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Thursday 25 April 2019
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Topic: Practical therapeutics

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 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 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.

 

January 23, 2018
The trial met its primary endpoint of percentage of patients on erenumab (AMG 334) achieving at least a 50% reduction of migraine days versus placebo, and all secondary endpoints

Novartis has announced positive results from the Phase IIIb LIBERTY study assessing the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects.

 

January 19, 2018
Marketing authorisation based on global development program showing MVASI is highly similar to Avastin® (bevacizumab)

Amgen and Allergan plc have that the European Commission (EC) has granted marketing authorisation for MVASI® (biosimilar bevacizumab).

 

January 19, 2018
Managed access agreement to be developed in parallel to urgently provide effective new treatment to patients in England

The National Institute for Health and Care Excellence (NICE) has formally invited Biogen to submit Spinraza (nusinersen), the first and only disease-modifying treatment for 5q spinal muscular atrophy (SMA), for assessment via the Single Technology Appraisal (STA) route.

 

January 12, 2018
If licensed, ocrelizumab will be the first and only treatment option for adults in the European Union with primary progressive multiple sclerosis

Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of ocrelizumab for adults with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for adults with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

 

January 12, 2018
Bezlotoxumab is the first EC licensed non-antibiotic option indicated to prevent Clostridium difficile infection recurrence in high-risk adults

MSD has announced the UK launch of Zinplava® (bezlotoxumab) - a new therapy for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.1

 

Bezlotoxumab is administered as a single, one-off, one-hour intravenous infusion alongside standard-of-care (SoC) antibiotic therapy for the treatment of CDI.1

 

December 15, 2017
Thrombotic thrombocytopenic purpura (TTP) is an acute, rare, thrombotic microangiopathy and current therapies and newer treatments expected for future care are discussed
December 15, 2017
Biologics and targeted treatments have revolutionised the management of patients with severe psoriasis unresponsive to conventional therapies
Psoriasis is a chronic inflammatory skin condition, characterised by inflamed, thickened, silver-white plaques, that is thought to affect up to 3% of the UK population.1 Although not life-threatening, psoriasis is associated with a significant impairment of quality of life2 and emotional well-being.3 Although there are several different presentations of psoriasis,2 the most common, affecting around 90% of patients, is the chronic plaque form.4
 
December 15, 2017
Prophylaxis with factor VIII has been shown to have a clear benefit for all patients with haemophilia A, and its use is supported by contemporary guidance
December 15, 2017
To compound, or not to compound, that is not the question: Whether it is preferable to use standardised multi-chamber bags, to keep the compounding in house, or to outsource it, should be decided by every hospital, being a unique case that requires a custom-fit approach
Support for the development of this editorial report was provided by the Business Unit Compounding of 
Fresenius Kabi

 
December 15, 2017
Perinatal mental health represents a challenging area for medicines management and a pharmacy health care professional can make a huge contribution towards helping the patient make informed decisions around her treatment
December 15, 2017
The following article discusses the composition, use and practical considerations of triple-chamber parenteral nutrition bags in meeting patient requirements within a clinical setting
December 13, 2017
Results from the pooled analysis presented at the American Epilepsy Society Annual Meeting 2017 in Washington DC, USA

Bial and Eisai have announced new real-world audit data presented at the American Epilepsy Society (AES) Annual Meeting 2017, which add to the existing clinical trials examining the effectiveness and tolerability of Zebinix® (eslicarbazepine acetate).

 

December 12, 2017
Renal cell carcinoma is the most common type of kidney cancer in adults, with 80% of kidney cancer patients in the UK diagnosed with this type

Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for the use of Kisplyx® (lenvatinib) in combination with everolimus for the treatment of adults with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy, if their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1, and the company provides lenvatinib with the discount agreed in the patient access scheme.1

December 12, 2017
The analysis was presented in a poster session at the 59th Annual Meeting of the American Society of Hematology

Sobi and Bioverativ Inc have announced the results of a new, post-hoc, longitudinal analysis of the pivotal Phase III A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its extended half-life therapy Elocta® (efmoroctocog alfa) has the potential to provide improved bleed protection over episodic treatment, resolve target joints and reduce the treatment burden associated with more frequent dosing intervals.

November 30, 2017
Patients with episodic migraine taking erenumab reported significant and meaningful benefits over six months, with reduced migraine days and acute medication use

Novartis has announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month).1

 

March 9, 2017
The position paper outlines some of the considerations that are relevent when making a decision to swtich.

EBE, EFPIA and IFPMA have launched a position paper entitled 'Considerations for physicians on switching decisions regarding biosimilars'


Switching describes a physician's decision to exchange one product that a patient receives for another. With the introduction of biosimilars, physicians may be encouraged to switch patients from an original biologic (reference product) to any of its biosimilars (or vice versa) in order to reduce costs.

January 18, 2017
In their position paper published in ESMO Open, the European Society for Medical Oncology outlines the potential benefit of biosimilars to patients and healthcare systems.

January 18, 2017
Boehringer Ingelheim's adalimumab biosimilar candidate to Humira® has been accepted for regulatory review by the EMA and FDA

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