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Anti-infectives Knowledge Network
Hospital infections can disrupt treatment programmes, and in many cases, threaten the lives of patients.
The Anti-Infectives Knowledge Network brings together the expertise and experience of a variety of leaders in this area. Multimedia presentations showing key lectures from all the major congresses and stand-alone events will be reported here, along with links to treatment guidelines and suggested further reading.
Our 2012 coverage starts with a two-day Symposium, Individual approaches to managing invasive candidiasis: from guidelines to practice. This meeting took place at the Institut Pasteur, Paris on 30th and 31st January 2012. Topics covered include new diagnostic techniques, antifungal agents, the impact of biofilms and the evolution of the ESCMID treatment guidelines. A number of patient case studies relating to haematology, transplantation, HIV, and neonates are also included. Multimedia presentations – slides and accompanying video – are available for the expert speakers appearing in the programme.
Besides all this, the Knowledge Network also features icase; a downloadable tool for creating interactive case studies, which can later be shared and reviewed.
We encourage you to return regularly for the latest news, clinical insights, and essential information from European congresses. Congresses being covered include ISICEM, ECCMID, EBMT, ICCN and ISHAM. Congress reports will be added regularly, so keep visiting for the latest information.
Click here to enter the Anti-Infectives Knowledge Network.
Date of Preparation March 2012
AI/12/0001/EUc
VEN 307(diltiazem crean) from S.L.A.Pharma met the primary endpoint in a pivitol Phase III study, showing a statistically significant reduction in Anal Pain on defecation after four weeks compared to placebo. Both 4% and 2% diltiazem cream arms demonstrated statistically significant improvement over placebo for change in week four NRS for worst anal pain. Reduction in pain score was 0.44 (p=0.0108) and 0.42 (p=0.0134), for 4% and 2% diltiazem, respectively. Ventrus Bioscience holds the US rights to the drug and plans to meet with FDA officials to discuss the next steps toward filing an NDA. A further Phase III trial is planned for the autumn of 2012.
NICE has issued new draft guidance recommending the use by the NHS of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with Prostate Cancer. After additional information about the drug was submitted to NICE by the company, the treatment will now be made routinely available for patients on the NHS. NICE had previously rejected the drug because it did not offer value for money however this update included a revised patient access scheme which involves providing the drug to the NHS at a discounted price. The draft guidance has been passed on to consultees, who have the opportunity to appeal against it. NHS bodies will make funding decisions locally until NICE issues its final guidance on the drug.
Adamas Pharmaceuticals has held an end-of-Phase II meeting with the FDA to discuss the proposed safety and efficacy studies to be conducted for the registration of Arimenda (memantine HCl extended release and donepezil HCl) capsules, for treatment of Alzheimers Disease. At the meeting, the FDA agreed to Adamas' Phase III clinical safety studies and confirmed that, if successful, those studies should be sufficient to support a future NDA submission. Arimenda capsules are expected to be the first once-daily fixed dose combination product for Alzheimer's disease available for the US market. The drug is designed to simplify the initiation of combination therapy by providing the most convenient means to introduce combination therapy to patients who are already taking donepezil. Adamas is on track to submit its first NDA for Arimenda in 2013.