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schven_boy 7 posts  |  Last Activity: Apr 9, 2015 9:45 AM Member since: Aug 19, 2002
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  • schven_boy by schven_boy Apr 9, 2015 9:45 AM Flag

    moving.

  • Rich Pharmaceuticals completes manufacturing of RP-323 study drug
    Published 05 February 2015
    http://www.pharmaceutical-business-review.com/news/rich-pharmaceuticals-completes-manufacturing-of-rp-323-study-drug-050215-4505396

    Rich Pharmaceuticals (RCHA), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, announced today that it has competed a GMP clinical batch of RP-323 study drug that was manufactured at the state-of-the-art Wuxi Apptec Biopharmaceutical's facility based in Shanghai, China.

    This new batch of RP-323 represents a new second-generation compound with improved product usability and stability.

    Rich Pharmaceuticals developed the new formulation and all regulatory required testing methods in 2014 and transferred the proprietary technology successfully to Wuxi Apptec for the GMP production of RP-323.

    Currently, the new study drug is in the final examination stage at Wuxi Apptec and is expected to be shipped to clinical sites starting mid-February 2015 for the upcoming planned clinical trials.

    Rich Pharmaceuticals submitted its Investigational New Drug (IND) Application for a Phase 2 multi-center study to evaluate the safety and efficacy of RP-323 in patients with AML and MDS in October 2014. In connection with the IND, Rich Pharmaceuticals was required to manufacture sufficient quantities of RP-323 under GMP.

    "We believe RP-323 has best-in-class potential and holds significant promise for patients suffering from AML and MDS," said Ben Chang, Rich Pharmaceuticals' Chief Executive Officer.

    Mr. Chang further stated, "We are especially excited to have a partner in the manufacture of RP-323 of the high caliber of Wuxi Apptec. We expect to pursue the approval of the IND promptly and to be in clinical studies in the very near term."

    Source: Company Press Releas

  • Rich Pharmaceuticals completes manufacturing of RP-323 study drug
    Published 05 February 2015
    http://www.pharmaceutical-business-review.com/news/rich-pharmaceuticals-completes-manufacturing-of-rp-323-study-drug-050215-4505396

    Rich Pharmaceuticals (RCHA), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, announced today that it has competed a GMP clinical batch of RP-323 study drug that was manufactured at the state-of-the-art Wuxi Apptec Biopharmaceutical's facility based in Shanghai, China.

    This new batch of RP-323 represents a new second-generation compound with improved product usability and stability.

    Rich Pharmaceuticals developed the new formulation and all regulatory required testing methods in 2014 and transferred the proprietary technology successfully to Wuxi Apptec for the GMP production of RP-323.

    Currently, the new study drug is in the final examination stage at Wuxi Apptec and is expected to be shipped to clinical sites starting mid-February 2015 for the upcoming planned clinical trials.

    Rich Pharmaceuticals submitted its Investigational New Drug (IND) Application for a Phase 2 multi-center study to evaluate the safety and efficacy of RP-323 in patients with AML and MDS in October 2014. In connection with the IND, Rich Pharmaceuticals was required to manufacture sufficient quantities of RP-323 under GMP.

    "We believe RP-323 has best-in-class potential and holds significant promise for patients suffering from AML and MDS," said Ben Chang, Rich Pharmaceuticals' Chief Executive Officer.

    Mr. Chang further stated, "We are especially excited to have a partner in the manufacture of RP-323 of the high caliber of Wuxi Apptec. We expect to pursue the approval of the IND promptly and to be in clinical studies in the very near term."

    Source: Company Press Release

  • seriously, not a single post with today's 600% jump?