Latest news with #ASPR
Yahoo
3 days ago
- Health
- Yahoo
Trump targets bolstering of US emergency drug reserve
US President Donald Trump has ordered the bolstering of the country's Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) with important drugs, aligning with his wider ambition to reduce reliance on imported pharmaceutical products. The executive order, signed on 13 August, will see the active pharmaceutical ingredients (API) of around 26 'critical drugs' added to the SAPIR. Trump has directed the Office of the Assistant Secretary for Preparedness and Response (ASPR) to curate the list of drugs whose APIs will be stored. The office of the ASPR is within the US Department of Health and Human Services (HHS) and is responsible for safeguarding drugs involved in the country's public health strategies. The SAPIR was established in 2020 by the Trump administration in response to the Covid-19 pandemic. The reserve is supposed to have nearly two years' worth of medicine supply for the most important treatments approved by the US Food and Drug Administration (FDA), but a lack of investment means it has been near-empty for the past few years. The White House blames the Biden administration for failing to advance domestic production or fill the SAPIR, 'despite spending billions on supply chain initiatives'. Trump has requested a shorter timeframe for how long the repository should be able to provide the 26 drugs in the event of an emergency. The ASPR is tasked with obtaining a six-month supply of the critical APIs. It also instructed to update the 2022 list of 86 essential medicines, with a six-month supply planned too. The executive order has asked the ASPR to preferentially source the API via 'domestically manufactured' means. However, the office might have its work cut out to find these providers, given how reliant the US is on importing APIs. Of the manufacturers that produce APIs used in FDA-approved products, only 11% are based in the US. Around 43% of branded pharmaceutical API come from the EU. In a statement, the White House said the move to fill the SAPIR with more drugs 'addresses supply chain vulnerabilities'. A spokesperson added: 'Restoring capacity for domestic production of essential pharmaceutical products is essential to safeguarding national health and security against global supply chain disruptions.' The SAPIR executive order is part of Trump's strategy to bolster domestic pharma manufacturing. This has mainly been mediated via tariffs and economic policies. Last week, the FDA introduced a new scheme that will streamline the introduction of new pharmaceutical manufacturing facilities in the US. The PreCheck programme, unveiled by the agency on 7 August, comprises a two-phase approach to facilitate new US drug manufacturing facilities. Big pharma has been responding to Trump's pressurised calls by outlaying significant funds to boost US manufacturing sites. Johnson & Johnson is set to invest $55bn over the next four years, including a $2bn biologics production site in North Carolina that promises to create 500 jobs. Roche outlaid a similar amount, planning $50bn worth of investment in the US, which will generate more than 1,000 jobs in new and expanded facilities. "Trump targets bolstering of US emergency drug reserve" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
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
18-03-2025
- Health
- Yahoo
Free COVID tests no longer available through this government site: How to get a test
Five years after COVID-19 was declared an official pandemic, the U.S. government has suspended its free at-home COVID test distribution program. The Administration for Strategic Preparedness and Response (ASPR), part of the U.S. Department of Health and Human Services, shut down ordering via Sunday, posting a notice that says, "The free at-home COVID-19 test distribution program is not currently accepting orders." Orders placed before 8 p.m. ET Sunday, March 9, 2025, will still be shipped, said the notice. The USPS website for ordering likewise said that "ordering through this program has been suspended effective March 9, 2025." Before that time, American households were able to place orders through the website for free at-home COVID tests, which were then shipped for no cost through the U.S. Postal Service. Ordering via the website has been closed and re-opened periodically since it was launched in late 2021, usually with renewed eligibilities. It was previously suspended in March 2024 before re-opening with the four free tests per household offer in September. The USPS landing page for the program points back to for more information on other free COVID-19 testing options. However, the government website simply advises on where to purchase tests, saying "At-home COVID-19 tests are sold at pharmacies, grocery stores and many other retailers nationwide." The agency did not indicate whether the suspension is permanent or temporary as with past closures. The HSS did not immediately respond to request for comment. The news comes less than a month after the Washington Post reported that the Trump administration had reversed a decision to shut down the program and potentially dispose of or destroy 160 million, or more than half a billion dollars worth, of mostly unexpired tests. The initiative was originally supposed to be shuttered on Feb. 18 but just minutes before the site was set to go dark, Human Services spokesman Andrew Nixon issued a statement saying it would remain open for the time being. He also told the newspaper that unexpired stockpiled tests would not be destroyed. 'With COVID-19 infections decreasing after a winter peak, we are in the process of regular discussions on closing this round of the COVID-19 test ordering program. At this point, the program is still open, and we will share additional updates as needed,' the statement sent to the Post said. The ASPR, in partnership with USPS, had sent more than 900 million tests directly to U.S. households via by Oct. 2024, according to a USPS release from that time. Millions more were distributed to community centers including nursing homes, libraries, local health departments and food banks. COVID antigen tests generally cost between $12-$35 dollars for a pack of two at pharmacies and retail locations, though the price can be even higher. PCR testing done by a medical professional can cost much more, depending on your insurance coverage. The Centers for Disease Control and Prevention is still offering free testing for uninsured adults who have symptoms of or have been exposed to COVID through the Increasing Community Access to Testing, Treatment and Response (ICATT) program. Around 10,000 ICATT sites nationwide continue to offer testing and disease surveillance in non-emergency situations to uninsured people and more than 19,000 are offering no-cost COVID-19 vaccines under the CDC Bridge Access program. A list of free COVID-19 testing sites can be found on the COVID-19 Testing Locator website. Locations offering free vaccines can be found at Some insurance plans also cover the full cost of COVID-19 tests. You can check your eligibility and order these insurance-covered tests through pharmacies like Walgreens and CVS. Your state, county or city health department may also have free or low-cost testing sites operating out of community locations like churches, rec centers and schools. Check your local departments' websites and social media channels or give them a call to ask about accessible testing options. This article originally appeared on USA TODAY: US suspends free COVID test program: Where to get one for free
USA Today
17-03-2025
- Health
- USA Today
Free COVID tests no longer available through this government site: How to get a test
Free COVID tests no longer available through this government site: How to get a test Show Caption Hide Caption 5 years since COVID-19 declared a global pandemic Tuesday marks five years since the start of the COVID-19 pandemic. On this day in 2020, the World Health Organization declared a global pandemic, triggering lockdowns across the world. Fox - 5 DC Five years after COVID-19 was declared an official pandemic, the U.S. government has suspended its free at-home COVID test distribution program. The Administration for Strategic Preparedness and Response (ASPR), part of the U.S. Department of Health and Human Services, shut down ordering via Sunday, posting a notice that says, "The free at-home COVID-19 test distribution program is not currently accepting orders." Orders placed before 8 p.m. ET Sunday, March 9, 2025, will still be shipped, said the notice. The USPS website for ordering likewise said that "ordering through this program has been suspended effective March 9, 2025." Before that time, American households were able to place orders through the website for free at-home COVID tests, which were then shipped for no cost through the U.S. Postal Service. Ordering via the website has been closed and re-opened periodically since it was launched in late 2021, usually with renewed eligibilities. It was previously suspended in March 2024 before re-opening with the four free tests per household offer in September. The USPS landing page for the program points back to for more information on other free COVID-19 testing options. However, the government website simply advises on where to purchase tests, saying "At-home COVID-19 tests are sold at pharmacies, grocery stores and many other retailers nationwide." The agency did not indicate whether the suspension is permanent or temporary as with past closures. The HSS did not immediately respond to request for comment. Free program sent more than 900 million COVID tests to American households The news comes less than a month after the Washington Post reported that the Trump administration had reversed a decision to shut down the program and potentially dispose of or destroy 160 million, or more than half a billion dollars worth, of mostly unexpired tests. The initiative was originally supposed to be shuttered on Feb. 18 but just minutes before the site was set to go dark, Human Services spokesman Andrew Nixon issued a statement saying it would remain open for the time being. He also told the newspaper that unexpired stockpiled tests would not be destroyed. 'With COVID-19 infections decreasing after a winter peak, we are in the process of regular discussions on closing this round of the COVID-19 test ordering program. At this point, the program is still open, and we will share additional updates as needed,' the statement sent to the Post said. The ASPR, in partnership with USPS, had sent more than 900 million tests directly to U.S. households via by Oct. 2024, according to a USPS release from that time. Millions more were distributed to community centers including nursing homes, libraries, local health departments and food banks. Other ways to get free or cheap COVID testing COVID antigen tests generally cost between $12-$35 dollars for a pack of two at pharmacies and retail locations, though the price can be even higher. PCR testing done by a medical professional can cost much more, depending on your insurance coverage. The Centers for Disease Control and Prevention is still offering free testing for uninsured adults who have symptoms of or have been exposed to COVID through the Increasing Community Access to Testing, Treatment and Response (ICATT) program. Around 10,000 ICATT sites nationwide continue to offer testing and disease surveillance in non-emergency situations to uninsured people and more than 19,000 are offering no-cost COVID-19 vaccines under the CDC Bridge Access program. A list of free COVID-19 testing sites can be found on the COVID-19 Testing Locator website. Locations offering free vaccines can be found at Some insurance plans also cover the full cost of COVID-19 tests. You can check your eligibility and order these insurance-covered tests through pharmacies like Walgreens and CVS. Your state, county or city health department may also have free or low-cost testing sites operating out of community locations like churches, rec centers and schools. Check your local departments' websites and social media channels or give them a call to ask about accessible testing options.
