CADTH rapid review: Antibiotics for the Prevention of Post-Caesarean Section Complications
Source: Canadian Agency for Drugs and Technologies in Health (CADTH) Area: News This Canadian review examines the efficacy and safety of antibiotic prophylaxis administered before or after clamping during caesarean sections for the prevention of maternal post-surgical infections.   A total of four systematic reviews and meta-analyses, four randomised controlled trials, and five non-randomised studies were included in this review. Some of the findings were as follows:   . Evidence from one systematic review and one non-randomized study suggested that compared to no antibiotic prophylaxis, antibiotic ...
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon Scanning: FDA grants orphan drug status to lenvatinib for thyroid cancer
Source: BioSpace Area: News According to a review in Biospace, The U.S FDA has granted orphan drug designation to lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer. Lenvatinib is an investigational small molecule tyrosine kinase inhibitor being studied as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC). (Source: NeLM - News)
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices examine reports of HRT delaying onset of dementia
Source: NHS Choices Area: News A number of newspapers have reported that taking hormone replacement therapy (HRT) could delay the onset of Alzheimer's disease for millions of women.   NHS Choices has assessed the study, published in PLOS ONE that involved 63 postmenopausal women who had been taking HRT. The research looked at the relationship between the genetic variant APOE-e4 (known to increase the risk of developing Alzheimer's disease), HRT and telomere length, which is an indicator of cell ageing. The study found that: . post-menopausal women who carried APOE-e4 had about six times higher odds of ...
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices assessment of press report that women's lung cancer death rates set to rise
Source: NHS Choices Area: News NHS Choices has assessed the study, published in Annals of Oncology, which predicted cancer deaths from all forms of cancer across the European Union in 2013, and reported that lung cancer is now the leading cause of cancer-related deaths in British women. The rise in lung cancer deaths may be caused by: . the long-term effect of the greater number of women smokers during the 1960s and 70s . the fact that lung cancer remains challenging to treat, as it is often not diagnosed until it is at an advanced stage. The study also found that between 2009 and 2013, overall death ...
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

Company restores some access to multiple sclerosis drug after pressure from neurologists
Source: BMJ Area: News Genzyme has restored some access to alemtuzumab that it had previously withdrawn. Genzyme withdrew off-label use of alemtuzumab last year for patients with multiple sclerosis, which caused a large amount of unrest amongst neurologists. (Source: NeLM - News)
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Positive data reported for bavituximab in Stage IV Pancreatic Cancer
Source: BioSpace Area: News According to a report in Biospace, an open-label, randomised phase II study of bavituximab in combination with gemcitabine in patients with previously untreated, advanced stage IV pancreatic cancer resulted in more that a doubling of overall response rate (ORR) and a marginal improvement in overall survival (OS) when compared with gemcitabine alone (control arm).   In the trial which enrolled 70 patients, patients treated with a combination of bavituximab and gemcitabine had a 28% tumour response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial...
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

RCT: Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in head and neck cancer (PARADIGM- a phase 3 trial).
Source: Lancet Oncology Area: News PARADIGM is a multicentre open-label phase 3 study comparing the use of docetaxel, cisplatin, and fluorouracil (TPF) induction chemotherapy followed by concurrent chemoradiotherapy with cisplatin-based concurrent chemoradiotherapy alone in patients with locally advanced head and neck cancer. One hundred and forty five patients were randomly assigned in a 1:1 ratio to receive either induction chemotherapy with three cycles of TPF followed by concurrent chemoradiotherapy with either docetaxel or carboplatin, or concurrent chemoradiotherapy alone with two cycles of bolus cisplatin. The prim...
Source: NeLM - News - February 15, 2013 Category: Drugs & Pharmacology Source Type: news

Review: Paget's disease of bone
Source: N Engl J Med Area: News This review on Paget's disease of bone begins with a case vignette followed by a discussion of the clinical problem, signs and symptoms, diagnosis, bisphosphonate treatment non-pharmacologic treatment, areas of uncertainty, guidelines, and ends with the author's clinical recommendations on the management of the case in hand. (Source: NeLM - News)
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

Bulletin for proposed CCGs: 7 February 2013
Source: NHS Commissioning Board Area: News The February bulletin focuses on the Francis report. Other topics covered include:   . 2013/14 NHS standard contract published . Consultation on 2014/15 CCG outcomes indicator set . CCG VAT registration . NHAIS / GP Payments . Changes to quality accounts reporting arrangements for 2012/13 . Authorisation of patient group directions by CCGs . Emergency planning framework . CCG training on new calculation service for QOF payments . Stronger together: Guidance for health and wellbeing boards . End ...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

No difference in overall survival reported in phase III TIVO-1 study of tivozanib vs. sorafenib for advanced renal cell carcinoma
Source: BioSpace Area: News AVEO Oncology and Astellas Pharma Inc. have announced overall survival (OS) data (secondary endpoint) for tivozanib, an oral, once-daily, investigational tyrosine kinase inhibitor, from the phase III TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study in patients with advanced renal cell carcinoma (RCC). The final analysis shows a median OS of 28.8 months (95% CI: 22.5-NA) for tivozanib vs. 29.3 months (29.3 to NA) for the comparator arm, sorafenib. No statistical difference between the two arms (hazard ratio 1.245, p=0.105) was observed.   TIVO-1 is a global, randomis...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

Longer-acting human growth hormone (hGH-CTP) receives orphan drug designation in Europe
Source: BioSpace Area: News The European Medicines has granted orphan drug designation to hGH-CTP, a longer-acting version of human growth hormone in development for the treatment of growth hormone deficiency. In Phase II studies in growth hormone-deficient adults, hGH-CTP was reported to be safe and well tolerated, and it demonstrated the potential to be administered once-weekly, replacing seven daily injections of currently marketed human growth hormone. The company PROLOR has initiated a phase II trial in children with growth hormone deficiency and plans a phase III trial in growth hormone-deficient adults, which is s...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

FDA grants 'Breakthrough Therapy Designation' to ibrutinib for treatment of relapsed or refractory mantle cell lymphoma and Waldenstrom's macroglobulinemia
Source: BioSpace , PharmaTimes Area: News The FDA has granted 'Breakthrough Therapy Designation' to ibrutinib (as monotherapy) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and for the treatment of patients with Waldenstrom's macroglobulinemia (WM).   Ibrutinib is an investigational oral agent designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK), a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel regulating apoptosis, adhesion, and cell migration and homing.   The Breakt...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

Kidney Disease CCG Profiles
Source: NHS Kidney Care Area: News NHS Kidney Care has produced a kidney disease profile for each of the 211 clinical commissioning groups (CCGs). The profiles are intended to help CCGs and other stakeholders, assess local kidney care need and current service levels in order to inform planning and facilitate improvements where necessary in the quality and productivity of services for those with kidney disease.   The profiles contain information for each CCG on:   . Observed and expected number of people with chronic kidney disease . Clinical management and achievement of chronic kidney disea...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

CADTH rapid review: Probiotics for antibiotic-associated diarrhoea, clostridium difficile infection and irritable bowel syndrome
Source: Canadian Agency for Drugs and Technologies in Health (CADTH) Area: News This Canadian review examines the efficacy and safety of probiotics in antibiotic-associated diarrhoea (AAD), clostridium difficile infection (CDI) and irritable bowel syndrome (IBS).   A total of one health technology assessment, five systematic reviews/meta-analyses, and 25 RCTs were included in this review. Some of the findings reported were as follows:   . There is a lack of assessment and systematic reporting of adverse events in probiotic trials.   . Evidence from two meta-analyses indicated probioti...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news

Australia launches national scheme to vaccinate boys against HPV
Source: BMJ Area: News According to a BMJ news report, Australia has started to vaccinate boys against human papillomavirus (HPV), making it the first country in the world to publicly fund HPV vaccination of this group, in a bid to protect against genital warts and anal, penile, and throat cancers. Starting in February, they will receive three doses of the quadrivalent vaccine Gardasil at ages 12-13, as part of a national, federally funded school based programme. A catch-up scheme will also run for 14-15 year old boys until the end of the school year in 2014. It will cost the federal government £13.8m over four years, in...
Source: NeLM - News - February 14, 2013 Category: Drugs & Pharmacology Source Type: news