Emergent BioSolutions

The Korean Ministry of Food and Drug Safety approved BARYTHRAX, the world's first recombinant protein-based anthrax vaccine developed by GC Biopharma and the Korea Disease Control and Prevention Agency.

• A recent study published in The Lancet Infectious Diseases found Bavarian Nordic's Jynneos vaccine was 84% effective in preventing mpox in individuals without HIV, but only 35% effective in those with HIV. • The research, conducted at Charité Universitätsmedizin Berlin with over 6,000 participants, highlights a significant unmet need for effective mpox prevention strategies in immunocompromised populations. • While the vaccine showed an overall 58% effectiveness after one dose, researchers emphasize the importance of completing the two-dose regimen, particularly for HIV-positive individuals who demonstrated reduced T-cell responses.

• The US FDA has approved Bavarian Nordic's freeze-dried formulation of Jynneos vaccine for mpox and smallpox prevention in adults, offering significant advantages in storage, transportation, and shelf life over the liquid-frozen version. • Clinical trials demonstrated comparable immune responses between the freeze-dried and liquid-frozen formulations, with no serious adverse events reported, supporting the supplemental Biologics License Application submitted in May 2024. • The approval represents a milestone in public health preparedness, with Bavarian Nordic manufacturing the freeze-dried vaccine under a contract with BARDA, with first deliveries expected later in 2025.

Health Canada has approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for treating known or suspected opioid overdoses in adults, providing a higher-dose alternative to existing treatments.

Syngene International has acquired its first US biologics manufacturing facility near Baltimore for $36.5 million, with plans to invest an additional $13.5 million in upgrades to make it operational by mid-2025.

Emergent BioSolutions has made a strategic financial investment in Swiss Rockets Ltd, the parent company of Rocketvax, to support research and infrastructure development.

The MOSA trial, led by Africa CDC, has begun enrolling patients in the Democratic Republic of Congo to evaluate potential Mpox therapeutics.

A clinical trial (MOSA) will assess brincidofovir's safety and efficacy against Mpox in the Democratic Republic of Congo and neighboring African countries.

Emergent BioSolutions supports a clinical trial led by Africa CDC to assess brincidofovir's safety and efficacy in treating mpox virus.

The Africa CDC and PANTHER have launched the Mpox Study in Africa (MOSA) to address the urgent need for effective Mpox treatments.