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Novartis' Pluvicto Approved by FDA for Metastatic Prostate Cancer

Novartis announced the US Food and Drug Administration approved Pluvicto in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer. Approval is based on the Phase III PSMAddition trial, which showed Pluvicto reduced the risk of progression or death by 28% when combined with standard of care compared to SoC alone. At a subsequent updated analysis, the Pluvicto combination further reduced the risk of progression or death by 33% with a positive overall survival trend favoring Pluvicto plus SoC, as data continue to mature ahead of final OS analysis. "The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters," said Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and a Principal Investigator of the study in the US. "Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients." Pluvicto can now be used across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. The approval builds on its established use in metastatic androgen pathway modulation-resistant prostate cancer, also known as metastatic castration-resistant prostate cancer.

Trump Announces Generic Drug Tariff Policy Starting 2026

Catch up on the top industries and stocks that were impacted, or were predicted to be impacted, by the comments, actions and policies of President Donald Trump with this daily recap compiled by The Fly.IMPORTED GENERIC DRUGS:U.S. President Donald Trump said in aon Truth Social, "Effective August 1st, 2026, all Generic Drugs being brought into the United States will continue to have a TARIFF of ZERO PERCENT for a two year period of time, after which the TARIFF will be raised to 100% for a one year period of time, and 200% thereafter. This is done in order to RESHORE Generic Pharmaceutical Production into America, with a penalty to those Companies that decide not to build Plant and Equipment within the stated period of time given to them. The objective of this Policy is to protect the people of the United States. The Policy on Patented, Branded, or Innovative Drugs, which has been so successful, will remain as is. Pharmaceutical Facilities are being built, at a level never seen before, all over the United States of America." Publicly traded companies in the space include AstraZeneca, Bristol Myers, Eli Lilly, GSK, Johnson & Johnson, Merck, Novartis, Pfizer, Rocheand Sanofi.HEALTH, CONSTRUCTION RESEARCH:Assistant to the President and Director of the White House Office of Science and Technology Policy Michael Kratsios published a newto President Trump that charts a course to revitalize American research and development. Scientists will have access to the Department of Energy's supercomputers, AI and specialized datasets, along with other components needed to run experiments using algorithms, said Michael Kratsios, chief technology adviser to U.S. President Donald Trump, in an interview with Reuters. Fifteen federal agencies will be involved in the project, including the Departments of Health and Human Services, Energy, Transportation, Defense and Interior. "The White House is helping bring together all of the different agencies that work on different domains to make them part of this larger effort on AI for science," Kratsios said. The Trump administration also plans to overhaul how the U.S. government funds federal research by supporting more individual scientists and the use of AI, rather than universities, according to a White House report.NEW AI MODELS:OpenAI Chief Executive Officer Sam Altman is planning to discuss the upcoming generation of AI models with the Trump administration and U.S. lawmakers as the U.S. works to create a process to review the safety of AI systems, Maggie Eastland of Bloomberg, citing a senior company executive. According to Chris Lehane, OpenAI's head of global public affairs, Altman's visit comes as U.S. officials develop a framework for safety reviews.AI ENERGY USAGE:The biggest utilities and data center developers in the U.S. have signed on to President Trump's pledge to pay more for the energy required to run large-language models, hoping to assuage concerns over energy use amid the AI boom, the Wall Street Journal's Meridith McGraw and Amrith Ramkumar. NextEra Energy, Duke Energy, Equinix, and Digital Realtyare among the nearly 200 companies committing to the pledge aimed at ensuring AI energy consumption doesn't increase electric bills for consumers across the country, the authors say, citing a White House list of signatories obtained by The Wall Street Journal.NUCLEAR REACTORS FOR AI:Okloand X-Energyare joining Microsoft, Nvidia, and other partners in a Trump administration-backed $200M initiative to accelerate deployment of advanced nuclear power for AI data centers, with national laboratories and universities also participating in the effort, Bloomberg's Naureen S. Malik and Ari Natter. Details of the effort could be announced as soon as Wednesday at an AI energy summit convened by the U.S. Department of Energy, according to the report.FLIGHTS TO LEBANON:U.S. President Donald Trump said in aon Truth Social, "After meeting with the President of Lebanon, Joseph Aoun, who has done a remarkable job working to transform his Country, I am hereby directing my Administration to allow all U.S. airline carriers to fly directly to Lebanon so that Americans can easily visit this beautiful land. Hopefully, other Countries will do the same." Publicly traded companies in the space include Alaska Air, American Airlines, Delta Air Lines, Frontier Group, JetBlue, Southwest, Sun Country Airlinesand United Airlines.