich Essex’s research pipeline and is aligned with EssexBio’s long-term research and commercial strategy.

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First Non-Invasive, Adaptive Neuromodulation Digital Treatment for Migraine

Posted by fidest press agency su giovedì, 11 luglio 2019

Neurolief, a developer of next-generation digital therapeutics brain neuromodulation technology, today announced that it has received the CE mark for its Relivion™ non-invasive, adaptive digital treatment for migraine. The CE mark allows Neurolief to market, sell and distribute the Relivion device as an over-the-counter therapy within the European Union and countries that participate with Agreements on Mutual Recognition of Conformity Assessment. The Relivion is the first non-invasive, adaptive multi-channel brain neuromodulation technology that offers a highly effective therapy, without the risks and costs associated with invasive procedures and without the side effects related to medications. This type of therapy was previously possible only with implanted devices. The Relivion system is simple and safe for patients to self-administer at home at a fraction of the cost of surgical implants. Neurolief’s Relivion is comprised of a comfortable and adjustable headset that provides precise modulated pulses simultaneously to six branches of the occipital and trigeminal nerves via several adaptive output channels around the patient’s head. The sophisticated cloud-enabled device connects to a proprietary mobile phone app and learns over time to deliver personalized treatment for each patient.
The CE mark was granted based on data from a randomized, double-blind, placebo-controlled clinical trial which showed very high efficacy and safety of the Relivion in treatment of migraine headache. Seventy-six percent of the participants achieved headache relief after only one treatment while no serious adverse effect were observed. Full results of the trial will be presented at the American Headache Society’s 61st Annual Scientific Meeting on Saturday, July 13, 2019 in Philadelphia.
Migraine is a prevalent and debilitating primary headache disorder that affects approximately 12 percent of the population worldwide. The World Health Organization (WHO) estimates that 324 million people worldwide suffer from migraines. It is the most prevalent pain condition, prompting loss of productivity with an estimated economic annual burden of over €27 billion in European Union countries.

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New Vaccine in the Treatment of Rheumatoid Arthritis

Posted by fidest press agency su mercoledì, 10 luglio 2019

CEL-SCI Corporation (NYSE American: CVM) announced that one of its key collaborators from Rush University Medical center, Dr. Adrienn Markovitz an Assistant professor in the department of Orthopedic Surgery, presented new LEAPS data at i-Chem2019, International Conference on Immunity and Immunochemistry in San Francisco, California on Wednesday July 3, 2019. The title of her presentation was “Vaccination with DerG LEAPS peptide conjugates incorporating distinct PG (aggrecan) epitopes protects by different immune mechanisms in the PG G1 domain induced mouse model of rheumatoid arthritis”. Dr. Markovitz also presented a poster on other aspects of her work on modulation of autoimmune arthritis by the tyrosine phosphatase enzyme SHP-1, and identification of immunogenic citrullinated proteoglycan epitopes that may play a role in this disease in mice and humans.The LEAPS work was performed in conjunction with researchers at CEL-SCI on CEL-4000 and a newly discovered LEAPS conjugate, DerG-PG275Cit. Both vaccines were evaluated alone and in combination in the model of proteoglycan [PG] induced arthritis (PGIA) called recombinant PG G1 domain-induced arthritis (GIA), an autoimmune mouse model of rheumatoid arthritis (RA).The conclusion presented by Dr. Markovitz’s was that vaccination with DerG LEAPS conjugates of distinct PG epitopes alone or together were effective at modulating the inflammatory response and arresting the progression of arthritis. As observed previously, the DerGPG70 conjugate modulated disease through up-regulation of Th2, and down-regulation of Th1 and Th17 responses. The results suggest that the two vaccines act mechanistically on different immune responses. The combination of the two vaccines provided not only broader epitope coverage, but also a greater therapeutic effect than either vaccine alone.
The LEAPS platform technology is currently being utilized to develop a therapeutic antigen-specific treatment for RA under a $1.5 million grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH). Upon completion of preclinical and Investigational New Drug (IND) enabling studies for the antigen-specific LEAPS vaccine treatment of RA, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration.

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Treatment of Patients with Acute Graft-Versus-Host Disease

Posted by fidest press agency su domenica, 26 maggio 2019

Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication.The approval was based on data from REACH1, an open-label, single-arm, multicenter study of Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. Of the 71 patients recruited into REACH1, 49 patients were refractory to steroids alone, 12 patients had received two or more prior anti-GVHD therapies and 10 patients did not otherwise meet the FDA definition of steroid-refractory. Jakafi was administered at 5 mg twice daily, and the dose could be increased to 10 mg twice daily after three days in the absence of toxicity.The efficacy of Jakafi was evaluated based upon Day 28 overall response rate (ORR), defined as a complete response (CR), very good partial response or partial response based on the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. The Day 28 ORR in the 49 patients refractory to steroids alone was 57 percent with a CR rate of 31 percent. The most frequently reported adverse reactions among all 71 study participants were infections (55 percent) and edema (51 percent), and the most common laboratory abnormalities were anemia (75 percent), thrombocytopenia (75 percent) and neutropenia (58 percent).GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) where the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD, acute and chronic, that can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver. Patients who develop steroid-refractory acute GVHD can progress to severe disease, with one-year mortality rates of approximately 70 percent. Previously, the FDA granted Jakafi Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with steroid-refractory acute GVHD, and the supplemental New Drug Application (sNDA) was reviewed under the FDA’s Priority Review program.Jakafi will be made available to appropriate patients with steroid-refractory acute GVHD immediately. Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Jakafi have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering patient support, including financial assistance and ongoing education and resources to eligible patients.

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Immunotherapies for the treatment of solid tumors

Posted by fidest press agency su martedì, 14 maggio 2019

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, today announces that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial of its lead myvac™ candidate TG4050 as a potential treatment for ovarian cancer patients after first-line surgery and chemotherapy.
G4050 is an individualized MVA-based immunotherapy derived from the myvac™ platform. It has been designed to stimulate and educate the immune system of patients to recognize and destroy tumor cells. Tumor cells accumulate mutations and each patient has a set of mutations that are unique to his tumor. TG4050 is designed to target a panel of patient specific mutations selected using a NEC’s Neoantigen Prediction System“We are very pleased to have been granted an IND for TG4050 by the FDA allowing us to commence the first trial with our lead myvac™ candidate in ovarian cancer patients who have already received first-line treatment” said Maud Brandely, Chief Medical Officer of Transgene. “We believe individualized vaccination is a promising solution with significant potential to transform treatment outcomes for a wide range of solid tumors. With TG4050, we are confident that we can show that this therapeutic modality will improve patient outcome. We look forward to updating you on the progress of this clinical trial, which is expected to start later this year.”The Phase 1 clinical trial will evaluate the safety and the tolerability of TG4050 in patients with ovarian, fallopian or peritoneal serous cell carcinoma. Antitumor activity will also be measured. This multi-center, one-arm trial will recruit patients in the United States and Europe.The study, sponsored by Transgene, will be co-financed by Transgene and its partner NEC, which will also support the trial by contributing to the therapeutic vaccine design and the selection of target neoantigens.

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“Transcatheter Treatment: Procedures and Heart Valve Market”

Posted by fidest press agency su giovedì, 14 febbraio 2019

This report is an analytical business tool with the primary purpose of providing a thorough evaluation of the global market for transcatheter treatment for heart valve diseases.
Regionally, the U.S. is expected to maintain dominance in the global market of transcatheter treatment devices. Those wishing to invest in the transcatheter treatment devices market ought to strongly consider high-growth areas such as transcatheter aortic valve repair (TAVR), transcatheter mitral valve implantation (TMVI), and transcatheter mitral valve repair (TMVR) devices and technologies.The market is growing primarily due to the growing geriatric population, increasing the prevalence of chronic diseases, continuous technological advancements, increasing adoption of transcatheter techniques, and positive reimbursement and other healthcare reforms.

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High-Level Dialogue on Diagnosis and Treatment of Paediatric HIV

Posted by fidest press agency su martedì, 11 dicembre 2018

Cardinal Peter Turkson, Prefect of the Dicastery for the Promotion of Integral Human Development, will convene a dialogue on Diagnosis and Treatment of Paediatric HIV at the Pontifical Academy of Sciences in the Vatican on 6-7 December 2018. He will address CEOs of pharmaceutical and diagnostic companies as part of the Holy See’s drive to assure optimal drugs formulations and testing tools for infants, children and adolescents living with HIV.
Building on consultations in April and May 2016 and November 2017, the meeting, fully titled High-Level Dialogue to Assess Progress on and Intensify Commitment to Scaling Up Diagnosis and Treatment of Paediatric HIV, will be organised by the co-chairs of the AIDS Free Working Group of the Start Free, Stay Free and AIDS Free Framework, PEPFAR, UNAIDS, in collaboration with partners of the AIDS Free Working Group, including Caritas Internationalis and the World Council of Churches-Ecumenical Advocacy Alliance.As well as leaders of major diagnostic and pharmaceutical companies, multilateral organisations, governments, regulators, faith-based and other organizations directly engaged in services to children living with HIV, and other key stakeholders, will participate in the consultation.The main aim of the meeting is to address bottlenecks that limit access to Early Infant Diagnostic products and programs and to scale up strategies that can help quickly identify HIV-exposed children and link them to testing and treatment services. In addition, the Dialogue will be an opportunity to assess progress on achieving the commitments made by participants in 2017.As the global community continues to make significant progress on scaling up access to adult HIV and AIDS testing and treatment services, more than 120,000 children continue to die each year from AIDS-related causes, and over 13,000 children are newly infected each month.
Participants in the Dialogue will agree to a plan of action to introduce and scale-up optimized diagnostics and case-finding strategies for HIV. Also, to intensify commitments in key challenging areas, including formulations development, and regulatory approval of optimal formulations and diagnostic products.Caritas Internationalis has taken strong responsibilities and commitments over mobilizing our network. We work with communities to help build treatment literacy and expand access to antitretroviral drugs among children. We also raise awareness in global fora about the unmet diagnostic and treatment needs of children with HIV.
Caritas members confirmed recently the need to continue to work at a global and national level for the wellbeing of children living with HIV. At the Dialogue, we will reaffirm our commitment and pledge to expand our efforts to help diagnose and treat those children.

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Women About Symptoms, Hormones and Latest Treatments for Menopause

Posted by fidest press agency su venerdì, 9 novembre 2018

As approximately one third of a woman’s life is spent post-menopause, doctors from Yale University hosted Yale’s “One-Day Medical School: Everything You Always Wanted to Know About Menopause but Were Too Afraid to Ask” event on October 25, 2018 to provide essential health education for women 45+.“Public health and medicine improvements over the past 150 years have increased the life expectancy of women into their late 80s. While the age of menopause onset has not changed, the transition to menopause has larger implications as it relates to sexuality and overall heath, both physiological and psychological,” says Mary Jane Minkin, MD, Clinical Professor of Obstetrics & Gynecology at Yale University. “It’s important for women to recognize the early signs of menopause and learn how to cope with hot flashes, changes in sleep quality, joint and muscle health, sexual functioning, and hindrances to comfort in everyday life.” Live stream available at: https://www.faboverfifty.com/events/day-medical-school/

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Pre-Clinical Evidence Demonstrates PBT434 as a Potential Treatment for MSA

Posted by fidest press agency su domenica, 7 ottobre 2018

Prana Biotechnology Ltd (ASX: PBT) (NASDAQ: PRAN) today announced further pre-clinical evidence for PBT434 will be presented in a poster at the International Congress of Parkinson’s Disease and Movement Disorders® in Hong Kong on Sunday, October 7th, 2018 at 1:45pm.The poster is entitled ‘PBT434 prevents the accumulation of glial cell inclusions and insoluble alpha-synuclein in a mouse model of Multiple System Atrophy’. Multiple System Atrophy (MSA) is a fatal neurodegenerative disease and an important form of atypical Parkinsonism. The data demonstrate in the most widely accepted animal model of the disease that PBT434 prevents α-synuclein aggregation, preserves neurons, decreases the number of glial cell inclusions and slows motor dysfunction. Glial cell inclusions are the key pathological finding in MSA and contain abundant aggregated α-synuclein that is associated with neurodegeneration. Alpha-synuclein is of great interest to scientists and clinicians because aggregated forms of the protein are toxic and underlie the pathology of neurological diseases such as MSA and Parkinson’s disease.“We are excited to share these data with the movement disorder community because Multiple System Atrophy is a terrible disease and has no approved treatments. The data indicate that PBT434 targets the key pathology in MSA and has excellent potential to treat this devastating condition. Our Phase 1 study in healthy volunteers is ongoing and we look forward to bringing PBT434 to patient studies in the future”, said David Stamler, Chief Medical Officer and Senior Vice President of Clinical Development.PBT434 is the first of a new generation of small molecules designed to inhibit the aggregation of α-synuclein and tau, vital intracellular proteins that are implicated in neurodegenerative diseases such as Parkinson’s disease and atypical Parkinsonism. http://www.pranabio.com.

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“The new frontiers in Gastric Cancer diagnosis and treatment”

Posted by fidest press agency su domenica, 2 settembre 2018

Forlì Giovedì 6 settembre 2018 h 11 c/o Ospedale Morgagni – Pierantoni via Carlo Forlanini 34 Padiglione Valsalva (Secondo Piano – saletta della Direzione Generale) Presentazione lavori congressuali illustrati dal – dott. Paolo Masperi , Direttore dell’ospedale “Morgagni – Pierantoni” di Forlì
– prof. Giorgio Ercolani, D irettore dell’Unità Operativa di Terapie e chirurgia e Terapie oncologiche avanzate all’Ospedale Morgagni- Pierantoni di Forlì e professore ordinario in Chirurgia Generale presso il Dipartimento di Scienze Mediche e Chirurgiche dell’Alma Mater di Bologna
– dottor Luca Saragoni, Dirigente medico dell’Uo Anatomia Patologica di Forlì
– dottor Paolo Morgagni, Dirigente medico UO Chirurgia generale di Forlì
“Il congresso si svolgerà a Forlì dal 13 al 14 settembre 2018, sotto l’egida dell’ Associazione Internazionale del Cancro Gastrico (IGCA) e vedrà la partecipazione dei massimi esperti mondiali nel settore – spiegano gli organizzatori, prof.Giorgio Ercolani, dottor Luca Saragoni e dottor Paolo Morgagni – L’ospedale di Forlì è da tempo impegnato nella lotta contro questo tumore a prognosi infausta, anche in virtù della elevata incidenza dello stesso nel territorio romagnolo. L’importante esperienza maturata sul campo, oltre a connotare l’ospedale forlivese per la sua vocazione in ambito oncologico gastro-enterologico, ha consentito al team multidisciplinare dedicato di diventare leader e punto di riferimento sul tema a livello mondiale. Al congresso verranno affrontati gli argomenti di maggiore attualità riguardanti la diagnosi e il trattamento di questa malattia, alcuni dei quali sono oggetto di studi e collaborazioni internazionali, in cui il team multidisciplinare dedicato dell’ospedale di Forlì risulta coinvolto attivamente.Dal confronto tra i vari esperti mondiali scaturiranno le future linee guida , ai fini di un appropriato inquadramento diagnostico ed approccio terapeutico.”

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First look at the new 2018 European Guidelines for the treatment of high blood pressure

Posted by fidest press agency su domenica, 10 giugno 2018

Barcelona. A first look at the new European Guidelines for the treatment of high blood pressure was presented at the European Society of Hypertension meeting in Barcelona on June 9th 2018. These long-awaited guidelines have been jointly developed by clinicians representing the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). The guidelines provide recommendations for doctors across Europe about how to diagnose high blood pressure, evaluate risk, and when and how to treat high blood pressure and reduce risk, with both lifestyle advice and medications. The development of the guidelines was led by Prof. Bryan Williams (ESC Chairperson), London UK, and Prof. Giuseppe Mancia (ESH Chairperson), Milan, Italy, as lead authors.Professor Bryan Williams, University College London said “These clinical guidelines are one of the most important in Europe because high blood pressure affects so many people, over 25% of the adult population. The focus of the guideline is to improve the treatment of high blood pressure and blood pressure control in treated patients, which at present is not as good as it should be”. Professor Giuseppe Mancia, University Milano-Bicocca Milan said “The 2018 ESC/ESH guidelines issue new recommendations on how to optimally treat hypertension. Drug therapy extends to additional groups of patients. Also, blood pressure values to aim at with treatment are lower than in the past. In addition, combination therapy is now recognized as the most effective initial treatment strategy in most patients.” The full text of the new joint guidelines for the Management of Arterial Hypertension will be published on 25 August 2018 in parallel with a corresponding presentation during the ESC Congress 2018 in Munich (August 25-29, 2018).

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European Sudden Cardiac Arrest network explores gender-based prevention and treatment

Posted by fidest press agency su lunedì, 19 marzo 2018

Barcelona, Spain Researchers will use a European network of 90,000 patients to explore different approaches to prevention and treatment of sudden cardiac arrest for men and women, they announced today during a workshop on sex and gender differences at EHRA 2018.1
The European Sudden Cardiac Arrest network (ESCAPE-NET) is backed by the European Heart Rhythm Association (EHRA), a branch of the European Society of Cardiology (ESC), and the European Resuscitation Council (ERC).Sudden cardiac arrest is the consequence of a heart rhythm disorder called ventricular fibrillation. It is deadly within minutes if left untreated and survival rates are just 5–20%.
ESCAPE-NET has pooled the patient populations of 16 organisations across Europe. The resulting database of sudden cardiac arrest in the community is sufficiently large to study causes, treatments and prevention strategies, and how these vary between women and men.The electrical properties of the heart differ between men and women. The heart beats by an electrical conduction system in which ions (electrically charged molecules such as potassium) move back and forth across channels in the membranes of heart cells. Women have fewer potassium channels than men.Commonly prescribed drugs that work by blocking ion channels can increase the risk of ventricular fibrillation and sudden cardiac arrest. For potassium channel blockers, such as selective serotonin reuptake inhibitors (SSRIs) for depression, antibiotics including erythromycin, antifungal medications, and domperidone, the increased risk of sudden cardiac arrest may be larger in women.“Doctors want to know when these drugs can be safely prescribed in women,” said Dr Hanno Tan, ESCAPE-NET project leader and cardiologist, Academic Medical Centre, Amsterdam, The Netherlands.
One of the aims of ESCAPE-NET is to create a risk score that includes age, sex, comorbidities and genetic profile. Doctors will be able to use the score to determine the risk, for example, of prescribing erythromycin for a female patient.Dr Tan said: “We think that sudden cardiac arrest is caused by the interaction of various risk factors. Our research will uncover which factors are relevant in women and men and use this information to develop a risk score.”There is also evidence that women are more likely to die from sudden cardiac arrest than men because they are less likely to be resuscitated by a bystander. This appears to be due to sociological factors rather than biological sex. For example, women are more likely to be living alone because they have outlived their spouse.
ESCAPE-NET will identify specific reasons for differences in survival between men and women and which factors might be changed.Dr Tan said: “The major strength of ESCAPE-NET is the large number of patients. These cohorts are normally very difficult to collect because sudden cardiac arrest occurs quickly.”

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GE, Roche Enter Partnership to Develop Integrated Digital Diagnostics Platform to Improve Oncology and Critical Care Treatment

Posted by fidest press agency su martedì, 9 gennaio 2018

Roche Enter PartnershipGE Healthcare has entered into a strategic, long-term partnership with Roche (SIX: RO, ROG; OTCQX: RHHBY) to jointly develop and co-market digital clinical decision support solutions. The partnership will initially focus on products that accelerate and improve individualized treatment options for cancer and critical care patients.The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration and analysis of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.For example, oncology care teams with multiple specialists will have a comprehensive data dashboard to review, collaborate and align on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, tissue pathology, genomic and sequencing data, helping physicians to identify, or even predict severe complications before they strike.GE Healthcare is a worldwide leader in medical imaging equipment, while Roche Diagnostics is the global leader in in-vitro diagnostics.“This is the first time that two major players in healthcare have combined advanced analytics with in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said Kieran Murphy, President & CEO of GE Healthcare.“This unique partnership will deliver innovative solutions and insights in clinical decision-making. Our goal is to support clinicians and other relevant stakeholders for the benefit of patients by providing the right decision support at the right time and through comprehensive digital offerings,” said Roland Diggelmann, CEO Roche Diagnostics.

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“Cardiometabolic Risk and Vascular Disease: from Mechanisms to Treatment”

Posted by fidest press agency su mercoledì, 22 novembre 2017

stoccolmaStoccolma dal 01 al 03 dicembre 2017 “Cardiometabolic Risk and Vascular Disease: from Mechanisms to Treatment”. Una circonferenza dell’addome sopra la media, colesterolo, glicemia e pressione del sangue oltre i livelli raccomandati: sono le caratteristiche del rischio metabolico, tra le principali cause di malattie cardiache e vascolari. Si tratta di una condizione che interessa circa il 25 per cento degli uomini ed addirittura il 27 per cento delle donne. Parliamo quindi di numeri altissimi, pari a circa 14 milioni di individui in Italia, ma che diventano ancora più impressionanti se pensiamo all’Europa, agli Stati Uniti, dove è obeso o in sovrappeso una persona su tre, e nel resto del mondo. E dato che lo studio della sindrome metabolica è una delle principali chiavi per migliorare a costo zero la prevenzione cardiovascolare, gli esperti europei si incontreranno a Stoccolma (Svezia) dall’1 al 3 dicembre 2017 in occasione del Simposio “Cardiometabolic Risk and Vascular Disease: from Mechanisms to Treatment” organizzato dal Karolinska Institute di Stoccolma con il supporto della Fondazione Internazionale Menarini. «Gli obiettivi del simposio sono la condivisione delle più recenti conoscenze relative ai progressi nella fisiologia, nella diagnosi e nel trattamento del rischio cardiometabolico e il suo impatto nella pratica clinica» spiega Francesco Cosentino, Direttore dell’Unità di Cardiologia del Karolinska Institute & Karolinska University Hospital di Stoccolma. «Il programma scientifico copre uno spettro di temi tra cui la relazione tra sistema immunitario e metabolismo, tra infiammazione e aterosclerosi, le strategie di prevenzione delle patologie cardiovascolari, la gestione dell’obesità e dell’insulino-resistenza, il controllo dell’aterotrombosi, della glicemia, del diabete, della sindrome coronarica acuta e dello scompenso cardiaco.

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Cardiac imaging experts create ‘imaging phenotype’ to improve personalised treatment

Posted by fidest press agency su lunedì, 6 novembre 2017

lisbonaLisbon, Portugal 6 to 9 December 2017 at the Centro de Congressos de Lisboa (CCL). EuroEcho-Imaging is the annual meeting of the European Association of Cardiovascular Imaging (EACVI), a registered branch of the European Society of Cardiology (ESC). The full scientific programme is available here. The EuroEcho-Imaging 2017 mobile app can be downloaded from the App Store or Google play – search for ‘EuroEcho2017’.
“Clinicians, scientists and engineers from across the globe attend EuroEcho-Imaging,” said Professor Erwan Donal, Chairperson of the Scientific Programme Committee. “It is the place to see the most innovative imaging techniques in cardiovascular diseases and journalists will find plenty of fresh material.” Phenomapping is an emerging field that will be discussed by specialists at the meeting. Using the statistical methods that condense large amounts of data from DNA sequences into understandable information, data from cardiac imaging (mainly echocardiography) is transformed into an ‘imaging phenotype’. Professor Donal said: “This is a completely new area in cardiovascular imaging. International leaders will reveal how phenomapping can be used to personalise treatment for patients with cardiovascular disease.” EuroEcho-Imaging is the place to be to meet world renowned global experts in the field of cardiovascular imaging. More than 3 200 healthcare professionals from over 90 countries are set to attend the four day event. Original research will be presented in the abstract programme and more than 150 scientific sessions will explore the hottest topics in cardiovascular imaging. Subjects of interest to the press include the use of holograms and 3D printing to guide procedures such as repair of congenital heart defects and replacement of heart valves; use of imaging for early detection and prevention of heart damage caused by cancer treatment; and foetal cardiac magnetic resonance (CMR) and fusion imaging to improve diagnosis and treatment of congenital heart diseases. The main themes of the congress are imaging in heart failure and interventional imaging. Cardiac imagers have played a key role in both areas, using echocardiography, cardiac computed tomography (CT), CMR, and nuclear imaging techniques to select patients and guide procedures. These include atrial fibrillation ablation, valve replacement, and implantation of cardiac resynchronisation therapy devices. Members of the press will hear the latest research in both fields. Members of the press can get a look into the future by attending sessions held in collaboration with Computers in Cardiology, a group of scientists in engineering, physics and computer science who will discuss techniques on the horizon to improve the diagnosis, monitoring, and treatment of patients with cardiovascular disease. Contentious issues will be debated giving media representatives both sides of the story. For example, should patients with coronary artery disease and heart failure receive revascularisation? Professor Donal said: “We don’t have convincing evidence on whether or not to treat the heart failure only. Those in favour of revascularisation argue that it improves ejection fraction and ameliorates heart failure. They will show how CMR can be used to assess viability of the myocardium and select candidates for revascularisation.” Dr Philippe Pibarot from Quebec, Canada, will give the EuroEcho-Imaging lecture “Why and how cardiac imaging has revolutionised the management of aortic stenosis”. Professor Donal said: “EuroEcho-Imaging will demonstrate how clinicians and scientists worldwide are using echocardiography, cardiac CT, CMR, and nuclear imaging to improve our understanding and treatment of cardiovascular diseases. This is the event of the year for breaking news in cardiovascular imaging.”

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Howsden Dermatology Joins Platinum Dermatology Partners

Posted by fidest press agency su sabato, 4 novembre 2017

Kevin F. Kia, Akash A. PatelPlatinum Dermatology Partners (“Platinum”) announced today that Howsden Dermatology has joined its network, further enhancing Platinum’s presence in the Dallas-Fort Worth area. Platinum is a dermatology-focused physician services organization with a rapidly growing network of top-ranked dermatology practices in Texas. Howsden Dermatology serves the eastern Dallas communities of Garland, Rowlett and Mesquite, and is known for its superior medical and surgical dermatological care, as well as its keen focus on skin cancer detection and treatment. Founded in 1983 by Dr. F. Lester Howsden, MD, FAAD, Howsden Dermatology patients today are cared for by Dr. Akash A. Patel, MD, FAAD, and Dr. Kevin F. Kia, MD, FAAD. Drs. Patel and Kia are devoted to serving the communities in which they work, and the dermatology community at large, with their highest commitment to quality skin care. Both are long-time honorees of D Magazine’s “Best Doctors in Dallas,” and since 2005, both have remained actively involved in teaching future dermatologists at The University of Texas Southwestern—many of whom are now practicing in the Dallas-Fort Worth area.
“Times are most definitely changing, and we were looking for the right partner to help us grow and provide the best care for our patients. Platinum became an obvious choice,” said Dr. Patel. “Dr. Kia and I have worked very hard to maximize quality and efficiency. We want our patients to have the highest quality of care; so to us, it was really important to find a partner who shares our goals and priorities. Platinum stands apart from the rest because they don’t want to change how we operate—they have no interest in micromanaging us; they are enhancing our strengths and showing us ways we can grow through their vast resources. One other huge distinguishing factor for us was the quality of physicians we join in the Platinum network. We have tremendous respect for these Platinum Dermatologists—all are well-regarded by their peers and the medical community at large—and we wanted to be part of this strong team. Platinum was by far the best choice for us.” Platinum’s model is attractive to physicians because it empowers dermatologists to grow and enhance their practices while providing exceptional clinical care and retaining ownership and autonomy. Platinum’s management creates partnerships with physicians that lead to better operational and clinical outcomes, encourages collaboration among dermatology professionals, and drives practice growth opportunities that are unmatched in an independent practice. (photo: Kevin F. Kia, Akash)

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The European Commission has granted marketing authorization for Vosevi® for the treatment chronic hepatitis C

Posted by fidest press agency su giovedì, 7 settembre 2017

voseviFOSTER CITY, Calif.–BUSINESS WIRE–Gilead Sciences, Inc. (NASDAQ:GILD) announced that the European Commission has granted marketing authorization for Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.Vosevi was authorized as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen. A 12-week regimen was also authorized for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.
Gilead also announced an extension of the marketing authorization for Harvoni® (ledipasvir 90mg/sofosbuvir 400mg). Previously authorized for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has been extended to include the treatment of chronic HCV genotype 1, 3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years. Harvoni is the first direct-acting antiviral regimen to receive marketing authorization in the European Union extended for use in the adolescent population.
The approval of Vosevi is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of Vosevi in DAA-naïve patients with european commissionhepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with Vosevi (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with hepatitis C genotypes 1-6 with and without cirrhosis treated with Vosevi (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and compensated cirrhosis treated with Vosevi (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse drug reactions among patients who received Vosevi in the POLARIS studies were headache, diarrhea and nausea.
Vosevi was approved by the U.S. Food and Drug Administration on July 18, 2017 for the re-treatment of adults with genotype 1-6 chronic HCV infection.
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) are contraindicated. Co-administration with strong OATP1B inhibitors (e.g. ciclosporin), rosuvastatin, dabigatran etexilate and ethinylestradiol-containing medicinal products is also contraindicated.Patients co-infected with hepatitis C and hepatitis B are at risk of hepatitis B virus reactivation and should therefore be monitored and managed according to current clinical guidelines. Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral treatments (e.g. tenofovir disoproxil fumarate- and efavirenz-containing regimens). Safety has not been established in patients with severe renal impairment (glomerular filtration rate <30ml/min).
Full European Summary of Product Characteristics for Vosevi, Sovaldi, Harvoni and Epclusa are available from the EMA website at http://www.ema.europa.eu. (photo: vosevi)

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Treatment for Ischemic Cardiomyopathy

Posted by fidest press agency su giovedì, 24 agosto 2017

SanRamonSAN RAMON, California and CAMBRIDGE /PRNewswire/BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced enrollment of the first patient in the international arm of the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the Revivent TC™ TransCatheter Ventricular Enhancement System; a hybrid closed-chest procedure to treat patients suffering from ischemic cardiomyopathy. BioVentrix received investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA).The Less Invasive Ventricular Enhancement™ or LIVE™ procedure was performed at Papworth Hospital in Cambridge, United Kingdom by consultant cardiothoracic surgeon Dr. Steven Tsui and consultant interventional cardiologist Dr. Michael O’Sullivan. The device was successfully implanted with three micro-anchor pairs in a 60-year-old patient suffering from ischemic heart failure. The procedure reshaped the left ventricle, decreased the Left Ventricular End Systolic Volume Index (LVESVI), and dramatically increased the Ejection Fraction (EF). Left Ventricular volume reduction has been shown to significantly impact short and long-term survival rates.”We are pleased to be the first center to implant the Revivent TC System as part of the ALIVE clinical trial. Before the LIVE procedure, this patient’s quality of life was severely limited by his heart failure. His treatment options were very limited because of his condition. We hope to provide him with significant clinical benefits by performing this novel procedure which is less invasive and less traumatic than conventional surgical reconstruction,” said Dr. Tsui.”The TransCatheter delivery system allows for more ischemic heart failure patients to be treated with reduced procedural risk relative to conventional surgery. Most importantly, this procedure enabled us to achieve a considerable amount of LV volume reduction without the need for open heart surgery or cardiopulmonary bypass,” said Dr. O’Sullivan.The ALIVE trial plans to enroll 120 patients at up to 20 sites in the U.S. and U.K. with a primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, 6 minute walk test, and rehospitalization. Readmission rates following heart failure hospitalization remain high using standard therapies, with ≥ 50% of patients readmitted to hospital within 6 months of discharge. Annually, over 1 million patients are hospitalized with a primary diagnosis of heart failure, accounting for a total Medicare expenditure exceeding $17 billion.

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