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Yahoo
21 minutes ago
- Yahoo
Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant recipients Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory demyelinating polyneuropathy in the US and EU Paris, June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi"Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients." Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients (NCT05156710). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: NCT06290128), and in IVIg-treated patients (VITALIZE, clinical study identifier: NCT06290141). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart's potential across multiple immune-mediated conditions with high unmet medical needs. About Riliprubart SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit About AMRAntibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient's immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection. Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Timothy Gilbert | +1 516 521 2929 | Léa Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Felix Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Nathalie Pham | +33 7 85 93 30 17 | Tarik Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Yun Li | +33 6 84 00 90 72 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press Release


New York Post
21 minutes ago
- New York Post
Teen nicknamed ‘Big Balls' leaves Trump's cost-cutting team after exposing wasteful spending
A White House official confirmed to Fox News that a teenaged employee with the nickname 'Big Balls' has resigned from his post at the Department of Government Efficiency (DOGE), adding to the recent shakeup within the department. The now-former DOGE employee – whose real name is Edward Coristine – told Fox News Anchor Jesse Watters last month that his nickname originally came from his LinkedIn social media account. 'I use it as my LinkedIn username,' Coristine told Watters, prompting laughter from the host as well as DOGE leader Elon Musk and the rest of his team at the interview. 'Well, people on LinkedIn take themselves super seriously, and they're pretty averse to risk, and I was like, 'Well, I want to be neither of those things.' So, I just, I set it and honestly, I didn't think anybody would notice,' the DOGE employee continued, mocking the career-focused social media platform. A 19-year-old college student and software developer, Coristine was criticized by Democrats and liberal media pundits during DOGE's first few weeks of investigating wasteful and fraudulent spending in the federal government. 3 Teen Edward Coristine, who goes by the nickname Big Balls, resigned from his position at DOGE. Fox News Many were upset about the young, irreverently named government employee being given access to government records to pursue DOGE's work. During his interview with Watters, Coristine said he had been looking through US Treasury Department payment computers and finding a multitude of outgoing payments from the federal government that lacked details about who they were going to and why. 'So, one of our initiatives is to root out fraud and waste, and to do that we started looking at the payment computers. And, as mentioned earlier, there's no accounting of what payments actually go to in the payment computer,' Coristine said. 'You look at a specific line item — $20 million. You're like, 'OK, what is this money going to?' And for the majority of payment systems, it's like, 'Well, we don't really know.'' 3 Elon Musk shakes hands with President Donald Trump at the 2025 NCAA wrestling championship in Philadelphia, Penn. on March 22, 2025. AP He continued, saying the system that distributes taxpayer money 'literally has no checks and no accountability' to the American taxpayer, adding that it is a 'huge vector for fraud, waste, and abuse.' Coristine's resignation comes less than a month after Musk departed from the agency. Musk's departure was followed by the departure of several other staffers and special government employees at DOGE, which now includes Coristine. Musk has been heading DOGE since President Donald Trump took office in January. 3 President Donald Trump speaks to reporters in the Oval Office of the White House on May 30, 2025. Getty Images The department was tasked with cutting $2 trillion from the federal government's budget through efforts to slash spending, government programs and federal workforce. While DOGE was tasked with cutting $2 trillion from the budget, its efforts have led to roughly $180 billion in savings due to asset sales, contract cancellations, fraud payment cuts and other ways to eliminate costs, according to an update on DOGE's website. The savings translate to about $1,118 in savings per taxpayer, the website notes. Fox News Digital's Gabriel Hays contributed to this report.
Yahoo
21 minutes ago
- Yahoo
Truist Lowers GitLab (GTLB) PT to $75, Maintains Buy Rating
GitLab Inc. (NASDAQ:) is one of the best technology stocks according to Wall Street analysts. Earlier on June 12, Truist adjusted the price target for GitLab to $75 from $80, while maintaining a Buy rating on the shares. This revision comes after GitLab's Q1 2025 results, which, although exceeding guidance, did not meet investor expectations for a larger beat. In Q1, the company reported a total revenue of $169.2 million, which marked a 33% increase year-over-year. GitLab also generated positive cash flow for the first time in a first quarter. The subscription revenue from self-managed and SaaS grew to $151.179 million from $111.191 million year-over-year, and license revenue from self-managed and other increased to $18.008 million from $15.687 million. A team of software engineers working together in an open office, developing innovative solutions. The company's customer base also expanded, with customers contributing over $5,000 of ARR, reaching 8,976, which showed a 21% increase year-over-year. Customers with over $100,000 of ARR grew by 35% year-over-year, totaling 1,025. In this quarter, GitLab also received the 2024 Google Cloud Technology Partner of the Year Award in the Application Development – DevOps category. GitLab Inc. (NASDAQ:GTLB) develops software for the software development lifecycle in the US, Europe, and the Asia Pacific. While we acknowledge the potential of GTLB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data