SERUM INSTITUTE OF INDIA PRIVATE LIMITED

The FDA temporarily paused IXCHIQ vaccine use in adults aged 60 and older in May 2025 after 17 serious adverse events globally, but lifted restrictions by August 2025 following safety review and updated labeling.

Serum Institute of India and DNDi have signed an MoU to co-develop a monoclonal antibody treatment for dengue that targets all four virus serotypes, focusing on affordability for low- and middle-income countries.

• Novo Holdings has made a strategic investment in SCHOTT Poonawalla, India's leading provider of injectable drug containment solutions, alongside TPG Growth to accelerate innovation and expansion. • SCHOTT Poonawalla, a joint venture between SCHOTT Pharma AG and Serum Institute of India, operates three manufacturing facilities with an annual capacity exceeding 3 billion units and serves over 100 pharmaceutical customers. • This marks Novo Holdings' first investment in India's medtech manufacturing sector, reinforcing its commitment to strengthening pharmaceutical infrastructure and supply chain resilience in Asia.

• US private equity firm TPG, along with co-investor Novo Holdings, has agreed to acquire a 35% stake in SCHOTT Poonawalla from Serum Institute of India (SII) for approximately $300 million, with the deal expected to close in the first half of 2025. • SCHOTT Poonawalla, India's largest injectables-focused drug containment solutions company, will maintain its existing structure with SCHOTT Pharma retaining 50% ownership while SII will keep a minority stake following the transaction. • The strategic partnership aims to accelerate SCHOTT Poonawalla's global expansion by combining TPG's healthcare investment expertise with the company's advanced drug delivery solutions portfolio, which includes prefillable syringes, cartridges, and vials for biologics and vaccines.

ImmunityBio receives FDA authorization to provide recombinant BCG (rBCG) to urologists, addressing the critical TICE BCG shortage for bladder cancer treatment.

Valneva's IXCHIQ vaccine demonstrates a sustained 98.3% sero-response rate one year after single vaccination in adolescents, supporting potential label extension.

• Serum Institute of India (SII) has received CDSCO panel approval to proceed with Phase II/III clinical trials for its typhoid conjugate vaccine (bivalent). • The typhoid vaccine trial will assess safety, immunogenicity, and lot-to-lot consistency in individuals aged 6 months to 65 years. • SII also secured approval to conduct a Phase III clinical trial for its yellow fever vaccine, following positive interim results from the Phase II study. • The yellow fever vaccine trial aims to further evaluate the vaccine's safety and immunogenicity based on a revised protocol.

Several dengue vaccine candidates are progressing through clinical trials, offering potential solutions for this widespread disease.

HERVolution Therapeutics raised $11.7 million in Series A funding to advance its immunotherapies targeting human endogenous retroviruses (HERVs).

Bavarian Nordic and Serum Institute of India (SII) have established a license and manufacturing agreement for the MVA-BN mpox vaccine, expanding global manufacturing capacity and distribution.