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Saturday 24 March 2018
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Topic: *** Editor's Pick

March 23, 2018
Eligible patients with FCS in the UK will be able to access the drug before the European Commission makes a formal decision for its use in Europe

Akcea Therapeutics has announced that volanesorsen has been granted a positive scientific opinion through the Early Access to Medicines Scheme (EAMS) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), for the treatment of familial chylomicronaemia syndrome (FCS), a rare genetic lipid disorder.

March 20, 2018
Initiatives will use data analysis to identify ways to improve care and access to services for patients across multiple types of cancer

Novartis has announced the launch of two new Joint Working Projects with national Cancer Vanguard sites, which aim to identify ways to improve cancer patient care pathways and access to services.

March 19, 2018
The largest compilation of kidney data ever collected has been analysed and presented at a joint scientific workshop

The National Kidney Foundation (NKF), along with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have concluded a scientific workshop collaboration to review the results of a major, multi-year meta-analysis examining the largest compilation of data ever collected on chronic kidney disease (CKD).

March 19, 2018
Safe and effective use of NOACs for stroke prevention in patients with atrial fibrillation

A new version of the EHRA Practical Guide on the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation has been published online in the European Heart Journal and an executive summary in EP Europace,and presented at EHRA 2018.1–3

March 19, 2018
Landmark natural history study of adenovirus in allogeneic haematopoietic cell transplant shows strong correlation between disease burden and mortality risk

Chimerix has announced data from AdVance, the first large, multi-centre study of adenovirus (AdV) incidence, natural history, management and clinical outcomes in allogeneic haematopoietic cell transplant (allo-HCT) recipients.

These data will be presented at the 44th Annual Meeting of the European Society of Blood and Marrow Transplantation held 18–21 March in Lisbon, Portugal.

March 19, 2018
International consensus document on arrhythmias and cognitive function has been published

Patients with atrial fibrillation could reduce the risk of dementia by taking stroke prevention medications, according to recommendations published online in EP Europace,1 a European Society of Cardiology journal, and presented at EHRA 2018.2

March 19, 2018
Study provides proof-of-concept that the heart can be enabled to terminate atrial fibrillation by itself after optogenetic gene therapy

The heart is capable of terminating arrhythmias itself after local gene therapy, potentially avoiding the need for patients to undergo painful electric shocks, according to a proof-of-concept study presented today at EHRA 2018.1

March 15, 2018
AC Immune's lead compound is highly selective for alpha-synuclein - a key protein in Parkinson's disease pathology

AC Immune SA has announced a significant step for a first potential PET tracer for Parkinson's disease.

March 15, 2018
Data related to the Poly(ADP-ribose) glycohydrolase (PARG) inhibitor programme to be presented at the American Association of Cancer Research Annual Meeting

March 14, 2018
Digital platform that enables orthopaedic surgeons, for the first time, to remotely track their patients’ real-time healing progress and satisfaction without requiring a clinical visit

In partnership with Wellframe Inc., a mobile-enabled care management solution provider, Smith & Nephew utilises HealthMeasures’s Patient-Reported Outcomes Measurement Information System (PROMIS) Computer-Adaptive Tests (CATs) to collect data from patients by measuring their recovery at regular time points.

March 13, 2018
In year one of the partnership there will 40 students overall (split over two eight week placement blocks), this will increase to 60 in year two and three (split over three placement blocks.)

Students at the University of Surrey in the UK are being given the chance to work at one of the world’s leading children’s hospitals as a result of a new partnership with Great Ormond Street Hospital (GOSH).

March 13, 2018
Patients with sickle cell disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels

Emmaus has announced that the company’s Marketing Authorisation Application (MAA) for Xyndari has been fully validated and is now under assessment by the European Medicines Agency (EMA) for the treatment of sickle cell disease.

March 13, 2018
The Steering Group on Influenza Vaccination was convened in November 2017, representing key stakeholders in the field of influenza. It is composed of eight members led by two co-chairs, including patient group representatives, healthcare professionals and academics

The Steering Group on Influenza Vaccination has released their Manifesto calling for more action to increase seasonal influenza vaccination coverage rates in Europe to reduce the unacknowledged burden of this disease.

March 9, 2018
Xolair is the only licensed treatment option for chronic spontaneous urticaria, for patients unresponsive to antihistamines and the guideline aims to achieve complete symptom control of patients

A global guideline on chronic urticaria (CU) recommends Xolair® (omalizumab), indicated as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines.1,2

Xolair is the only licensed treatment option for CSU, a type of CU, for patients unresponsive to antihistamines.1

March 8, 2018
Ontruzant is the first breast cancer biosimilar to be launched in the UK, and is the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co Ltd

MSD has announced the launch of Ontruzant®, (trastuzumab), a biosimilar referencing Herceptin® (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.1

March 7, 2018
Danish pharmaceutical company Novo Nordisk’s diabetes drug, semaglutide, which could also be used to treat obesity, has passed its first Phase III clinical trial. Semaglutide is taken once daily as a tablet and works by increasing insulin production

As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative. In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

March 3, 2018
A briefing warns that unless the right deal is reached, collaborative trials, networks and research activities of benefits to patients across Europe may be set back after Brexit

Children and rare disease patients could be excluded from lifesaving clinical trials and networks when the UK leaves the EU, according to the Brexit Health Alliance.

March 3, 2018
Welcome news for patients in England, Wales and Northern Ireland as avelumab is recommended for routine NHS use in previously treated metastatic Merkel Cell Carcinoma (mMCC) patients and for use in England within the Cancer Drugs Fund for those with previously untreated mMCC

The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) that recommends avelumab for treating adults with metastatic Merkel Cell Carcinoma (mMCC).1

March 2, 2018
Clinical validation was based on the PANOTPIC (PulmonAry NOdule Plasma proTeomIc Classifier) clinical trial, a large prospective lung nodule clinical trial

Integrated Diagnostics has announced the e-publication of full results of a large prospective clinical trial validating its Xpresys Lung 2® in the peer-reviewed medical journal, CHEST.

March 1, 2018
Hemlibra is a bispecific monoclonal antibody, which was developed using Chugai’s proprietary antibody engineering technologies

Chugai has announced that Roche has received regulatory approval from the European Commission for Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.

March 1, 2018
Seqiris expects QIVc to be the first four-strain, cell-based seasonal influenza vaccine licensed in Europe, expanding the options available to help tackle the significant number of influenza-related deaths and hospitalisations in the region

Seqirus has announced plans to commercialise its novel cell-based quadrivalent influenza vaccine (QIVc) across Europe.

The company expects QIVc to be the first four-strain, cell-based seasonal influenza vaccine licensed in Europe, expanding the options available to help tackle the significant number of influenza-related deaths and hospitalisations in the region.

February 28, 2018
There are 7000 rare diseases affecting an estimated 350 million people globally

Amicus Therapeutics is honouring Rare Disease Day today with the launch of Healing Beyond Disease™, a global, Amicus employee-driven initiative inspired by people living with rare diseases and their families.

Healing Beyond Disease is designed to enhance and expand the Company’s support for patients, families and advocacy organisations beyond the Company’s research and development of novel medicines. More information on Healing Beyond Disease is available in an infographic on the Amicus corporate website.

February 28, 2018
Innovative Neulasta® Onpro® kit is designed to provide the right dose for patients at the right time

Amgen has announced that the CHMP has issued a positive opinion recommending a label variation for Neulasta® (pegfilgrastim) to include the Neulasta® Onpro® Kit.

February 27, 2018
Adult-onset Still’s disease and systemic juvenile idiopathic arthritis are rare systemic disorders of auto-inflammatory nature, which share common clinical manifestations such as daily spiking fever, typical transient cutaneous rash, arthritis and serositis

Sobi has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for anakinra for the treatment of Still’s disease.