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Monday 23 April 2018
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Topic: *** Editor's Pick

April 20, 2018
<p>Once-daily single inhaler triple therapy superior to Relvar, Ellipta and Anoro Ellipta across multiple endpoints including exacerbations, lung function and quality of life</p>

GlaxoSmithKline and Innoviva, Inc have announced the publication in the New England Journal of Medicine of the landmark IMPACT study, one of the biggest ever conducted in patients with chronic obstructive pulmonary disease (COPD) with a history of exacerbations.1

April 19, 2018
<p>Three studies shed light on cancer evolution and could lead to tests that give more accurate prognoses and personalised treatment</p>

Kidney cancer follows distinct evolutionary paths, scientists have discovered. Their findings will enable them to detect whether a tumour will be aggressive, and also reveal that the first seeds of kidney cancer are sown as early as childhood.


April 19, 2018
<p>Novartis announces Aimovig&trade; could be an effective preventive treatment option for episodic migraine patients where previous treatments have failed</p>

A treatment for patients with episodic migraines could at least halve the number of days they experience them every month, researchers have found.


This April, healthcare organisation Novartis announced the results of a study that looked specifically at episodic migraine patients who had previously failed 2 to 4 preventive treatments, due to lack of efficacy and/or intolerable side effects.


April 19, 2018
<p>Europe&rsquo;s national science and medical academies call for tailor-made interventions, European vaccination card and registry</p>

With the dramatic increase in measles in Europe – a four-fold increase from 2016 to 2017, according to a recent report by the World Health Organization – and the urgent need for vaccines protecting against infections for which no vaccines currently exist, the European Commission has drafted a roadmap for ‘Strengthened cooperation against vaccine preventable diseases’ and aims to adopt a proposal by mid-2018 for a Council Recommendation on Strengthened Cooperation against Vaccine Preventable Diseases.


April 19, 2018
<p>Consortium encourages patients to get involved in the drug development and approval processes</p>

A new collaboration involving 34 public and private partners has been formed in an effort  to enable patients to be engaged in drug development and approval processes.


April 12, 2018
<p>Gene discovery could lead to future individualised therapy in myeloma, researchers find</p>

Researchers have increased the understanding of the complex genetics behind an incurable blood cancer.


The Institute of Cancer Research, London, has conducted a study which has revealed 40 genes involved in the development of myeloma, enhancing the knowledge about the complex genetics associated with this condition.


April 11, 2018
<p>The Scottish Medicines Consortium (SMC) has accepted Shire&#39;s Revestive&reg; (teduglutide) for restricted use in children aged one and above with short bowel syndrome</p>

Global biotechnology company Shire has announced that the Scottish Medicines Consortium (SMC) has accepted its Revestive® (teduglutide) 5mg and 1.25mg for restricted use in the treatment of children aged one year and above with short bowel syndrome (SBS).


April 11, 2018
<p>After previous negative decision, NICE now recommends Tecentriq<sup>&reg;</sup> (atezolizumab) for patients whose disease has progressed following standard chemotherapy</p>

The National Institute for Health and Care Excellence (NICE) has recommended new immunotherapy for people with advanced lung cancer.


Biotech company Roche has announced that patients with advanced non-small-cell lung cancer (NSCLC) whose disease has progressed following standard chemotherapy, can now access its immunotherapy Tecentriq® (atezolizumab) through the NHS in England and Wales.1


April 9, 2018
<p>Italian research-focussed group granted marketing authorisation for treatment for ultra-rare disorder</p>

International research-focussed healthcare group Chiesi, has announced that the European Commission has granted the marketing authorisation for Lamzede® (velmanase alfa).


This is the first enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis (AM) - an ultra-rare, progressive, and debilitating disease. Patients present with a broad range of symptoms and their long-term prognosis is generally poor, with reduced life expectancy.1


April 6, 2018
<p>UK Biobank has announced a major initiative to sequence the full genomes of 50,000 UK Biobank volunteer participants</p>

Funded by a £30M grant from the Medical Research Council (MRC), sequencing of the whole genome will be undertaken during 2018 and 2019 by the Wellcome Sanger Institute, which is based in Cambridge.


April 6, 2018
<p><span itemprop="articleBody">Boehringer Ingelheim and OSE Immunotherapeutics enter into a global license and collaboration agreement in immuno-oncology to develop OSE-172, a novel checkpoint inhibitor antibody targeting myeloid lineage cells</span></p>

Boehringer Ingelheim and OSE Immunotherapeutics have announced a collaboration and exclusive worldwide collaboration and license agreement to jointly develop OSE-172, a SIRP-alpha antagonist targeting myeloid lineage cells.


April 6, 2018
<p>The health body felt there was uncertainty about cost-effectiveness estimates for this treatment of atopic dermatitis</p>

The National Institute for Health and Care Excellence (NICE) has issued draft guidance that does not recommend Dupixent® (dupilumab), within its marketing authorisation, for the treatment of moderate-to-severe atopic dermatitis in adults when systemic therapy is suitable.


March 26, 2018
Positive opinion for ABP 980 is supported by Phase III data in patients with HER2-postive early breast cancer

Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of ABP 980, a biosimilar to Herceptin® (trastuzumab).


March 23, 2018
For patients with urea cycle disorders, early treatment and adequate ammonia control are critical for maintaining the intellectual function, preventing neurologic damage and reducing the frequency of hyperammonaemic crises

Sobi has announced that the company has gained reimbursement for Ravicti®, a new therapy option for the treatment of patients with urea cycle disorders (UCDs) in several EU member states and EEA-countries.


Sweden, Denmark, Austria and Germany are the first countries to launch, followed by UK, Spain and the Netherlands.


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
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


The guide, now in its third edition with more than 400,000 copies of previous versions distributed worldwide, was produced by the European Heart Rhythm Association (EHRA), a branch of the ESC.

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 14, 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 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 new 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.


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