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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

    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
    Tags: INFI, PSDV, ALIM
    Jul 08 9:46 AM | Link | Comment!
  • BioPharmCatalyst morning news update
    FDA Calendar Updates

    (ImmunoGen, Inc.) $8.60;

    Announced today that Genentech had submitted a BLA on July 6/7 for trastuzumab-DM1, or T-DM1, to treat patients with advanced HER2-positive breast cancer who had previously received multiple chemotherapies and HER2-targeted medicines. Roche have stated that sales of the drug could be close to just under $2b. Press release here.

    NLTX (Nile Therapeutics, Inc) $0.31

    Announced today that it had completed the dosing in its Phase 2 trial for acute decompensated heart failure, or ADHF. Data is due 4Q this year.Press release here.

    Clinical Trial Database Updates

    XNPT (XenoPort) $6.45

    GSK (GlaxoSmithKline) $34.04

    Reported today that it failed its Phase 2b trial for GSK1838262/XP13512 (gabapentin enacarbil) for migraines noting a higher than expected placebo response rate. This is the same product that received a CRL (Complete Response Letter) from the FDA earlier this year for Restless Legs Syndrome, citing safety concerns from preclinical studies. They intend to resubmit their NDA later this year. Press release here.

    Other news

    ONTY (Oncothyreon Inc). $3.27

    Announced that it will issue up to $20m in common shares over a 2 year period to Small Cap Biotech Value Ltd. Press release here.

    For more information on small cap biotech, FDA Calendar and a complete database of clinical trials see BioPharmCatalyst

    Disclosure: No positions
    Jul 07 11:24 AM | Link | Comment!
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