Latest news with #BARDA
Herald Sun
5 days ago
- Business
- Herald Sun
StockTake: Lumos Diagnostics
Stockhead's Tylah Tully unpacks the latest from Lumos Diagnostics (ASX:LDX), who have enrolled its 500th patient in a CLIA waiver study for FebriDx, its rapid point-of-care diagnostic test to differentiate between bacterial and non-bacterial acute respiratory infections. The company has a funding partnership with the US government's Biomedical Advanced Research and Development Authority (BARDA). Lumos has now received more than US$1.2 million in milestone payments from BARDA, which has pledged nearly US$3 million toward the study. Watch the video to learn more. This video was developed in collaboration with Lumos Diagnostics, a Stockhead advertiser at the time of publishing. This video does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as StockTake: Lumos enrols 500th patient in crucial respiratory diagnostic test study
Yahoo
5 days ago
- Business
- Yahoo
CHO Plus Selected for 2025 BioTools Innovator Accelerator Program
Biomanufacturing Technology Developer Joins Top-Tier Global Cohort Competing for $300,000 in Cash Awards SOUTH SAN FRANCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Privately-held CHO Plus, Inc., a leading developer of biopharmaceutical manufacturing technology, announced its selection for the 2025 BioTools Innovator Accelerator, the first and only program focused exclusively on life science tools and diagnostics companies. Chosen from over 400 applicants, CHO Plus is among just 31 startups to earn a spot in this year's prestigious cohort. BioTools Innovator provides a four-month accelerator program offering tailored mentorship from senior industry leaders, investor exposure, and networking opportunities with peers and experts across the global life science community. At the end of the program, companies will compete for $300,000 in non-dilutive cash prizes. 'We are honored to be recognized among the most promising innovators in life science tools and diagnostics,' said Lawrence Forman, Founder and CEO of CHO Plus, Inc. 'This opportunity will help us accelerate the development and commercialization of our high-productivity cell lines for biologics production. We're excited to engage with industry mentors, and to connect with peers as part of the BioTools Innovator ecosystem.' CHO Plus was also selected with nine other companies to participate in the VANGUARD Accelerator, a joint initiative with Biomedical Advanced Research and Development Authority (BARDA) to support companies advancing medical countermeasures for public health emergencies. VANGUARD is a joint initiative between BioTools Innovator and BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, to support startups in deploying innovative medical countermeasures that enhance the U.S.'s readiness for public health emergencies.* As part of the BioTools Innovator 2025 program CHO Plus will participate in a series of events, including the Innovator Summit (June 24–26 in Mountain View, CA), pitch opportunities, and a final Capstone Event where companies will compete for a share of $300,000 in non-dilutive funding. *This project has been supported in whole or in part with funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under agreement number 75A50124C00034. About CHO Plus, Plus, a privately held company, was founded in 2014 with the mission of increasing the productivity of cells used for manufacturing life-saving therapeutic agents for treating human disease. CHO Plus has patents granted and pending for several different technologies in over ten jurisdictions around the world. Current CHO Plus studies demonstrate that our engineered CHO cells produce up to 10-fold more therapeutic antibodies than un-engineered cells and our engineered HEK-293 cells produce up to 20-fold more AAV vectors, with up to 55% full capsids before purification. With a focus on innovation and collaboration, the company is committed to advancing production of therapeutic proteins and gene therapy vectors to address a wide range of clinical conditions. About BioTools InnovatorBioTools Innovator (BTI), based in Los Angeles, advances cutting-edge research and improves human health by accelerating the growth of life science tools and diagnostics startups. Powered by MedTech Innovator, the world's largest accelerator for medical technology companies, BTI supports early-stage and emerging growth companies through mentorship, visibility, and non-dilutive funding more at Media ContactLawrence Forman, CHO Plus, Inc. Founder and CEOLarry@ 845 380 6993
Yahoo
11-06-2025
- Health
- Yahoo
CROSSJECT advances on the development of ZEPIZURE® Junior, its solution for epilepsy crises in children
Press release CROSSJECT advances on the development of ZEPIZURE® , its solution for epilepsy crises in children Announces the effective calibration of ZENEO® for the use of ZEPIZURE® in the pediatric population. CROSSJECT completed an echography clinical study allowing to determine and validate the targeted depth of injection in children as compared to adults. Dijon, France 11 June 2025 (07h30 CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharma company in advanced phases of development and registration for ZEPIZURE® in adults, is progressing in the development of its pediatric version of ZEPIZURE®, branded ZEPIZURE® Junior. According to the 2022 National Survey of Children's Health and as reported by the U.S. Centers for Disease Control and Prevention (CDC) on its 'Epilepsy Facts & Stats' pages, there are approximately 456,000 children with active epilepsy in the U.S. The active epilepsy population is defined as patients who are diagnosed and actively managed by a caregiver. Under its contract with the Biomedical Advanced Research and Development Authority (BARDA), CROSSJECT completed a clinical echography study in a 90 adults and children (2-18 years old) to measure and compare the anatomical characteristics of thighs, i.e. the thickness of layers from skin to muscle (CJTCDZ2301, NCT06279689). In parallel CROSSJECT conducted studies on its ex-vivo experimental models that reconstitute the skin and the subcutaneous and muscle layers in children. These tests have successfully enabled the calibration of the pressure to be exerted by the ZENEO® device gas generators to expel the drug solution with the suitable penetration depth and confirmed the adequacy of the ZENEO® device in its 'Junior' mode. Previous Human Factors studies had also included a significant number of children above 8 years of age and did successfully demonstrate their ability to use the autoinjector ZENEO® effectively. « We are excited by this incremental innovation and the success in our product development. Pediatrics is strategic to CROSSJECT as we want to establish ZEPIZURE® as the standard of care early in this chronic condition. We look forward to advancing with the Food and Drug Administration (FDA) and having concrete clinical solutions to propose to the pediatric patient community », said Patrick ALEXANDRE, CEO of CROSSJECT. About CROSSJECT CROSSJECT SA (Euronext: ALCJ; is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million contract* with BARDA. The Company's versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company's other products in developmentmainly include solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications. * This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031. *** For further information, please contact: Investor Relationsinvestors@ Attachment CROSSJECT advances on the development of ZEPIZURE® Junior
Yahoo
06-06-2025
- Health
- Yahoo
In axing mRNA contract, Trump delivers another blow to US biosecurity, former officials say
This is a KFF Health News story. The Trump administration's cancellation of $766 million in contracts to develop mRNA vaccines against potential pandemic flu viruses is the latest blow to national defense, former health security officials said. They warned that the U.S. could be at the mercy of other countries in the next pandemic. "The administration's actions are gutting our deterrence from biological threats," said Beth Cameron, a senior adviser to the Brown University Pandemic Center and a former director at the White House National Security Council. "Canceling this investment is a signal that we are changing our posture on pandemic preparedness," she added, "and that is not good for the American people." Flu pandemics killed up to 103 million people worldwide last century, researchers estimate. MORE: Bird flu is continuing to spread in animals across the US. Here's what you need to know In anticipation of the next big one, the U.S. government began bolstering the nation's pandemic flu defenses during the George W. Bush administration. These strategies were designed by the security council and the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, among other agencies. The plans rely on rolling out vaccines rapidly in a pandemic. Moving fast hinges on producing vaccines domestically, ensuring their safety and getting them into arms across the nation through the public health system. The Trump administration is undermining each of these steps as it guts health agencies, cuts research and health budgets and issues perplexing policy changes, health security experts said. Since President Donald Trump took office, at least half of the security council's staff have been laid off or left, and the future of BARDA is murky. The nation's top vaccine adviser, Peter Marks, resigned under pressure in March, citing "the unprecedented assault on scientific truth." Most recently, Trump's clawback of funds for mRNA vaccine development put Americans on shakier ground in the next pandemic. "When the need hits and we aren't ready, no other country will come to our rescue and we will suffer greatly," said Rick Bright, an immunologist and a former BARDA director. Countries that produced their own vaccines in the COVID-19 pandemic had first dibs on the shots. While the United States, home to Moderna and Pfizer, rolled out second doses of mRNA vaccines in 2021, hundreds of thousands of people in countries that didn't manufacture vaccines died waiting for them. The most pertinent pandemic threat today is the bird flu virus H5N1. Researchers around the world were alarmed when it began spreading among cattle in the U.S. last year. Cows are closer to humans biologically than birds, indicating that the virus had evolved to thrive in cells like our own. As hundreds of herds and dozens of people were infected in the U.S., the Biden administration funded Moderna to develop bird flu vaccines using mRNA technology. As part of the agreement, the U.S. government stipulated it could purchase doses in advance of a pandemic. That no longer stands. Researchers can make bird flu vaccines in other ways, but mRNA vaccines are developed much more quickly because they don't rely on finicky biological processes, such as growing elements of vaccines in chicken eggs or cells kept alive in laboratory tanks. Time matters because flu viruses mutate constantly, and vaccines work better when they match whatever variant is circulating. MORE: 2nd bird flu virus detected in western US. What does this mean for prevention? Developing vaccines within eggs or cells can take 10 months after the genetic sequence of a variant is known, Bright said. And relying on eggs presents an additional risk when it comes to bird flu because a pandemic could wipe out billions of chickens, crashing egg supplies. Decades-old methods that rely on inactivated flu viruses are riskier for researchers and time-consuming. Still the Trump administration invested $500 million into this approach, which was largely abandoned by the 1980s after it caused seizures in children. "This politicized regression is baffling," Bright said. A bird flu pandemic may begin quietly in the U.S. if the virus evolves to spread between people but no one is tested at first. Indeed, the Centers for Disease Control and Prevention's dashboard suggests that only 10 farmworkers have been tested for the bird flu since March. Because of their close contact with cattle and poultry, farmworkers are at highest risk of infection. As with many diseases, only a fraction of people with the bird flu become severely sick. So the first sign that the virus is widespread might be a surge in hospital cases. "We'd need to immediately make vaccines," said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. The U.S. government could scale up production of existing bird flu vaccines developed in eggs or cells. However, these vaccines target an older strain of H5N1 and their efficacy against the virus circulating now is unknown. In addition to the months it takes to develop an updated version within eggs or cells, Rasmussen questioned the ability of the government to rapidly test and license updated shots, with a quarter of HHS staff gone. If the Senate approves Trump's proposed budget, the agency faces about $32 billion in cuts. Further, the Trump administration's cuts to biomedical research and its push to slash grant money for overhead costs could undermine academic hospitals, rendering them unable to conduct large clinical trials. And its cuts to the CDC and to public health funds to states mean that fewer health officials will be available in an emergency. "You can't just turn this all back on," Rasmussen said. "The longer it takes to respond, the more people die." Researchers suggest other countries would produce bird flu vaccines first. "The U.S. may be on the receiving end like India was, where everyone -- rich people, too -- got vaccines late," said Achal Prabhala, a public health researcher in India at medicines access group AccessIBSA. He sits on the board of a World Health Organization initiative to improve access to mRNA vaccines in the next pandemic. A member of the initiative, the company Sinergium Biotech in Argentina, is testing an mRNA vaccine against the bird flu. If it works, Sinergium will share the intellectual property behind the vaccine with about a dozen other groups in the program from middle-income countries so they can produce it. MORE: 12 months and 70 cases since the first human bird flu infection: Are we any safer? The Coalition for Epidemic Preparedness Innovations, an international partnership headquartered in Norway, is providing funds to research groups developing rapid-response vaccine technology, including mRNA, in South Korea, Singapore and France. And CEPI committed up to $20 million to efforts to prepare for a bird flu pandemic. This year, the Indian government issued a call for grant applications to develop mRNA vaccines for the bird flu, warning it "poses a grave public health risk." Pharmaceutical companies are investing in mRNA vaccines for the bird flu as well. However, Prabhala says private capital isn't sufficient to bring early-stage vaccines through clinical trials and large-scale manufacturing. That's because there's no market for bird flu vaccines until a pandemic hits. Limited supplies means the United States would have to wait in line for mRNA vaccines made abroad. States and cities may compete against one another for deals with outside governments and companies, like they did for medical equipment at the peak of the covid pandemic. "I fear we will once again see the kind of hunger games we saw in 2020," Cameron said. In an email response to queries, HHS communications director Andrew Nixon said, "We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable." He added, "The decision reflects broader concerns about the use of mRNA platforms -- particularly in light of mounting evidence of adverse events associated with COVID-19 mRNA vaccines." Nixon did not back up the claim by citing analyses published in scientific journals. In dozens of published studies, researchers have found that mRNA vaccines against COVID are safe. For example, a placebo-controlled trial of more than 30,000 people in the U.S. found that adverse effects of Moderna's vaccine were rare and transient, whereas 30 participants in the placebo group suffered severe cases of COVID and one died. More recently, a study revealed that three of nearly 20,000 people who got Moderna's vaccines and booster had significant adverse effects related to the vaccine, which resolved within a few months. COVID, on the other hand, killed four people during the course of the study. As for concerns about the heart issue, myocarditis, a study of 2.5 million people who got at least one dose of Pfizer's mRNA vaccine revealed about two cases per 100,000 people. COVID causes 10 to 105 myocarditis cases per 100,000. Nonetheless, HHS Secretary Robert F. Kennedy Jr., who founded an anti-vaccine organization, has falsely called COVID shots "the deadliest vaccine ever made." And without providing evidence, he said the 1918 flu pandemic "came from vaccine research." Politicized mistrust in vaccines has grown. Far more Republicans said they trust Kennedy to provide reliable information on vaccines than their local health department or the CDC in a recent KFF poll: 73% versus about half. Should the bird flu become a pandemic in the next few years, Rasmussen said, "we will be screwed on multiple levels." In axing mRNA contract, Trump delivers another blow to US biosecurity, former officials say originally appeared on
06-06-2025
- Health
In axing mRNA contract, Trump delivers another blow to US biosecurity, former officials say
This is a KFF Health News story. The Trump administration's cancellation of $766 million in contracts to develop mRNA vaccines against potential pandemic flu viruses is the latest blow to national defense, former health security officials said. They warned that the U.S. could be at the mercy of other countries in the next pandemic. "The administration's actions are gutting our deterrence from biological threats," said Beth Cameron, a senior adviser to the Brown University Pandemic Center and a former director at the White House National Security Council. "Canceling this investment is a signal that we are changing our posture on pandemic preparedness," she added, "and that is not good for the American people." Flu pandemics killed up to 103 million people worldwide last century, researchers estimate. In anticipation of the next big one, the U.S. government began bolstering the nation's pandemic flu defenses during the George W. Bush administration. These strategies were designed by the security council and the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, among other agencies. The plans rely on rolling out vaccines rapidly in a pandemic. Moving fast hinges on producing vaccines domestically, ensuring their safety and getting them into arms across the nation through the public health system. The Trump administration is undermining each of these steps as it guts health agencies, cuts research and health budgets and issues perplexing policy changes, health security experts said. Since President Donald Trump took office, at least half of the security council's staff have been laid off or left, and the future of BARDA is murky. The nation's top vaccine adviser, Peter Marks, resigned under pressure in March, citing "the unprecedented assault on scientific truth." Most recently, Trump's clawback of funds for mRNA vaccine development put Americans on shakier ground in the next pandemic. "When the need hits and we aren't ready, no other country will come to our rescue and we will suffer greatly," said Rick Bright, an immunologist and a former BARDA director. Countries that produced their own vaccines in the COVID-19 pandemic had first dibs on the shots. While the United States, home to Moderna and Pfizer, rolled out second doses of mRNA vaccines in 2021, hundreds of thousands of people in countries that didn't manufacture vaccines died waiting for them. The most pertinent pandemic threat today is the bird flu virus H5N1. Researchers around the world were alarmed when it began spreading among cattle in the U.S. last year. Cows are closer to humans biologically than birds, indicating that the virus had evolved to thrive in cells like our own. As hundreds of herds and dozens of people were infected in the U.S., the Biden administration funded Moderna to develop bird flu vaccines using mRNA technology. As part of the agreement, the U.S. government stipulated it could purchase doses in advance of a pandemic. That no longer stands. Researchers can make bird flu vaccines in other ways, but mRNA vaccines are developed much more quickly because they don't rely on finicky biological processes, such as growing elements of vaccines in chicken eggs or cells kept alive in laboratory tanks. Time matters because flu viruses mutate constantly, and vaccines work better when they match whatever variant is circulating. Developing vaccines within eggs or cells can take 10 months after the genetic sequence of a variant is known, Bright said. And relying on eggs presents an additional risk when it comes to bird flu because a pandemic could wipe out billions of chickens, crashing egg supplies. Decades-old methods that rely on inactivated flu viruses are riskier for researchers and time-consuming. Still the Trump administration invested $500 million into this approach, which was largely abandoned by the 1980s after it caused seizures in children. "This politicized regression is baffling," Bright said. A bird flu pandemic may begin quietly in the U.S. if the virus evolves to spread between people but no one is tested at first. Indeed, the Centers for Disease Control and Prevention's dashboard suggests that only 10 farmworkers have been tested for the bird flu since March. Because of their close contact with cattle and poultry, farmworkers are at highest risk of infection. As with many diseases, only a fraction of people with the bird flu become severely sick. So the first sign that the virus is widespread might be a surge in hospital cases. "We'd need to immediately make vaccines," said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. The U.S. government could scale up production of existing bird flu vaccines developed in eggs or cells. However, these vaccines target an older strain of H5N1 and their efficacy against the virus circulating now is unknown. In addition to the months it takes to develop an updated version within eggs or cells, Rasmussen questioned the ability of the government to rapidly test and license updated shots, with a quarter of HHS staff gone. If the Senate approves Trump's proposed budget, the agency faces about $32 billion in cuts. Further, the Trump administration's cuts to biomedical research and its push to slash grant money for overhead costs could undermine academic hospitals, rendering them unable to conduct large clinical trials. And its cuts to the CDC and to public health funds to states mean that fewer health officials will be available in an emergency. "You can't just turn this all back on," Rasmussen said. "The longer it takes to respond, the more people die." Researchers suggest other countries would produce bird flu vaccines first. "The U.S. may be on the receiving end like India was, where everyone -- rich people, too -- got vaccines late," said Achal Prabhala, a public health researcher in India at medicines access group AccessIBSA. He sits on the board of a World Health Organization initiative to improve access to mRNA vaccines in the next pandemic. A member of the initiative, the company Sinergium Biotech in Argentina, is testing an mRNA vaccine against the bird flu. If it works, Sinergium will share the intellectual property behind the vaccine with about a dozen other groups in the program from middle-income countries so they can produce it. The Coalition for Epidemic Preparedness Innovations, an international partnership headquartered in Norway, is providing funds to research groups developing rapid-response vaccine technology, including mRNA, in South Korea, Singapore and France. And CEPI committed up to $20 million to efforts to prepare for a bird flu pandemic. This year, the Indian government issued a call for grant applications to develop mRNA vaccines for the bird flu, warning it "poses a grave public health risk." Pharmaceutical companies are investing in mRNA vaccines for the bird flu as well. However, Prabhala says private capital isn't sufficient to bring early-stage vaccines through clinical trials and large-scale manufacturing. That's because there's no market for bird flu vaccines until a pandemic hits. Limited supplies means the United States would have to wait in line for mRNA vaccines made abroad. States and cities may compete against one another for deals with outside governments and companies, like they did for medical equipment at the peak of the covid pandemic. "I fear we will once again see the kind of hunger games we saw in 2020," Cameron said. In an email response to queries, HHS communications director Andrew Nixon said, "We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable." He added, "The decision reflects broader concerns about the use of mRNA platforms -- particularly in light of mounting evidence of adverse events associated with COVID-19 mRNA vaccines." Nixon did not back up the claim by citing analyses published in scientific journals. In dozens of published studies, researchers have found that mRNA vaccines against COVID are safe. For example, a placebo-controlled trial of more than 30,000 people in the U.S. found that adverse effects of Moderna's vaccine were rare and transient, whereas 30 participants in the placebo group suffered severe cases of COVID and one died. More recently, a study revealed that three of nearly 20,000 people who got Moderna's vaccines and booster had significant adverse effects related to the vaccine, which resolved within a few months. COVID, on the other hand, killed four people during the course of the study. As for concerns about the heart issue, myocarditis, a study of 2.5 million people who got at least one dose of Pfizer's mRNA vaccine revealed about two cases per 100,000 people. COVID causes 10 to 105 myocarditis cases per 100,000. Nonetheless, HHS Secretary Robert F. Kennedy Jr., who founded an anti-vaccine organization, has falsely called COVID shots"the deadliest vaccine ever made." And without providing evidence, he said the 1918 flu pandemic "came from vaccine research." Politicized mistrust in vaccines has grown. Far more Republicans said they trust Kennedy to provide reliable information on vaccines than their local health department or the CDC in a recent KFF poll: 73% versus about half. Should the bird flu become a pandemic in the next few years, Rasmussen said, "we will be screwed on multiple levels."
