Kyowa Kirin Pharmaceutical Research, Inc.

73 articles about Kyowa Kirin Pharmaceutical Research, Inc.

• MEI Pharma and Kyowa Kirin Announce Updated Clinical Data from the Phase 1b Study Evaluating ME-401 on an Intermittent Schedule in Patients with Follicular Lymphoma and Other B-cell Malignancies;

  5/13/2020

  Data to be Featured in the American Society of Clinical Oncology 2020 Virtual Scientific Program

• MEI Pharma and Kyowa Kirin Announce Global License, Development and Commercialization Agreement for ME-401

  4/14/2020

  MEI Pharma and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S.; MEI to book U.S. sales on 50-50 profit and cost sharing

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  BioSpace Movers & Shakers, April 10

  4/10/2020

  Biopharma companies strengthen their leadership teams and boards with this week's Movers & Shakers.

• Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)

  2/27/2020

  Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application for Crysvita® for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.

• Kyowa Kirin Announces NOURIANZ™ (Istradefylline) Now Available in the U.S. for Treatment of Parkinson’s Disease “Off” Episodes

  10/14/2019

  First and only Adenosine A2A receptor antagonist for use in Parkinson’s disease in the U.S.

• Ultragenyx and Kyowa Kirin Announce Intent to Submit Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) in Tumor-Induced Osteomalacia (TIO)

  9/10/2019

  Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced plans to submit a supplemental Biologics License Application to the U.S. Food and Drug Administration for Crysvita® for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.

• Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease

  8/28/2019

  First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in the U.S.

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  Kyowa Kirin's Nourianz Given the Green Light by FDA for Parkinson's Disease

  8/28/2019

  Nourianz (istradefylline) was given the thumbs-up as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience “OFF” episodes.

• Ultragenyx and Kyowa Kirin Announce Positive 64-Week Results for Crysvita® (burosumab) from Phase 3 Study in Children with X-linked Hypophosphatemia (XLH)

  2/14/2019

  Results Confirm and Extend 40-Week Findings that Treatment with Crysvita is Superior to Conventional Therapy

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  FDA Approves Eight Novel Drugs in August

  8/31/2018

  The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.

• FDA approves treatment for two rare types of non-Hodgkin lymphoma

  8/8/2018

  The U.S. Food and Drug Administration today approved Poteligeo injection.

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  ASCO 2018: Results Keep Rolling In

  6/4/2018

  There’s plenty of news coming out of the American Society of Clinical Oncology (ASCO) Annual Meeting behind held in Chicago. Here’s a look at a few more of the top stories.
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  Ultragenyx Stock Booms After Burosumab Continues to Impress in Phase III Study

  12/4/2017

  Shares of Ultragenyx are sharply climbing this morning after the company announced positive results from its Phase III study of burosumab in adults with XLH.

• Ultragenyx And Kyowa Hakko Kirin Announce FDA Acceptance And Priority Review Designation Of Burosumab’s Biologics License Application

  10/10/2017

• Syndax Announces Dosing Of First Patient In Pivotal Trial Of Entinostat For The Treatment Of Advanced Or Recurrent Breast Cancer In Japan By Partner Kyowa Hakko Kirin

  10/5/2017

• Kyowa Hakko Kirin Joins Certara Corporation’s Simcyp Consortium

  9/13/2017

• Ultragenyx And Kyowa Hakko Kirin Announce Submission Of Burosumab’s Biologics License Application In The U.S.

  8/24/2017

• Ultragenyx, Kyowa Hakko Kirin And Kyowa Kirin International Announce Positive 24-Week Data From Adult Phase II Study Of Burosumab (KRN23) In X-Linked Hypophosphatemia

  4/19/2017

• GHIT Fund Welcomes Ten New Partnerships With FUJIFILM, Otsuka, GlaxoSmithKline, Johnson & Johnson, Kyowa Hakko Kirin, Merck & Co., Mitsubishi Tanabe, Nipro Corporation, Sumitomo Dainippon Pharma Co., Ltd. And Salesforce.Com

  6/6/2016

• Kyowa Hakko Kirin And Bristol-Myers Squibb Announce Immuno-Oncology Clinical Collaboration Studying Mogamulizumab And Opdivo (Nivolumab) In Advanced Solid Tumors In The U.S.

  7/30/2015