Haemagglutinin-strain A(H1N1)

Novavax initiated a phase III study for its COVID-19-influenza combo and standalone influenza vaccines, targeting adults 65+. Utilizing Matrix-M adjuvant, it aims for FDA accelerated approval, supported by mid-stage study data. Novavax's shares rose 82.7% YTD. Competitors like Pfizer and Moderna are also developing COVID/flu vaccines, with Moderna leading in late-stage development.

Osivax initiated a phase 2a trial (NCT06582277) to assess OVX836, a broad-spectrum influenza vaccine, as a booster in participants previously vaccinated with OVX836. The study aims to evaluate safety and immunogenicity at Ghent University Hospital's Center for Vaccinology (CEVAC). Topline results are expected by the end of 2025.

Pharmacists must stay updated on vaccine recommendations as COVID-19, influenza, RSV, and other viruses circulate. COVID-19 vaccines for 2024-2025 include mRNA from Moderna, Pfizer, and Novavax. ACIP recommends 1 dose for those 5 years and older, with additional doses for high-risk groups. Influenza vaccines have a new trivalent formulation, and RSV vaccination is crucial for older adults. Pneumococcal vaccination age has been lowered to 50, with new vaccines targeting prevalent serotypes.

EMA's CHMP recommended 10 new medicines for approval, including vaccines Fluad and Flucelax for influenza, and extensions for 6 drugs. Biosimilars Absimky and Imuldosa, and generic Eltrombopag Viatris were also recommended. CHMP maintained its refusal for Masitinib AB Science and withdrew applications for Apremilast Viatris and Epixram.

The European Medicines Agency's CHMP recommended 10 new medicines for approval, including vaccines Fluad and Flucelax for influenza, and extensions for six drugs. Two biosimilars and two generic drugs were also approved. CHMP confirmed its refusal of Masitinib AB Science for amyotrophic lateral sclerosis and withdrew consideration for Apremilast Viatris and Epixram due to data issues and regulatory strategy changes, respectively.

The committee recommended marketing authorisations for ten new medicines, including treatments for haemophilia, influenza, malignant ascites, tuberculosis diagnosis, hereditary transthyretin-mediated amyloidosis, and opioid dependence. Six existing medicines received extensions of indication, while two applications were withdrawn. The CHMP confirmed refusals for conditional marketing authorisations for masitinib and non-renewal for Translarna. Updates to COVID-19 vaccines were also approved. Outi Mäki-Ikola was elected as the new CHMP vice-chair.

The FDA placed a hold on Novavax’s COVID-19 and influenza combination vaccine candidate due to a serious adverse event reported in a phase 2 trial participant. Novavax is working with the FDA to resolve the issue, emphasizing safety as a priority. The hold affects the combination vaccine and a standalone influenza vaccine, but not the standalone COVID-19 vaccine.

The digital health market, valued at $180.2 billion in 2023, is expected to grow to $549.7 billion by 2028, driven by technologies like mHealth, telehealth, and digital therapeutics. Key players include DexCom and Teladoc Health, with the US market leading at $88 billion in 2023. Telemedicine and wearable devices are pivotal, with the telemedicine market projected to reach $286.22 billion by 2030. Precision medicine and medical imaging technologies are also transforming healthcare, with companies like Merck & Co., Sanofi, and AstraZeneca leading in innovation and growth.