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Peter Lurie

Peter Lurie

The U.S. Food and Drug Administration (FDA) banned Red Dye #3 in January 2025—an act that was a long time coming for the federal government, the American public, and Dr. Peter Lurie. Back in 1984, during a gap year from medical school, Lurie helped a public interest group called Public Citizen advocate against harmful synthetic chemicals in food, including Red Dye #3. Research has linked Red Dye #3 to cancer and ADHD-like symptoms in children.
Since then, whether as a physician, academic researcher, or federal official, his work has often focused on ridding the food supply of toxic chemicals. As the president and executive director of Center for Science in the Public Interest (CSPI), he directed his organization in 2022 to petition the FDA to ban Red Dye #3. But from previously working at the FDA, Lurie knew that their best shot was to pressure the agency—through the states.
In California, CSPI helped develop legislation that led to a state-level ban and the removal of certain food dyes from the school meal program in 2024. After four decades, Lurie was 'thrilled' when the FDA finally passed a federal ban. Just weeks later, his team successfully helped pressure the agency to define 'healthy' food labels, so that they better align with nutrition science. 'Most people believe the government is protecting them, but it often isn't,' Lurie says. 'That's where we step in.'
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Inovio Pharmaceuticals Inc (INO) Q2 2025 Earnings Call Highlights: Strategic Advances and ...
Inovio Pharmaceuticals Inc (INO) Q2 2025 Earnings Call Highlights: Strategic Advances and ...

Yahoo

time31 minutes ago

  • Yahoo

Inovio Pharmaceuticals Inc (INO) Q2 2025 Earnings Call Highlights: Strategic Advances and ...

Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Inovio Pharmaceuticals Inc (NASDAQ:INO) is on track to submit its BLA for INO 3,107 in the second half of 2025, with the goal of file acceptance by year-end. The company has completed the design verification testing of its Selecttra 5 PSP device, a key milestone for regulatory progress. INO 3,107 has been granted breakthrough therapy designation by the FDA, allowing for a rolling submission of the BLA. Clinical data from INO 3,107 has been published in reputable journals, supporting its potential as a preferred treatment for RRP. Inovio Pharmaceuticals Inc (NASDAQ:INO) has significantly reduced its operating expenses by 31% year-over-year, demonstrating fiscal responsibility. Negative Points Inovio Pharmaceuticals Inc (NASDAQ:INO) experienced a decrease in cash equivalents and short-term investments, from $94.1 million at the end of 2024 to $47.5 million by mid-2025. The company anticipates an operational net cash burn of approximately $22 million for the third quarter of 2025. There is uncertainty regarding the potential need for an advisory committee meeting for the BLA submission, which could impact timelines. The company faces competition from other treatments in the RRP space, which could affect market share and enrollment in confirmatory trials. Inovio Pharmaceuticals Inc (NASDAQ:INO) has not provided specific guidance on the size of its commercial organization, which may impact its ability to effectively launch INO 3,107. Q & A Highlights Warning! GuruFocus has detected 5 Warning Signs with INO. Q: Are you anticipating having an advisory committee meeting for the BLA submission of INO 3,107? A: Dr. Mike Sumner, Chief Medical Officer, stated that based on interactions with the FDA, there has been no indication that an advisory committee meeting will be necessary. The overall risk-benefit data presented does not suggest a requirement for such a meeting, although the final decision rests with the agency. Q: How does the upcoming regulatory decision for a competitor affect Inovio's launch plans for INO 3,107? A: Dr. Jackie Shea, President and CEO, highlighted significant differences between Inovio's program and the competitor's, including trial design and technology. Inovio's focus is on a placebo-controlled confirmatory trial, and the differences in technology and trial design suggest distinct paths for each product. Q: Was there any delay in the DV testing for the Selecttra 5 PSP device, and how does it impact the BLA submission timeline? A: Dr. Jackie Shea confirmed that while the DV testing involved multiple external vendors and was complex, the overall timeline for the BLA submission remains on track for the second half of the year, with file acceptance expected by year-end. Q: What is the strategy for a redosing approach for INO 3,107 based on recent data? A: Dr. Mike Sumner explained that Inovio plans to implement a redosing strategy, likely involving annual dosing, to enhance the clinical effect and maintain the reduction in surgeries for RRP patients. This approach leverages the strengths of their DNA medicine platform. Q: How does Inovio plan to address potential enrollment challenges for the confirmatory trial if a competitor's product is approved? A: Dr. Mike Sumner noted that the trial is designed to recruit 100 patients across 20 sites in the U.S., and despite potential market competition, there remains a sizable population of patients who may not have immediate access to the competitor's product due to insurance coverage and other factors. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.

Alzheimer's DMT Market to Grow at 67.8% CAGR Through 2030
Alzheimer's DMT Market to Grow at 67.8% CAGR Through 2030

Yahoo

time38 minutes ago

  • Yahoo

Alzheimer's DMT Market to Grow at 67.8% CAGR Through 2030

"Driven by urgent unmet needs and scientific advances, the Alzheimer's Disease DMT market is poised for rapid growth as pharmaceutical companies shift their focus to multi-target therapies that address the complex pathology of the disease." BOSTON, Aug. 13, 2025 /PRNewswire/ -- According to the latest study from BCC Research, the "Disease-Modifying Therapies for Alzheimer's Disease: Global Markets" is projected to reach $13.1 billion by the end of 2030, growing at a CAGR of 67.8% during the forecast period of 2025-2030. The Alzheimer's disease (AD) disease-modifying therapies (DMTs) market is in its early stages, with lecanemab being the first fully approved DMT by the U.S. FDA in July 2023. Several other DMTs in late-stage trials could significantly expand the market if approved. BCC Research forecasts future revenues based on current products and potential candidates. The report analyzes the market by target type (anti-amyloid and emerging targets), drug (Leqembi, Kisunla, and others), molecule type (large and small), and region (Asia-Pacific, North America, Europe, South America, and the Middle East and Africa). This report is particularly relevant today because the Alzheimer's disease (AD) DMT market is in its early stage of development, with several therapies currently in late-stage clinical trials. If these therapies are approved, they could significantly expand the market and reshape treatment options. In this context, studying the AD DMTs market is both timely and crucial for pharmaceutical companies and industry stakeholders. The report offers essential market and business insights, helping participants in the AD drugs industry make informed decisions and prepare for upcoming opportunities. 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Report Synopsis Report Metric Details Base year considered 2024 Forecast period considered 2025-2030 Base year market size $235.8 million Market size forecast $13.1 billion Growth rate CAGR of 67.8% for the forecast period of 2025-2030 Segments covered Target Type, Drug Type, Drug Molecule Type, and Region Regions covered North America, Europe, Asia-Pacific, South America, Middle East and Africa Market drivers • High unmet need in AD treatment. • Use of biomarkers to accelerate AD DMTs approval. Interesting facts: As of May 2025, over half of the AD therapeutic candidates in phase 3 trials are disease modifying small molecules ( There are very few DMTs targeting the moderate to advanced stages of AD. Emerging startups: AgeneBio Inc.: The company is investigating AGB101 (levetiracetam) in phase 2 and 3 clinical trials for the treatment of hippocampal overactivity and to assess its ability to control progression to Alzheimer's dementia. 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For further information on any of these reports or to make a purchase, contact info@ About BCC Research BCC Research market research reports provide objective, unbiased measurement and assessment of market opportunities. Our experienced industry analysts' goal is to help you make informed business decisions free of noise and hype. Contact Us Corporate HQ: 50 Milk St., Ste. 16, Boston, MA 02109, USA Email: info@ Phone: +1 781-489-7301 For media inquiries, email press@ or visit our media page for access to our market research library. Any data and analysis extracted from this press release must be accompanied by a statement identifying BCC Research LLC as the source and publisher. Logo - View original content to download multimedia: SOURCE BCC Research LLC Sign in to access your portfolio

Cognitive Therapy Offers Sustained Relief of Low Back Pain
Cognitive Therapy Offers Sustained Relief of Low Back Pain

Medscape

time3 hours ago

  • Medscape

Cognitive Therapy Offers Sustained Relief of Low Back Pain

A personalized protocol involving self-managed cognitive functional therapy (CFT) was associated with sustained symptom improvement at 3 years in patients with chronic low back pain in a phase 3 follow-up study. The three-armed RESTORE trial assessed adult patients in Australia with chronic disabling low back pain, showing effectiveness for CFT with or without motion sensor biofeedback compared with usual care for up to 1 year. In this new extension analysis of RESTORE, both CFT treatments were still more effective than usual care at 3 years, with greater reductions in both pain intensity and activity limitation. Interestingly, no differences in outcomes were found between the CFT-only group and the CFT plus biofeedback group. 'It shows that if we empower patients with knowledge and skills to manage back pain, including future flare-ups that are almost inevitable, then we can markedly reduce the massive personal and societal burden of back pain,' lead author Mark Hancock, PhD, Spinal Pain Research Center, Macquarie University, Sydney, Australia, told Medscape Medical News. 'We hoped to see these results, given the intervention design, but we were still somewhat surprised how well the effects lasted over time,' he added. The findings were published online on August 5 in The Lancet Rheumatology . Building on 'Unusual' Initial Findings Hancock noted that most treatments for low back pain produce small, short-lasting benefits. 'The CFT intervention is specifically designed to have long-term effects, as it gives people the skills, knowledge, and confidence to self-manage. The results we previously published showed the effects were sustained at 1 year, which is unusual, and we wanted to see if it remained effective at 3 years,' he said. In the original RESTORE trial, the investigators recruited adult patients who had low back pain lasting more than 3 months and randomly assigned them to receive one of three treatments: CFT only (n = 164), CFT plus biofeedback (n = 163), or usual care (n = 165). The CFT groups received up to seven treatments over 12 weeks plus a booster session at 26 weeks, all of which were delivered by trained physiotherapists. Investigators noted that CFT targets biopsychosocial barriers to recovery and has three components that are based on an individual patient's goals. These components include 'making sense of pain,' exposure with control, and lifestyle change. Both CFT groups wore movement sensors during their sessions, but only the CFT plus biofeedback group and their physiotherapists had access to the data. Usual care involved treatment that was chosen by the patient themselves and/or recommended by their healthcare provider. The new 3-year follow-up included 312 of the original participants (mean age, 48 years; 60% women) and between 60% and 65% of each of the original treatment groups. The extension's primary outcome was self-reported pain-related physical activity limitation, as measured on the Roland-Morris Disability Questionnaire. The secondary outcome was pain intensity, as measured by the numeric pain rating scale. Long-Term Pain Reduction Results showed that CFT with biofeedback was more effective in reducing activity limitation at the 3-year mark vs usual care (mean difference, -4.1; P < .0001), as was CFT alone (mean difference, -3.5; P < .0001). Additionally, CFT with or without biofeedback was more effective in reducing pain intensity vs usual care (mean differences, -1.5 and -1.0, respectively; P < .0001 for both). For both measures, the differences between the two CFT groups were not significant. Sensitivity analyses showed similar, although slightly smaller, effects. In addition, 49% of the CFT plus biofeedback and 43% of the CFT-only groups maintained recovery level scores between the 1-year and 3-year follow-ups compared with 17% of the usual care group. 'These long-term effects are novel and provide the opportunity to markedly reduce the effect of chronic back pain if the intervention can be widely implemented,' the investigators wrote. They noted that this would include an increase in clinician training and replication studies in other populations. 'This type of biopsychosocial intervention is widely recommended in guidelines, but the evidence [for it] is now becoming much stronger,' Hancock said. 'Many clinicians aim to deliver these interventions, but they often find it hard, especially if they were trained in a more pure biomedical way of thinking. There are now more resources to assist clinicians in upskilling in these approaches,' he added. 'Cautious Optimism' In an accompanying editorial, Dimitrios Lytras, PhD, Department of Physiotherapy, International Hellenic University, Thessaloniki, Greece, applauded how the study was conducted. 'Methodologically, RESTORE is exemplary: a pragmatic, multicenter trial embedded in routine care [and] supported by thorough therapist training,' Lytras wrote. He added that the results 'offer cautious optimism' and a shift from passive care models to ones that are more patient-centered. The addition of biofeedback not leading to added benefit could be explained by the fact that CFT 'already incorporates rich feedback mechanisms, making supplementary sensor input redundant,' he noted. Lytras wrote that the intervention is also low risk and high value. Durable Functional Gains Commenting for Medscape Medical News, Sean Mackey, MD, PhD, Redlich professor and chief of the Division of Pain Medicine at Stanford Medicine, Palo Alto, California, said the study showed durable functional gains and modest pain changes. The dose of seven visits over 12 weeks plus a 26-week booster was 'lean,' but the effects held, which was 'pleasantly surprising,' said Mackey, who was not involved with the research. However, he did note a few caveats, including that only 63% of the randomized cohort contributed to the 3-year data. In addition, 'those followed were less severe at baseline and did better at 1 year, though loss to follow-up was nondifferential by arm,' he said. In reflecting on the study design, Mackey noted that an 'attention-matched active comparator to blunt performance and expectancy bias' would have been helpful. He pointed out that the researchers themselves acknowledged that usual care was not contact-matched. He added that it would also have been valuable to include data on 3-year adverse events, healthcare utilization, and costs. If future research confirms its generalizability to other countries, Mackey said he would recommend clinicians 'adopt the CFT package' of graded exposure with a control and lifestyle coaching, schedule 6-8 visits plus a 6-month booster, measure function as the primary outcome, and set expectations for about a one-point reduction in pain. He recommended against adding sensor biofeedback because 'it didn't help.'

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