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Sunday 25 February 2018
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Topic: *** Editor's Pick

February 23, 2018
The CHAMPION trial is assessing the effectiveness and safety of heat-stable carbetocin versus oxytocin, the current standard of care, for preventing postpartum haemorrhage after vaginal birth

Ferring Pharmaceuticals and MSD, through its MSD for Mothersinitiative, has announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO).


February 22, 2018
Vosevi® is the first single tablet regimen for patients who have previously failed therapy with direct-acting antivirals

Gilead Sciences has welcomed the Technology Appraisal Guidance (TAG) issued by the National Institute for Health and Care Excellence (NICE), which recommends Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg; SOF/VEL/VOX).1


February 22, 2018
Rare Disease Day was established in Europe in 2008 by EURORDIS-Rare Diseases Europe, the organisation representing rare disease patients in Europe, and is now observed in more than 90 nations

Shire has announced its continuing global education and awareness efforts on Rare Disease Day 2018, to deliver on its commitment to champion those impacted by rare disease, including patients, families and caregivers.


The company is helping to raise awareness about the impact and prevalence of rare diseases, while also listening to and working with an extended community of stakeholders on potential innovative solutions to help reduce the time to diagnosis.


February 22, 2018
In 2016, eribulin became the first breast cancer treatment to be recommended by NICE in nearly a decade for the treatment of adults with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens

Halaven® (eribulin) continues to be available for the treatment of adults with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens1 even though recent guidance from the National Institute of Health and Care Excellence (NICE) is not recommending eribulin for use in an earlier setting.2


February 19, 2018
PANTS study shows that CT-P13 is an efficacious therapy option when investigating personalised approaches to anti-TNF therapy

Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO).


The results indicate that the clinical effectiveness, safety and immunogenicity of Pfizer and Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1


February 19, 2018
New data from VOYAGE 2 trial shows high efficacy response rates were achieved with continuous guselkumab treatment versus withdrawal

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving Tremfya® (guselkumab), who achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72.1


February 16, 2018
Nusinersen demonstrated stabilisation or improvement from baseline in motor function in individuals with 5q spinal muscular atrophy where the natural history of the disease is a decline in motor function over time

Biogen and Ionis Pharmaceuticals, Inc have announced end of study results from CHERISH, the Phase III study evaluating Spinraza® (nusinersen) for the treatment of individuals with later-onset 5q spinal muscular atrophy (SMA), were published in The New England Journal of Medicine.


The full manuscript titled, “Nusinersen Versus Sham Control in Later-Onset Spinal Muscular Atrophy,” appears in the 15 February 2018 issue of The New England Journal of Medicine.


February 16, 2018
NICE recommends NHS-wide prescribing of Ipsen’s cabozantinib for patients with medullary thyroid cancer

Ipsen has announced that adult patients in England and Wales with medullary thyroid cancer (MTC) could now benefit from treatment with Cometriq® (cabozantinib).


February 15, 2018
Each year, around 25,000 people take part in a clinical trial that is supported by Cancer Research UK

Cancer Research UK has announced that £45million will be invested into its network of clinical trials units across the UK, one of the charity's largest investments in clinical research to date.

Cancer Research UK’s clinical trials units (CTUs) bring together world leading researchers and clinicians to find life-saving new treatments and tests for cancer patients.

February 15, 2018
Herzuma® (CT-P6) granted EU marketing authorisation to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer

Celltrion Healthcare has announced that the European Commission (EC) has approved Herzuma® (trastuzumab biosimilar, CT-P6) for all indications of reference trastuzumab in the European Union (EU).


The approval of Herzuma® marks the third Celltrion Healthcare product approved in the EU and builds on the company’s expanding biosimilar portfolio.

February 15, 2018
Positive NICE recommendation ensures access to Eisai's lenvatinib for subset of patients with very limited options

Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) issued its final appraisal decision (FAD) recommending reimbursement of Lenvima® (lenvatinib) for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine (RAI-R DTC).1


February 13, 2018
Draft NICE guidance paves the way for access to treatment with brodalumab on the National Health Service

LEO Pharma welcomes the news that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the use of brodalumab 210mg for the treatment of adult patients with severe plaque psoriasis, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, who have not responded to standard systemic therapies or who are unable to take them.1


February 12, 2018
Tivozanib was licensed by the European Commission in August 2017 and is an oral, once-daily, potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitor

EUSA Pharma has announced that the National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending tivozanib as a first-line treatment option for advanced renal cell carcinoma (aRCC) in line with its licensed indication.


February 9, 2018
Phase III SPARTAN data showed apalutamide improved median metastasis-free survival by over two years compared to placebo

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).


February 9, 2018
XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma

Amgen has announced results from the XGEVA® (denosumab) Phase III ‘482 study, the largest international multiple myeloma trial for the prevention of skeletal-related events ever conducted (n=1718), were published in The Lancet Oncology.


In this study, XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95% CI: 0.85-1.14).

February 8, 2018
Label variation to include overall survival data from Phase III ENDEAVOR trial

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for Kyprolis® (carfilzomib) to include updated overall survival (OS) data from the Phase III head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade® [bortezomib] and dexamethasone [Vd]).


February 8, 2018
Heart disease patients should seek medical advice before adopting a very low calorie diet

Crash diets can cause a transient deterioration in heart function, according to research presented at CMR 2018.1 Patients with heart disease should seek medical advice before adopting a very low calorie diet.

Crash diets, also called meal replacement programmes, have become increasingly fashionable in the past few years,” said lead author Dr Jennifer Rayner, clinical research fellow, Oxford Centre for Magnetic Resonance, University of Oxford, Oxford, UK.

February 8, 2018
Doctors have developed a new five-minute procedure to scan the blood vessels which offers hope for claustrophobic patients unable to tolerate the conventional longer test

Magnetic resonance angiography (MRA) is a magnetic resonance imaging (MRI) exam that takes pictures of the blood vessels. Physicians use the images to diagnose diseases of the blood vessels, such as aneurysms or blockages.

February 8, 2018
The Republic of Ireland becomes the first country in Europe to switch an entire population undergoing treatment from conventional short-acting therapies to extended half-life therapies for haemophilia A and B

The Republic of Ireland has become the first country in Europe where every person with haemophilia will have access to the newest generation of haemophilia treatments, extended half-life therapies, under new supply contracts signed between the HSE (Health Services Executive) and Sobi™.

February 1, 2018
The study showed that eslicarbazepine acetate monotherapy was non-inferior to twice-daily controlled-release carbamazepine, the current standard of care

Bial and Eisai have announced that leading clinical journal, Epilepsia, has published positive results from a pivotal Phase III monotherapy study of once-daily Zebinix® (eslicarbazepine acetate) in newly diagnosed focal epilepsy patients.1

January 31, 2018
Letermovir is a first-in-class antiviral drug that inhibits cytomegalovirus replication

MSD has announced that the European Commission (EC) has granted marketing authorisation for letermovir as an orphan medicinal product for prophylaxis (prevention) of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).1


January 29, 2018
A study led by the University of Warwick in the UK could help thousands of headache sufferers

Researchers at Warwick Medical School are investigating whether a new education and self-management programme will help improve quality of life for people living with chronic headaches.

The study, Chronic Headache Education and Self-management Study (CHESS), is funded by the National Institute for Health Research, and is led by Professor Martin Underwood.  

January 23, 2018
Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor

Eli Lilly and Company has announced that the European Commission has granted marketing authorisation (MA) for Taltz® (ixekizumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1,2,3


January 23, 2018
Randomised controlled trial to compare two different treatments and aims to reduce reliance on strong painkillers

The University of Warwick in the UK is starting a trial to improve the lives of long-term strong painkiller users.


Researchers from the University’s Warwick Medical School and The James Cook University Hospital, Middlesbrough, have developed a support programme that they hope will help people with long term pain reduce their dependency on strong pain killers (opioids) and improve their quality of life.


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