Horizon scanning: Phase III study on elesclomol for advanced melanoma fails to meet primary endpoint of progression-free survival
Source: Journal of Clinical Oncology
Area: News
According to the phase III study SYMMETRY published early online in the Journal of Clinical Oncology, elesclomol added to paclitaxel does not improve progression-free survival in patients with advanced melanoma.
The study involved a total of 651 patients with stage IV chemotherapy-naive melanoma who were randomised to receive paclitaxel 80 mg/m2 either alone or in combination with elesclomol 213 mg/m2 administered weekly for 3 weeks of a 4-week cycle. Patients were stratified by prior systemic treatment, M1 subclass, and baseline lactate dehydrogenase (LDH) levels...
Source: NeLM - News - February 12, 2013 Category: Drugs & Pharmacology Source Type: news
BMJ Analysis: Nutrition and fluid balance must be taken seriously
Source: British Medical Journal (BMJ)
Area: News
The authors of this article examine the scale of malnutrition and poor hydration in hospitals and communities, explain why it matters, and put forward proposals for change. (Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
NHS governance review 2013
Source: NHS Primary Care Commissioning (NHS PCC)
Area: News
This second annual review, based on desk-top research of over 100 NHS trust, Foundation Trust and PCT annual reports, assesses NHS governance and how these arrangements are communicated. It also draws on comparisons from last year and survey responses from over 60 NHS leaders, to highlight areas for improvement and provide practical advice for achieving best practice.
Please see the link below for details. (Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Department of Health recommends product label messages on vitamin D supplements for at risk groups
Source: Department of Health (DH)
Area: News
The Department of Health, in agreement with the food supplements industry, has produced some voluntary statements to apply to vitamin D supplements for at risk groups. Please see the link below for details. (Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Statement of collaboration between NICE and Public Heath England
Source: NICE
Area: News
According to a press release, NICE and Public Health England (PHE) have agreed to collaborate on:
. Communicating with and supporting the local public health system . Reviewing evidence and providing evidence-based guidance and other products . Providing access to evidence about public health . Providing support to put guidance into practice . Creating a standard public health taxonomy
Please see the link below for further details of the collaboration.
(Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Horizon scanning: Eziclen®/Izinova® for bowel cleansing completes European decentralised registration procedure
Source: MarketWatch
Area: News
According to a Market Watch report, the sulphate-based bowel cleansing preparation Eziclen® / Izinova® (containing sodium, magnesium and potassium sulphates) has successfully completed its European decentralised registration procedure involving 16 countries, with launch expected by the end of 2013. The product will be indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel (e.g. bowel visualisation including bowel endoscopy and radiology or surgical procedure). Each Member State (including the UK) should now adopt a national decision within 30 days.
...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
RPS and NPA support new inhaler recycling scheme
Source: Royal Pharmaceutical Society (RPS)
Area: News
The Royal Pharmaceutical Society (RPS) and National Pharmacy Association are supporting the first UK-wide inhaler recycling and recovery scheme, which is being launched today (11 Feb 2013) in over 1,300 community pharmacies.
The 'Complete the Cycle' scheme, which is being run by GlaxoSmithKline (GSK), provides the opportunity for pharmacists to interact with their patients to help them improve their inhaler technique, better manage their condition and reduce medicine wastage. Please see the link below for details. (Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Horizon scanning: Interim analysis shows improved survival with bevacizumab in recurrent and metastatic cervical cancer
Source: PharmaLive
Area: News
PharmaLive has reported on the results of an interim analysis of the GOG240 randomised controlled trial, which evaluated the addition of bevacizumab to chemotherapy in patients with advanced, recurrent, or persistent cervical cancer that was not curable with standard treatment.
The study enrolled 452 patients in the US and Spain between 2009 and 2012, and was designed to address two questions: 1) is topotecan plus paclitaxel superior to cisplatin plus paclitaxel in combination and 2) does the addition of bevacizumab to either regimen improved overall survival (OS). Patients were th...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Horizon scanning: US FDA approves pomalidomide (Pomalyst®) for advanced multiple myeloma
The objective response rate was 7.4% in the monotherapy arm (median duration of response not yet reached) and 29.2% in the combination group (median duration of response of 7.4 months).
Pomalidomide carries a Boxed Warning alerting patients and healthcare professionals that it should not be used in pregnant women due to a risk of severe life-threatening birth defects, and that it can cause blood clots. It is available only through a Risk Evaluation and Mitigation Strategy (REMS) Program, similar to those in ... (Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Company-led drug recall: Fosavance® (alendronic acid and colecalciferol)
Source: MHRA
Area: News
A company-led recall of a batch of Fosavance® (alendronic acid and colecalciferol) has been issued, as 239 packs have been inadvertently parallel distributed in the UK (when intended for the Irish market). The content of colecalciferol in tablets from this batch is 140mcg whereas the colecalciferol content of the presentation authorised in the UK is 70mcg.
The company is B&S Healthcare and the affected batch is 10F341 (Expiry September 2013). For further details, please see the link below.
(Source: NeLM - News)
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Review of the shortcomings of product information for medicines - UK Government view
Source: MHRA
Area: News
The new Pharmacovigilance Directive requires the European Commission (EC) to produce a report on the shortcomings of product information and to bring forward proposals for legislative change. The EC has engaged consultants to produce this report and publication is expected in the summer of 2013.
The UK Government's position on this review is available via the link below. This makes a number of recommendations on what legislative changes are required, and the Government urges the EC to 'take this important opportunity to address the serious shortcomings in the current legisla...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
HPA: Measles at highest level for 18 years
Source: Health Protection Agency (HPA)
Area: News
According to figures published by the Health Protection Agency (HPA), there were 2,016 confirmed cases of measles in England and Wales reported in 2012 - the highest annual total since 1994. The cases reported during 2012 have been associated with prolonged outbreaks in Merseyside and Sussex, as well as several smaller outbreaks in travelling communities across England and Wales.
The head of immunisation at the HPA commented that MMR vaccine uptake is now at historically high levels, but that measles can spread easily among communities that are poorly vaccinated...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Department of Health letter reminds healthcare professionals of the importance of finger prick tests in managing type 1 diabetes
Source: Department of Health (DH)
Area: News
The Department of Health has issued a letter to PCTs, chief executives, doctors and community pharmacists to remind them of the importance of finger prick glucose testing (self-blood glucose measurement; SBGM) for people with type 1 diabetes, and to highlight the following:
. The requirements placed upon those with type 1 diabetes by the Driver and Vehicle Licensing Agency
. The differences between type 1 and type 2 diabetes
. The essential role of SBGM in helping those with type 1 to remain safe, and to cope with the demands of day-to-...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
Systematic review and meta-analysis: Maternal omega-3 supplementation and offspring development
Source: American Journal of Clinical Nutrition
Area: News
According to the results of a systematic review and meta-analysis, there is no conclusive evidence to either support or refute the hypothesis that omega-3 long-chain PUFA (LCPUFA) supplementation in pregnancy improves cognitive or visual development.
The authors note that maternal fish consumption during pregnancy has been positively associated with cognitive and visual abilities in the offspring; leading to the hypothesis that maternal omega-3 LCPUFA supplementation improves children's neurological and visual development. The purpose of their systematic...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
UK observational study finds association between insulin use and increased risk of adverse outcomes in patients with type 2 diabetes
Source: Journal of Clinical Endocrinology and Metabolism
Area: News
According to the results of a UK retrospective cohort study published early online in the Journal of Clinical Endocrinology and Metabolism, use of insulin therapy was associated with an increased risk of diabetes-related complications, cancer, and death in patients with type 2 diabetes, when compared to a reference group of metformin monotherapy. Differences in baseline characteristics between treatment groups should however be considered when interpreting these results.
The authors note that the use of exogenous insulin in people with...
Source: NeLM - News - February 11, 2013 Category: Drugs & Pharmacology Source Type: news
