Since its emergence in the spring, the monkeypox outbreak has spawned a small but growing pipeline of drugs and vaccines, many of them repurposed smallpox products.

While Moderna plans preclinical studies and Tonix Pharma’s candidate is to enter trials in H1, Bavarian Nordic is seeking US and Indian manufacturing partners for its approved monkeypox vaccine. Scrip examines if the disease presents an opportunity for vaccine makers, like COVID-19 did or it could go the H1N1 way

The decision to maintain or revoke breakthrough therapy status when trial results do not appear to support the original designation will depend on the facts specific to a development program, the US FDA says in new draft guidance. Since 2012, the agency has granted 475 breakthrough therapy designation requests and rescinded 35 designations.

National Resilience, Parker Institute team to incubate cancer startups. Metropolitan AntiViral Drug Accelerator will focus on eight molecular features of SARS-CoV-2 to create novel oral antivirals.