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St. Jude Medical Announces FDA Approval Of The Cool Point Irrigation Pump
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) approval of its Cool Point™ Irrigation Pump. Used in conjunction with SJM open-irrigated ablation catheters, an irrigation pump supplies a continuous flow of saline through the catheter"s inner lumen to cool the ablation electrode for more effective energy delivery. Designed to enhance physicians" ability to perform successful atrial ablations, the new Cool Point irrigation pump was developed specifically for use with the company"s IBI-1500T9-CP cardiac ablation generator and family of Therapy™ Cool Path™ irrigated catheters.
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FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months
Centocor Ortho Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market STELARA for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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FDA Approves NovoLog(R) Labeling Update Increasing The Time Patients Can Use And Store NovoLog(R) In Their Pumps From Two Days To Six Days
Diabetes patients taking NovoLog® (insulin aspart [rDNA origin] injection) can now use the insulin in their pump for up to six days following the U.S. Food and Drug Administration (FDA) approval of a labeling change, diabetes care company Novo Nordisk announced today.[i] The previous label allowed for NovoLog® to be stored in the pump reservoir for two days. This makes NovoLog® the first and only rapid-acting insulin with this extended in-use time.
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New Faster-Acting Prostate Cancer Drug Hailed As "Significant Advance" In Improving Quality Of Life For Patients, UK

FIRMAGON® (degarelix) a new fast-acting hormone treatment for advanced prostate cancer is being offically launched in the UK yesterday at the British Association of Urological Surgeons Annual Meeting in Glasgow. Prostate cancer is the most common cancer in men, and over 35,000 cases a year (1) are diagnosed in the UK , with 10,239 men dying in 2007.(2) Prostate cancer is fuelled by the male hormone testosterone. The most widely used hormone treatments slow cancer cell growth by lowering production of testosterone in the testicles. FIRMAGON® is given as a simple injection beneath the skin and acts in a unique way by forming a self gelling depot. It rapidly blocks hormone receptors in the pituitary gland, taking almost immediate effect. This is unlike existing hormone treatments which take up to four weeks to reduce testosterone to the required levels.(3) Trials have shown that the new drug can reduce levels of the male hormone, testosterone, below 0.5ng/ml within three days in more than 96 per cent of patients (4). This makes FIRMAGON ® as effective as surgery to remove the testicles, Mr John Anderson , consultant urological surgeon at the Royal Hallamshire Hospital says: "This is an important new step for the treatment of advanced hormone-dependent prostate cancer, with FIRMAGON ® offering a new option and hope for many patients." "Our goal is to achieve fast and sustained reduction in tesosterone levels and FIRMAGON® offers a rapid impact which is comparable to the immediacy achieved by surgery." FIRMAGON® can also improve quality of life for patients by avoiding the initial surges in testosterone associated with the most common treatment currently used.Testosterone surges in some patients with advanced disease can cause tumours to grow rapidly resulting in increased pain, obstruction of the urethra and in severe cases paralysis due to spinal cord compression.(5, 6) Doctors currently prescribe anti-androgen therapy alongside hormone treatments to combat this, but this approach, means additional complication and is associated with the possibility of more side effects. FIRMAGON ® doesn"t cause these initial hormone surges (7) and so doctors don"t have to prescribe anti-androgen therapy to conteract this, avoiding associated side effects and offering an effective monotherapy. In clinical trials FIRMAGON® is generally well-tolerated. The most common side effects in clinical trials were due to the expected physiological effects of testosterone suppression,(such as hot flushes and weight increase) or injection site pain or reddening .(8) A new free DVD "Progress for a Healthy Lifestyle: A Guide for Men on Hormone Therapy for Prostate Cancer" aimed at patients has been produced by Ferring Pharmaceuticals who hold the marketing authorisation for FIRMAGON®, in partnership with the British Uro-oncology Group and ProstateUK, to promote a holistic approach to living with prostate cancer. The DVD features information about hormone treatment but also gives advice on healthy lifestyle inlcuidng excercise and how to eat a prostate-healthy diet with recipes from celebrity chef Brian Turner. It also includes practical advice from top medical experts on how to cope with some of the issues of living with hormone therapy such as sex problems and hot flushes. It also features an interview with BBC radio DJ "Whispering" Bob Harris, who has received treatment for prostate cancer. For more information about Firmagon®, prostate cancer, diet and exercise, please go to the Prostate UK website - http://www.prostateuk.org/ References (1) Incidence on prostate cancer in UK (2) Statistics on deaths from prostate cancer in 2007 (3) 2007 Update of ASCO Practice Guideline for the Initial Hormonal Management of Androgen-Sensitive Metastatic, Recurrent, or Progressive Prostate Cancer: Guideline Summary (4) Boccon-Gibod L, Klotz L, Schroder FH et al. Degarelix compared to leuprolide depot 7.5mg in a 12 month randomised open lable parrallel group phase III study in prostate cancer patients.Abstract 537 presented at the 23rd EAU Congress, Milan, Italy 2008. (5) Labrie F, Dupont A, Belanger A, et al: Flutamide eliminates the risk of disease flare in prostatic cancer patients treated with a luteinizing hormone-releasing hormone agonist. J Urol 138:804-806, 1987. (6) el-Rayes BF, Hussain MH: Hormonal therapy for prostate cancer: Past, present and future. Expert Rev Anticancer Ther 2:37-47, 2002. (7) Anderson J et al. Management of advanced prostate cancer, can we improve on androgen deprivation therapy/ BJU International 2008; 101 (12):1497-1501. (8) FIRMAGON® Summary of Product Characteristics February 2009 Prostate UK


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