Core Insights - Emergent BioSolutions has announced a collaboration with PANTHER to support the Africa CDC-led 'MpOx Study in Africa' (MOSA), aimed at researching treatments for mpox, a virus lacking dedicated antiviral therapy [1] - The MOSA study, launched in 2024, is a double-blind, platform-adaptive clinical trial evaluating treatment options for mpox across multiple African countries, initially funded by the European Union and Africa CDC [1] - An independent data and safety monitoring board (DSMB) reviewed the safety data of MOSA in December 2025, recommending the continuation of the trial with no safety concerns identified [2] Company and Industry Overview - Emergent BioSolutions focuses on protecting public health by delivering life-saving solutions for various health threats, including mpox [5] - PANTHER is an African-led pandemic preparedness platform that aims to enhance regional response to emerging infectious diseases, particularly in Africa [6] - The Africa CDC is a public health agency of the African Union, supporting member states in strengthening health systems and improving disease surveillance and emergency response [8] Study Progress and Impact - The MOSA study represents a significant step in generating evidence for mpox treatment and enhancing Africa's capacity to respond to health threats, with over 61,383 confirmed cases and 296 deaths reported across 32 countries since 2024 [4] - The study will expand to new countries, including Uganda, as part of its efforts to reach the next milestone in patient enrollment [3]

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Core Viewpoint - The U.S. government has terminated its contract with Moderna for the late-stage development of an mRNA-based bird flu vaccine, impacting the company's funding and development plans [1][2]. Group 1: Contract and Funding - The Biden administration had awarded Moderna two contracts totaling $766 million, including $590 million for advancing vaccine development and $176 million to expedite vaccine development [2]. - The termination of the contract was anticipated due to a review of agreements made during the Biden administration by the Trump administration [3]. Group 2: Clinical Data and Future Plans - Despite the funding setback, Moderna reported positive interim data from a phase I/II study of its mRNA-1018 vaccine, showing an increase in protective antibody levels from 2.1% to 97.8% after the second dose among 300 participants [4]. - The company plans to present further clinical findings at an upcoming scientific conference and is exploring new paths for pandemic preparedness in light of the funding loss [5]. Group 3: Stock Performance and Market Sentiment - Year-to-date, Moderna's stock has decreased by 37%, contrasting with a 5% decline in the industry [6]. - Negative sentiment surrounding Moderna's stock has been exacerbated by recent FDA guidance limiting COVID-19 booster eligibility and the voluntary withdrawal of a regulatory filing for its COVID-19/influenza vaccine [8][9]. - The company is also working to reduce operating expenses and streamline its R&D pipeline amid these challenges [10].

Core Viewpoint - Traws Pharma is advancing the development of tivoxavir marboxil (TXM) as a treatment for bird flu and seasonal influenza, with recent FDA feedback guiding their regulatory strategy and clinical study plans [1][2][3]. Group 1: FDA Interaction and Development Plans - The FDA provided written responses regarding the development paths for TXM, including the potential use of the Animal Rule for approval [1][2]. - Traws Pharma is requesting a Type D meeting with the FDA to clarify next steps in the development process for TXM [2]. - The company aims to conduct a combined clinical study involving subjects infected with seasonal and bird flu [2]. Group 2: Therapeutic Efficacy and Urgency - Positive therapeutic effects of TXM have been observed in three animal models of bird flu, reinforcing the need for rapid progression towards stockpiling and pandemic readiness [3]. - Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) for stockpiling TXM in preparation for potential pandemics [3]. - The historical context of H5N1 virus outbreaks, which have had death rates up to 50%, underscores the urgency of these actions [3]. Group 3: Product Overview and Market Opportunity - TXM is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains [4]. - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government tenders, with additional potential from pandemic outbreaks [4]. - The data supporting TXM's development as a treatment for both bird flu and seasonal flu is considered robust [4].