Emergent BioSolutions

Emergent BioSolutions received a $50M BARDA contract for CYFENDUS® anthrax vaccine, deliveries by April 2025. FDA-approved in July 2023, it's a two-dose post-exposure prophylaxis for ages 18-65. The contract enhances national anthrax preparedness, with Emergent's portfolio including BioThrax® and treatments Anthrasil® and raxibacumab.

A second NIH clinical trial shows SIGA Technologies' tecovirimat ineffective for mpox, halting recruitment. The STOMP trial found no reduction in lesion resolution or pain vs. placebo in mild to moderate clade 2 mpox cases. This follows the PALM 007 study in DRC, also finding tecovirimat no better than placebo. Despite setbacks, three vaccines remain available, and three ongoing trials for tecovirimat continue.

Pharma leaders discussed clinical trial quality at SCOPE Europe, emphasizing the shift from reactive to proactive, risk-based approaches. Challenges include cultural resistance and high implementation costs, highlighting the need for senior leadership support and data-driven decision-making to ensure quality and efficiency in clinical trials.

Investors react negatively to Trump's nomination of RFK Jr. for HHS, causing COVID-19 vaccine stocks to tumble, with Moderna and BioNTech seeing significant losses. RFK Jr.'s criticism of COVID-19 vaccines and potential impact on vaccine policy contribute to investor concerns. Psychedelic drug companies, however, see stock increases due to RFK's support for the field.

110+ organizations urge Congress to reauthorize PAHPA by Dec 31, recognizing the opportunity to strengthen national health security during the 2025 leadership transition.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

H5N1 in swine in Oregon, serosurvey in farm workers, fatal Lassa Fever in Iowa, WHO's top endemic pathogens list, potential CDC impact under another Trump administration, and Russia's bioweapons lab expansion.

Clinical trials for brincidofovir, an antiviral treatment for Mpox, will begin in Q4 2024 in the Democratic Republic of Congo and neighboring countries, led by Africa CDC and PANTHER. The MOSA trial aims to evaluate the drug's safety and efficacy, addressing a significant health threat in Africa, particularly for vulnerable populations. The study includes interim analyses for rapid decision-making, with the first expected in early 2025.

Africa CDC and PANTHER announce MOSA, a clinical trial evaluating brincidofovir's safety and efficacy for Mpox treatment in Africa, starting in DRC and neighboring countries in Q4 2024. The trial aims to address the urgent healthcare gap for Mpox, with Emergent BioSolutions providing study drugs and placebo free of charge.

Emergent BioSolutions appoints Dr. Simon Lowry as chief medical officer, head of research and development, effective November 18, to advance the company's strategic scientific roadmap. Jessica Perl is promoted to General Counsel and Corporate Secretary.