TAK

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Wednesday, November 8, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survival, VEGF, TAK, RAS, PDUFA, Food, Colorectal Cancer Alliance, MAA, Priority, JAMA, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Priority review, PMDA, Colorectal cancer, CRC, EMA, FACP, Cancer, Metastasis, Patient, Diagnosis, Vanderbilt University Medical Center, Pharmaceutical industry, Takeda, EU, Lancet

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.

Key Points: 
  • "There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.
  • “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized.

Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, C-reactive protein, Headache, American College, TAK, MDA, PGA, MD, Research and development, Skin, Inflammation, AM, Ulcerative colitis, Psoriasis Area and Severity Index, Rash, MACR, Lower respiratory tract infection, Lupus, Common, American College of Rheumatology, Body surface area, Safety, Patient, ACR, BSA, Abstract, PASI, TYK2, Pharmaceutical industry, Copper, Takeda, Psoriasis

These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.

Key Points: 
  • These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.
  • There was no clinically significant difference in adverse event rates between doses of TAK-279.
  • “We are also advancing the development of TAK-279 in Crohn’s disease, ulcerative colitis and systemic lupus erythematosus and exploring a range of other potential indications.
  • These opportunities are being explored in parallel with the psoriasis and psoriatic arthritis programs.”

Domo Tactical Communications (DTC) and Silentium Defence Partner to Deliver a Low-SWaP, Covert Air Defense Solution

Retrieved on: 
Thursday, November 2, 2023
TAK, Silentium, Radio, Law enforcement, COFDM, Swap, Multiplexing, Partnership, Probability, DTC, Telescopic sight

The soldier-portable solution distributes critical sensor and targeting data real-time across DTC’s MESH or Coded Orthogonal Frequency Division Multiplexing (COFDM) waveforms to assess threats in contested environments.

Key Points: 
  • The soldier-portable solution distributes critical sensor and targeting data real-time across DTC’s MESH or Coded Orthogonal Frequency Division Multiplexing (COFDM) waveforms to assess threats in contested environments.
  • The systems are designed to operate either independently or as part of a meshed network in highly dynamic operating environments.
  • “This collaboration between DTC and Silentium provides our military, law enforcement, and commercial customers a low-SWaP passive air and surface radar system with no electromagnetic signature.
  • “DTC is a trusted partner that has a track record of delivering mission critical communications solutions to warfighters around the world,” said Simon Palumbo, Chief Experience, Silentium Defence.

Takeda Announces FY2023 H1 Results; Updates Full-Year Forecasts While Remaining on Track Towards Management Guidance

Retrieved on: 
Thursday, October 26, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Infectious Diseases, Growth, TAK, Quality of life, EPS, Risk, CER, Rare-earth element, Pharmaceutical industry, Takeda, Core

Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the first half of fiscal year 2023 (six months ended September 30, 2023), updating reported and Core forecasts and reconfirming Management Guidance for Core change at CER.

Key Points: 
  • Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the first half of fiscal year 2023 (six months ended September 30, 2023), updating reported and Core forecasts and reconfirming Management Guidance for Core change at CER.
  • Our pipeline is robust and we anticipate a number of important milestones in the second half of the fiscal year, including potentially up to three new product approvals in the U.S., for TAK-755, fruquintinib, and TAK-721.
  • These items do not reflect the underlying momentum of the business, and we remain on track to our Management Guidance, which is on a Core basis at CER.
  • “We continue to see strong performance of our Growth and Launch Products, which grew +13% at CER in the first half of the fiscal year and represent 42% of total revenue.

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

Retrieved on: 
Wednesday, October 18, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Survival, Brentuximab vedotin, Christie, TAK, Progression-free survival, CHMP, European Commission, IRF, Committee, Bleomycin, Vinblastine, European Directive on Traditional Herbal Medicinal Products, AVD, Doxorubicin, PFS, EC, University of Manchester, Civil service commission, Hodgkin lymphoma, ADC, CD30, ABVD, Risk, Dacarbazine, University, The Christie NHS Foundation Trust, Committee for Medicinal Products for Human Use, Hatim al-Awni, Overalls, Safety, ADCETRIS, Patient, OS, Lymphoma, Medical device, Medical imaging, Pharmaceutical industry, Takeda, Fellow of the Academy of Medical Sciences

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
  • ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
  • The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.
  • “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, M.D., head of global medical affairs oncology, Takeda.

Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn’s Perianal Fistulas

Retrieved on: 
Wednesday, October 18, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, GI, Inflammation, TAK, CPF, Observational study, Asset, INSPIRE, Safety, European, Patient, Pharmaceutical industry, Medical device, Takeda, Darvadstrocel

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.

Key Points: 
  • 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 studies and there were no new safety signals identified.
  • “While we are disappointed with this outcome, we recognize that medical research for difficult-to-treat conditions such as complex CPF remains challenging," said Chinwe Ukomadu, head of the GI & Inflammation Therapeutic Area Unit at Takeda.
  • Any revisions to the consolidated forecast for the fiscal year ending March 31, 2024 (FY2023) will be announced during Takeda’s second quarter earnings call, scheduled for October 26, 2023.

Takeda Settles Tax Dispute with Irish Revenue over Break Fee Received by Shire

Retrieved on: 
Wednesday, October 18, 2023
Biotechnology, Pharmaceutical, Health, Shire (pharmaceutical company), TAK, TAC, Acquisition, Bank statement, Wisconsin Tax Appeals Commission, Revenue Commissioners, EUR, USD, AbbVie, IST, Pharmaceutical industry, Takeda

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 billion for Takeda.

Key Points: 
  • 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 billion for Takeda.
  • On November 28, 2018, Shire received a tax assessment from the Irish Revenue for EUR 398 million in relation to the USD 1,635 million break fee Shire received in connection with the terminated offer by AbbVie to acquire Shire in 2014.
  • Takeda appealed this assessment, and in late 2020 a hearing took place before the Irish Tax Appeals Commission (“TAC”).
  • On July 30, 2021, Takeda received a ruling on the matter, with the TAC ruling in favor of Irish Revenue.

goTenna debuts new software and hardware features during an Air Force demonstration

Retrieved on: 
Tuesday, October 17, 2023
Ellington Field Joint Reserve Base, Partnership, Department of Defense Cyber Crime Center, TAK, Android, Government, ASOS, Department of the Air Force Office of Special Investigations, Defense Contract Audit Agency, ATAK, Air Force Research Laboratory, IOS, United States Air Force, Air force, Policy, Ernest K. Warburton (US Air Force), 165th Air Support Operations Squadron, AFWERX, Radio, GoTenna

During the demonstration, goTenna and the 147 ASOS simulated a disaster response in Austin, Texas.

Key Points: 
  • During the demonstration, goTenna and the 147 ASOS simulated a disaster response in Austin, Texas.
  • Multiple organizations gathered to rapidly construct an ad-hoc, off-grid network for interoperable communications and critical coordination of multi-agency responses.
  • We are grateful for this amazing public-private partnership as we continue to deliver advanced capabilities to the US Air Force."
  • This material is based upon work supported by the Air Force Research Lab/AFWERX under Contract No.

Pontimax Technologies' Inferencing Agent Delivers Inferencing & Reasoning Ability to UAVs Operating Over the Battle Space

Retrieved on: 
Tuesday, October 10, 2023
Knowledge, Weapon, ROE, TAK, Unmanned aerial vehicle, RCIC, Dynamics, UAV, C&C, Inference, Capability, Machine learning, Predicate, Atmosphere, Management

"Pontimax's Dynamic Inferencing Agent, with its innovative inferencing and reasoning capabilities, when positioned in Battlespace UAVs, is capable of delivering multi-command echelon situation awareness that can be combined with Rules of Engagement (ROE) based autonomous weapons deployment.

Key Points: 
  • "Pontimax's Dynamic Inferencing Agent, with its innovative inferencing and reasoning capabilities, when positioned in Battlespace UAVs, is capable of delivering multi-command echelon situation awareness that can be combined with Rules of Engagement (ROE) based autonomous weapons deployment.
  • Moreover, predicate-based Inferencing & Reasoning provides the only currently available capability to directly embody ROE with real-time enforcement."
  • The Capability & Coverage Knowledge Base is the key to the Inferencing Agent's ability to apply its inferencing & reasoning capabilities to mission-relevant sensor data.
  • The Inferencing Deployment Harness uses the mission inferencing requirements contained in the Capabilities & Coverage Knowledge Base to marshal the necessary mission Inferencing Profiles Inferencing Predicates and download their constituent components to the C&C determined mission Inferencing Platforms.

Takeda’s Dengue Vaccine Recommended by World Health Organization Advisory Group for Introduction in High Dengue Burden and Transmission Areas in Children Ages Six to 16 Years

Retrieved on: 
Tuesday, October 3, 2023
Biotechnology, Pharmaceutical, Teens, Health, Children, Infectious Diseases, Consumer, Clinical Trials, Vaccine, Immunization, Communication, VE, SAGE, Dengue fever, Hospital, Public, Feedback, TAK, Infection, Overalls, Fever, Person, Incidence, Fever Dream, Risk, VCD, Ageing, WHO, Safety, Disease, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).
  • SAGE made the following recommendations:
    The vaccine to be considered for introduction in settings with high dengue disease burden and high transmission intensity to maximize the public health impact and minimize any potential risk in seronegative persons.
  • The vaccine to be introduced to children aged 6 to 16 years of age.
  • Within this age range, the vaccine should be introduced about 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations.