Watch live: Matters of Life and Breath: Championing COPD Care
Chronic obstructive pulmonary disease (COPD) affects 25 million people in the U.S. and is the fifth leading cause of death from disease — on track to be the third by 2035 if nothing changes.
Gaps in treatment, policy inaction, and access barriers give way to high rates of ER visits, hospital admissions, readmissions, and worse. With 150,000 deaths each year and direct-medical costs reaching $31 billion annually, COPD remains an urgent but underprioritized health crisis.
Will the new administration breathe new life into COPD care? How should gaps in treatment be addressed? How can public and private partnerships improve patient outcomes? What does a comprehensive COPD policy framework look like, and when can we expect it? And how can patients with COPD prioritize their own health in the meantime?
Join The Hill as we convene leaders in the administration, Congress, and COPD advocacy to answer these questions and more.
The event is scheduled to begin at 8:30 a.m. EDT
Watch the live video above.
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Yahoo
37 minutes ago
- Yahoo
BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders® Congress
CARSON CITY, Nev., June 24, 2025 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) ('BioVie' or the 'Company') a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson's disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders® Congress, to be held at National Harbor, MD, from June 27 to June 30, 2025. Details for the poster session are as follows: Title: SUNRISE-PD: An Ongoing, Hybrid, Decentralized Phase 2 Study of Bezisterim (NE3107) in Early Parkinson's DiseasePoster session: 11:30am to 12:30pm, Friday June 27Authors: Mark Stacy; Clarence Ahlem; Christopher L. Reading; Jeffrey Zhang; Joseph M. PalumboPoster position: P 49Poster displayed from 7:00am Friday June 27 through 2:00pm Sunday June 29 SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design that will last 20 weeks from the initial screening phase to the safety follow up. As part of the trial, patients may participate either completely from their home or at a clinical site. At-home participants will be visited by study nurses who will complete study assessments with the assistance of a neurologist who will attend the visit remotely by video and supervise administration of a modified MDS-UPDRS Part III examination, which will be recorded for review and scoring by a central rating committee. If the trial's results are positive, participants may be eligible to enter a longer-term, open-label safety study. About Parkinson's Disease Parkinson's disease (PD) is a progressive neurodegenerative disorder that primarily affects movement. It is characterized by the loss of dopamine-producing neurons in the substantia nigra, a region of the brain critical for motor control. Core symptoms include tremors, muscle rigidity, bradykinesia (slowness of movement), postural instability, and difficulties with speech.1-2 Non-motor symptoms, such as cognitive impairment, mood disorders, and autonomic dysfunction, also significantly impact patients' quality of life.3 In the early stages, symptoms are often mild and may include subtle tremors, slight movement difficulties, and changes in handwriting or facial expressions. As the disease progresses, motor symptoms become more pronounced, leading to difficulties with balance, speech, and daily activities, often requiring full-time care in later stages.4 Since the 1960s, when dopamine's critical role in Parkinson's disease was first identified, levodopa has remained the cornerstone of treatment, providing significant symptom relief by replenishing dopamine levels in the brain.5-6 However, long-term use is associated with complications such as motor fluctuations—where symptom control becomes less stable—and dyskinesia, involuntary movements that can become debilitating.7-9 Emerging research highlights the role of chronic inflammation and insulin resistance in the onset and progression of Parkinson's disease. Neuroinflammation, driven by activated microglia and elevated levels of pro-inflammatory cytokines, contributes to oxidative stress and accelerates neuronal degeneration.10-12 Additionally, insulin resistance, which impairs the brain's ability to regulate glucose metabolism, has been linked to increased neurodegeneration and worsening motor symptoms.13-14 These metabolic dysfunctions create a harmful cycle that exacerbates disease progression, underscoring the potential of anti-inflammatory and insulin-sensitizing therapies as new avenues for treatment. About Bezisterim Bezisterim (NE3107) is an orally bioavailable, blood-brain barrier (BBB)-permeable modulator of inflammation and insulin-sensitizer. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. By binding to ERK and selectively modulating NFκB activation and TNF-α production, BioVie believes that bezisterim may offer clinical improvements in several disease indications, including Alzheimer's disease, Parkinson's disease and long COVID. In Parkinson's disease, BioVie is currently enrolling patients in the Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim on motor and non-motor symptoms in patients who have not been treated with carbidopa/levodopa, with topline data expected in late 2025 or early 2026. A previous Phase 2 study of bezisterim in Parkinson's disease (NCT05083260) completed in 2022, and data presented at the AD/PD™ 2023 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in 'morning on' symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa versus patients treated with levodopa alone, and no drug-related adverse events. In long COVID, bezisterim has the potential to reduce neurological symptoms including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). BioVIe's Phase 2 ADDRESS-LC study, is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with long COVID, including difficulty concentrating or remembering things ('brain fog') and fatigue. In Alzheimer's disease, BioVie conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate Alzheimer's disease (NCT04669028) in 2023. Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer's Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer's disease. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Alzheimer's disease, Parkinson's disease and long COVID) and advanced liver disease. In neurodegenerative disease, the Company's drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-κB, and the associated neuroinflammation and insulin resistance but not ERK and NFκB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of AD and PD. Persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of long COVID. In liver disease, the Company's Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit Forward-Looking Statements This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. References 1 Cleveland Clinic. Parkinson's Disease. Last reviewed: 2022 Apr 15.2 Jankovic J. J Neurol Neurosurg Psychiatry. 2008;79(4):368-376.3 Postuma RB, Berg D, Stern M, et al. Mov Disord. 2015;30(12):1591-1601.4 Kalia LV and Lang AE. Lancet. 2015;386(9996):896-912.5 Hornykiewicz O. Angew Chem Int Ed. 2002;41(17):2934-2941.6 Olanow CW, Obeso JA and Stocchi F. Lancet Neurol. 2006;5(8):677-687.7 Ahlskog JE and Muenter MD. Mov Disord. 2001;16(3):448-458.8 Espay AJ, Morgante F, Merola A, et al. Ann Neurol. 2018;84(6):797-811.9 Cilia R and Akpalu A. J Neural Transm. 2020;127(5):889-916.10 Jurcau A, Andronie-Cioara FL, Nistor-Cseppento DC, et al. Int J Mol Sci. 2023;24:14582.11 Pajares M, Rojo AI, Manda G, et al. Cells. 2020;9:1687.12 Isik S, Kiyak BY, Akbayir R, et al. Cells. 2023;12:1012.13 Zagare A, Hemedan A, Almeida C, et al. Mov Disord. 2025;40(1):67-76.14 Ruiz-Pozo VA, Tamayo-Trujillo R, Cadena-Ullauri S, et al. Nutrients. 2023;15(16): Chuck Padala Managing Director LifeSci Advisors, LLC chuck@ Melyssa WeibleManaging Partner, Elixir Health Public Relations Ph: +1 201-723-5705mweible@
Politico
2 hours ago
- Politico
White House sends Dr. Oz to calm Senate nerves
The Senate Republican megabill is ailing. The White House thinks it has a doctor for that. Dr. Mehmet Oz, the celebrity surgeon best known for dispensing medical advice on television and now a top Trump health official, has emerged as the administration's go-to salesman for the sweeping Medicaid overhaul at the center of the GOP's legislative ambitions. Oz is increasingly pressing Republicans to back controversial cuts to the health program for low-income Americans, trekking to Capitol Hill several times in recent weeks to push for their support. He's privately counseled Republican senators and governors nervous over the potential fallout for their home states, and publicly promoted the far-reaching changes in a flurry of interviews. And as the White House and Congress race to meet a self-imposed July 4 deadline to pass the legislation, officials are betting that Oz's medical credentials — and his personal star power — can convince Republicans and their constituents to embrace the legislation despite warnings it will cost millions of people their health care coverage. 'The more he can be out talking to members, and just in general, about the changes we're making and why they're so important and good is very helpful,' said Sen. John Hoeven (R-N.D.), who has urged senior White House aides to deploy Oz more frequently in the coming days. 'We think we've put together a good product, but there's others that we're still working to get on board.' The megabill push represents the most visible role Oz has taken since joining the administration in April as Medicaid and Medicare chief, where he oversees an agency responsible for more than 160 million Americans' health care despite having little government or policymaking experience. It's also perhaps the toughest sales job of his career, requiring Oz to sway skeptical Republicans in favor of policies that are projected to eliminate health insurance for 16 million people — many of whom live in red states. Several Republicans remain wary of provisions that could cut insurance coverage and upend the finances of hospitals in their states. They've bristled at the efforts by Oz and others to downplay the tax-and-spending bill's implications, threatening to withhold their votes over worries it would decimate access to care where it's most needed. 'Our goal here needs to be to protect rural hospitals and make sure that they can keep their doors open,' said Sen. Josh Hawley (R-Mo.), one of a handful of holdouts who has expressed reservations about the depth of the Medicaid cuts. At the same time, a separate GOP faction has demanded deeper cuts to government spending, with some taking their case this week directly to President Donald Trump. And among the public, polls show only a small minority of Americans support the overall bill. The White House is nevertheless counting on Oz to play a central role in building support for the legislation, calculating that he has both the health care background and the bedside manner to assuage lawmakers' policy concerns. A cardiothoracic surgeon by training, Oz became a daytime television fixture first as a health expert for The Oprah Winfrey Show before helming his own health and wellness show for more than a decade. A longtime Trump friend who frequently speaks with the president, the 65 year old has also maintained close ties to some Republican senators from his own failed run for office just a few years ago. On Monday, Oz met with Senate Republican chiefs of staff to push for a decision on a so-called provider tax provision that has proven particularly politically divisive, while also trying to dissuade them from seeking new, deeper Medicaid cuts. The session followed an appearance last week at GOP senators' group lunch to pitch the merits of the bill's health care provisions. 'He's a very big asset in getting us across the finish line,' said a White House official, granted anonymity to discuss internal strategy. 'He has a lot of credibility to go into these lawmaker discussions, to talk to them and hear concerns out and then give the administration's viewpoint.' Within the administration, Oz helped shape the White House's public messaging on Medicaid, at various points blaming 'lots of lobbyists' for fueling criticism of the bill, while downplaying its impact on health coverage across a series of television interviews — even amid nonpartisan projections that hundreds of billions of dollars would be cut from the safety net program. 'There is no scenario, not in this bill, not in anywhere I've seen, where we're not spending more money on Medicaid,' Oz said in a recent Newsmax interview. Those aggressive performances have won praise among Trump officials, who dispatched him at times to help lawmakers and other allies workshop their own talking points. The work has also raised Oz's standing in the White House, where senior aides have been impressed by what two White House officials familiar with the dynamics and granted anonymity to discuss them described as his willingness to be a team player in government after decades as a high-profile celebrity. 'For over a decade, Dr. Oz developed a personal rapport with millions of Americans who tuned into his iconic TV show about health and wellness,' White House spokesman Kush Desai said in a statement, adding that as CMS administrator he's 'leveraging the immense intellect and telegenic charm he used build that following to now help President Trump deliver on his mandate of protecting and preserving Medicaid by slashing waste, fraud, and abuse.' Yet as the megabill hits the home stretch, the persistent divide among Republican lawmakers has also exposed the limits of his salesmanship. Despite overseeing the Medicaid program and facing the task of enacting whatever policy is signed into law, Oz — barely three months into his first government job — has had little direct control over the specifics of the policy negotiations. Those details have instead been coordinated largely between White House domestic policy aides and Republican leaders on the Hill. That has limited his ability to win over skeptics across the health care industry, including hospital groups that have been particularly outspoken in drumming up concerns about the bill's impact on Medicaid. In one private meeting with hospital representatives earlier this month, Oz listened as they detailed the sprawling financial consequences for providers should Republicans forge ahead with major changes to Medicaid, according to a person in the room. But he had little to offer in response, insisting primarily that the GOP needed to find ways to limit the government's health spending. 'I don't know what he believes,' said the person, who was granted anonymity to detail the closed-door discussion. 'He's a real bright guy and everything, but he doesn't have control of the policy.' Oz now faces an even trickier situation with the politically delicate provider tax that's divided Republicans on the Hill, jeopardizing the race to the party's July 4 deadline. After Senate lawmakers debuted a deeper funding cut than what Republicans proposed in the House, Oz publicly defended the effort, blasting the existing arrangements between states and hospitals as a form of 'legalized money laundering' that the administration needs to remedy, and breaking with Hawley and other GOP skeptics. 'I would disagree that that money goes to rural hospitals,' Oz said in a CNN appearance. 'The reality is that extra money that's left over goes to hospitals that are better connected, the hospitals with the biggest lobbyists and the best ability to influence what happens in the state capitals.' Yet behind closed doors days later, Oz struck a more measured note, nudging Senate GOP staffers instead to stick to the language laid out by the House. 'He is a really gifted communicator,' said Avik Roy, chair of the Foundation for Research on Equal Opportunity and a longtime conservative policy expert. 'He may exceed people's expectations. But obviously what matters to some degree is what the policy is. And is the policy something that ordinary people are going to buy as a good policy?'
Yahoo
2 hours ago
- Yahoo
GOP chair asks RFK Jr. to retract claim against Democrat in hearing
A House Energy and Commerce Subcommittee on Health hearing came to a brief halt Tuesday as the Republican chair asked Health and Human Services Secretary Robert F. Kennedy Jr. to retract his accusations that a Democratic member's stance on vaccines was influenced by campaign contributions from pharmaceutical companies. Kennedy appeared before the subcommittee to defend the Trump administration's budget request, which includes steep cuts to the Department of Health and Human Services (HHS). Rep. Frank Pallone (D-N.J.), ranking member of the Energy and Commerce Committee, used his time to blast the firings at HHS and the apparent lack of transparency under Kennedy's tenure so far. He and other Democrats said many of their letters to the HHS have gone unanswered, with Pallone counting 10 of his letters receiving no response. Pallone said this lack of transparency extended to Kennedy's changes to the federal vaccine approval process. 'You have made a number of major decisions about vaccines. And … there's been no public comment process or public accountability on that either. What are you afraid of?' he asked Kennedy. 'I mean, with regard to vaccines, are you just afraid of receiving public comments on proposals where you just think these are fringe views that are contrary to the views of most scientists?' 'The bottom line is here, we have no transparency. We have no response. You feel no responsibility to Congress whatsoever, and you just continue this ideology that's anti science, anti vaccine. That's all I see. I see nothing else,' Pallone added. The questioning then moved on to Rep. Neal Dunn (R-Fla.), vice chair of the health committee, who asked Kennedy how he planned to restore public trust in health institutions. With only a brief response to Dunn's question, Kennedy quickly returned his focus to Pallone's criticisms. 'Congressman Pallone, 15 years ago, you and I met. You were, at that time, a champion of people who had suffered injuries from vaccines. You were very adamant about it. You were the leading member of Congress on that issue,' said Kennedy. 'Since then, you've accepted $2 million from pharmaceutical companies in contributions, more than any other member of this committee,' he continued. 'And your enthusiasm for supporting the old [Advisory Committee on Immunization Practices], which was completely rife and pervasive with pharmaceutical conflicts, seems to be an outcome of those contributions.' Rep. Diana DeGette (D-Colo.), ranking member of the health subcommittee, immediately raised a point order, saying Kennedy was 'impugning Mr. Pallone.' Subcommittee Chair Buddy Carter (R-Ga.) asked that the clock be paused. After a brief back and forth with committee members and staffers, he acknowledged it was a valid point of order and asked Kennedy to retract his remarks about Pallone. Kennedy retracted his words. According to OpenSecrets, Pallone has received roughly $2.2 million from the pharmaceutical/health products industry since 1988, when he first joined Congress. Kennedy was likely referring to Pallone having previously raised concerns in the 90s about the presence of mercury in products approved by the Food and Drug Administration (FDA). In 1997, Pallone added an amendment to the FDA reauthorization bill at the time that directed the agency to compile a list of foods and drugs that contain 'intentionally introduced mercury compounds.' Mercury exposure and poisoning have long been issues of concern for Pallone's district. Kennedy and other vaccine skeptics have long pointed to thimerosal, a mercury-containing preservative in vaccines, as a potential cause for harm. Though studies have backed the safety of thimerosal-containing vaccines, the preservative was removed from almost all childhood vaccines a few decades ago as a precautionary measure due to public uncertainty. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
