Latest news with #BARDA
Yahoo
12-07-2025
- Business
- Yahoo
Spectral AI (MDAI) Submits FDA Application for DeepView Burn Assessment System
Spectral AI, Inc. (NASDAQ:MDAI) is one of the most popular AI penny stocks to buy according to billionaires. On June 30, Spectral AI (NASDAQ:MDAI) submitted a De Novo 510k application to the FDA for its DeepView System, a non-invasive diagnostic tool that uses multispectral imaging and proprietary AI to predict burn wound healing. An aesthetic doctor making use of innovative, cutting-edge medical technology in their practice. Designed for use in emergency departments and burn centers, the system provides clinicians with same-day and week-long injury assessments to guide early treatment decisions. Due to its novel approach and lack of an existing equivalent device, the company is pursuing FDA clearance through the De Novo pathway. Company Chairman Dr. J. Michael DiMaio called the submission a major milestone for bringing DeepView to market and improving patient outcomes. Supported in part by federal funding from BARDA and the U.S. Department of Health and Human Services, the project has received multiple development contracts since 2013, reflecting ongoing public-sector support for the technology's advancement. Spectral AI, Inc. (NASDAQ:MDAI) is a Dallas-based medical technology company specializing in predictive diagnostics powered by AI. Its flagship product, the DeepView System, uses proprietary AI algorithms to assess wound healing potential. The platform has received Breakthrough Device Designation from the FDA and is undergoing regulatory review. While we acknowledge the potential of MDAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: Top 10 Materials Stocks to Buy According to Analysts and 10 Best Defensive Stocks to Buy in a Volatile Market. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Independent
08-07-2025
- Health
- The Independent
Despite RFK Jr's hesitancy the HHS is quietly looking at developing two new vaccines
Despite the known skepticism of its leader Robert F Kennedy Jr, the Department of Health and Human Services quietly announced last month two new vaccines aimed at addressing 'material threats to national health security.' The vaccines are intended to be developed for use against Marburg virus and Sudan ebolavirus, two hemorrhagic fevers in the same family as the Ebola virus, which can cause uncontrolled bleeding and death. A pre-solicitation notice was posted to a government contracting website on June 27 by the Biomedical Advanced Research and Development Authority. BARDA is a center within the Administration for Strategic Preparedness and Response within HHS which is responsible for the development of medical countermeasures – principally bioterrorism. The notice of the new vaccines comes as Kennedy continues his overhaul of the department and makes cuts to research on infectious diseases. A known vaccine skeptic, he recently canned the Advisory Committee for Immunization Practices, in order to restore "public trust above any pro or anti-vaccine agenda,' he said. The ACIP is responsible for evaluating the safety, efficacy and clinical need of vaccines and then presenting its findings to the Centers for Disease Control and Prevention. Kennedy removed all 17 committee members last month and replaced them with several people who have also been critical of vaccines, saying his picks were 'committed to evidence-based medicine, gold-standard science, and common sense.' The new vaccine proposals demonstrate an awareness within HHS of the dangers posed by further outbreaks of serious disease and the consequences of being unprepared. The pre-solicitation notice notes that the Filovirus family, which includes Marburg virus and the Ebola and Sudan viruses, 'are known to cause severe health consequences, including death, in humans' and that infections with EBOV, SUDV, and MARV 'can lead to case fatality rates of up to 90 percent.' The immediate need for MARV and SUDV vaccines has been emphasized by recent outbreaks, according to BARDA, which cites the SUDV outbreak in 2022 that resulted in 141 confirmed cases and 55 deaths. Additionally, a MARV outbreak in 2024 led to 66 confirmed cases and 15 deaths. The Marburg and Sudan ebolavirus vaccines that BARDA has proposed are not mRNA vaccines – which have been a specific target of Kennedy's skepticism during the coronavirus pandemic.
Yahoo
08-07-2025
- Business
- Yahoo
Basilea receives USD 39 million funding under BARDA agreement to continue to advance novel antifungals fosmanogepix and BAL2062
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, July 08, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 39 million to Basilea to continue to advance the development of Basilea's novel antifungals fosmanogepix and BAL2062. This additional funding is based on the successful completion of a milestone within the 'Other Transaction Agreement' (OTA, agreement number 75A50124C00033) that was awarded on September 30, 2024, and which allows for potential funding of up to approximately USD 268 million in total to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: 'We are very pleased to receive the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections. These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients. Infections with difficult-to-treat rare molds or with resistance to current therapies are increasing. Hence, there continues to be a high medical need for new innovative antifungals.' He added: 'This second tranche of funding within the BARDA OTA will support the ongoing phase 3 study with fosmanogepix in yeast infections and the second phase 3 study, in mold infections, which is expected to start soon. It also provides funding for the preparation for the start of the phase 2 study for our antifungal BAL2062.' The USD 39 million is in addition to the initial USD 29 million BARDA committed at the signing of the OTA in September 2024. BARDA's financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing and the initiation of a second phase 3 study, in the treatment of adult patients with invasive mold infections, is expected soon.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). About BAL2062 BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@ This ad hoc announcement can be downloaded from References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 FAST study (candidemia/invasive candidiasis): identifier NCT05421858; FORWARD study (invasive mold infections): identifier NCT06925321 K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909 identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19 J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434 M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10 Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: (Accessed: July 07, 2025) B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)
Yahoo
08-07-2025
- Business
- Yahoo
Basilea receives USD 39 million funding under BARDA agreement to continue to advance novel antifungals fosmanogepix and BAL2062
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, July 08, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 39 million to Basilea to continue to advance the development of Basilea's novel antifungals fosmanogepix and BAL2062. This additional funding is based on the successful completion of a milestone within the 'Other Transaction Agreement' (OTA, agreement number 75A50124C00033) that was awarded on September 30, 2024, and which allows for potential funding of up to approximately USD 268 million in total to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: 'We are very pleased to receive the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections. These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients. Infections with difficult-to-treat rare molds or with resistance to current therapies are increasing. Hence, there continues to be a high medical need for new innovative antifungals.' He added: 'This second tranche of funding within the BARDA OTA will support the ongoing phase 3 study with fosmanogepix in yeast infections and the second phase 3 study, in mold infections, which is expected to start soon. It also provides funding for the preparation for the start of the phase 2 study for our antifungal BAL2062.' The USD 39 million is in addition to the initial USD 29 million BARDA committed at the signing of the OTA in September 2024. BARDA's financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing and the initiation of a second phase 3 study, in the treatment of adult patients with invasive mold infections, is expected soon.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). About BAL2062 BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@ This ad hoc announcement can be downloaded from References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 FAST study (candidemia/invasive candidiasis): identifier NCT05421858; FORWARD study (invasive mold infections): identifier NCT06925321 K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909 identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19 J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434 M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10 Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: (Accessed: July 07, 2025) B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)
National Post
02-07-2025
- Business
- National Post
Synedgen Promotes Dr. Laura Saward to Chief Executive Officer and Appoints Dr. Kenton Gregory to Chief Medical Officer
Article content – As Synedgen's Chief Executive Officer and Chief Scientific Officer, Dr. Saward will continue to lead the company to deliver on the successful partnership with Biomedical Advanced Research Agency (BARDA) and leverage her significant expertise in drug development and licensure – Article content – Dr. Gregory has been appointed Chief Medical Officer bringing a wealth of experience to support the development of Synedgen's platform and products to meet the needs of patients and key customers such as the US government – Article content Article content CLAREMONT, Calif. — Synedgen, Inc., a biotechnology company with a validated platform targeting human glycobiology to treat a range of diseases including gastrointestinal targets, today announced that it has promoted Dr. Laura Saward, PhD, to be the company's President and Chief Executive Officer. Dr. Saward joined Synedgen in 2024 in the capacity of Chief Scientific Officer to launch their transformative program for GI Acute Radiation Syndrome, and she will continue to serve in this role as well. Article content 'We are delighted that Laura has agreed to lead Synedgen through the next stage of our company's growth, and through the execution of our contract with BARDA, valued at up to $119 million if all Options are exercised, for the development of MIIST305 as a medical countermeasure for gastrointestinal acute radiation syndrome,' said Dr. Kenton Gregory, Chairman of the Board of Directors for Synedgen. 'Dr. Saward's extensive experience with successfully executing on government contracts and achieving FDA approval makes her the ideal candidate to shape Synedgen's future. The Board is confident in her ability to grow our company and progress our development pipeline, and on behalf of my fellow directors I offer her our full support.' Article content Dr. Saward is an accomplished biotechnology executive with more than 25 years of experience in therapeutic drug development from preclinical to licensure. Prior to joining Synedgen, Dr. Saward served as Executive Vice President Health and Medical for Adva Diagnostics Inc., a start-up where she was a key member of the executive team focused on strategy, growth planning, and partnerships expansion to strengthen the business. Previously she held several executive roles at Emergent BioSolutions Inc. including leading the Therapeutics Business Unit. Before joining Emergent, Dr. Saward held various leadership roles at Cangene Corporation including Chief Scientific Officer. She has had the opportunity to direct the licensure of multiple products for commercial markets and government partners. Article content 'I am thrilled to lead Synedgen at this exciting time in the company's history and thank our Board and shareholders for the trust they have placed in me,' said Dr. Saward, President and Chief Executive Officer of Synedgen. 'Synedgen possesses unique technologies with both biodefense and commercial applications – underlined by recent partnerships with BARDA and U.S. Department of Defense – and I look forward to delivering on these contracts to the benefit of all stakeholders. The further expansion of our team with the appointment of Dr. Gregory as our Chief Medical Officer will deepen our expertise and add significant value in driving the success of our programs and partnerships.' Article content Dr. Gregory, Professor of Medicine and Biomedical Engineering at Oregon Health & Sciences University, has a 30 year record of successfully conceiving, developing and deploying medical technologies for saving lives that has launched seven companies to commercialize his research. Dr. Gregory's contributions range from advanced hemorrhage control technologies, laser-based diagnostics and therapeutics, CBRN countermeasures and regenerative medicine to AI-based imaging diagnostics for point of care diagnosis and triage at mass casualty incidents with over 50 US and foreign issued or pending patents. Dr. Gregory has experience as the CMO for other biotech companies with over a dozen FDA approved products and has experience as PI for another BARDA CBRN program for extended field care and mass casualty care. Article content About Synedgen Article content Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company's lead development candidate is MIIST305, an oral, glycocalyx targeted induction and maintenance therapy for ulcerative colitis (UC). With US Government support, MIIST305 is also being developed in parallel as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through twenty-two (22) National Institutes of Health grants and Department of Defense contracts. Synedgen has an in-house GMP manufacturing facility. For more information, please visit Synedgen's GI-ARS program is funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority, under Contract No. 75A50124C00047. For more information, please visit Article content Article content Article content Article content
