Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in Japan for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade OSAKA, Japan & CAMBRIDGE, Mass. / Sep 24, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to... Read More

Presentations Include New Data from the TAK-861-2001 Phase 2b Trial in Narcolepsy Type 1 Highlighting Impact on Daily Functioning Including Cognition and Sleep Quality Data from Long-Term Extension Study will also be Presented Phase 3 Trial of an Orexin Agonist for Narcolepsy Type 1 Now Enrolling Patients Globally OSAKA, Japan & CAMBRIDGE, Mass. / Sep 19, 2024 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) will present... Read More

More Than 22,000 Takeda Employees Selected the FY2024 New Partners: Population Services International, Bulungula Incubator, Reach Out Cameroon, Seed Global Health and VillageReach Takeda’s Five New Partnerships Boost Total Global CSR Program Contributions to JPY 28.8 Billion (Approx. USD 199.1 million) Across 34 Diverse Partnerships Worldwide and extend our reach to an additional 2 million direct beneficiaries Takeda’s... Read More

Vatroslav Mateljic's innovative approach and commitment to transforming the lives of patients will strengthen Takeda's leadership position in the Canadian biopharmaceutical sector TORONTO , Sept. 16, 2024 /CNW/ - Takeda Canada Inc . (" Takeda Canada ") is pleased to announce the appointment of Vatroslav (Vatro) Mateljic as its... Read More

cTTP is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90% 1,2 Approval Based on Totality of Evidence, Including Results from the First Randomized, Controlled, Open-label, Crossover Phase 3 cTTP Trial OSAKA, Japan & CAMBRIDGE, Mass. / Aug 07, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the European... Read More

Revenue Growth of 14.1% at Actual Exchange Rates (AER); +2.1% at Constant Exchange Rate (CER) Driven by Acceleration of Growth & Launch Products (+17.8% at CER) Core Operating Profit Increase of 4.5% at CER Reflecting Phasing of R&D Investment and Other OPEX Reduction; Core Operating Profit Margin of 31.6% for the Quarter No Change to Full Year Forecast or Management Guidance Geographic Expansion with Approvals of LIVTENCITY... Read More

OSAKA, Japan / Jun 26, 2024 / Business Wire / Takeda (TOKYO:4502/NYSE:TAK) has announced new assignments of directors, determined at the Board of Directors meeting and at the Audit and Supervisory Committee meeting, following the 148th Ordinary Meeting of Shareholders, held in Osaka today. Takeda's Board of Directors has 11 members serving as external directors out of a total of 14 members, helping to ensure transparency and... Read More

LIVTENCITY Is the First and Only Post-Transplant Anti-CMV Treatment Approved in Japan That Targets/Inhibits UL97 Protein Kinase 1 CMV Is One of the Most Common and Serious Post-transplant Infections and Can Lead to Secondary Infections and Serious Consequences, Including Loss of Transplanted Organ and Failure of Graft 2,3 OSAKA, Japan & CAMBRIDGE, Mass. / Jun 24, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today... Read More

Mezagitamab-Treated Patients Showed Rapid and Sustained Increases in Platelet Counts That Persisted 8 Weeks After the Last Dose Through to Week 16 1 Mezagitamab Had a Favorable Safety Profile, with No New Safety Signals 1 Takeda Plans to Initiate Global Phase 3 Trial of Mezagitamab in ITP in the Second Half of FY2024 OSAKA, Japan & CAMBRIDGE, Mass. / Jun 22, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today presented... Read More

Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in the EU for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade OSAKA, Japan & CAMBRIDGE, Mass. / Jun 21, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy... Read More

HyQvia®, which may be administered at home, will provide children and adolescents living with immunodeficiencies with a new treatment option TORONTO , June 21, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia ® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement... Read More

Favorable Findings from the Longest Public Clinical Study in CIDP Support HYQVIA as an Effective Long-Term Treatment Option for Maintaining Stable Disease Course in CIDP ADVANCE Clinical Program Reflects Takeda’s Commitment to Continued Research on the Role of Immunoglobulin (IG) Therapy for Patients with Rare Neuroimmunological Disorders OSAKA, Japan & CAMBRIDGE, Mass. / Jun 18, 2024 / Business Wire / Takeda... Read More

SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency and Showed Clinically Meaningful and Nominally Significant Effects in Multiple Key Secondary Efficacy Endpoints SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures Soticlestat Showed a Consistent and Favorable Safety and Tolerability Profile in Both... Read More

Takeda to Receive Exclusive Option to License Global Rights to Olverembatinib in All Territories Outside of Mainland China, Hong Kong, Macau, Taiwan and Russia Olverembatinib Has the Potential to Address Significant Unmet Need for Patients with Chronic Myeloid Leukemia Following Treatment with Currently Approved TKIs Ascentage Pharma to Advance Late-Stage Clinical Development of Olverembatinib Prior to Potential Exercise of... Read More

The New Expanded Partnership Will Aim to Support the Dismantling of Systemic Barriers to Equity and Help Strengthen the Health Workforce in Massachusetts The Existing Global Partnership Has Provided Screening and Diagnostic Services to Over 8 Million People in Community Settings CAMBRIDGE, Mass. / Jun 11, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) announced that it has expanded its partnership with Partners In Health... Read More

Phase 2b Trial Demonstrated Statistically Significant and Clinically Meaningful Improvements Across Primary and all Secondary Endpoints up to 8 Weeks TAK-861 is the First Oral Orexin Receptor 2 Agonist to Potentially Address the Underlying Pathophysiology of NT1 Safety Results Indicated TAK-861 is Generally Safe and Well Tolerated Phase 3 Trials of TAK-861 to be Initiated in 1H FY2024 OSAKA, Japan & CAMBRIDGE, Mass. / Jun... Read More

Four-year Analysis Conducted by GHSG Reported ADCETRIS + ECADD Combination Improved Progression-Free Survival, Showing Superior Efficacy and Tolerable Safety Profile in Patients with Newly Diagnosed Stage IIb/III/IV Classical Hodgkin Lymphoma vs eBEACOPP, a Current Standard of Care in This Setting in Europe The HD21 Study Adds to the Body of Evidence Supporting ADCETRIS as a Backbone Agent in the Treatment of Specific... Read More

cTTP Is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90% 1,2 If Approved in the European Union, rADAMTS13 Will Be the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for cTTP Positive Opinion Based on Totality of Evidence, Including Results from the First Randomized, Controlled, Open-label, Crossover Phase 3 cTTP... Read More

The Letter of Intent is an important step for patients living with a post-transplant cytomegalovirus (CMV) infection to have public access to treatment. TORONTO , May 16, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent (LOI) for LIVTENCITY ® (maribavir) for the treatment for adults with a... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / May 14, 2024 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that it will present data from its oncology pipeline and product portfolio at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 31-June 4, 2024, in Chicago, Ill. Takeda’s presentations will span across a range of cancers, including colorectal, lung, lymphoma, multiple myeloma... Read More

Takeda to receive exclusive option to license global rights to ACI-24.060, a potential first-in-class active immunotherapy designed to delay or slow Alzheimer’s disease progression AC Immune to receive upfront payment of $100 million upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately $2.1 billion AC Immune to host conference call and webcast today at 8:30 a.m.... Read More

Revenue Growth of +5.9% at Actual Exchange Rates (AER); +1.5% at Constant Exchange Rate (CER) Driven by Growth & Launch Products Core Operating Profit Change of -13.3% at CER Reflecting Generic Impact and Investment in R&D and Data, Digital & Technology Three New Molecular Entity (NME) Approvals from U.S. FDA in FY2023 Up to Six NMEs with Significant Revenue Potential in Phase 3 Development in FY2024 Committed to 100-250... Read More

If Approved in the European Union, Fruquintinib Will Be the First Novel Targeted Therapy for Metastatic Colorectal Cancer Regardless of Biomarker Status in Over a Decade Positive Opinion Based on Results from a Phase 3 Clinical Trial Which Demonstrated Significant Improvements in Overall Survival and Progression Free Survival versus Placebo Plus Best Supportive Care, with Benefit Seen Regardless of Prior Types of Therapy... Read More

TOKYO , April 22, 2024 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, President and CEO; Christophe Weber , "Takeda"), Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura , "Astellas"), and Sumitomo Mitsui Banking Corporation (President & CEO: Akihiro Fukutome , "SMBC") today announced that the three companies signed a master agreement on April 22, 2024 , to establish a joint... Read More

ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease OSAKA, Japan & CAMBRIDGE, Mass. / Apr 18, 2024 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO ® (vedolizumab) subcutaneous (SC) administration for... Read More

FY23 Investment Brings Program Total to Nearly $55 Million, Welcoming Eight New Grant Partners Company Continues to Advance Equity in Under-Resourced Communities with a Focus on Nutrition and STEM Education Takeda Publishes its Annual U.S. Community Impact Report Highlighting Program Progress CAMBRIDGE, Mass. / Apr 08, 2024 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced the selection of eight new U.S.... Read More

Takeda's 'In Their Shoes' initiative illuminates the daily struggles of IBD patients in the UAE, fostering empathy and understanding among participants. DUBAI , UAE , March 27, 2024 /PRNewswire/ -- Takeda , the patient-centric biopharmaceutical company, brought its global 'In Their Shoes' program to the UAE. The initiative, focused on raising awareness of the difficult symptoms of Inflammatory Bowel Disease (IBD), entailed... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Mar 26, 2024 / Business Wire / Takeda (TOKYO:4502/NYSE:TAK) today announced that its Board of Directors decided on March 26, 2024 (CET) to propose candidates for Board of Directors at the 148th Ordinary General Meeting of Shareholders to be held on June 26, 2024. Mr. Milano Furuta, currently president of the Japan Pharma Business Unit (JPBU), will succeed Mr. Constantine Saroukos as chief... Read More

cTTP is an Ultra-rare Blood Clotting Disorder Associated with Life-Threatening Acute Events and Debilitating Chronic Symptoms ADZYNMA (apadamtase alfa /cinaxadamtase alfa) is the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for People with cTTP OSAKA, Japan & CAMBRIDGE, Mass. / Mar 26, 2024 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare... Read More

ICLUSIG Becomes the First and Only Targeted Treatment Approved in the U.S. for Frontline Ph+ Acute Lymphoblastic Leukemia (ALL) in Combination with Chemotherapy First FDA Approval in Ph+ ALL Based on Novel Primary Endpoint of Minimal Residual Disease (MRD)-negative Complete Remission (CR) Accelerated Approval Based on Data from the Phase 3 PhALLCON Trial, in which ICLUSIG Demonstrated Superiority in MRD-negative Complete... Read More

Pre-Specified Interim Analysis Shows Positive Safety and Efficacy Results; Mezagitamab Safe and Well Tolerated Takeda Intends to Initiate a Global Phase 3 Trial of Mezagitamab in Patients with Primary Immune Thrombocytopenia in Fiscal Year 2024 Late-Stage Pipeline Continues to Gain Momentum With Five New Molecular Entities in Phase 3 Development in Fiscal Year 2024 OSAKA, Japan & CAMBRIDGE, Mass. / Mar 13, 2024 / Business... Read More

Biological E. Limited (BE) to Manufacture Up to 50 Million Doses of QDENGA Per Year, Accelerating Takeda’s Ability to Deliver 100 Million Doses Per Year by 2030 At the Latest Addresses the Specific Need to Offer Multi-Dose Vials for National Immunization Programs to Help Protect the Most Vulnerable Populations Dengue Incidence Continues to Increase and Poses a Growing Threat to Public Health Worldwide CAMBRIDGE, Mass. &... Read More

1 in 12 Canadians will be impacted by rare disease in their lifetime 1 I Am Number 12 campaign continues to drive action for rare disease community TORONTO , Feb. 26, 2024 /CNW/ - February 29 th marks Rare Disease Day. On the rarest day of the year, we are reminded of the reality that 1 in 12 Canadians will be impacted by rare disease in their lifetime. 1 A critical need exists to create meaningful change and action for the... Read More

12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing OSAKA, Japan & CAMBRIDGE, Mass. / Feb 12, 2024 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration... Read More

Primary and Key Secondary Endpoints Were Met in Narcolepsy Type 1 Phase 2b Trial TAK-861 Was Found to be Generally Safe and Well-Tolerated Results Will be Presented at an Upcoming Scientific Congress OSAKA, Japan & CAMBRIDGE, Mass. / Feb 08, 2024 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a randomized, double-blind, placebo-controlled, multiple dose Phase 2b trial evaluating... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Feb 01, 2024 / Business Wire / Takeda (TOKYO:4502/NYSE:TAK) today announced that Costa Saroukos, chief financial officer, has decided to leave Takeda to return to his home-country of Australia to be closer to family. Mr. Saroukos will step down as CFO, effective April 1, 2024 and will remain with the company as a board director until June 28, 2024. Milano Furuta, president of Takeda’s Japan... Read More

Two New U.S. FDA Approvals in FY2023 Q3: FRUZAQLA for Adults With Previously Treated Metastatic Colorectal Cancer and ADZYNMA for Ultra-Rare Blood Clotting Disorder cTTP Strong Commercial Execution Maximizing Value of Existing Portfolio: ENTYVIO ® Pen Launched in U.S. for Ulcerative Colitis; U.S. FDA Approval Decision on Crohn’s Disease Filing Expected in early FY2024 QDENGA ® Dengue Vaccine Now Launched in 21 Countries... Read More

New Indication Delivers on Takeda’s Commitment to Expanding its Broad and Diverse Immunoglobulin (IG) Portfolio to Meet the Needs of People Living with CIDP Approval Supported by Phase 3 ADVANCE-CIDP Open-label Study Data Demonstrating Safety and Efficacy as an Intravenous Therapy for Adults with CIDP GAMMAGARD LIQUID [Immune Globulin Infusion (Human) 10% Solution] is the Only Intravenous IG (IVIG) Approved for the Treatment... Read More

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] becomes the Only Facilitated Subcutaneous Immunoglobulin, Offering Patients an up to Once-Monthly Treatment Option At-Home or In-Office Administration Provides CIDP Patients with a Personalized Treatment Experience Approval Expands Takeda’s Portfolio of Differentiated Immunoglobulin Therapies for Patients with Neuroimmunological Disorders... Read More

Cognizant will support Takeda's ambition to modernize technology capabilities TEANECK, N.J. , Jan. 25, 2024 /PRNewswire/ -- Cognizant (NASDAQ: CTSH) announced today an expanded agreement with Takeda ( NYSE: TAK), a global biopharmaceutical company, to support the company's digital transformation strategy by reinforcing and supporting its technology efforts. Together, Takeda and Cognizant will embark on a new project to... Read More

Achieved Global Recognition and Top Employer Certification in 24 Countries from Top Employers Institute Global Recognition Reinforces Commitment to Creating an Exceptional People Experience OSAKA, Japan & CAMBRIDGE, Mass. / Jan 18, 2024 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that for the seventh consecutive year, it has received global Top Employer® certification for 2024. Takeda is one of just 17... Read More

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only up to Once Monthly (every 2, 3 or 4 weeks) Subcutaneous Immunoglobulin (SCIG) Infusion to Treat CIDP, Can Be Administered by a Healthcare Professional or Self-Administered after Appropriate Training Approval Based on Phase 3 ADVANCE-CIDP 1 Study Demonstrating a Statistically Significant Difference in Relapse Rate in Favor of HYQVIA... Read More

LIVTENCITY Is the First and Only Inhibitor of CMV-specific UL97 Protein Kinase Approved in China for the Treatment of Adults With Post-transplant CMV Infection/Disease Refractory * to Conventional Anti-CMV Treatment Approval Based on Phase 3 TAK-620-303 SOLSTICE Study Demonstrating Maribavir Was Superior to Conventional Therapies at Week 8, for Primary Endpoint 1 CMV Is One of the Most Common and Serious Post-transplant... Read More

Availability of GLASSIA ® represents significant milestone for patients with emphysema due to severe hereditary deficiency of Alpha-1 antitrypsin TORONTO , Dec. 20, 2023 /CNW/ - Takeda Canada Inc. (Takeda) has entered into a contract with Canadian Blood Services (CBS) for GLASSIA ® (alpha-1 proteinase inhibitor) resulting from CBS's request for proposal for hereditary deficiency of Alpha-1 Antitrypsin Deficiency (Alpha-1).... Read More

If Approved, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Would Offer an up to Once-Monthly Facilitated Subcutaneous At-Home or In-Office Treatment Option Positive Opinion Based on Phase 3 ADVANCE-CIDP 1 Study, Which Met its Primary Endpoint Demonstrating a Statistically Significant Reduction in Relapse Rate 1 OSAKA, Japan & CAMBRIDGE, Mass. / Dec 15, 2023 / Business Wire / Takeda... Read More

2024 Award Celebrates Outstanding Research in Cancer Immunology Winners Discovered Novel Connections Between the Immune System and Cancer Recipients Each Receive Unrestricted USD 200,000 Awards OSAKA, Japan & CAMBRIDGE, Mass. / Dec 05, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) and The New York Academy of Sciences today announced the winners of the 2024 Innovators in Science Award for their excellence in, and... Read More

Company to Feature 17 Company-Sponsored and Nine Collaborative Abstracts in Oncology and Hematology Hematology Presentations Include New Data from the Phase 3 and Continuation Trials Supporting the Recent U.S. FDA Approval of ADZYNMA (ADAMTS13, recombinant-krhn) Oncology Presentations Feature New Insights into Treatment of Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia and Hodgkin Lymphoma OSAKA, Japan & CAMBRIDGE, Mass. /... Read More

cTTP is an Ultra-rare Blood Clotting Disorder Associated with Life-Threatening Acute Events and Debilitating Chronic Symptoms Takeda Continues 70-plus Year Legacy of Driving Innovation for the Rare Hematology Community OSAKA, Japan & CAMBRIDGE, Mass. / Nov 09, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved ADZYNMA (ADAMTS13, recombinant-krhn)... Read More

FRUZAQLA is the First Targeted Therapy Approved for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status or Prior Types of Therapies in More Than a Decade FRUZAQLA Plus Best Supportive Care Demonstrated Significant Improvements in Overall Survival, with Corresponding Improvements in Progression Free Survival, Versus Placebo Plus Best Supportive Care in Two Phase 3 Clinical Trials FRUZAQLA Demonstrated a... Read More

The Study Met Its Primary Endpoint with 53.3% and 54.2% of Patients Treated With TAK-279 (15 mg and 30 mg Respectively) Achieving At Least an ACR 20 Response Compared to 29.2% in the Placebo Group at Week 12 (p = 0.002) 1 TAK-279 Demonstrated Improvements in Key Secondary Endpoints and a Safety Profile Consistent with the Phase 2b Psoriasis Study 1 Takeda Will Initiate Phase 3 Studies in Plaque Psoriasis in FY23 and... Read More

Revenue Growth of +6.4% at Actual Exchange Rate (AER); +1.4% Growth at Constant Exchange Rate (CER), Driven by Growth & Launch Products (+13% at CER) Core Operating Profit Year-on-Year Change of -9.5% at CER Reflecting Generic Impact, Lower Demand for Coronavirus Vaccines and Increased Investment in R&D and Data & Technology Reported Operating Profit and Net Profit Impacted by Non-Cash Impairment of Intangible Assets Booked... Read More

Approval Based on Updated Positive Overall Survival Results from the Phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma First Significant Improvement in Overall Survival in Two Decades in Stage III & IV Hodgkin Lymphoma Approval Expands on Six Current Indications for ADCETRIS in the European Union OSAKA, Japan & CAMBRIDGE, Mass. / Oct 18, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the... Read More

OSAKA, Japan / Oct 17, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that, on October 17, 2023 (IST), it agreed with the Irish Revenue Commissioners (“Irish Revenue”) to settle a tax assessment related to the treatment of an acquisition break fee received by Shire plc (“Shire”) in October 2014 from AbbVie Inc. (“AbbVie”), for EUR 130 million, resulting in a tax expense reduction of approximately JPY 63... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Oct 17, 2023 / Business Wire / Takeda (TSE:4502/NYSE: TAK) today announced that the Phase 3 ADMIRE-CD II study, assessing the efficacy and safety of Alofisel ® (darvadstrocel) for the treatment of complex Crohn’s Perianal Fistulas (CPF), did not meet its primary endpoint of combined remission at 24 weeks, based on topline data. The safety profile for darvadstrocel was consistent with prior... Read More

TORONTO , Oct. 5, 2023 /CNW/ - Takeda Canada Inc. ("Takeda"), a leading biopharmaceutical company, is pleased to announce it has received the Corporate Leader Award by the Daily Bread Food Bank for outstanding commitment to fighting hunger in the community. The award recognizes Takeda's significant contributions to the Daily Bread Food Bank's mission to end hunger in Toronto . "We are honoured to receive the Corporate Leader... Read More

Experts Reviewed Data from QDENGA’s Clinical Program Across 19 Phase 1, 2 and 3 Trials with More Than 28,000 Participants WHO Will Consider the SAGE Recommendation and Provide Final Guidance on the Use of QDENGA in Public Vaccination Programs in the Coming Months Dengue Poses a Significant and Growing Public Health Burden to People Living in and Traveling to Endemic Countries OSAKA, Japan & CAMBRIDGE, Mass. / Oct 03, 2023 /... Read More

TORONTO , Oct. 3, 2023 /CNW/ - Today, Takeda Canada Inc. ("Takeda") announced the launch of Clinical Trials (CT) Lexicon, an innovative app that provides healthcare professionals with a centralized library of key studies and data at their fingertips. The initial launch of the app focuses on Inflammatory Bowel Disease (IBD) with additional clinical focus areas to be rolled-out at later stages. Dr. Jesse Siffledeen , Director,... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Oct 02, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary withdrawal of EXKIVITY ® (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or... Read More

ENTYVIO Is the Only FDA-Approved Ulcerative Colitis Biologic That Offers the Choice of Intravenous or Subcutaneous Maintenance Therapy OSAKA, Japan & CAMBRIDGE, Mass. / Sep 27, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) administration of ENTYVIO ® (vedolizumab) for maintenance therapy in adults with moderately to... Read More

Approval is Based on Clinical Studies Conducted in Japan, Europe and North America Confirming the Efficacy and Safety of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] CUVITRU is Takeda’s First Subcutaneous Immunoglobulin Plasma Therapy in Japan, Delivering on the Company’s Commitment to Reach Patients with High Unmet Needs OSAKA, Japan & CAMBRIDGE, Mass. / Sep 25, 2023 / Business Wire / Takeda (... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Sep 20, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the... Read More

Takeda’s Five New Partnerships Boost Total Global CSR Program Contributions to JPY 24.2 Billion (Approx. USD 167.5 million) Since Program Inception in 2016. More Than 24,500 Takeda Employees Worldwide Participated in the Selection of the Five New Partnerships: Society for Family Health Rwanda, Relief International, Mercy Corps, University of Nairobi and Partners In Health. With This New Cohort of Partnerships, Takeda’s... Read More

Applications for Investigational Subcutaneous Administrations for Both Crohn’s Disease and Ulcerative Colitis Are Now Under Review by the FDA OSAKA, Japan & CAMBRIDGE, Mass. / Sep 13, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of... Read More

The 2023 Winners are Ayble Health and IBDrelief TORONTO , Sept. 12, 2023 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce two winners of the 2023 Takeda Canada Digital Health Innovation Challenge , a competition to identify and support innovative digital health solutions to improve patient outcomes and experiences. This year's challenge winners are two patient-led organizations with disruptive digital solutions... Read More

Topline Results for TAK-279 Show that a Significantly Greater Proportion of Psoriatic Arthritis Patients Achieved at Least an ACR20 Response Compared to Placebo at Week 12 1 Based on the Positive Results, Takeda Intends to Initiate a Phase 3 Study of TAK-279 in Psoriatic Arthritis Full Clinical Results Will be Presented at an Upcoming Medical Meeting OSAKA, Japan & CAMBRIDGE, Mass. / Sep 11, 2023 / Business Wire / Takeda... Read More

No Change to Full-Year Forecasts or Management Guidance Revenue Growth of +8.9% at Actual Exchange Rate (AER); +3.7% Growth at Constant Exchange Rate (CER), Driven by Growth & Launch Products (+16.2% at CER) Reported Operating Profit Growth of +12.0% at AER; Core Operating Profit Decline of -2.0% at CER Reflecting Generic Impact, Lower Demand for Coronavirus Vaccines and Increased Investment in R&D and Data & Technology Core... Read More

Trial Was Stopped Due to Hepatotoxicity and Consequently TAK-994 Program Terminated for Further Development In Patients with Narcolepsy Type 1, Oral Orexin Receptor 2 Agonist Demonstrated Statistically Significant Improvement in Daytime Wakefulness; Weekly Cataplexy Rates Reduced or Abolished at All Doses Compared to Placebo Findings Indicate Orexin Receptor 2 as Promising Novel Biologic Target for Future Development of... Read More

Data from First and Only Phase 3 Controlled Trial in cTTP Demonstrate Strong Efficacy and Favorable Safety Profile with TAK-755 (recombinant ADAMTS13), Compared to Plasma-Based Therapies Patients Receiving TAK-755 Achieved an Increase in Plasma ADAMTS13 Enzyme Activity Levels, Which Are Deficient in Patients with cTTP, Compared to Plasma-Based Therapies OSAKA, Japan & CAMBRIDGE, Mass. / Jun 25, 2023 / Business Wire / Takeda... Read More

Pivotal Phase 3 Findings with HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Showed a Clinically Significant Reduction in Relapse Rate as well as a Delayed Time to Relapse Compared to Placebo When Used as a Maintenance Therapy in Adult Patients with CIDP ADVANCE Clinical Program Reflects Takeda’s Commitment to Investigating Immunoglobin (IG) Therapy for Patients with Neuroimmunological... Read More

Publication shows FRESCO-2 demonstrated treatment with fruquintinib reduced the risk of death by 34% in previously treated metastatic colorectal cancer (0.66 HR) Data support regulatory submissions in the U.S., Europe and Japan during 2023 OSAKA, Japan & CAMBRIDGE, Mass. & HONG KONG & SHANGHAI & FLORHAM PARK, N.J. / Jun 15, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM,... Read More

CAMBRIDGE, Mass. & OSAKA, Japan / May 26, 2023 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that it will present data from its expanding oncology pipeline and established product portfolio at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 2-6, 2023, in Chicago, Ill. and the 31st Congress of the European Hematology Association (EHA), June 8-11, 2023, in Frankfurt,... Read More

Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 30, 2023 NDA Includes Results From the Phase 3 FRESCO-2 and FRESCO Clinical Trials OSAKA, Japan & CAMBRIDGE, Mass. & HONG KONG & SHANGHAI & FLORHAM PARK, N.J. / May 25, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that the U.S. Food and Drug Administration (FDA)... Read More

Submission Based on Favorable Results from the First Phase 3 Randomized, Controlled Trial in Patients with cTTP FDA has Granted TAK-755 Priority Review and Rare Pediatric Disease Designation, as well as Fast Track Designation and Orphan Drug Designation in cTTP OSAKA, Japan & CAMBRIDGE, Mass. / May 16, 2023 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has... Read More

Full Year Reported Revenue Growth of +12.8%; Core Revenue Growth of +3.5% at Constant Exchange Rate Driven by Growth & Launch Products; Reported EPS Growth of +38.8% Achieved Core Operating Profit of 1,188.4 Billion Yen – Exceeding 1 Trillion Yen for the First Tim e in the Company’s History FY2023 Core Operating Profit Expected to Remain >1 Trillion Yen Despite Impact of Loss of Exclusivity and Lower Expectations for... Read More

TORONTO , May 10, 2023 /CNW/ - Takeda Canada Inc. ("Takeda") announces results from the EVOLVE Expansion study, which evaluated the safety and efficacy of vedolizumab (ENTYVIO ®) , a gut-selective α4β7-integrin inhibitor and ustekinumab (UST), an IL-12/23 p40 inhibitor, as first-line biologic treatment for patients with Crohn's disease (CD). The data were presented as an oral presentation at Digestive Disease Week ® (DDW)... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Apr 27, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio ® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC)... Read More

WESTWOOD, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Corza Medical announced today that it has entered into a definitive agreement with a subsidiary of T akeda Pharmaceuticals Company (TSE:4502/NYSE:TAK) (“Takeda”) to acquire the TachoSil manufacturing operations in Linz, Austria. Corza Medical had previously acquired the commercial product rights for TachoSil , a best-in-class surgical patch trusted by medical professionals... Read More

Takeda continues its commitment to delivering innovative therapies that allow Canadians with primary and secondary immunodeficiency to live their lives to the fullest TORONTO , April 20, 2023 /CNW/ - Takeda Canada Inc. (Takeda) has entered into a three-year agreement with Canadian Blood Services (CBS) that includes GAMMAGARD LIQUID ® , GAMMAGARD ® S/D and CUVITRU ® , resulting from CBS's request for proposal for... Read More

HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only Once-a-Month – Every Three or Four Weeks – Subcutaneous Immunoglobulin (ScIG), is Now Approved for People Two Years of Age and Older with Primary Immunodeficiency Approval Supported by Pivotal Phase 3 Study that Demonstrated Reliable Infection Protection in Children 2-16 Years Old CAMBRIDGE, Mass. / Apr 11, 2023 / Business Wire /... Read More

FY22 Investment Brings Program Total to Nearly $40 Million, Adding 21 New Grant Partners Company Continues to Improve Equity Among Under-Resourced Communities Focusing on Areas of Health, Education, Environment and Providing First U.S. CSR Report, Takeda Cares for Communities, Highlights Program Efforts Since its FY21 Launch CAMBRIDGE, Mass. / Apr 03, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that... Read More

The Phase 4 EARNEST Study Met Its Primary Efficacy Endpoint of Remission of Chronic or Recurrent Pouchitis at Week 14, with 31% of Participants Receiving Vedolizumab Achieving Remission versus 10% Receiving Placebo. 1 Superiority over Placebo Was Also Demonstrated at Week 34, with 35% of Vedolizumab Patients Achieving Remission Compared with 18% on Placebo. 1 OSAKA, Japan & CAMBRIDGE, Mass. / Mar 30, 2023 / Business Wire /... Read More

OSAKA, Japan / Mar 30, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) announced that its Board of Directors today decided that it will propose a new candidate for independent external director at the 147 th Ordinary Meeting of Shareholders on June 28 th , 2023. The new candidate, Miki Tsusaka, will join the board effective June 28 th , if approved by the shareholders. Furthermore, Masato Iwasaki, Representative Director,... Read More

Expansion Contributes to the Company's Efforts Toward a Sustainable Global Plasma Supply to Support the Needs of People who Depend on Life-Saving Plasma Therapies. BANNOCKBURN, Ill. / Mar 27, 2023 / Business Wire / BioLife Plasma Services , part of the global biopharmaceutical company Takeda, today announced the opening of its 200 th plasma donation center in the United States (U.S.)., with new locations in West Springfield,... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Mar 18, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis. The study met its primary and secondary endpoints, with a statistically significant greater proportion of TAK-279... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Feb 18, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced late-breaking data from the Phase 3 GRAPHITE study presented at the 2023 Tandem Meetings, demonstrating vedolizumab achieved a statistically significant and clinically meaningful improvement in lower gastrointestinal (GI) aGvHD-free survival by Day 180 after allo-HSCT with no relevant differences in safety profile... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Feb 08, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. (“Lakshmi”) from Nimbus Therapeutics, LLC (“Nimbus”), on February 8, 2023 (EST), as set forth in the share purchase agreement, following clearance from the United States Federal Trade Commission and a satisfaction of other closing conditions.... Read More

OSAKA, Japan & CAMBRIDGE, Mass. / Feb 03, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO ® (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age. 1 Prior to today’s approval, the only... Read More

Announced Agreement With Nimbus Therapeutics in December to Acquire a Potential Best-in-Class TYK2 Inhibitor, and with HUTCHMED in January to In-license Highly Selective, Oral Tyrosine Kinase Inhibitor Continued Momentum With Q3 Year-to-Date Reported Revenue Growth of +13.9% and Core Revenue Growth of +4.5% at Constant Exchange Rate; Reported EPS Growth of +19.6% Approval for Dengue Vaccine, QDENGA ® in EU; U.S. FDA Priority... Read More

With Marketing Authorization Submissions in the U.S., European Union and Japan Planned in 2023, Fruquintinib Offers a Potential New Treatment Option for Patients with Refractory Metastatic Colorectal Cancer Licensing Agreement for Fruquintinib Strengthens Takeda’s Growing Oncology Portfolio OSAKA, Japan & CAMBRIDGE, Mass. / Jan 23, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that it has entered into an... Read More

TORONTO , Jan. 17, 2023 /CNW/ - The Top Employers Institute has named Takeda Canada Inc. ("Takeda") a top employer in Canada for 2023. The distinction is recognized by the Top Employers Institute that certifies organizations who are focused on putting their people first through their exceptional HR policies. The Top Employers Institute program certifies organizations based on the participation and results of their HR Best... Read More

Achieved Global Recognition and Top Employer Certification in 22 Countries from Top Employers Institute Global Recognition Reinforces Commitment to People and Outstanding People Policies Takeda ( TSE:4502/NYSE:TAK ) today announced that, for the sixth consecutive year, it was one of only 15 companies to achieve global Top Employer® certification for 2023. In addition to the global certification, Takeda is also recognized as... Read More

EXKIVITY is the First Category-1 Innovative Drug Approved for Takeda China Following a Phase 2 Global Pivotal Study Approval Based on Data from the Phase 1/2 Clinical Trial Demonstrating EXKIVITY’s Clinical Benefit and Durable Responses in EGFR Exon20 Insertion+ NSCLC Results Demonstrated a Confirmed Overall Response Rate (ORR) of 28% and Median Duration of Response (DoR) of 15.8 Months per Independent Review Committee (IRC)... Read More

Fibrosis regression observed in 50% of patients receiving fazirsiran Median reductions of 94% of Z-AAT accumulation in the liver and mean reduction of 68% in histologic globule burden Treatment emergent adverse events were generally well balanced between fazirsiran and placebo groups Results consistent with AROAAT-2002 open-label study previously published in The New England Journal of Medicine Arrowhead to host webcast... Read More

Results are From First and Only Phase 3 Trial in cTTP, an Ultra-Rare Disease with Limited Treatment Options cTTP is Caused by a Deficiency in ADAMTS13 Protease; 1 TAK-755 Is Designed to Replace Missing or Deficient ADAMTS13 Enzyme 2 Takeda Plans to Seek Marketing Authorization for TAK-755 as the First ADAMTS13 Replacement Therapy for the Treatment of cTTP Takeda (TSE:4502/NYSE:TAK) today announced that the totality of... Read More

TOKYO and OSAKA, Japan , Dec. 21, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa , "Astellas"), Eisai Co., Ltd. (TSE: 4523, CEO: Haruo Naito , "Eisai"), Daiichi Sankyo Company, Limited (TSE: 4568, President : Sunao Manabe , "Daiichi Sankyo") and Takeda Pharmaceutical Company Limited . (TSE: 4502 / NYSE:TAK, President and CEO Christophe Weber , "Takeda") today announced that the four... Read More