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AMA Calls for ACIP Answers, Stable Federal Funding

AMA Calls for ACIP Answers, Stable Federal Funding

Medscape2 days ago

Leaders and delegates at this week's American Medical Association (AMA) annual meeting called for more stable funding for medical care and research, and a US Senate investigation into unprecedented changes to a federal vaccine advisory panel.
AMA delegates passed an emergency resolution asking for that investigation after US Department of Health and Human Services Secretary Robert F. Kennedy Jr earlier this week removed all 17 members of the Advisory Committee on Immunization Practices (ACIP), replacing them with eight new members, some regarded as vaccine skeptics. The resolution also directs AMA to send a letter asking Kennedy to immediately reverse the changes.
Jason M. Goldman, MD, president of the American College of Physicians said at the meeting that Kennedy's action puts at risk insurance coverage for vaccines. ACIP's recommendations influence insurance coverage and vaccine uptake.
'As physicians, we must be the voice for our patients,' said Goldman. 'We must be the voice for science, evidence, and knowledge, and we must make sure that our institutions are protected.'
Other delegates pressed the AMA to fight back against deep cuts to federal funding for healthcare and medical research.
In his inaugural speech on Tuesday as AMA president, Bobby Mukkamala, MD, an otolaryngologist, said the 'importance of access to physician care is very much on my mind.'
'We cannot lose sight of what medicine and science have achieved in our lifetimes, and we cannot abandon this progress and endanger the health of millions whose illnesses could have been treated had we stayed on course,' Mukkamala said.
Congressional Republicans have proposed cutting Medicaid spending and reducing subsidies for plans sold by exchanges created by the Affordable Care Act. Separately, the Trump administration has proposed a roughly 40% cut, or almost $18 billion, in the annual funding of the National Institutes of Health for fiscal 2026, the budget year starting in October.
Mukkamala also called for efforts to reduce the administrative burden of prior authorization and to address Medicare physician payments, which have not kept up with inflation in recent years.
More Transparency for Artificial Intelligence (AI) in Medicine
The AMA also adopted policies regarding AI-driven tools and guidance for physicians regarding corporate investment in their practices.
One policy calls for independent third parties to determine whether an AI tool for clinicians is 'explainable' — that it can explain to users its decisions and the evidence behind them. The new AMA policy calls for more transparency regarding these tools, including disclosure of their algorithms.
Physicians at the conference raised concerns about AI-based tools making errors that could potentially harm patients and leave clinicians liable for the tools' flaws. AMA members' concerns included the potential for AI hallucinations about billing codes to leave a busy physician at risk for allegations of fraud.
Among those who pushed for the AMA to adopt new policies on AI-driven tools was Jennifer Bryan, MD, chair of the Mississippi delegation to the AMA and president of the Mississippi State Medical Association.
Decisions made at this AMA meeting will help physicians know when 'AI informs clinical decisions and exactly how confident the AI is in its recommendations,' Bryan told Medscape Medical News in an email. 'This is a big step forward in not just setting standards today but shaping responsible AI practices in medicine for years to come.'
Corporate Intrusion
The AMA delegates also voted to strengthen guidance for physicians regarding corporate or private equity investment in their practices.
Corporate investment can offer an alternative to selling a practice to a hospital or health system, AMA said. These kinds of arrangements can include private or public for-profit companies, investment firms, and insurance companies.
Physicians may benefit from these arrangements by being freed of some business and administrative responsibilities to spend more time with patients.
But such arrangements may also pose risks, including the loss of independent authority over clinical decisions and operations, the AMA said.
AMA's updated guidance recommends that decisions that should remain in the ultimate control of the physicians partnered with other entities include:
Determining which diagnostic tests are appropriate for patients.
Determining the need for referral or consultation with another clinician.
Determining how many patients a physician should see or how many hours a physician should work.
Determining the content of patient medical records.
Making decisions regarding coding and billing procedures for patient care services.

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‘I'll use private sector to help clear NHS backlog', says Streeting
‘I'll use private sector to help clear NHS backlog', says Streeting

Yahoo

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  • Yahoo

‘I'll use private sector to help clear NHS backlog', says Streeting

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Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne
Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne

Associated Press

timean hour ago

  • Associated Press

Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 15, 2025-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. Sarepta is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for ELEVIDYS. This panel will evaluate data and assess our proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. Suspending Shipments of ELEVIDYS for Non-Ambulatory Patients: Sarepta is temporarily suspending shipments of ELEVIDYS for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after ELEVIDYS infusion, along with post-treatment monitoring, remains the same. ENVISION Study Paused: Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). FDA concurs with this action. The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume. ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating ELEVIDYS in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy. In the U.S., it serves as the confirmatory trial required under the FDA's accelerated approval pathway for non-ambulatory patients. 'Our paramount priority is the safety and well-being of the patients we serve. We are taking immediate, decisive steps to better understand and mitigate the risk of acute liver failure, including enhancing the immunosuppressive regimen, for those with Duchenne who are non-ambulatory,' said Louise Rodino-Klapac, Ph.D., chief scientific officer and head of research & development, Sarepta. 'We are deeply saddened by the loss of a second patient and extend our heartfelt condolences to the patient's family and his care team during this incredibly difficult time. Duchenne muscular dystrophy is a devastating disease that profoundly affects lives and often cuts them far too short. With more than 900 individuals treated to-date, we know how much hope families place in new treatment options like ELEVIDYS – and we are committed to honoring that hope by acting swiftly, guided by scientific rigor and the insights of leading experts, to strengthen safety for all future patients.' Commitment to Long-Term Safety and Understanding Sarepta remains committed to a thorough approach and the highest standards of patient safety and scientific rigor. The event has been reported to FDA and global health authorities and will inform ongoing discussions around a potential label update to reflect the risk of severe ALF and additional immune management strategies for non-ambulatory patients. While elevated liver enzymes are a known class effect of all AAV-based gene therapies, the exact mechanism behind AAV-related liver toxicity remains unclear. Current evidence suggests it is likely driven by an adaptive immune response. The Company will provide additional updates as appropriate. Investor Conference Call Details Sarepta will be hosting a conference call and webcast to discuss this update and provide an update on the Company's business on Monday, June 16, 2025, at 8:00 am Eastern time. The event will be webcast live under the investor relations section of Sarepta's website at: and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Acute Serious Liver Injury: Immune-mediated Myositis: Myocarditis: Preexisting Immunity against AAVrh74: Adverse Reactions: Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to source version on CONTACT: Investor Contact: Ian Estepan 617-274-4052 [email protected] Contacts: Tracy Sorrentino 617-301-8566 [email protected] Hoeger 617-710-3898 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: INFECTIOUS DISEASES HEALTH GENETICS PHARMACEUTICAL CLINICAL TRIALS SOURCE: Sarepta Therapeutics, Inc. Copyright Business Wire 2025. PUB: 06/15/2025 01:00 AM/DISC: 06/15/2025 01:01 AM

NovoSculpt Named Best Body Contouring Clinic in the Tri-State Area for 2025
NovoSculpt Named Best Body Contouring Clinic in the Tri-State Area for 2025

Associated Press

timean hour ago

  • Associated Press

NovoSculpt Named Best Body Contouring Clinic in the Tri-State Area for 2025

NovoSculpt has been honored as the Best Body Contouring Clinic in the Tri-State Area for 2025, solidifying its place as a leader in aesthetic care and body sculpting services. Greenwich, CT, USA, June 15, 2025 -- NovoSculpt Celebrates Prestigious Recognition in Body Contouring Excellence NovoSculpt proudly announces its recognition as the Best Body Contouring Clinic in the Tri-State Area for 2025, a prestigious title that highlights the clinic's leadership in the rapidly growing field of body sculpting. The award emphasizes NovoSculpt's unwavering commitment to providing safe, effective, and customized solutions for those seeking transformative aesthetic results. The recognition celebrates the clinic's dedication to patient care, innovative treatments, and personalized experiences, solidifying its position as the premier destination for body contouring in the region. 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This personalized approach has contributed to NovoSculpt's reputation for excellence and its status as the top body contouring clinic in the Tri-State Area. A Vision of Innovation and Care NovoSculpt's success story is one of innovation, care, and patient-centric solutions. Founded by Roberto Magana, the clinic was created with the goal of offering a minimally invasive, highly effective approach to body contouring. Roberto's vision has led to the development of a clinic that fills the gaps in the market for minimally invasive, customized body sculpting treatments that deliver lasting results. As the clinic continues to innovate and grow, NovoSculpt's commitment to patient satisfaction and exceptional care remains at the forefront. The clinic's ability to adapt to changing industry trends while maintaining its focus on personalized, safe, and effective treatments has allowed it to remain a leader in the body contouring field. Celebrating Success: The 2025 Recognition NovoSculpt's recognition as the Best Body Contouring Clinic in the Tri-State Area for 2025 is a monumental achievement that celebrates the clinic's leadership, innovation, and dedication to its patients. This award reaffirms NovoSculpt's position as a disruptor in the body contouring industry, offering cutting-edge treatments that prioritize both safety and transformative results. As the clinic looks toward the future, it remains committed to setting the standard for excellence in aesthetic medicine. With a growing reputation for delivering remarkable body sculpting results, NovoSculpt continues to reshape the way individuals approach body contouring and aesthetic care. 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Media Contact Roberto Magana, MBA Founder & CEO, NovoSculpt Website: Email: [email protected] Instagram: @novosculptus Facebook: @NovoSculpt TikTok: @novosculptus LinkedIn: NovoSculpt Contact Info: Name: Roberto Magana Email: Send Email Organization: NovoSculpt Website: Release ID: 89162338 If you encounter any issues, discrepancies, or concerns regarding the content provided in this press release, or if there is a need for a press release takedown, we urge you to notify us without delay at [email protected] (it is important to note that this email is the authorized channel for such matters, sending multiple emails to multiple addresses does not necessarily help expedite your request). Our expert team will be available to promptly respond within 8 hours – ensuring swift resolution of identified issues or offering guidance on removal procedures. Delivering accurate and reliable information is fundamental to our mission.

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