VIIV HEALTHCARE PTY LTD

GSK's Shingrix prefilled syringe under US FDA review; Nucala approved in China for chronic rhinosinusitis. Vocabria + Rekambys gets CHMP positive opinion for HIV treatment in adolescents. Jemperli receives FDA Breakthrough Therapy Designation for rectal cancer. Nucala submission for COPD use accepted by FDA. Arexvy approval expanded in Japan. GSK ranks 2nd in ATMI. Linerixibat shows positive Phase III results in PBC. Blenrep demonstrates survival benefit in multiple myeloma trial.

2024 was challenging for healthcare, with patent expirations, cost scrutiny, and declining reimbursement rates. 2025 faces policy uncertainty under Trump, impacting Medicaid, ACA subsidies, and biopharma. Despite this, therapeutic innovation thrives, with advancements in obesity drugs, cancer treatments, HIV prevention, and ATTR-CM therapies.

Since the 1980s, HIV has affected 88.4 million globally, with 40 million currently living with it. Understanding HIV/AIDS, testing, pharmacotherapy, PrEP, and PEP is crucial for health professionals. HIV attacks CD4+ cells, leading to AIDS if untreated. Testing is vital, with methods including oral swabs and blood tests. ART reduces morbidity and prevents transmission. PrEP and PEP are preventive measures, with specific medications and guidelines for use.

Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, received FDA approval for treating adult solid tumors. Co-formulated with Halozyme's ENHANZE technology, it offers faster administration and comparable efficacy and safety to IV Opdivo, as shown in the Phase 3 CheckMate-67T trial.

Halozyme Therapeutics announced Takeda's HYQVIA® received Japanese regulatory approval for treating agammaglobulinemia or hypogammaglobulinemia, offering reduced dosing frequency with Halozyme's ENHANZE® technology.

Halozyme Therapeutics announced Japan's MHLW approved argenx's VYVDURA, co-formulated with Halozyme's ENHANZE® technology, for CIDP treatment. VYVDURA, a once-weekly subcutaneous injection, is the first FcRn blocker for CIDP, following its approval for gMG in Japan. The approval is based on the ADHERE Study, showing significant clinical improvement in patients.

Halozyme announced argenx's VYVDURA, co-formulated with ENHANZE®, received Japan's MHLW approval for CIDP treatment, marking the first FcRn blocker for CIDP. Approved for weekly self-administered subcutaneous injection, it follows ADHERE Study's positive outcomes, offering a new treatment option in Japan.

ViiV Healthcare, a GSK subsidiary, received a positive opinion from EMA's CHMP for marketing authorization of a new long-acting HIV regimen, Vocabria with Rekambys, for adolescents. GSK also announced CHMP's recommendation for expanded use of Jemperli in endometrial cancer treatment and FDA's Breakthrough Therapy designation for Jemperli in rectal cancer.

Emma Walmsley and other GSK executives presented at various healthcare conferences, discussing GSK's progress in R&D, vaccines, oncology, HIV, and consumer healthcare. Events included the JP Morgan Healthcare Conference, Evercore ISI HealthCONx, and others, featuring presentations and Q&A sessions on GSK's strategies and innovations.