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Sky News AU
3 hours ago
- Sky News AU
America's reliance on China's pharmaceuticals is ‘unacceptable'
President of the Centre of the American Experiment John Hinderaker discusses US President Donald Trump's tariffs on pharmaceuticals, criticising America's heavy reliance on China for essential drugs. 'We import a huge percentage of our pharmaceuticals, especially our generics, from China, and that's just unacceptable,' Mr Hinderaker told Sky News host Rita Panahi. 'To some extent, Australia might be a little bit caught in the crossfire here. I don't mind Australia producing drugs for the US, but I don't want to rely on the Chinese for it.'
News.com.au
10 hours ago
- News.com.au
Why $487 million US distribution deal is a ‘watershed moment' for skyrocketing biotech Lumos
Lumos signs six-year exclusive deal valued at up to US$317 million with PHASE Scientific for distribution of FebriDX in US subject to CLIA waiver US$2 million payable immediately, comprising US$1 million exclusivity fee and US$1 million pre-paid purchase order Further US$1.5 million pre-paid purchase order will become payable on FebriDx CLIA waiver application to US FDA, expected within three months Lumos Diagnostics (ASX:LDX) has skyrocketed more than 150% after inking a landmark six-year distributor deal worth hundreds of millions of dollars to sell its rapid point-of-care diagnostic in the US market. The FebriDx product is a simple test able to differentiate between bacterial and non-bacterial acute respiratory infections. A lucrative US licencing deal with Hong-Kong based PHASE Scientific could see Lumos net up to to US$317m (~A$487m), and has been described as one of the largest distribution deals of its type to be done by an ASX-listed point-of-care diagnostics company. It's all positive for investors including Tenmile, a wholly-owned subsidiary of billionaire backers Andrew 'Twiggy' and Nicole Forest's private investment vehicle Tattarang. Tenmile is the largest shareholder of Lumos, holding 19.9% of the stock. PHASE backs cutting-edge test The deal assigns exclusive distribution rights to PHASE for the point-of-care blood test, which helps clinicians differentiate between a bacterial or viral respiratory infection within about 10 minutes. The agreement includes a US$1 million non-refundable exclusivity payment upon signing, along with an additional US$7.5m in non-refundable prepaid purchase orders, payable in three instalments including: US$1m upon signing of agreement US$1.5m upon submission of the FebriDx CLIA waiver application to the US Food and Drug Administration (FDA); and US$5m on granting of the US FDA CLIA waiver. Assuming PHASE achieves all payment milestones outlined and meets minimum order quantities, which are expected to "progressively ramp up", Lumos forecasts total value of the agreement reaching up to US$317m (~A$487m) over its six year duration. Lumos is currently undertaking a CLIA waiver study in the US to enable FebriDx to be used in a broader range of healthcare settings, including physician offices that do not operate under high-complexity laboratory certification. As of July 9, the study had enrolled 105 bacterial positive patients of the targeted 120 bacterial positive patient results required for the study. At the current accrual rate, the study is forecast to be completed during August with an FDA CLIA waiver application submitted about one month after completion. 'Watershed moment' Speaking with Stockhead from the US, Lumos managing director Doug Ward described the deal as transformational financially for the company, which listed on the ASX in July 2021. "I think this is a watershed moment for the business going forward," he said. "It will take hard work to realise everything but at the same time we have put ourselves in a great trajectory here to be very successful." As Lumos edges closer to wrapping up the CLIA waiver study, it has been quite the belle of the ball, attracting several suitors for its FebriDX distribution rights. "We selected PHASE for several reasons including they have a great understanding and experience in the US point-of-care market," Ward said. "While Hong Kong-based the majority of their sales are US based, and they know this point of care market very well." Ward said launching a brand-new product into the US market takes knowledge and experience of the landscape, but also financial commitment. "PHASE have made it clear of their intention to invest, and they just did a significant funding round in Hong Kong so have the means and commitment to make this happen," he said. "We also wanted to go with a company where we knew we were their primary focus so there were other companies which had more products in their bag, but we didn't want to be one of 50 or 100." Instead, Ward said he wanted to be one of small number of synergistic products for a distributor. "I think that hunger and focus is there, and PHASE should be very successful," he said. Non-executive chairman Sam Lanyon also praised PHASE and said he was confident the company would be a motivated partner to push the commercialisation of FebriDX in the US. Tapping into lucrative market opportunity Ward said in the US, point-of-care testing for respiratory illnesses like influenza and covid-19 represented a market worth more than US$1 billion, with strong demand for fast, accurate diagnostics in primary care and outpatient settings. "If you have a respiratory element to your sickness here in the US, you'll be immediately tested for covid or flu and we see FebriDX sitting side by side with those point-of care tests," Ward said. "The doctor can determine whether their patient does or doesn't have covid or flu and then whether their patient has a bacterial infection and needs antibiotics. "So, we don't need to teach doctors what we call a new care pathway but rather get them to be aware they can add FebriDX to their testing arsenal to assist with patient treatment." Lumos is tackling antimicrobial resistance (AMR) – the ability of microbes to resist the effects of medication – with FebriDX, which according to the World Health Organization is one of the top global public health threats. Ward said a significant contributor to the AMR crisis was the inappropriate prescribing of antibiotics, particularly for acute respiratory infections in primary care settings. "Our mission is to impact and improve the practice of medicine and we think FebriDX does that so we're very excited," he said. "It is something which is fresh, novel and should really improve care." Positioned to bring FebriDX to frontlines of care PHASE Scientific founder and CEO Dr Ricky Chiu said the company was proud to partner with Lumos as their exclusive US distributor for FebriDx, and to welcome the test into its INDICAID family, its trusted rapid diagnostics brand known for accessibility and quality. "With strong product differentiation and a CLIA waiver on the horizon, FebriDX is poised to transform the landscape of rapid respiratory diagnostics and clinical decision-making," Chiu said. "Backed by PHASE's record of having sold over 100 million INDICAID tests and a nationwide network of urgent care centres and clinics, we're uniquely positioned to bring this innovation to the frontlines of care — where speed, accuracy, and reliability matter most." At Stockhead, we tell it like it is. While Lumos Diagnostics is a Stockhead advertiser, it did not sponsor this article.
ABC News
10 hours ago
- ABC News
More than 10 million vapes seized in Australia since import ban
Almost half a billon dollars worth of vapes have been taken off the street since new laws came into force 18 months ago as research shows fewer young Australians are taking up vaping. The Therapeutic Goods Authority and Australian Border Force (ABF) said they have seized more than 10 million vapes since they were banned at the start of 2024. The federal government said the street value was worth almost half a billion dollars. In the past year, other reforms have also come into place like limiting the sale of vapes to pharmacies and banning vaping advertising. ABF Assistant Commissioner Tony Smith said authorities were determined to continue disrupting the trade. "It's a market that targets our communities including our children," he said. "[It] sends profits into the hands of organised crime, profits that are used to cause further harm through intimidation tactics, arson, firearms, drugs and even cyber crime." Assistant Commissioner Smith said the ABF had "ramped up" its engagements with countries in South Asia and South East Asia, and has officers working in the United Kingdom, Thailand and Hong Kong to stem the flow of illegal vaping products entering Australia. "In the last financial year, ABF officers made on average 120 detections a day, contributing to 10 million vapes, 2.5 billion cigarette sticks and 435 tonnes of illicit tobacco," he said. Meanwhile, government-funded research from the Cancer Council and University of Sydney has found fewer young people are taking up vaping. The Generation Vape Research Project conducted an anonymous survey of 3,000 young Australians. It showed from 2023 to mid-2025, vaping rates among 18 to 24-year-olds dropped from 20 to 18 per cent. From 2023 to late 2024, the number of 14 to 17-year-olds vaping decreased from 18 per cent to 15 per cent. It also found those who had never smoked or even had a few puffs of a cigarette was at its highest rate on record at 94 per cent. "The peak vaping rates appear to be behind us," University of Sydney Professor Becky Freeman said. She said young people used to think vaping was harmless and perceived differently to "your grandfather's stinky cigarette", but attitudes have shifted. "They can't believe that something that they were just using at parties for fun on the weekends, that they were told if they took to music festivals would be a great way to enhance their good time. "Now their wellbeing is being impacted, they're waking up with a vape under their pillow." Dr Freeman said law enforcement, education, mass media campaigns and quitting support needed to continue. Federal Health Minister Mark Butler said import controls contributed to the decline in youth vaping rates. "It looks like we have turned a corner and at least stopped the explosion in vaping among young Australians that was emerging as one of the most significant public health challenges for our community," he said. Mr Butler said some vaping products still "leak" through the border. "From the time we put this ban in place we never pretended we'd be able to stop every vape coming in," he said. "But we do know that it is harder to get your hands on a disposable vape … that's led to a very significant increase in the price of vapes where they are still accessible, and that's having a positive impact on young people."
