Dengue vaccine tetravalent(Takeda)

Takeda announced that India's Drug Controller General of India (DCGI) has granted Marketing Authorisation (MA) for Takeda's dengue vaccine (TAK-003) for the prevention of dengue disease in individuals 4 to 60 years of age. TAK-003 is India's first-ever approved dengue vaccine and was approved for use in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing. Like many countries in South and Southeast Asia, dengue transmission in India is no longer confined to monsoon season. Several states report sustained year-round dengue transmissions expanding across both urban and rural areas. Reported cases exceeded 233,000 in 2024, but modeling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year. With cases rising more than 11-fold in the past 2 decades and outbreaks growing more frequent and harder to predict, dengue is no longer a sporadic public health threat—it's an accelerating global challenge. Dr. Mahender Nayak, Head of Intercontinental Markets, Takeda, said, "Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest 7-year data for TAK-003 shows continued protection against dengue infection and hospitalisation across all 4 serotypes; an important milestone for communities and health systems. Since its launch in 2022, TAK-003 has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India. Building on Takeda's 245-year heritage and more than 70 years of vaccine expertise, we remain committed to working with public health authorities, healthcare professionals, and partners to support equitable and sustainable access." TAK-003's approval in India is supported by an extensive global clinical development program, including a local phase 3 study as well as data from the pivotal phase 3 Tetravalent Immunisation against Dengue Efficacy Study (TIDES), the largest and longest efficacy trial conducted for a dengue vaccine. In the TIDES trial, TAK-003 demonstrated sustained protection against dengue and dengue?related hospitalisation and a favorable safety profile. Peter Streibl, Cluster General Manager, Southeast Asia and India, Takeda, said, "Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals and partners across South and Southeast Asia, not only to support access to TAK-003, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control and community engagement. Our aim is to contribute to sustainable, evidence-based solutions that reflect the needs of each country." Since 2023, WHO's Strategic Advisory Group of Experts on Immunization (SAGE) endorsed the use of TAK-003 without the need for pre-vaccination screening. Since then, TAK-003 has been recommended by the WHO for use in dengue-endemic settings, supporting its introduction in public immunisation programs in areas with high transmission. The vaccine has also received WHO prequalification, confirming it meets global standards for quality, safety and efficacy, and enabling eligibility for procurement through international agencies such as UNICEF and PAHO to support wider access. Following the approval by DCGI, Takeda will continue to collaborate with Indian regulatory authorities, public health stakeholders, and healthcare providers to support the planning, delivery, and availability of TAK-003 in India. In addition to India, TAK-003 is also approved in Indonesia, Thailand, Malaysia and Vietnam across the region. To date, TAK-003 has been distributed worldwide through public and private programs across Asia, Latin America and Europe, including Brazil's National Immunization Program and public programs in Argentina, Colombia and Indonesia.

Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in its fourth-quarter earnings presentation. That figure doesn’t account for hiring plans, including 2,200 roles that are currently open and new jobs that will be created throughout the year, a Takeda spokesperson told Endpoints News. No further details were shared about the timeline and which roles will be affected. Takeda is the latest biopharma to announce four-digit layoffs, following Novo Nordisk’s September 2025 decision to cut 9,000 jobs and Merck’s July announcement targeting 6,000 positions. Bayer CEO Bill Anderson confirmed this month that it’s made 14,000 reductions as part of a broader restructuring. Takeda’s outgoing CEO Christophe Weber laid out plans in 2024 to simplify the company’s structure, remove layers and broaden roles. Incoming CEO Julie Kim also cited efficiency as a priority as she prepares to take the reins in June. Going forward, Takeda said it would prioritize resources to advance its late-stage pipeline, including three products that Kim hopes will be blockbusters: the narcolepsy drug oveporexton, the blood cancer drug rusfertide, and a plaque psoriasis drug called zasocitinib. The FDA is currently mulling applications for oveporexton and rusfertide, with decisions expected in the third quarter of the calendar year. Meanwhile, Takeda made a handful of pipeline cuts last quarter, including a Phase 1 program for nausea and vomiting called TAK-004 and a Phase 2b program for the enzyme replacement therapy TAK-755 in immune thrombotic thrombocytopenic purpura. The Japanese pharma cited strategic reasons for both cuts. Takeda also returned the rights for a frontotemporal dementia candidate called TAK-594 to Denali after severing the partnership . The company is also discontinuing a booster program for its dengue vaccine Qdenga after data suggested additional dosing wasn’t needed for sustained protection.