Orexo AB’s subsidiary Orexo US Inc. has been awarded $8 million in funding by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support the development of OX-390, an intranasal rescue medication for adulterated opioid overdoses.
Grifols SA has entered into a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to test investigational ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sulfur mustard exposure.
Gigagen Inc., a subsidiary of Grifols SA, has been awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a recombinant polyclonal antibody therapy for botulinum neurotoxins and a second biothreat of interest yet to be determined.
Arcturus Therapeutics Holdings Inc. has announced its pandemic influenza vaccine is on track to enter a phase I clinical trial in Q4 of 2024. The vaccine, ARCT-2304, utilizes Arcturus’ STARR self-amplifying mRNA and LUNAR delivery platform technologies to deliver antigens designed to elicit a protective response against the H5N1 strain of avian influenza.
Armed with $55 million in series A funds and a U.S. government contract, Cambridge, Mass.-based Red Queen Therapeutics Inc. launched operations this week, with plans to advance its novel stapled lipopeptide platform, which creates new antiviral therapies that do not rely on the immune system to work.
The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response, has awarded Vir Biotechnology Inc. approximately $50 million in new funding to advance the development of novel monoclonal antibody (MAb) candidates and delivery solutions to widen the applicability of MAbs in COVID-19 and in pandemic preparedness and response.
Modex Therapeutics Inc. has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to advance a platform and specific candidates designed to address a range of public health threats in viral infectious diseases.
If the modification to Regeneron Pharmaceuticals Inc.’s $326 million contract with the U.S. Biomedical Advanced Research and Development Authority is anything to go by, pricing clauses could once again become a common feature in biopharma contracts involving government R&D funding.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
The U.S. Government Accountability Office (GAO) has sounded off again about the ability of other federal government agencies to respond to future crises and pandemics, arguing that the Department of Health and Human Services (HHS) has not forged a comprehensive assessment mechanism to account for the associated medical countermeasure production needs. However, GAO also remarked that HHS does not have a dedicated funding mechanism to finance these activities, a resource that might not become available until after HHS officials draft a budget for the activities associated with such efforts for congressional review.
