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FDA approval datum agenda

1. rijkerrrr 9 maart 2010 11:25

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   post hier FDA approval datums op die gaan komen.
2. [verwijderd] 9 maart 2010 11:32

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   CXM: FDA-decision expected on 3thrd of March.
   IS nog niet ontvangen.
3. [verwijderd] 9 maart 2010 15:17

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   CTIC de 22e maart pre op 23 april definitieve ;)
   vorige maand ingestapt at ctic 0.67, met bescheiden 5k
4. [verwijderd] 9 maart 2010 15:49

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   NEXM zou volgens geruchten rond de 8ste maart bericht krijgen van FDA. Ik heb hier echter nog niets van kunnen terugvinden in offciele PB's.
   Nu gaan ze toch al lekker omhoog...+15%. Voorkennis??
   
5. [verwijderd] 9 maart 2010 21:22

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   Kennen jullie deze site al?
   
   www.fdacal.com/
6. [verwijderd] 9 maart 2010 22:02

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   [Modbreak IEX]: Gelieve op de inhoud van uw berichten te letten, bericht is bij dezen verwijderd.]
7. [verwijderd] 10 maart 2010 12:49

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   quote:

   Koning Ruf schreef:

   [quote=rijkerrrr]
   post hier FDA approval datums op die gaan komen.
   [/quote]
   heb je geen flikker aan!
   

   toch wel zeker wel
8. [verwijderd] 3 mei 2010 12:08

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   link met de verwachte fda-data komende week van
   
   intermune
   questcor pharmaceutical
   bayer
   
   www.rttnews.com/ArticleView.aspx?Id=1...
   
   
9. real life 8 september 2010 22:56

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   (SVNT) Savient Pharmaceuticals
   Drug/indication: Krystexxa for gout
   Approval decision date: Sept. 14
   The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.
   
   (JAV) Javelin Pharmaceuticals
   Drug/indication: Dyloject for acute moderate-to-severe pain in adults
   Approval decision date: Oct. 3
   If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID.
   
   (HGSI) Human Genome Sciences
   Drug/indication: Zalbin for hepatitis C
   Approval decision date: Oct. 4
   Zalbin is a longer-acting formulation of interferon that can be dosed as infrequently as every two weeks for the treatment of hepatitis C. Currently approved long-acting interferons required once-weekly dosing.
   
   (ALXA)Alexza Pharmaceuticals
   Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder
   Approval decision date: Oct. 11
   AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder. Biovail(BVF) will market AZ-004 in the U.S. and Canada, if approved
   
   (JAZZ)Jazz Pharmaceuticals
   Drug/indication: JZP-6 for fibromyalgia
   Approval decision date: Oct. 11
   JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.
   
   (ARNA) Arena Pharmaceuticals
   Drug/indication: Lorcaserin for obesity
   Approval decision date: Oct. 22
   Lorcaserin is one of three obesity drugs currently under review by the FDA. Regulators have not yet indicated whether Arena will be required to bring lorcaserin in front of an advisory panel.
   
   (VVUS) Vivus
   Drug/indication: Qnexa for obesity
   Approval decision date: October 28
   The FDA has scheduled an advisory committee meeting on July 15 to review Qnexa's safety and efficacy as a weight-loss drug. The FDA's review of Qnexa will be posted to the agency's web site on July 13 or July 14.
   
   (BOID) Biodel
   Drug/indication: VIAject for diabetes
   Approval decision date: Oct. 30
   VIAject is a fast-acting insulin analogue designed for absorption into the bloodstream that's faster than currently marketed rapid-acting insulin.
   
10. staalfreak2 12 september 2010 11:38

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    finance.yahoo.com/news/BSD-Medical-Re...
    
    BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System
    
    
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    {"s" : "bsdm","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: BSD Medical Corporation On Wednesday August 18, 2010, 7:00 am EDT
    SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (NASDAQ:BSDM - News) (Company or BSD) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market its MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of BSD’s 510(k) Premarket Notification submission authorizes the commercial sale of the MTX-180 in the United States. The MTX-180 was designed to provide a higher power, optimized system targeted to the growing therapeutic interventional and surgical oncology market.
    
    The MTX-180 utilizes innovative synchronous phased array technology that was developed and patented by BSD to deliver targeted microwave energy to ablate (destroy) soft tissue. BSD employed its extensive 32-year background in developing thermal therapy systems in the design of the MTX-180. BSD’s patented and patents pending technology allows the MTX-180 to provide larger and more uniform zones of ablation during a single procedure. Third party independent testing was conducted at a U.S. university medical center that is a world leader in ablation treatments. The testing data demonstrated that the MTX-180 is a user-friendly system that delivers larger, more uniform ablation zones in shorter periods of time.
    
    The MTX-180 is a compact, mobile, state-of-the-art, proprietary system that includes a microwave generator, single-patient-use disposable antennas, and a thermistor-based temperature monitoring system. The innovative design of the MTX-180 is the first of its kind that allows delivery of higher power levels using a single generator. The delivery of microwave energy is controlled utilizing an interactive, touch screen monitor that allows the operator to quickly and easily control the treatment.
    
    “The MTX-180 represents a significant advance in our strategy to diversify BSD’s products and increase revenue,” said Harold Wolcott, BSD President. “The MTX-180 introduces into the Company’s product line an innovative, high-end disposable that is used in each ablation treatment, and will provide a significant ongoing revenue stream. The soft tissue ablation world market potential is estimated to exceed $2 billion. We believe that the MicroThermX System provides significant advantages over currently available devices that will allow us to capitalize on this rapidly expanding market.”
    
    Currently, radiofrequency (RF) energy is utilized most frequently in the interventional oncology ablation market. Published studies have demonstrated that the use of microwave energy has numerous advantages over RF energy for the delivery of ablation therapy, including faster set-up, shorter ablation times, larger ablation zones, and higher intratumoral temperatures. For these reasons, interventional oncology key opinion leaders regard microwave as the future of soft tissue ablation therapy. The MTX-180 has been designed to provide optimized microwave ablation therapy.
    
    The MTX-180 provides minimally invasive access to the target tissue and can be used in open surgical as well as in percutaneous ablation procedures, which will allow the MTX-180 to be used by both surgeons and interventional radiologists.
    
    CE Marking approval for the MTX-180 System is imminent and will allow BSD to initiate a European market launch.
    
    About BSD Medical Corporation
    
    BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radiofrequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system has been developed as a stand-alone therapy to ablate and destroy soft tissue. The Company has developed extensive intellectual property, multiple products in the market and well established distribution in the United States, Europe and Asia. Certain of the Company’s products have received regulatory approvals in the United States, Europe and China. For further information visit BSD Medical's website at www.BSDMedical.com.
    
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