Health Check: Breast cancer patients are the winners in Imagion's SQUID game
Biome's offshore push reaps rewards
FDA introduces pricing test in new fast-track drug review program
Shares in molecular diagnostic imaging house Imagion Biosystems (ASX:IBX) are on a roll again, after positive feedback from the US Food & Drug Administration (FDA) about the conduct of a phase II breast cancer diagnostics trial.
In a video hookup, FDA reps did not raise any concerns about the proposed study, having requested earlier clarification about its 'structuring and operation'.
Imagion plans to file an Investigational New Drug application – permission to start a trial – with the FDA in the current quarter.
While the chinwag may seem a formality, it comes at a time when the FDA's intentions are increasingly difficult to divine.
'Our clinical team was pleased and very encouraged with the level of engagement we had with the reviewers,' said Imagion executive chairman Bob Proulx.
'The fact that senior staff participated on the call is a sign the agency is interested in … our plans for the phase II trial and the potential impact our technology may have on breast cancer diagnosis and staging.'
The trial will road test Imagion's Magsense tech, for detecting Her-2 positive breast cancer.
Magsense involves injecting nanoparticles labelled with cell-specific targeting antibodies, contained within an iron oxide solution.
SQUID game with a happier ending
The technology is known as super-paramagnetic relaxometry. It may sound like something out of a Nimbin shopfront – but it's totally legit.
The nanoparticles are subject to a low magnetic pulse, with their location detected by an ultra-sensitive super-conducting quantum interference device.
Yep, that's a SQUID.
The nanoparticles attached to the cancer cells lose their magnetism more slowly than the unattached ones, acting as a magnetic beacon.
The open-label trial will be carried out across multiple US sites.
After a rough start to 2025, Imagion shares have risen 80% over the past month.
Syntara enrols first burns scar patient
Syntara (ASX:SNT) says the first patient in a phase Ic study to treat keloid scars – an unsightly and painful legacy of burns – has been dosed.
Dubbed Satellite, the study evaluates Syntara's topical lysyl oxidase inhibitor SNT-6302.
The trial was initiated by the investigator, famous Perth burns surgeon Professor Fiona Wood (in partnership with the University of Western Australia).
The open-label, placebo-controlled study will enrol up to 20 participants, with active keloids measuring between 5-25cm2.
An earlier study showed a 30% reduction in collagen content and improved scar vascularisation – both good things.
The patients will apply SNT-6302 four times a week over three months.
In truth, Syntara focuses on its flagship trial for myelofibrosis. But the company values the market for burns scars at US$3.5 billion globally, which is nothing to sneeze at.
For Biome, there's no place like offshore
Following an earlier update, probiotics and complementary medicines provider Biome Australia (ASX:BIO) reported $1.5 million of overseas revenue for the year to June 30, up 69%.
The company recently secured three 'prominent strategic distribution partnerships' in three markets: Ireland, NZ and Canada.
Irish eyes are smiling after a hook up with the Emerald Isle's pharmacy wholesaler and retailer, Uniphar.
In NZ, Biome has entered a new distribution tie-up with pharmacy wholesaler Propharma, owned by EBOS Group (ASX:EBO).
EBOS also owns pharmacy wholesaler Symbion, a key Biome distributor in Australia.
In Canada, Biome has secured 'multiple high-value agreements with prominent pharmacy and health food retail groups'.
On July 1 Biome reported overall record sales revenue of $18.4 million for the year, up 41%. The company also posted record June quarter revenue of $5 million, up 33%.
The company also expects another quarter of positive underlying earnings for the quarter, translating to an inaugural full year net profit.
Biome is also on track to meet its target of $75 million of annual revenue by 2027.
Biome develops, licences and commercialises 'evidence based' live biotherapeutics – a.k.a probiotics.
The company says its Activated Probiotics line can treat 'various health concerns' including low mood and sleep, bone health, iron malabsorption, mild eczema and irritable bowel syndrome.
Biome shares have lost 15% of their value over the last year but have improved 24% over the last month.
FDA links new vouchers with drug prices
The FDA is taking a new line in the drug pricing debate by linking drug affordability with a new fast-track drug approval mechanism.
Known as the Commissioner's National Priority Voucher (CNPV), the scheme will run alongside the existing Priority Review Voucher (PRV) program.
The CNPV could cut approval times from up to a year, to as little as a month. At least that's for drugs that address criteria such as addressing a health crisis, innovating or increasing US national security.
Getting a blockbuster drug to market a few months earlier can mean billions of dollars of extra sales.
FDA new head honcho Marty Makary says drugs for type 1 diabetes, neurodegenerative diseases and advanced cancers could fit the bill.
Last month's CNPV reveal did not mention pricing.
Now, Makary says the agency will consider drug affordability when granting new vouchers.
Given drug makers and gatekeepers usually determine drug prices post launch, it's not clear how the FDA could take them into account.
PRVs are valuable – and Neuren can vouch-er for it
The FDA will continue the PRV program, unchanged.
The agency bestows PRVs on drug developers who get selected therapies to market, such as a rare childhood disease.
PRV recipients usually sell them to a third party.
The developer of the FDA approved Rett syndrome drug Daybue, Neuren Pharmaceuticals (ASX:NEU) enjoyed a US$50 million windfall after its US partner Acadia sold the attached PRV for US$150 million.
However, the CNPVs will be non-transferable.
In the meantime, President Trump plans to revive a 'most favoured nation' mechanism. This ties the price of a certain drug in the US to that imposed in the cheapest western country.
Trump has also threatened a 200% tariff on imported drugs, which in theory would drive drug prices higher.
So, it's a balancing act – rather like playing off Vladimir and Volodymyr.
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ABC News
2 hours ago
- ABC News
Laura Tingle on tricky diplomacy in China
Sam Hawley: Will Australia join a US war against China if it invades Taiwan? That's the stark question Anthony Albanese faced during his delicate visit to Beijing. He's trying to strengthen trade and business ties. So with the prime minister meeting the Chinese president, can he drum up more business while managing tensions in the relationship? Today, the ABC's newly appointed global affairs editor, Laura Tingle, joins us from Beijing. I'm Sam Hawley on Gadigal land in Sydney. This is ABC News Daily. Sam Hawley: Laura, Anthony Albanese and President Xi, they're two leaders that have a lot to talk about, to say the least, aren't they? Laura Tingle: They do have a lot to talk about, Sam. News report: Prime Minister is sitting down with China's president in Beijing in a high profile meeting being closely watched in Canberra and Washington. Anthony Albanese, Prime Minister: Australia values our relationship with China and will continue to approach it in a calm and consistent manner. It's important we have these direct discussions on issues that matter to us and to the stability and prosperity of our region. Xi Jinping, Chinese President: With joint efforts from both sides, the China-Australia relationship has rose from the setback and turned around. Laura Tingle: There are all the sort of cliches about relationships and all those sorts of things, but it's interesting to me to come back to China on a prime ministerial trip after a bit of a break, because it does feel very much like the trips of the 80s and 90s, where it was all love and kisses and opportunities, which, given that there are points of significant difference between the two sides, is interesting. Sam Hawley: Well, Laura, the prime minister did speak after the meeting. He says he raised the detention of the Australian writer Yang Hengjun with the Chinese president. But overall, he was really positive about the economic relationship that Australia has with China right now. Anthony Albanese, Prime Minister: We had a very constructive meeting with President Xi in which we spoke about the range of issues facing our relationship with China. My government's approach to our relationship with China is patient, is calibrated and is deliberate. Sam Hawley: Not to mention, of course, Donald Trump. He's ever present, isn't he? And his tariffs. Laura Tingle: Absolutely. He's ever present. And just in the last 24 hours, we've had yet another announcement from Donald Trump, of course, about the possibility of really tough tariffs on Russia, over Ukraine, if Vladimir Putin doesn't do as he should, according to Donald Trump. And he's threatening secondary sanctions on China, or he hasn't named China, but on countries that have strong trading relationships with Russia, which would hit China as its biggest trading partner. So it affects everything that's going on here in Beijing at the moment. The world is being rewired before our eyes, I think, Sam. Sam Hawley: Well, we know, of course, that trade and business are crucial items for Anthony Albanese during this trip. Anthony Albanese, Prime Minister: And given that China is overwhelmingly, by far, the largest trading partner that Australia has, it is very much in the interest of Australian jobs and the Australian economy to have a positive and constructive relationship with China. Sam Hawley: But the thing is, Laura, we've seen before that this relationship with China is so delicate that it can fall apart in a nanosecond. We saw that, didn't we, with Scott Morrison when he called for an inquiry into COVID, trade was just cut by Beijing. So why are we trying to build it up when we know that it can fall apart so easily? Laura Tingle: Well, it can fall apart around the edges, but realistically, we still have this massive trade relationship with China. That's the reality of it. They've cut us off on some particular markets in the past few years, but still 25% of our exports go to China. So that relationship is really solid. China, for the time being, certainly, or for the next little while, is reliant on our iron ore. So while you have these disruptions and things, it's still a fundamental relationship. Now, it is extraordinary to just think about how bad things did get a few years ago, where basically no minister could get a phone call from anybody in China. They were throwing Australian journalists out of the country and jailing others. It was, you know, it was pretty ugly. News report: An Australian journalist working in China has been detained by the Chinese government in a highly sensitive case, posing a fresh challenge to those already fraught Australia-China relations. News report: First, it was barley. Now it's beef. Our largest trading partner suspending imports from four abattoirs. News report: Beyond meat, China is now refusing to accept timber from four states. Lobsters are shut out. Wine exporters face up to 200% tariff. Laura Tingle: I think there's been a bit of a change at the Chinese end. I think the whole culture of the so-called wolf warrior diplomacy was something that they ultimately decided wasn't really working in their interests. And I think once again, to mention Donald Trump, you can see, I think, that not just in their relationship with Australia, but in their relationship with countries like Vietnam. China is really pushing this message that, you know, we're the safe and steady, you know, people who make very sensible, rational, calm decisions about our trade relationships. China's playing the sort of adult in the room role, if you like. Sam Hawley: Well, Laura, of course, trade is one thing. But then there is the flip side to this relationship, and that is security, of course, and the elephant, if you like, in the room, which is Taiwan. And that is when things get really complicated, don't they, for Anthony Albanese? Laura Tingle: Well, they do and they don't get complicated in some way, Sam. If you think about sort of the domestic way this issue has to play out at some point and also then how it plays out on the international stage. Now, a story was leaked over the weekend, just as the prime minister was arriving in Shanghai, about how the Under Secretary of Defense, Elbridge Colby, was pushing Australia and Japan to say exactly what their position would be in the case of a war with Taiwan. On one level, that's sort of a bit embarrassing for the prime minister, but he's made it clear that, you know, we make our own decisions about these things. Reporter: Do you think it's important, from the point of view of deterrence, of China, that you say, yes, we're involved or no, we're not involved? Anthony Albanese, Prime Minister: I think it's important that we have a consistent position, which Australia has had for a long period of time. We support the status quo when it comes to Taiwan. We don't support any unilateral action. Laura Tingle: And it was being linked to the AUKUS submarines, the Virginia class submarines that we're supposed to be getting from the Americans. Now, it's quite clear, talking to Australian officials, that they don't regard the AUKUS deal is in any way, gives the Americans any right to tell us what we would do with the US submarines once we got them, because they'd be ours, you know, we would buy them. Now, there seems to be a fair degree of confidence that despite these stories, you know, that will all sort of settle down. And I sort of also think you've got to back engineer this a little bit. I mean, if you took Elbridge Colby's comments seriously and said, he's saying that we can't get the submarines unless we're prepared to go to war with Taiwan. Well, wait a minute. The Americans haven't said that they would go to war with China over Taiwan. It sort of doesn't all quite stack up. Sam Hawley: There was some confusion, wasn't there, when Joe Biden was president over some questioning on this, whether the US would support Taiwan militarily. Laura Tingle: Yes. Sam Hawley: That was never really cleared up, but he came pretty close to saying they would. Laura Tingle: He certainly did come close to saying that they would. Donald Trump certainly hasn't. Sam Hawley: What do you think, though, Laura, is the Trump administration justified in asking this question, asking nations if they would support the US if China did invade Taiwan? You know, China has continually been flexing its muscles, hasn't it? Military exercises around the Pacific, including almost all the way around Australia. So there's reason for concern. There's reason for discussions like this. Laura Tingle: Absolutely. There's a really legitimate reason for discussions. And I think it's really important that Australia has that discussion internally, because I don't think we've been having it until now. And it affects those decisions about whether we have a forward strategic stance in the South China Sea or not. But I think the crucial question is it's fine for the Americans to ask that question if their own position is clarified. And I think this is the dodgy bit of it, to use the technical phrase. I mean, I think the Americans don't want to say what their position is. And it's not clear that they would go to war over Taiwan with China. Reporter: Would it be reasonable for the United States to demand any sort of assurances from Australia on a Taiwan contingency, given the United States itself maintains a policy of strategic ambiguity, at least in theory, on Taiwan? Anthony Albanese, Prime Minister: Well, you've just answered the question yourself, I think, through the comments that you've made. Sam Hawley: Well, Laura, just sum this up for me. How successful do you think the prime minister's approach to China will be? Because it is remarkably different, isn't it, to the way that Scott Morrison, for instance, dealt with Beijing or Donald Trump, for that matter? Laura Tingle: Well, you'd have to say at this stage, it's certainly more successful, Sam, just because we have restored those trade links. He's here. This is another visit. You know, as you say, it's always volatile. But for now, it's quite a good relationship. And it serves both countries well in the context of this global trade war that Donald Trump has started. So I think, you know, it's a it's a good basis to be operating in this very uncertain world. Sam Hawley: But Laura, what about tensions in the relationship? What do you think? Will Anthony Albanese actually tackle those head on? Or is he going to bring some sort of softer approach for fear of backlash from China? Laura Tingle: Look, well, I suppose there are two observations on that. One of them is Penny Wong has in the last week gone out very hard on these issues, both in a speech and also in her meetings with her counterpart when she was at the ASEAN meeting. Penny Wong, Foreign Minister: China continues to assert its strategic influence and project its military power further into our region. And we have seen the worrying pace of China's nuclear and conventional military build up without the transparency that the region expects. We are realistic about China's objectives in changing the regional balance of power. Laura Tingle: So she's laid down Australia's protests on all these issues in a very forthright way. And the prime minister has said that, you know, these issues will not be avoided in his conversations with the president and premier while he's here in Beijing. But, you know, it's always the case that those leader to leader meetings, they're a little bit more diplomatic about what they might say publicly. But Anthony Albanese says that, one, he's on the case and two, that it's been successful in the interests of Australia since he's been prime minister. Sam Hawley: All right. Well, Laura, it's a true balancing act. That's for sure. The PM's trying to work with China, but he also wants to keep the US happy too. So this, I think, is one of the most complicated relationships he has to deal with as the leader of Australia, right? Laura Tingle: Absolutely. Absolutely. But I can't help but feeling that the way that the Trump administration has been behaving, if you like, in that broader description of its sort of erraticness and everything, has created both political space at home and abroad for the prime minister to establish a more assertive position with both major powers and sort of establish that more independent voice of our own. I think it's been quite useful because I think people at home are sort of, they look at what Donald Trump's been doing with a bit of confusion and concern, and it's just given him some space. And of course, also, you know, three years ago, there was this sense that the Labor Party couldn't say anything negative about the United States at all or about the alliance because they'd get absolutely pummelled by the coalition. It's harder to do that now because of the way the US has been going. But also, of course, the coalition is weakened politically and its both its capacity and its taste for, you know, fighting every last fight as a sign of, you know, being disloyal to the Americans has really subsided. So I think there's a lot of tectonic plate shifting, which give government of the day room to manoeuvre with both major powers. Sam Hawley: Laura Tingle is the ABC's Global Affairs Editor. This episode was produced by Sydney Pead and Kara Jensen-Mackinnon. Audio production by Sam Dunn. Our supervising producer is David Coady. I'm Sam Hawley. Thanks for listening.
News.com.au
4 hours ago
- News.com.au
Stocks diverge, as US inflation puts focus on Trump's tariffs
Global stock markets went in different directions on Tuesday, as an uptick in US inflation suggested President Donald Trump's tariffs could be beginning to feed into the American economy. New York was generally trading higher on the back of healthy results from major US banks and buoyant news in the tech sector. The S&P 500 and Nasdaq were up, though the Dow Jones was struggling. Most Asian indices rose but Europe's stock markets slipped into the red late in the day. The US consumer price index for June showed an acceleration to 2.7 percent from a year earlier, in line with economists' forecasts. "The CPI release showed some early signs of tariff pass-through but underlying inflation remains muted," said Stephen Innes, managing partner at SPI Asset Management. While US inflation remained relatively tame, analysts said businesses were working through stockpiles amassed in anticipation of Trump's duties and further price rises could be expected later this year. Since April, the United States has imposed a baseline 10-percent tariff on goods imported from almost all trading partners, with steeper levies on steel, aluminium and cars. Trump has threatened 30-percent tariffs on European Union and Mexican goods from August 1 if they do not cut trade deals. The US Federal Reserve, which has an inflation target of two percent, could cut rates in September -- but not if the tariffs also end up putting a brake on US economic growth. China, which has negotiated a US tariff truce, issued economic growth data that met expectations, largely thanks to an April-June export surge to get ahead of Trump's levies. But the US president on Monday warned of new tariffs of up to 100 percent on Russia's trading partners -- which include China -- if Moscow does not end its war on Ukraine within 50 days. Even though Russia is a major crude producer, oil prices dropped after Trump's announcement and continued lower on Tuesday. "Investors seem convinced that the 50-day window gives the US, Russia and Ukraine an opportunity to hammer out some kind of deal," said David Morrison, senior market analyst at Trade Nation. - OPEC forecast - OPEC said in its latest monthly market report it expected its production forecasts for this year and next to hold, despite uncertainties generated by the US tariffs. It forecast that oil demand would rise by 1.3 million barrels in 2025 and again in 2026. "Continued robust global economic growth is expected... despite ongoing US-centred trade challenges and geopolitical uncertainties," it said. In corporate news, US banks JPMorgan Chase and Wells Fargo posted better-than-expected second-quarter results. JPMorgan boss Jamie Dimon described the US economy as "resilient" while facing "significant risks", including over tariffs uncertainty. And tech darling Nvidia's share price jumped after it said US export restrictions will be eased to allow it to sell its H20 artificial intelligence chips to China. That gave fuel to the Nasdaq, which had closed on Monday on another record high. Bitcoin slid on likely profit-taking, after having hit a record high above $123,200 on Monday, thanks to optimism over possible regulatory changes for crypto assets in the United States. - Key figures at around 1345 GMT - New York - Dow: DOWN 0.3 percent at 44,329.45 points New York - S&P 500: UP 0.2 percent at 6,283.26 New York - Nasdaq Composite: UP 0.7 percent at 20,790.24 London - FTSE 100: DOWN 0.2 percent at 8,979.87 Paris - CAC 40: DOWN 0.2 percent at 7,791.87 Frankfurt - DAX: DOWN 0.1 percent at 24,134.73 Tokyo - Nikkei 225: UP 0.6 percent at 39,678.02 (close) Hong Kong - Hang Seng Index: UP 1.6 percent at 24,590.12 (close) Shanghai - Composite: DOWN 0.4 percent at 3,505.00 (close) Euro/dollar: DOWN at $1.1644 from $1.1670 Pound/dollar: DOWN at $1.3408 from $1.3428 Dollar/yen: UP at 148.55 yen from 147.77 yen Euro/pound: DOWN at 86.86 pence from 86.88 pence Brent North Sea Crude: DOWN 0.3 percent at $69.00 per barrel
News.com.au
4 hours ago
- News.com.au
‘Gives us justification': Angry bunch of taxi drivers win payout in Uber legal row
Cabbies and hire-car drivers and owners who lost out in the introduction of Uber to Australia will share a colossal $271.8 million compensation package. The massive victory for 8700 drivers and owners nationwide who registered to be involved in the class action has been confirmed after the appeal period in a world-first action expired last week. Assessment will now begin to determine how much individual members of the action will receive. Law firm Maurice Blackburn has been running the legal fight. Former taxi driver and ex-Victorian member of parliament Rod Barton said the seven-year fight against Uber had been justified by the massive settlement. 'We've just got past the last hurdle and we will work towards distribution,' he said. 'But it doesn't get close to the cost and harm that was done to this industry. 'No one is going to get Tattslotto amounts out of this but it gives us justification. 'The government failed the whole industry, they failed to protect us. 'And it's really cool that an angry bunch of taxi drivers were able to drag a unicorn company into court and get this payout.' Mr Barton said other class actions were being explored by taxi drivers in other jurisdictions. 'We set the wheels in motion,' he said. Kim Adey, the manager of Maurice Blackburn's settlement claims assessment team, said last week's passage of the appeal period marked a significant step forward. 'There are thousands of claims to process, so the work will take some time and we will need some help from class members to finalise things along the way,' Ms Adey said. 'We're really looking forward to the claims assessed and payments made as soon as possible.'
