UK and EU Seek to Link Carbon Markets in Wider Post-Brexit Reset
The move comes as part of Monday's UK-EU summit, which aims to improve relations five years after Britain left the bloc, according to a draft document seen by Bloomberg, laying out a 'common understanding' between London and Brussels.
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Associated Press
23 minutes ago
- Associated Press
Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul 25, 2025-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission (EC) decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo ®. The marketing authorization application (MAA) recommendation will now be reviewed by the EC as it evaluates lenacapavir as a potential new preventative strategy against HIV in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication. The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs). 'This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,' said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. 'Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care.' Despite ongoing advances in HIV prevention, persistent social and economic factors including stigma and discrimination continue to cause disparities in PrEP use. In 2023, a total of 24,731 new HIV diagnoses were reported across 30 EU/European Economic Area countries—an increase of 11.8% compared with 2022. 'These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030,' said Jean-Michel Molina, MD, PhD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. 'The opinions reflect the strength of the clinical evidence and the potential of long-acting innovations like lenacapavir to address real-world barriers to the use of PrEP. Expanding the range of PrEP options, in Europe and in countries around the world, is essential to making HIV prevention more accessible for people who need it most.' The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial ( NCT04994509 ), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial ( NCT04925752 ), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified . Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 'Breakthrough of the Year.' Continued Global Regulatory Filings for Lenacapavir for HIV Prevention, Milestone Partnerships and Global Guidance Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. More information about Gilead's recently announced strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as updates on Gilead's access strategies in countries and regions around the world: See Gilead press release More information about the WHO's recently announced guidelines for the use of lenacapavir for PrEP: See Gilead company statement Lenacapavir for PrEP is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents (≥35kg) who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 'Breakthrough of the Year.' U.S. Indication for Yeztugo® Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Contraindications Warnings and precautions Adverse reactions Drug interactions Dosage and administration About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on CONTACT: Ashleigh Koss, Media [email protected] Ross, Investors [email protected] KEYWORD: EUROPE UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: AIDS HEALTH INFECTIOUS DISEASES HOSPITALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Gilead Sciences, Inc. Copyright Business Wire 2025. PUB: 07/25/2025 03:00 AM/DISC: 07/25/2025 03:01 AM
Yahoo
an hour ago
- Yahoo
Goldman, J.P. Morgan scale back ECB rate cut views on resilient economy, potential EU-US deal
(Reuters) -Goldman Sachs and J.P. Morgan downsized their expectations for further rate cuts by the European Central Bank a day after the central bank kept rates steady, pointing to a resilient economy and hopes that a European Union-U.S. tariff deal was on the cards. In notes dated July 24, Goldman said it no longer expects the ECB to deliver a rate cut this year, while J.P. Morgan has pushed its rate-cut forecast to October from September previously. On Thursday, the ECB held policy rates unchanged at 2% after having cut interest rates eight times since June 2024. "We are in this wait-and-watch situation," ECB President Christine Lagarde told a press conference, adding that the economy was now in a "good place". Lagarde's comments suggest "that the Governing Council will likely hold rates unless the outlook deteriorates materially," analysts at Goldman Sachs wrote. The outcome of EU-U.S. trade talks remains uncertain, but two diplomats with inside information say a deal that includes a broad 15% tariff on EU goods is likely. Earlier this month, Trump had threatened to impose 30% tariffs on EU imports starting August 1. On the other hand, Bank of America, Barclays, Citigroup, Deutsche Bank and Morgan Stanley have reiterated their expectations for a September rate cut, though some of them warned of risks to their calls. "The risks to that view(a September rate cut) have clearly increased," analysts at Morgan Stanley said in a note. "In case data were to come in stronger than we expect, we think the ECB could extent the current hold into December." Money markets show traders are unsure about another ECB rate cut this year, attaching about a 30% chance of a drop below the current 2% level by the end of December. 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
Yahoo
2 hours ago
- Yahoo
China's premier tells EU leaders 'we can't afford' massive industrial subsidies
Chinese Premier Li Qiang dismissed EU fears over Beijing's allegedly excessive subsidies to its industry, telling the bloc's leaders "we can't afford it" in markedly candid remarks during a tense summit. Speaking during a roundtable with EU chief Ursula von der Leyen on Thursday, Li insisted that "China is by no means doing what some call a subsidies policy or fiscal subsidies". "China is not as rich as Europe, and we can't afford it," he said. "We would not be stupid enough to use the fiscal funds accumulated through the government and the hard work of our people to sell our products to foreign consumers," Li added. Von der Leyen and European Council President Antonio Costa were in Beijing on Thursday for a summit dominated by tensions between the EU and China over trade and Russia's war in Ukraine. Chief among the bloc's concerns was its yawning trade deficit with China, which stood at around $360 billion last year. The EU has also raised fears that Beijing's vast subsidies to its industry could help it undercut European competitors with a flood of cheap exports to the continent. Li, China's number two official, rejected those claims in a roundtable with the EU's leadership. "Some enterprises, especially manufacturing enterprises, feel more deeply that China's manufacturing capabilities are too strong, and Chinese people are too hardworking," the Chinese premier said. "Factories run 24 hours a day," he said. "Some people think this will cause some new problems in the balance of supply and demand in world production," the Chinese premier said, admitting: "We see this problem too." Li also rejected claims the Chinese economy -- plagued by sluggish growth for years now -- was in dire straits. "Of course, there are difficulties and challenges, but it is difficult for us to say that China's economy is in a downturn," he said. "Our GDP growth rate is always above five percent," he insisted. ll-mjw-oho/je/tym
