Break it Down: MTM locks in national security heavyweight
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ABC News
4 hours ago
- ABC News
Justice Department to begin giving Congress files from Jeffrey Epstein investigation
The Justice Department has agreed to provide to Congress documents from the Jeffrey Epstein sex trafficking investigation, a key House member has announced — a move that appears to avert, at least temporarily, a potential separation of powers clash. The records are to be turned over to the House Oversight Committee from Friday. Earlier this month, the committee issued a broad subpoena to the Justice Department about a criminal case that has long captivated public attention, recently roiled the top rungs of President Donald Trump's administration and been a consistent magnet for conspiracy theories. Kentucky representative James Comer, the Republican committee chair, said it would take some time for the Department of Justice (DOJ) to release the files in question. "There are many records in DOJ's custody, and it will take the Department time to produce all the records and ensure the identification of victims and any child sexual abuse material are redacted," he said in a statement. A wealthy and well-connected financier, Epstein was found dead in his New York jail cell weeks after his 2019 arrest in what investigators ruled a suicide. His former girlfriend, Ghislaine Maxwell, was convicted in 2021 of helping lure teenage girls to be sexually abused by Epstein and is serving a 20-year prison sentence. The House committee's subpoena sought all documents and communications from the case files of Epstein and Maxwell. It also demanded records about communications between former US president Joe Biden's administration and the Justice Department regarding Epstein, as well as documents related to an earlier federal investigation into Epstein in Florida that resulted in a non-prosecution agreement. It was not clear exactly which or how many documents might be produced or whether the cooperation with Congress reflected a broader change in posture since last month. At the time, the FBI and Justice Department abruptly announced that they would not be releasing any additional records from the Epstein investigation after determining that no "further disclosure would be appropriate or warranted". That announcement put the Trump administration on the defensive, with officials since then scrambling both to tamp down angry questions from the president's base and also labouring to appear transparent. Deputy Attorney-General Todd Blanche interviewed Maxwell at a Florida courthouse over two days last month — though no records from those conversations have been made public — and the Justice Department has also sought to unseal grand jury transcripts in the Epstein and Maxwell cases, though so far those requests have been denied. A Justice Department spokesperson declined to comment on Monday. The House Oversight panel separately issued subpoenas to eight former law enforcement leaders as well as former US president Bill Clinton and former secretary of state Hillary Clinton. Mr Clinton was among a number of luminaries acquainted with Epstein before the criminal investigation against him in Florida became public two decades ago. Mr Clinton has never been accused of wrongdoing by any of the women who say Epstein abused them. AP
SBS Australia
5 hours ago
- SBS Australia
The Ukrainian areas Putin badly wants, amid doubt over Trump's plan for Putin-Zelenskyy meeting
Face-to-face peace talks between the presidents of Ukraine and Russia would be "incredibly significant", and they're the goal of US President Donald Trump as he pushes to end the war in Ukraine. After meeting with Ukrainian President Volodymyr Zelenskyy at the White House on Monday, Trump suggested a trilateral meeting is in the works. "I called President Putin, and began the arrangements for a meeting, between President Putin and President Zelenskyy," he wrote in a social media post. He told reporters that meeting would be followed by another where he would join. "We'll see what happens there," he said of a meeting between Putin and Zelenskyy. "If that works out, if it works out, then I'll go to the trilat and close it up." But experts have told SBS News that a ceasefire arrangement would be complicated, and part of the reason is the protracted disputes over Ukrainian territories. Will a trilateral meeting even happen? German Chancellor Friedrich Merz, who attended talks between Zelenskyy and Trump, reportedly said a meeting between the pair and Putin could take place in as little as two weeks. "We do not know whether the Russian president will have the courage to attend such a summit. That is why persuasion is needed," Reuters reported him saying. Dr Jessica Genauer, a senior lecturer in international relations at Flinders University, said there was a "slim chance" Putin would agree to meet Zelenskyy face-to-face. "It would be incredibly significant if President Putin would meet with President Zelenskyy because it would mean acknowledging that President Zelenskyy is the legitimate leader of a legitimate state," she told SBS News. "Trump has talked about it and Trump is clearly pursuing the idea, but I think it's very unlikely that it will actually eventuate." Trump himself has said that while he "hopes President Putin's going to be good", it was going to be a "rough situation" if he didn't. Zelenskyy "has to show some flexibility also", Trump said. Zelenskyy has expressed interest in meeting with Putin, but the Russian president may be more likely to prefer to speak via Trump. "I think it's much more likely we'll see Putin agreeing to additional meetings with Trump — which are very much to his benefit — it means that he can show the Russian people that he is a peer to the United States, which is how he views himself and how he wants to appear domestically within the Russian context," Genauer said. "That's not true in reality, but that is what President Putin would like to broadcast to his people." Since Russia's full-scale invasion of Ukraine in 2022, it has occupied large swathes of land and displaced millions of people. Russian-controlled territory and its future ownership will be a focus at any future peace meetings, as Putin has reportedly refused to withdraw Russian troops from those regions. Significance of this territory Russia currently controls large parts of four Ukrainian regions or 'oblasts' as they are known in Russia and some post-Soviet states. These oblasts share their names with their respective administrative capitals — Kherson, Zaporizhzhia, Donetsk and Luhansk — which are along Ukraine's eastern border. Russia annexed Crimea in 2014. Source: SBS News These regions have reportedly been the hardest hit in the last three years, and Genauer said Putin has ambitions to gain even more Ukrainian territory. "He thinks that he can still gain control over more Ukrainian territory on the ground. He's determined to keep the territory that Russia has already captured. And what President Putin would like is for Trump to pressure Ukraine to formally cede territory to Russia," she said. The Russian-controlled area represents around 20 per cent of Ukrainian sovereign territory, according to Genauer. Pro-Russian sympathy An area of particular interest to Putin is the Donbas region, which overlaps with the Donetsk and Luhansk regions. The Russian president has reportedly said he would not withdraw soldiers from that region in particular during talks with the White House. But Zelenskyy has signalled that ceding Donbas is not an option for Ukraine, and could embolden future Russian assaults. "We will not leave Donbas. We cannot do this," he said. "Our territories are illegally occupied. Donbas for the Russians is a springboard for a future new offensive." Professor emeritus Graeme Gill, a political scientist from the University of Sydney, said the region has an interesting history. He told SBS News the "loyalty" of the area has been "very fluid" due in part to the Russian heritage of some of its citizens. "Putin's argument is that it's always been primarily a Russian area, which was arbitrarily carved out of Russia and given to Ukraine when the Soviet Union was established. So it's also part of getting back some of what he feels was lost as a result of the collapse of the Soviet Union," he said. "The taking of this region and the incorporation of it into Russia itself would conceivably be a lot easier than it would in those areas of Ukraine, which are not traditionally pro-Russian." Source: SBS News He explained that while Donbas has some Russian roots, people in the area ultimately voted in a referendum to become independent from the Soviet Union following its 1991 collapse. However, Russian-installed officials had taken ballot boxes from house to house in what Ukraine and the West said was an illegitimate, coercive exercise to create a legal pretext for Russia to annex the four regions. "This farce in the occupied territories cannot even be called an imitation of a referendum," Zelenskyy said at the time. Gill said Donbas also has important geographical and economic factors that could be desirable to Putin, as a major exporter of coal and heavy industiral production. "They make railway sleepers and industrial equipment, which would be attractive to Putin," he said. State of the war It's been three years since Russia launched its full-scale invasion of Ukraine, and almost a decade since it annexed Crimea in 2014. Gill said Putin appears determined to continue the war. "Putin's not going to give up. And although his economy has run into some problems or he's running into some problems now, there's no evidence that those are sufficient to prevent him from continuing the war," he said. He added that Ukraine is losing ground "virtually every day to Russia". "The Ukrainians have been able to hold on through grit, determination, and the use of weapons from the West. But the problem for them is that they're very greatly outnumbered. "They cannot replace the soldiers that they're losing as a result of the conflict." Genauer said Zelenskyy "needs a ceasefire". "Ukraine is still bearing a lot of costs from the war. It's still being bombarded by Russia in terms of drones and other artillery. "So that's going to be the main sticking point between what Ukraine and the Europeans want, which will be a ceasefire first, followed by negotiations for some kind of territorial agreement."
News.com.au
5 hours ago
- News.com.au
Biocurious: Clinical trial readouts show road to approval can be as exciting as the destination
In the medical device sector, sometimes trial news can excite investors more than the approval endgame At the application stage, devices have a much higher chance of being approved than drugs Investors can expect news from several companies with pivotal or late-stage trials For a drug or device maker, there's no prouder moment than when a health regulator – especially the US Food & Drug Administration (FDA) – approves their product to be unleashed on unsuspecting patients. It's like watching your kid graduate – and you can even tolerate the long-winded speeches. But don't confuse this coming-of-age moment with being the ultimate share price catalyst. For investors, the 'ker-ching' can be much earlier, such as with trial progress or even the FDA granting permission to begin a study. For instance, PainChek (ASX:PCK) shares had a nice run last October, after a positive validation study that supported the pain measurement app maker's US approval application. In late June Blinklab (ASX:BB1) shares soared after the autism test developer won ethics approval for a 1000-patient US trial. In the case of devices, FDA device approval tends to be less of a dramatic moment than for a drug go-ahead, because the chances of success are much higher. Most applicants avail of the 510(k) route, which means that a device only needs to be substantially equivalent to a legal equivalent. According to the contract research organisation Bioaccess, the FDA processes around 10,000 510(k) applications annually, with an approval rate of around 90%. Review times are also shorter: 120 days compared with 420 days for the de novo (new device) route. Here are some device (or quasi device) plays with advanced trials – typically- pivotal ones – that could move the share price dial. Emvision runs with Emu trial EMvision Medical Devices (ASX:EMV) in enrolling up to 300 suspected stroke victims in a pivotal trial of its stroke detection device Emu, across six local and US sites. Emu is a portable bedside scanning unit that's much lighter than a conventional computed tomography (CT) unit. The company is also developing an even small version, First Responder. As its name suggests, this one's for ambulance use. The trial sites are all high calibre research centres handling high stroke volumes. The stroke patients will receive the standard of care and an Emu scan. Given the device is a trail blazer, Emvision is girding for approval under the de novo route. After that, the company hopes the agency will approve First Responder approval under the 510(k) channel. Emu/First Responder will determine whether a stroke is a blockage (ischaemic)or a bleed (hemorrhagic). This will decide the type of treatment and it's crucial to get the diagnosis right. The company expects a six-to-12-month recruitment period. Micro-X also is on strike with strokes Meanwhile, x-ray imaging house Micro-X (ASX:MX1) plans to launch trails of its portable stroke unit, Head CT, across three local hospitals in the current half. The trials will entail suspected stroke victims being subject to standard CT imaging, then overlaid with the Micro-X scan that deploys a more effective 'cold cathode' method. Aiming for 'several hundred' scans, the studies only need to prove that the Micro-X tech is just as good as the conventional ones, Funded by $8 million from the Australian Stroke Alliance, the study supports a proposed 510(k) application next year, in view of a US launch in 2027. The company expects the trials to run for nine months. Micro-X had multiple applications for its tech, bomb and baggage screening. As part of a 'strategy re-set' the company is focused on medical applications. Micro-X has commercialised two mobile digital radiology devices: the first-generation Nano and a sturdier iteration called Rover. Heart patients move like Jagger In the past, heart patients too old or too sick for surgical aortic valve replacement – or open-heart surgery – in effect were given a death sentence. Transcatheter Aortic Valve Replacement (TAVR) procedures enable malfunctioning valves to be replaced in a non-invasive, 20-minute procedure. TAVR recipients include Arnold Schwarzenegger and Mick Jagger – and they're still rockin'. TAVR also applies to replacing artificial valves that have an effective operating life of five years or so. Anteris Technologies (ASX:AVR) is on track to commence a pivotal trial of its Duravr device in the current quarter, pending FDA approval. The company says it's qualified 79 sites globally for the trial, which will enroll patients with a 'broad array of risk profiles'. The trial will be designed to provide the 'primary clinical evidence' for the FDA to mull premarket approval. In parallel, Anteris is pursuing European clearance. More than Imagion-ation Shares also can pop on the strength of trial approval alone. In the drug/device sphere, Imagion Biosystems (ASX:IBX) awaits clearance to carry out a phase II study of its cancer imaging agent, Magsense for Her-2 positive beast cancers. For use with magnetic resonance imaging (MRI), Magsense improves cancer detection by adding 'molecular specificity'. In lay terms, this avoids painful, error-prone biopsies. This month, Imagion formed an alliance with Michigan's Wayne State University School of Medicine. In part, the institution's MRI gurus will help to devise an optimal dose to be used in the study. Trip the light fantastic Invion (ASX:IVX) highlights how the trial journey, rather than the destination can evoke investor excitement. Invion is advancing photodynamic therapy (PDT) for tumor types including non-melanoma skin cancers and ano-genital cancers. Someone has to do it. The idea is that light-activated photosensitisers leave the healthy tissue unharmed, but zap the diseased stuff. Thus, PTD is a promising non-toxic, non-invasive alternative to chemotherapy, radiation or surgery. Invion shares early last December rocketed more than 300% after the company said it had enrolled its first patient in its Queensland based phase I/II skin cancer trial. The adaptive study now is poised to enter is second stage. The next Sirtex? OncoSil Medical (ASX:OSL) is equated with a less developed version of the targeted liver cancer radiation treatment house Sirtex, acquired for $1.9 billion in 2018 by Chinese interests. Relative commercial immaturity aside, Oncosil targets the difficult pancreatic cancer. Oncosil is trialling its eponymous targeted treatment with the standard-of-care chemo, Folfirinix. The study, TRIPP-FFX, has completed recruitment and investors should expect data in early 2026. The study pertains to patients with locally advanced pancreatic cancer. The trial has recruited 'at least' 88 patients across 15 local and European hospitals. So - there you have it. While bonanza share gains are never guaranteed, investors know where to look for surprise pit stops along the circuitous approval journey.
