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Biotech researcher whose aim is to provide as much free and readily available information to all, in particular those starting out with their biotech research. I research more than I trade but am always willing to throw a dollar or two towards companies with upcoming catalysts. I live in New... More
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  • BioPharmCatalyst news 7/8/10 0 comments
    Jul 8, 2010 9:46 AM | about stocks: INFI, PSDV, ALIM

    ALIM ($7.13) and PSDV ($3.16) announced today that following last week's NDA filing for Diabetic Macular Edema, a Marketing Authorization Application (NYSE:MAA) had been filed in Europe for the approval of Iluvien. Unlike in the US, no definitive action date is given for approval.

    PSDV develops tiny delivery products that are implanted and then provide sustained release of drugs.

    PSDV's main product in its pipeline is Iluvien for the treatment of Diabetic Macular Edema (DMA). There is currently no approved drug for this indication where the current standard of care is laser treatment. This is a back of they eye condition and front of the eye treatments such as eye drops are of little use as they do not reach the back of the eye. PSDV offers to insert a device directly to the back of the eye. DME is the primary cause of vision loss of diabetes patients.

    NDA was filed on June 29, 2010, with a request for a 6 month Priority Review. If granted, a PDUFA action date of December 29, 2010 is expected. The FDA is required to respond to the Priority Review request within 45 days or by August 13.

    Read press release here

    INFI announced today that It had formed a partnership with Intellikine, Inc for the development and commercialisation of Intellikine's portfolio of inhibitors of the delta and gamma isoforms of phosphoinositide-3-kinase (PI3K). The products at this stage a pre-clinical, with INK1197, for inflammatory diseases, expected to start clinical trials in 2011. INFI will pay an initial $13.5m and up to $25 million in success-based milestones for the development of two distinct product candidates (also PI3K) and up to $450 million in success-based milestones for the approval and commercialization of two distinct products. Read press release here

    FDA Calendar available by clicking HERE

    Disclosure: No positions
    Stocks: INFI, PSDV, ALIM
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