Vocal FDA critic to serve as agency's top vaccine regulator
Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency's top regulator of vaccines, gene therapies and the blood supply.
Prasad, a University of California at San Francisco professor and epidemiologist, will replace Peter Marks, whom the Trump administration forced out in late March. Prasad, who is also a hematologist and oncologist, is the latest vocal critic of pandemic-era policies to join the administration.
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LIfT BioSciences Expands U.S. Footprint with New Facility at Portal Innovations, Houston Helix Park
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Medscape
42 minutes ago
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Routine Checks for Cancer Metastases: A Help or Harm?
Patients who have undergone a full course of curative-intent cancer treatment are often monitored for years with imaging scans and blood tests to identify recurrences early. For some solid tumors, scans are recommended as frequently as every 6 months over 5 years. However, there are longstanding concerns about the value of surveillance after curative-intent cancer treatment in patients who remain asymptomatic. The authors of a recent perspective in The New England Journal of Medicine questioned whether the common practice of scheduling scans and blood tests in symptom-free cancer survivors actually improves survival or quality of life. Based on existing data, routine surveillance finds more recurrences but does not reduce mortality and often inflicts financial, physical, and psychological harm, H. Gilbert Welch, MD, MPH, with the Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, and Lesly A. 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A consistent theme across specialty societies that participate in the Choosing Wisely campaign, including the American Society of Clinical Oncology (ASCO), is to avoid ordering imaging scans (PET, CT, or bone scans) or blood-based tumor-marker tests as part of routine follow-up care for asymptomatic patients after curative cancer treatment for solid tumors unless strong evidence shows that the testing leads to improved survival or quality of life. Current guidelines typically endorse routine surveillance in these patients, but the benefits are often not clear. For colon cancer, despite the latest data showing no survival benefit, guidelines uniformly support routine surveillance with imaging after curative treatment, though the recommended schedule varies. For prostate cancer, annual prostate-specific antigen testing is recommended after curative-intent treatment despite the high 20-year survival rate. For non-small cell lung cancer, all major guidelines recommend routine imaging surveillance following curative-intent surgery, though the interval varies as well. How ever, the evidence to date does not show an overall survival benefit with routine surveillance in this population, according to Brooke E. Wilson, MBBS, from the Department of Oncology at Queen's University, Kingston, Ontario, Canada, and co-authors in a recent review of the evidence. For pancreatic cancer, guidelines are inconsistent, given the lack of randomized data to support surveillance. The National Comprehensive Cancer Network (NCCN), for instance, recommends routine CT chest, abdomen, and pelvis surveillance every 3-6 months for 2 years, and then every 6-12 months after, while the European Society for Medical Oncology highlights the lack of evidence to support regular imaging surveillance. For breast cancer, however, ASCO and NCCN recommend against routine surveillance for metastatic disease in asymptomatic patients. Even so, some studies suggest that, in practice, many physicians may still order imaging, including chest radiographs, MRI, PET, CT, or bone scans. What's the evidence in favor of routine surveillance in asymptomatic patients? In their perspective, Welch and Dossett explain that the theoretical case for routine cancer surveillance is 'strong.' Tumor burden will likely be lower before symptoms of recurrence develop, and treatment is expected to be more effective when a recurrence is detected at an earlier stage. Some data appear to back up this argument, showing that 5-year survival rates are higher among patients with asymptomatic vs symptomatic recurrences. But there's a caveat, Welch and Dossett cautioned. When recurrences are detected earlier in patients who are asymptomatic, survival will always appear to be longer than when recurrences are detected clinically simply because the 'survival clock' starts sooner (classic lead-time bias). Only randomized controlled trials (RCTs) that randomize patients before recurrence can give an unbiased answer. Despite the theoretical case for routine cancer surveillance, the empirical case is 'weak,' according to Welch and Dossett. A case in point: Among 12 RCTs of imaging-based surveillance across several solid tumors that were included in a 2021 systematic review, none found a statistically significant mortality benefit in asymptomatic patients. In a 'coin flip' pattern, the risk for death was slightly lower in the surveillance group in six of the trials and slightly lower in the control group in the other six trials. Although routine surveillance is common in practice, 'these findings suggest that detection and treatment of asymptomatic cancer recurrences offers no advantage over initiation of treatment only after symptoms develop,' Welch and Dossett concluded. However, Mark A. Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare, Salt Lake City, noted that when it comes to surveillance in asymptomatic patients, he doesn't think there is necessarily a 'one-size-fits-all approach to all cancers.' 'Speaking from personal experience, surveillance allowed me to catch my own pancreas changing 'in time' for a surgery that — to date — has postponed or prevented metastasis to my liver,' Lewis explained, with the caveat that he has a hereditary condition that calls for annual surveillance. In addition to genetics, cancer type may matter as well. 'From a lung-cancer standpoint, the statement that surveillance does more harm than good is inaccurate,' Raja M. 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The authors of a recent Comments and Controversies perspective article in the Journal of Clinical Oncology also voiced concern that the risk-benefit ratio of routine surveillance imaging is 'not adequately considered by many practice guidelines, nor is it routinely discussed with patients.' Decisions about surveillance imaging after curative intent cancer treatment should be 'patient-centered,' Wilson and co-authors wrote. While surveillance imaging may be appropriate for some patients, 'the onus is on clinicians to critically evaluate guideline recommendations and to clearly communicate the harms vs benefits of routine surveillance to patients,' Wilson and colleagues advised. Will Liquid Biopsies Change the Risk-Benefit? Testing for minimal residual disease via circulating tumor DNA (ctDNA), which is now becoming more mainstream in solid tumors, 'is arguably making a difference in both the psychological and physical aspects of follow-up,' Lewis said. There is evidence that minimal residual disease testing may reduce patient apprehension. And a recent study from Japan supports the utility of serial monitoring of ctDNA after curative-intent colorectal cancer resection, Lewis noted. Welch and Dossett think ctDNA from the original tumor during surveillance will likely constitute a 'highly specific finding, providing powerful evidence that a cancer has come back. But whether detection of molecular recurrences helps patients live longer or live better is a question that has yet to be answered — and one that can be addressed only with an RCT.' Welch and Dossett call on regulators and policymakers to 'raise the bar' for approving new blood-based biomarker tests and require that trials measure not just analytic validity (does a test detect ctDNA accurately?) but also clinical utility (does it help patients live longer or better?). Although detecting minimal residual disease through ctDNA testing offers 'new opportunities for noninvasive surveillance, early detection, and potentially early interventions,' widespread adoption as a surveillance strategy 'should be discouraged' until randomized data demonstrate that early treatment of minimal residual disease leads to improved survival or quality of life for patients, Wilson and colleagues concluded.
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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
