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Takeda Pharma (TKPYY) 22.9200 $TKPYY

Takeda Receives Marketing Authorization in Canada for NINLARO(TM) (ixazomib) in Relapsed/Refractory Multiple Myeloma
BusinessWire - Mon Aug 08, 6:00AM CDT
Takeda Pharmaceutical Company Limited (TSE:4502) today announced Takeda Canada has received approval from Health Canada for NINLARO(TM) (ixazomib) capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.In Canada, it is estimated that approximately 7,500 people live with multiple myeloma. The approval was primarily based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1, which demonstrated that NINLARO in combination with lenalidomide and dexamethasone significantly extended progression-free survival, with a manageable safety profile in patients with relapsed/refractory multiple myeloma. Due to the high unmet need in multiple myeloma, the New Drug Submission for NINLARO was granted a Priority Review by Health Canada.

Takeda and TiGenix Announce Publication in The Lancet of 24-Week Results of the Phase 3 ADMIRE-CD Trial Investigating Cx601 in the Treatment of Complex Perianal Fistulas in Patients with Crohn's Disease
PR Newswire Europe - Tue Aug 02, 2:08AM CDT
OSAKA, Japan and LEUVEN, Belgium, Aug. 2, 2016 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda" and TiGenix NV ("TiGenix" today announced that the 24-week results of the Phase 3 ADMIRE-CD trial investigating Cx601 have been published in The Lancet. Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally for the treatment of complex perianal fistulas in patients with Crohn's disease with an inadequate response to at least one conventional or biologic therapy.

Takeda & TiGenix Announce Publication in The Lancet of 24-Week Results of the Phase 3 ADMIRE-CD Trial Investigating Cx601 in the Treatment of Complex Perianal Fistulas in Patients with Crohn's Disease
GlobeNewswire - Tue Aug 02, 1:09AM CDT
Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda" and TiGenix NV (Euronext Brussels: TIG) ("TiGenix" today announced that the 24-week results of the Phase 3 ADMIRE-CD trial investigating Cx601 have been published in The Lancet. Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally for the treatment of complex perianal fistulas in patients with Crohn's disease with an inadequate response to at least one conventional or biologic therapy.

Takeda Reports 1st Quarter 2016 Results with a Strong Start to the Year and Confidence in Management Guidance
BusinessWire - Fri Jul 29, 1:00AM CDT
Takeda Pharmaceutical Company Limited (TOKYO:4502):

7 Ultra Safe Stocks to Wait Out Brexit Results
Swarup Gupta - Zacks Investment Research - Thu Jun 23, 9:28AM CDT
Opinion polls suggest that it is difficult to determine which way the referendum over Brexit will go.
NTT: 46.78 (+0.65), WMT: 72.30 (-0.40), TSN: 75.31 (-0.29), NGG: 71.39 (-0.19), DTE: 94.90 (-0.22)

Takeda and M2Gen Collaborate with ORIEN to Speed Clinical Development and Discovery of Cancer Treatments Through Health Informatics
PR Newswire - Thu Jun 16, 6:30AM CDT
Takeda Pharmaceutical Company Limited (TSE: 4502) and M2Gen®, a healthcare informatics solutions company, have established a new collaboration to generate broad genomic data from consenting cancer patients. Under the agreement, Takeda will help build the Oncology Research Information Exchange Network (ORIEN) AvatarTM Research Program based on the Total Cancer Care® Protocol, a prospective observational study enrolling patients with various cancers, and access information generated under this program.

EXAMINE Trial Post-Hoc Analyses of Mortality Data Regarding Cardiovascular Safety of Alogliptin Presented at American Diabetes Association's 76th Scientific Sessions and Published in Diabetes Care
PR Newswire Europe - Sat Jun 11, 12:39PM CDT
Takeda Pharmaceutical Company Limited [TSE: 4502 [http://www.takeda.com/investor-information/]], ("Takeda" announced the publication of a post-hoc analysis from the global EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial (CVOT), which suggested that in patients with Type 2 diabetes and recent acute coronary syndrome (ACS), the risk of death, including CV death, was not higher with the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin compared to placebo during a median follow-up period of 18 months.(1) Trial results reported that in both groups of patients the occurrence of an additional non-fatal CV event, including myocardial infarction (MI), stroke, and unstable angina, was common and increased the risk of death, particularly after hospitalization for heart failure (HHF). This data was presented at the American Diabetes Association's 76(th) Scientific Sessions, and also published in Diabetes Care.

Theravance Biopharma Signs Licensing Deal with Takeda
Zacks Equity Research - Zacks Investment Research - Thu Jun 09, 10:23AM CDT
Theravance Biopharma (TBPH) has entered into a global license, development and commercialization agreement with Takeda (TKPYY) for TD-8954.
PFE: 35.12 (+0.28), TBPH: 27.97 (+0.92), BMY: 59.88 (+0.62)

Takeda Licenses Global Rights to Theravance Biopharma's TD-8954, a Novel 5-HT4 Agonist and Motility Agent for Gastrointestinal Motility Disorders
PR Newswire Europe - Wed Jun 08, 7:52AM CDT
Deal Provides Takeda Global Rights to Selective 5-HT4 Agonist; Highlights Takeda's Commitment to Gastroenterology as a Core Therapeutic Area
TBPH: 27.97 (+0.92)

Roivant Sciences and Takeda Launch Myovant Sciences to Develop Innovative Therapeutics for Women's Health and Prostate Cancer
PR Newswire - Mon Jun 06, 6:00AM CDT
Takeda Pharmaceutical Company Limited (TSE: 4502) and Roivant Sciences Ltd. today announced the formation of Myovant Sciences Ltd. ("Myovant" , a biopharmaceutical company focused on delivering innovative women's health and prostate cancer solutions by efficiently advancing new medicines to market that have the potential to improve the lives of millions of patients. In addition, Lynn Seely, MD, an endocrinologist who led the development of XTANDI® (enzalutamide) for the treatment of prostate cancer as the Chief Medical Officer of Medivation from 2005 to 2015, was named the President & Chief Executive Officer of Myovant Sciences, Inc.

Trintellix (vortioxetine) Now Available in U.S. Pharmacies
PR Newswire - Wed Jun 01, 9:00AM CDT
Takeda Pharmaceuticals U.S.A., Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4502), and Lundbeck announced today that Trintellix (vortioxetine), a once-daily oral antidepressant indicated for the treatment of major depressive disorder (MDD) in adults, is now available in United States pharmacies.

Takeda Receives Positive CHMP Opinion for ADCETRIS(R) (brentuximab vedotin) as Consolidation Treatment in Post-Transplant Hodgkin Lymphoma
BusinessWire - Fri May 27, 7:30AM CDT
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the current conditional approval of ADCETRIS(R) (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT). On average 50 percent of Hodgkin lymphoma patients relapse after ASCT and those patients with additional risk factors can be at even higher risk of relapse. ADCETRIS after ASCT is a new treatment paradigm based on the largest randomized study ever conducted in relapsed or refractory Hodgkin lymphoma. The AETHERA Phase 3 trial is the first completed study that has explored consolidation treatment immediately following ASCT as a way of extending the effect of transplant for prevention of relapse among people with Hodgkin lymphoma. The use of ADCETRIS in this setting may provide a meaningful treatment option where none currently exist for patients.

Takeda Provides Update on EU Marketing Authorization Application for NINLARO(R) (ixazomib) in Relapsed/Refractory Multiple Myeloma
BusinessWire - Fri May 27, 7:00AM CDT
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending against the authorization of NINLARO(R) (ixazomib) capsules, an oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. Takeda intends to appeal this opinion and request a re-examination by the CHMP.

Takeda Presents Analyses From Vedolizumab Data in Ulcerative Colitis at 2016 Digestive Disease Week (DDW) Annual Meeting
PR Newswire Europe - Mon May 23, 11:49AM CDT
Takeda Pharmaceutical Company Limited [TSE: 4502 [http://www.takeda.com/investor-information/]], ("Takeda" today announced the oral presentations of two data analyses: one evaluating the optimal position of vedolizumab in the ulcerative colitis (UC) treatment paradigm, and a second separate analysis assessing whether early vedolizumab trough levels were associated with subsequent drug efficacy. Findings were presented during the 2016 Digestive Disease Week (DDW) Annual Meeting in San Diego, California, and were included in a total of 13 Takeda-sponsored vedolizumab or inflammatory bowel disease (IBD)-focused abstracts, including four oral presentations and nine posters.

Long-Term Integrated Safety Analysis Published in Gut Reports a Favorable Benefit-Risk Profile for Vedolizumab in an Extended Treatment Period
PR Newswire Europe - Thu May 12, 8:02AM CDT
This analysis examining treatment with vedolizumab in patients with moderately to severely active ulcerative colitis or Crohn's disease observed no significant safety concerns

Takeda Reports Results for Fiscal Year 2015 (April 2015 - March 2016) and Forecast for Fiscal Year 2016
BusinessWire - Tue May 10, 1:00AM CDT
Takeda Pharmaceutical Company Limited (TOKYO:4502):

Takeda Receives $38 Million Grant from the Bill & Melinda Gates Foundation to Support Polio Eradication in Developing Countries
BusinessWire - Sun May 08, 6:00PM CDT
Takeda Pharmaceutical Company Limited (TOKYO:4502), ("Takeda" today announced a partnership with the Bill & Melinda Gates Foundation to support global polio eradication in developing countries. With this funding, Takeda will develop, license and supply at least 50 million doses per year of Sabin-strain inactivated poliovirus vaccine (sIPV) to more than 70 developing countries. The vaccine will be manufactured at Takeda's facility in Hikari, Japan. This effort is aligned with Takeda's strategy to utilize innovation and partnerships to address critical unmet needs in global public health, and the Sustainable Development Goals adopted by the United Nations in September 2015.

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