takeda pharmaceutical co ltd (TKPHF) Key Developments
Takeda Pharmaceutical Company's Copaxone Available in Japan
Nov 26 15
Takeda Pharmaceutical Company Limited announced that the multiple sclerosis treatment drug, "Copaxone Subcutaneous Injection 20 mg Syringe" (generic name: glatiramer acetate, hereinafter "Copaxone") has become available in Japan. In March 2013, Takeda and Teva entered into a licensing agreement for commercialization of this drug in Japan, and on September 28, 2015 Takeda obtained NDA approval.
U.S. FDA Approves Takeda’s NINLARO® (ixazomib), First and Only Oral Proteasome Inhibitor to Treat Multiple Myeloma
Nov 20 15
Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved NINLARO® (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Takeda submitted a New Drug Application for NINLARO to the FDA in July 2015, and in September NINLARO was granted Priority Review status with a PDUFA date of March 10, 2016, reflecting the profound and continuing unmet need for new treatments for multiple myeloma, a devastating, relapsing and incurable rare cancer.
Takeda Pharmaceutical Company Limited Presents at Boston Biotech Conferences 2015, Nov-11-2015 01:00 PM
Nov 8 15
Takeda Pharmaceutical Company Limited Presents at Boston Biotech Conferences 2015, Nov-11-2015 01:00 PM. Venue: Apella, 450 East 29th Street, NY 10016, New York, United States.
Takeda Pharmaceutical Company Limited to Present Data from Ixazomib’s Phase 3 Study in Relapsed/Refractory Multiple Myeloma at Upcoming American Society of Hematology Annual Meeting
Nov 5 15
Takeda Pharmaceutical Company Limited announced that it will present Phase 3 data from the TOURMALINE-MM1 ixazomib clinical trial at the 57th American Society of Hematology annual meeting to be held in Orlando, Florida from December 5 to 8, 2015. It will be presenting pivotal data on the ixazomib program, as well as the five year overall survival data for ADCETRIS in relapsed/refractory Hodgkin lymphoma. The success of these two programs, in addition to data it will be presenting on VELCADE and its pipeline, is the realization of decades of commitment to patients with hematological malignancies. This is the first time Phase 3 data will be presented for ixazomib, an oral, once-weekly proteasome inhibitor which, if approved, would enable the first all-oral triplet regimen containing a proteasome inhibitor for the treatment of relapsed/refractory multiple myeloma. Ixazomib is the first oral proteasome inhibitor in late stage clinical development. The TOURMALINE-MM1 study is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial which was designed to evaluate the superiority of once-a-week oral ixazomib plus lenalidomide and dexamethasone vs. placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Ixazomib has been granted Priority Review from the U.S. Food and Drug Administration and Accelerated Assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency, respectively, validating the profound and continuing unmet need for new multiple myeloma treatments. These submissions for the treatment of patients with relapsed and/or refractory multiple myeloma were based on the TOURMALINE-MM1 data.
Takeda Pharmaceutical Company Limited Obtains the New Drug Application Approval for Copaxone Subcutaneous Injection 20 Mg Syringe
Nov 2 15
Takeda Pharmaceutical Company Limited obtained the New Drug Application approval for Copaxone Subcutaneous Injection 20 mg Syringe (generic name: glatiramer acetate), a drug for the treatment of multiple sclerosis, from the Japanese Ministry of Health, Labour and Welfare. Developed by Teva Pharmaceutical Industries Ltd. (Teva), Copaxone is a subcutaneous injection administered once daily to prevent the relapse of multiple sclerosis. Copaxone is one of the most frequently-used drugs in multiple sclerosis therapy and is approved in more than 50 countries worldwide. The approval is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted in Japan by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis as well as 3 clinical trials from overseas conducted by Teva in patients with relapsing-remitting multiple sclerosis.