News Articles

U.S. Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda’s Investigational Compound,... CAMBRIDGE, Mass. & OSAKA, Japan -Wednesday 28 July 2021

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to...

Takeda Data at ISTH 2021 Highlight the Benefits of Prophylaxis for Patients with Rare Bleeding Disorders -Wednesday 21 July 2021

− Data Include Phase 3 Results Showing that the Primary Endpoint of Spontaneous, Treated Annualized Bleeding Rates During Prophylaxis with Recombinant von Willebrand Factor in Adults with von Willebrand Disease, was Met − 12 Abstracts Presented Across Takeda’s Hematology Portfolio and...

Takeda Announces the Submission of Its Corporate Governance Report to the Tokyo Stock Exchange -Monday 19 July 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (“Takeda”) (TOKYO:4502) (NYSE:TAK) today announced that it has filed its Corporate Governance Report with the Tokyo Stock Exchange (“TSE”) in accordance with the regulations* for TSE listed companies. The Report can be accessed on...

New Data from the Phase 3 HELP Study™ Open-Label Extension Evaluating Safety and Efficacy of... -Saturday 10 July 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from two final analyses from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE), which evaluated the long-term safety (primary...

Takeda Announces the Publication of Its Annual Report on Form 20-F for FY2020  -Wednesday 30 June 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (“Takeda”) (TSE:4502/NYSE:TAK) today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended March 31, 2021 (the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”). Takeda...

Phase 3 Clinical Trial Subgroup Analysis Across Solid Organ Transplant (SOT) Types Supports Efficacy of Maribavir Over... -Monday 7 June 2021

Building Upon Previous Data Showing More Than Twice as Many SOT Recipients Receiving Maribavir Achieved CMV Viremia Clearance Compared to Conventional Antiviral Therapies, Subgroup Analysis Showed Consistent Efficacy in SOT Recipients Receiving Investigational Drug Maribavir In Heart, Lung...

Potential Impact of Takeda’s Dengue Vaccine Candidate Reinforced by Long-Term Safety and Efficacy Results -Thursday 27 May 2021

− Takeda’s dengue vaccine candidate (TAK-003) prevented 83.6% of hospitalizations and 62.0% of dengue illness overall, with no identified important safety risks through three years following vaccination in ongoing pivotal Phase 3 TIDES trial − Regulatory filings for TAK-003 progressing...

Takeda to Present Positive Primary Analysis from Phase 2 OPTIC Trial of ICLUSIG® (ponatinib), Reinforcing... -Wednesday 26 May 2021

– OPTIC Trial Evaluating Response-Based Dosing Regimens of ICLUSIG for the Treatment of Resistant / Intolerant Chronic-Phase CML Demonstrates Durable, Clinically Meaningful Depth of Response While Managing Arterial Occlusive Event Risk – Oral Presentation of the OPTIC Primary Analysis at...

Takeda Announces Approval of Moderna’s COVID-19 Vaccine in Japan -Tuesday 25 May 2021

− The Ministry of Health, Labour and Welfare (MHLW) Grants Regulatory Approval of Moderna’s COVID-19 Vaccine (COVID-19 Vaccine Moderna Intramuscular Injection) Following Positive Interim Results in Takeda’s Phase 1/2 Immunogenicity and Safety Clinical Trial − Interim Results Indicate...

Takeda Presents Updated Results for Mobocertinib, Further Substantiating the Clinical Benefit in Patients with EGFR... -Monday 24 May 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced updated data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+)...

U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients... -Friday 21 May 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those...

Takeda Delivers Resilient FY2020 Results With Strong Margins & Robust Cashflow; Underlying Revenue Growth Expected... -Thursday 20 May 2021

Delivered FY2020 Management Guidance with Results Driven by +16% Underlying Revenue Growth of 14 Global Brands (e.g., ENTYVIO ® +26.2% YOY, TAKHZYRO® +30.0% YOY, Immunoglobulin + 15.7% YOY) Accelerated Cost Synergies and Achieved $2.3 Billion Target One Year Ahead of Plan Reported Net...

Takeda Manufacturing Facilities in Japan and Ireland Recognized With Category Awards for 2021 Facilities of the Year -Thursday 29 April 2021

Both Awards, Issued by the International Society for Pharmaceutical Engineering (ISPE), Underscore Takeda’s Leadership in Digital and Innovative Technologies New Solid Pharmaceutical Packaging Building With Automatic Line Clearance in Hikari, Japan, Wins Process Intelligence and...

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for... -Wednesday 28 April 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients...

Takeda Hosts Wave 1 Pipeline Market Call -Saturday 3 April 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it will host a conference call on April 6, 2021 to provide updates on select New Molecular Entities (NMEs) in its Wave 1 pipeline portfolio. With several NME regulatory filings...

Takeda Completes Sale of Its Japan Consumer Health Care Business Unit to Blackstone -Friday 2 April 2021

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) (“Takeda”) today announced the completion of its previously-announced sale of Takeda Consumer Healthcare Company Limited (“TCHC”) to Oscar A-Co KK, a company controlled by funds managed by The Blackstone...

Takeda Completes Sale of Select OTC and Non-Core Assets to Orifarm -Wednesday 31 March 2021

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the completion of its previously-announced sale of a portfolio of select products to Orifarm Group (“Orifarm”) for a total value of up to $670 million USD. The portfolio includes...

Takeda Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries -Saturday 27 March 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency (EMA) has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue...

Takeda and IDT Support Manufacturing of Johnson & Johnson’s COVID-19 Vaccine -Tuesday 16 March 2021

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced a mutual agreement with IDT Biologika GmbH (“IDT”), a contract development and manufacturing organization, to utilize capacity at IDT previously reserved for Takeda’s dengue...

Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant... -Monday 15 March 2021

More Than Three Times as Many Transplant Recipients With Confirmed Resistant Cytomegalovirus (CMV) Infection at Baseline Receiving the Investigational Drug Maribavir Achieved CMV Viremia Clearance Compared to Conventional Antiviral Therapies, Building on Previously Presented Results Supporting...