The Commodity Futures Trading Commission is looking at how to let some registered futures exchanges list leveraged digital assets like Ether and Bitcoin.
“There is a clear and simple solution the CFTC can implement now,” acting Chairman Caroline Pham said in a news release, referencing a March op-ed in which she suggested that the agency could use its authority to exempt companies from rules that currently limit futures exchanges to only listing derivatives products.
Via Headline USA,
Attorney General Pam Bondi has directed that the Justice Department move forward with a probe into the origins of the Trump-Russia investigation, following the recent release of documents about collusion between the Obama administration and the 2016 Hillary Clinton campaign.
Bondi has directed a prosecutor to present evidence to a grand jury after referrals from the Trump administration’s top intelligence official, a person familiar with the matter said Monday.
Fox News first reported the development.
It was not clear which former officials might be the target of any grand jury activity, where the grand jury that might ultimately hear evidence will be located or which prosecutors — whether career employees or political appointees — might be involved in pursuing the investigation.
It was also not clear what precise claims of misconduct Trump administration officials believe could form the basis of criminal charges, which a grand jury would have to sign off on for an indictment to be issued.
In one batch of documents released last month, Gabbard disclosed emails showing that senior Obama administration officials were aware in 2016 that Russians had not hacked state election systems to manipulate the votes in Trump’s favor.
Sen. Chuck Grassley, the Republican chairman of the Senate Judiciary Committee, also released a set of emails last week.
The emails were part of a classified annex of a report issued in 2023 by John Durham, the special counsel who was appointed during the first Trump administration to hunt for any government misconduct during the Russia investigation.
According to the annex, an FBI informer identified as “TI” provided the bureau in 2016 with two intelligence reports, which described “confidential conversations” between then-Democratic National Committee Chair Debbie Wasserman Schultz and two people at the George Soros-funded Open Society Foundation: Leonard Bernardo and Jeffrey Goldstein.
The report said that then-President Barack Obama didn’t want Hillary’s scandal to taint his legacy.
Accordingly, “To solve the problem, the President puts pressure on FBI Director James Comey through Attorney General Lynch, however, so far without concrete results.”
The same report also said that Comey favored Republicans, and that the FBI didn’t have any evidence against Clinton—because she deleted her emails.
While the FBI informant’s intelligence wasn’t corroborated at the time, the FBI indeed closed its investigation into Clinton without recommending charges.
Republicans have particularly focused on a July 27, 2016, email in Durham’s newly declassified annex that claimed that Hillary Clinton had approved a plan during the heat of the campaign to link Trump with Russia.
Durham’s own report took pain to note that investigators had not corroborated the communications as authentic and said the best assessment was that the message was “a composites of several emails” the Russians had obtained from hacking.
https://www.zerohedge.com/political/doj-present-russiagate-hoax-grand-jury-criminal-charges
by Thomas Brooke via Remix News,
The European Court of Justice (ECJ) has carried out a “migration policy castration of the EU member states,” German constitutional lawyer Prof. Markus C. Kerber warned following a landmark asylum ruling that critics say strips national governments of the ability to manage their own borders.
The ruling, handed down in Luxembourg on Friday, states that a third country may only be designated as a “safe country of origin” if it offers effective protection to all population groups — and that this designation must be based on transparent, public information accessible to asylum seekers and the courts. Otherwise, fast-track returns are invalid.
The judgment has major implications for national migration policies, particularly in countries like Italy and Austria that have drawn up their own lists of safe third countries. In the specific case reviewed, two Bangladeshi migrants had been transferred to Albania under Italy’s agreement to process asylum claims outside the EU. Their claims were dismissed on the grounds that Bangladesh was safe, but the Italian law did not cite any sources, which the European Court ruled was a violation of EU law.
Prof. Kerber, a Berlin-based constitutional expert, accused the Court of overreach.
“The strengthening of the judiciary by the ECJ for all cases of reviewing asylum applications leads to the castration of EU member states’ migration policy,” he said in an interview with Austrian media outlet, exxpress.
“The public will increasingly perceive the EU as an entity acting against its own citizens.”
He warned that the court was imposing an “overly bureaucratized procedure” that would make meaningful control over migration impossible. “Social systems are bursting,” Kerber said. “And the willingness of the majority of society to accept refugees is declining drastically.”
“What will happen if suddenly 3 million people from an unsafe country of origin appear at our border? Should we then accept them all?” he asked.
Kerber is a constitutional lawyer and professor of public finance and political economy at the Technical University of Berlin. He also serves as a visiting professor at Sciences Po in Paris and has been involved in several high-profile legal cases, including a 2008 challenge to the Lisbon Treaty before Germany’s Constitutional Court. He is the founder of the Berlin-based think tank Europolis, which advocates for market-based reforms within the European Union.
The Court’s ruling is also likely to undermine similar policies elsewhere in Europe. Austria’s safe country list includes nations such as Algeria, Morocco, Ghana, and Serbia, but legal experts warn these could now be challenged if minorities within those countries are found to be at risk. Going forward, all such designations must be based on current, verifiable, and publicly available data.
Andreas Rosenfelder, editor at Welt, called the ruling an act of “do-gooder justice” that sacrifices the rights of EU citizens in the name of universal morality. “This moralized judiciary would rather negotiate the injustices of the world than defend its own population,” he wrote. “If this impression continues to harden, then the citizens will choose a different Europe with a different judiciary.”
Responding to Friday’s ruling, Italian Prime Minister Giorgia Meloni expressed her outrage at the latest example of a supranational judiciary meddling in the domestic affairs of a member state.
Posting on social media, Meloni wrote, “The decision of the EU Court of Justice regarding the safe countries of origin for illegal migrants is surprising. Once again, the judiciary, this time at the European level, claims spaces that do not belong to it.
“This is a development that should concern everyone, including the political forces that today celebrate the ruling, because it further reduces the already limited margins of autonomy for governments and parliaments in shaping the normative and administrative direction of the migration phenomenon.
“The Court’s decision weakens policies aimed at countering mass illegal immigration and defending national borders. The Italian Government, for the 10 months remaining until the EU migration pact takes effect, will not cease to seek every possible solution, technical or normative, to protect the safety of citizens.”
Deputy Prime Minister Matteo Salvini called the ruling “another slap in the face to our country’s national sovereignty, yet another incentive for limitless landings, yet another confirmation not only of the uselessness but also of the harmfulness of European institutions of this kind, which are paid for by Italian citizens who, however, are constantly humiliated.”
Opioids like morphine are widely used in medical practice due to their powerful pain-relieving effects, yet they carry the risk of serious adverse effects such as respiratory depression and drug dependence. For this reason, Japan has strict regulations in place to ensure that these medications are prescribed only by authorized physicians.
In the United States, the opioid OxyContin was once frequently prescribed, triggering a surge in the misuse of synthetic opioids such as fentanyl. As a result, the number of deaths caused by opioid overdose surpassed 80,000 in 2023, escalating into a national public health crisis now referred to as the "opioid crisis."
Opioids may soon have a rival, however. A team of researchers at Kyoto University has recently discovered a novel analgesic, or pain reliever, that exerts its effect through an entirely different mechanism. Clinical development of their drug ADRIANA is currently underway as part of an international collaborative effort.
The work is published in the Proceedings of the National Academy of Sciences.
"If successfully commercialized, ADRIANA would offer a new pain management option that does not rely on opioids, contributing significantly to the reduction of opioid use in clinical settings," says corresponding author Masatoshi Hagiwara, a specially-appointed professor at Kyoto University.
The research team was first inspired by substances that mimic noradrenaline, which is released in life-threatening situations and activates α2A-adrenoceptors to suppress pain, but these pose a high risk of cardiovascular instability.
After observing noradrenaline levels and α2B-adrenoceptors, the team hypothesized that selectively blocking α2B-adrenoceptors could elevate noradrenaline levels, leading to activation of α2A-adrenoceptors and resulting in pain relief without causing cardiovascular instability.
To identify selective inhibitors of α2B-adrenoceptors and measure the activity of individual α2-adrenoceptor subtypes, the researchers employed a novel technology known as the TGFα shedding assay and conducted compound screening, leading to their discovery of the world's first selective α2B-adrenoceptor antagonist.
After success in administering the compound to mice and conducting non-clinical studies to assess its safety, physician-led clinical trials were conducted at Kyoto University Hospital. Both the Phase I trial in healthy volunteers and the Phase II trial in patients with postoperative pain following lung cancer surgery yielded highly promising results.
Building on these outcomes, preparations are now underway for a large-scale Phase II clinical trial in the United States, in collaboration with BTB Therapeutics, Inc, a Kyoto University-originated venture company.
As Japan's first non-opioid analgesic, ADRIANA has the potential not only to relieve severe pain for patients worldwide but could also play a meaningful role in addressing the opioid crisis—a pressing social issue in the United States—and thus contribute to international public health efforts.
"We aim to evaluate the analgesic effects of ADRIANA across various types of pain and ultimately make this treatment accessible to a broader population of patients suffering from chronic pain," says Hagiwara.
More information: Hagiwara, Masatoshi, Discovery and development of an oral analgesic targeting the α2B adrenoceptor, Proceedings of the National Academy of Sciences (2025). DOI: 10.1073/pnas.2500006122. doi.org/10.1073/pnas.2500006122
https://medicalxpress.com/news/2025-08-discovery-analgesic-pain-relief-downsides.html
Two weeks ago, Replimmune received a surprise rejection from the FDA for its advanced melanoma drug, RP1. New reporting from multiple outlets reveals that the agency’s top cancer regulator directly intervened to issue the complete response letter.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence (OCE) and acting director of the Office of Oncologic Diseases, both offices within the Center for Drug Evaluation and Research (CDER), had a hand in issuing the complete response letter to Replimmune, according to reporting Friday from Endpoints News, with confirmation from STAT News on Monday.
“This was Rick Pazdur’s doing,” an FDA official told STAT on the condition of anonymity. “I didn’t agree with all the decisions made here by Vinay [Prasad], but he had little to do with this one.”
Replimmune’s stock crashed 75% after the rejection and was down another 30% Monday morning after market open.
The rejection appears to have come down to a late intervention from CDER into a review at its sister office, the Center for Biologics Evaluation and Research (CBER), where RP1 was under review. Another anonymous FDA official said that CBER had “mishandled” the review, prompting Pazdur and OCE to get involved.
RP1 is a herpes virus–based immunotherapy that induces an immune response against tumors. It was being tested in combination with BMS’ immunotherapy Opdivo.
When the rejection came down, speculation swirled that the CRL was related to the design of the trials that provided supporting data. Pazdur and his team, according to STAT, were indeed troubled by the design, saying that the drug’s tumor killing effect could not be separated from the effect elicited by Opdivo.
“The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews,” Replimmune CEO Sushil Patel said in a statement on July 22nd announcing the news. “Additionally, we had also aligned on the design of the confirmatory study.”
Then-CBER director Vinay Prasad attended a conference in early July, along with Pazdur, where the merits of RP1 were debated. The consensus from the CBER side was that RP1 should be approved, but Pazdur was in opposition. Prasad ultimately deferred to Pazdur, according to STAT.
A week after the Replimmune CRL, following a hail of criticism from conservative figures centered on a variety of issues, including his handling of Sarepta’s gene therapy Elevidys and his past support for progressive policy positions, Prasad left the agency.
Replimmune intends to request a follow-up meeting with the FDA to understand how to move forward.
https://www.biospace.com/fda/top-fda-cancer-regulator-intervened-to-reject-replimmunes-melanoma-drug
Inspire Medical (NYSE: INSP)
shares took a massive hit after hours today on second-quarter results that included a significantly reduced outlook.
The company previously projected adjusted earnings per share to range between $2.20 to $2.30 in 2025. However, it now forecasts between 40¢ and 50¢ for the full year. Inspire also reduced its sales guidance from between $940 million and $955 million to between $900 million and $910 million.
This slash comes as Inspire faces certain headwinds, along with $1.7 million in litigation-related legal expenses. Those costs represent legal-related expenses related to a civil investigative demand from the Department of Justice and a patent infringement suit filed against Nyxoah.
Shares of INSP fell more than 19% to $129.95 apiece in post-market trading today.
“Importantly, we believe the operational headwinds are temporary, and actions are underway to address them,” said Tim Herbert, Inspire chair and CEO. “We remain steadfast in our commitment to serving the many patients who struggle with untreated moderate to severe [obstructive sleep apnea], delivering strong patient outcomes and executing on our strategy to drive profitable growth and value creation for all stakeholders.”
The Minneapolis-based developer of implantable neuromodulation technology for treating sleep apnea reported losses of $3.6 million. That equals 12¢ per share on sales of $217.1 million for the three months ended June 30, 2025.
Inspire recorded a large bottom-line slide into the red on a sales increase of 10.8%.
Adjusted to exclude one-time items, earnings per share came in at 45¢. That landed 25¢ ahead of expectations on Wall Street. Sales also eclipsed projections as experts forecast $214.3 million in revenue.
Highlights for the quarter included the launch of the Inspire V next-generation sleep apnea therapy system.
“The full launch of our FDA-cleared Inspire V system in the U.S. is an important milestone for Inspire. We have been receiving strong positive feedback from both surgeons and patients who value the simplified procedure and excellent patient outcomes enabled by this next generation technology,” Herbert said. “In the near future, we look forward to presenting the clinical evidence collected to date.”
“The broad enthusiasm for Inspire V gives us confidence that it will be a growth engine for the company. However, the U.S. commercial launch is progressing slower than expected, and the timeline to complete the full transition to Inspire V has been pushed forward, which will impact financial results for the year.”
https://www.massdevice.com/inspire-medical-stock-q2-2025-guidance/
