
Johnson & Johnson announces new data from Cohort 2 of Phase 2b SunRISe-1
Johnson & Johnson announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200-an intravesical gemcitabine releasing system-for patients with certain types of bladder cancer. The findings demonstrate the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months. These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guerin-unresponsive, high-risk non-muscle-invasive bladder cancer, HR-NMIBC, with carcinoma in situ, CIS, with or without papillary tumors who are ineligible or refuse radical cystectomy. As of March 2025, 82.4 percent of the 85 enrolled patients in the study achieved a complete response, meaning their cancer was undetectable following treatment. This high response rate translated into sustained disease control, with 52.9 percent of responders maintaining complete response at one year. The median duration of response was 25.8 months, indicating that many patients remained cancer-free for over two years without the need for reinduction therapy. At 12 months, 86.6 percent of responders remained cystectomy-free. Importantly, the treatment was well-tolerated, with most adverse events being mild urinary symptoms. These findings show that TAR-200 offers a highly effective and durable treatment option for patients with certain types of BCG-unresponsive HR-NMIBC.
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Yahoo
3 hours ago
- Yahoo
Crypto Currents: Strategy buys more bitcoin
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4 hours ago
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4 hours ago
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Fact Check: What we know about 'Big Beautiful Bill' banning states from regulating AI for 10 years
Claim: H.R. 1, commonly known as the One Big Beautiful Bill Act, contains a provision that bans states from regulating artificial intelligence for 10 years. Rating: Context: If the "Big Beautiful Bill" becomes law, states and local governments would be unable to enforce any regulations on AI systems and models involved in interstate commerce for 10 years. There are exceptions for any laws or regulations that facilitate the rollout, operations or adoption of AI models and systems. A budget bill that Republicans in the U.S. House of Representatives passed on May 22, 2025, allegedly bans all 50 states from regulating artificial intelligence for a decade, according to claims shared on social media in early June. As the Senate prepared to take up H.R. 1, more commonly known as the One Big Beautiful Bill Act, people online expressed their concerns about the alleged AI-related provisions in the legislation. For example, one X user shared this claim (archived) on June 2, 2025: Similar claims also appeared in Facebook (archived) posts (archived) around the same time. Snopes reviewed the text of H.R. 1 and found a provision that bans states from regulating AI systems "entered into interstate commerce" for 10 years in Section 43201 of the bill. Paragraph (c) in that section outlines the 10-year moratorium on states' AI regulation: (1) In general. – Except as provided in paragraph (2), no State or political subdivision thereof may enforce, during the 10-year period beginning on the date of the enactment of this Act, any law or regulation of that State or a political subdivision thereof limiting, restricting, or otherwise regulating artificial intelligence models, artificial intelligence systems, or automated decision systems entered into interstate commerce. In other words, if the bill becomes law, states and local governments will be blocked from enforcing any regulations on AI systems and models that are involved in interstate commerce for 10 years. The phrase "interstate commerce" broadly refers to business or activity that crosses state lines. But in the context of this bill, the distinction likely doesn't mean much. As a result, we've rated the claim mostly true. The Supreme Court has said activities that happen entirely within one state can still count as interstate commerce if they have a significant enough impact on the national economy, as David Brody, a civil rights and technology legal expert, explained in an article for Tech Policy Press published on May 27, 2025. That means many AI systems would likely be subject to the federal rules if H.R. 1 passes. However, there are some exceptions to the 10-year moratorium on states' AI regulation — notably for any laws or regulations that facilitate the rollout, operations or adoption of AI models and systems, according to the bill text. Snopes reached out to the White House and the office of U.S. Rep. Jodey Arrington, R-Texas, who introduced H.R. 1, for comment about the 10-year moratorium on states regulating AI and the purpose of including it in the bill, and is awaiting responses. Multiple Republican lawmakers have voiced support for the 10-year moratorium, with some saying a patchwork of state laws doesn't support innovation and others stressing the importance of a federal approach to AI regulation. But other federal and state lawmakers as well as watchdog groups have strongly opposed the proposed rule over concerns about limiting states' ability to deal with potential harms caused by AI. For example, U.S. Rep. Marjorie Taylor Greene, R-Ga., said in an X post on June 3, 2025, that she "did not know about" the section of H.R. 1 that bans states from regulating AI for a decade, adding that she is "adamantly opposed" to the provision. Hundreds of state lawmakers across the political spectrum also signed a letter addressed to the U.S. House and Senate on June 3, 2025, expressing "strong opposition" to the 10-year moratorium on AI regulation. The letter read in part, "The proposed 10-year freeze of state and local regulation of AI and automated decision systems would cut short democratic discussion of AI policy in the states with a sweeping moratorium that threatens to halt a broad array of laws and restrict policymakers from responding to emerging issues." Nearly two weeks earlier, a coalition of advocacy organizations, including Common Sense Media, Fairplay and Encode, also called on congressional leaders to oppose the provision, writing in part that AI companies would have "no rules, no accountability and total control" if it were to take effect. In a letter dated May 21, 2025, the groups wrote: As written, the provision is so broad it would block states from enacting any AI-related legislation, including bills addressing hyper-sexualized AI companions, social media recommendation algorithms, protections for whistleblowers, and more. It ties lawmakers' hands for a decade, sidelining policymakers and leaving families on their own as they face risks and harms that emerge with this fast-evolving technology in the years to come. Discussions about AI companions and possible issues arising from their use have gained prominence in recent months. For example, research from Drexel University in Philadelphia suggests that inappropriate behavior, including sexual harassment, during conversations with AI chatbots is "becoming a widespread problem," the university said on May 5, 2025. Consumer Reports, another advocacy organization, also raised concerns about states being unable to deal with a variety of issues that AI technology poses, including sexually explicit images, audio and video created without a person's consent. Snopes has previously looked into other claims about the "Big Beautiful Bill," including whether it contains a provision allowing the U.S. president to delay or cancel elections. Arrington, Jodey. "Text - H.R.1 - 119th Congress (2025-2026): One Big Beautiful Bill Act." 2025, Accessed 4 June 2025. Brody, David. "The Big Beautiful Bill Could Decimate Legal Accountability for Tech and Anything Tech Touches." Tech Policy Press, 27 May 2025, Accessed 4 June 2025. Cornell Law School. "Commerce Clause." Legal Information Institute, 18 Sept. 2018, Accessed 4 June 2025. Hendrix, Justin. "Transcript: US House Subcommittee Hosts Hearing on 'AI Regulation and the Future of US Leadership.'" Tech Policy Press, 21 May 2025, Accessed 4 June 2025. Open letter from consumer advocacy organizations to congressional leadership. Common Sense Media, 21 May 2025, Accessed 4 June 2025.