Americans for Safe and Effective Medicines (ASEM) has been established as a national advocacy organization focused on safeguarding patients from the risks associated with illegal large-scale drug compounding, counterfeit medications, and deceptive marketing practices. The organization also aims to hold companies and individuals accountable for practices that may compromise patient safety. Its launch coincides with the release of its first national survey, which found that while 84% of consumers prefer GLP-1 medications that have received approval from the U.S. Food and Drug Administration (FDA), only 17% are aware that compounded GLP-1 products do not undergo FDA approval.

Compounded GLP-1 products continue to be widely promoted through telehealth providers, medical spas, online vendors, and other distribution channels. These marketing practices often fail to clearly distinguish FDA-approved medicines from compounded alternatives, leading many patients to mistakenly assume that all such products meet the same regulatory standards for safety, effectiveness, and quality.

Fred Mills, Chief Policy Officer at ASEM, stated that many patients are making treatment decisions without receiving complete information about the products they use. He noted that ASEM was created to address a marketplace where consumer misunderstanding has become commercially advantageous. According to Mills, pharmaceutical compounding was originally intended to address the unique needs of individual patients rather than serve as a large-scale commercial enterprise.

Survey Highlights: Consumer Expectations vs. Awareness
The organization's survey identified a substantial gap between consumer expectations and their understanding of compounded GLP-1 medications:

Report Highlights Risks Associated with Mass Compounding
In addition to the survey, ASEM released a report titled The Shortage is Over. The Risks Are Not: How Illegal Mass Compounding Is Undermining Patient Safety—And What Must Happen Next. The report argues that temporary compounding practices permitted during the GLP-1 drug shortage have expanded into a largely unregulated commercial market for compounded GLP-1 products. According to the report, these products are distributed outside many of the regulatory safeguards that apply to FDA-approved medicines.

Drawing on FDA inspection records, product recalls, warning letters, and state regulatory enforcement actions, the report concludes that patient safety is being compromised by several factors, including:

SetPoint Medical, a commercial-stage medical technology company focused on advancing treatment options for individuals with chronic autoimmune disorders, has announced the successful completion of the first implantation of the SetPoint System in North Carolina. The procedure was carried out in partnership with Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), the largest independent rheumatology practice in the Southeastern United States. The patient was referred by Dr. Ashley Toci, MD, FACR, CCD, a rheumatologist at AOCC.

This milestone represents another advancement in SetPoint Medical's nationwide expansion efforts, increasing patient access to the first and only vagus nerve-mediated neuroimmune modulation therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis (RA).

The SetPoint System is intended for adults with moderate to severe rheumatoid arthritis who have not achieved adequate results from, or are unable to tolerate, biologic or targeted RA medications. The treatment introduces a novel, drug-free approach by using an implanted device that stimulates the vagus nerve, thereby activating the body's natural anti-inflammatory mechanisms.

According to Dr. Gordon K.W. Lam, MD, FACR, a rheumatologist at AOCC and investigator in the RESET-RA clinical study, the first use of SetPoint Therapy in North Carolina marks a significant development in the treatment of rheumatoid arthritis. He noted that despite substantial progress in RA therapies, many patients continue to experience ongoing disease activity or must try multiple treatment options before finding relief. Dr. Lam emphasized that neuroimmune modulation offers a completely new therapeutic strategy by harnessing the body's own neural pathways to manage inflammation. He added that the SetPoint System has the potential to redefine RA treatment and that AOCC is pleased to offer the therapy at its Midtown and Ballantyne locations in Charlotte.

Murthy Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical, stated that expanding access to SetPoint Therapy in North Carolina highlights the increasing acceptance of neuroimmune modulation as an innovative treatment approach for rheumatoid arthritis. He credited the progress to collaborative efforts by physicians such as Dr. Lam and Dr. Toci, who are working across specialties to provide patients with scientifically validated treatment alternatives. Simhambhatla further noted that as the company broadens availability throughout the Southeast and across the United States, it remains committed to partnering with leading healthcare professionals to establish neuroimmune modulation as a distinctive option for patients seeking alternatives to conventional drug therapies.

The FDA approved the SetPoint System in 2025. The device is designed to deliver a one-minute stimulation to the vagus nerve each day, triggering neural pathways involved in regulating inflammation. Findings from the pivotal RESET-RA clinical trial demonstrated significant improvements in disease activity among rheumatoid arthritis patients, supporting the therapy's potential to address an important unmet medical need.

Nuvation Bio, a global oncology company dedicated to addressing some of the most challenging areas in cancer care, has announced that the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review a Marketing Authorisation Application (MAA) submitted by its partner, Eisai Co., Ltd., for taletrectinib as a treatment for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

The submission was made under the International Recognition Procedure, a pathway designed to accelerate patient access to medicines by considering approvals from trusted international regulatory authorities. The MHRA will now conduct its assessment to determine whether the therapy should be authorized in the United Kingdom.

In January 2026, Nuvation Bio and Eisai entered into an exclusive licensing and collaboration agreement covering Europe and several territories outside the United States, China, and Japan, with the goal of expanding global access to taletrectinib. The oral therapy, marketed as IBTROZI® in the U.S. and Japan, is intended for patients with advanced ROS1+ NSCLC. The European Medicines Agency accepted the drug's MAA for review in March 2026, and additional regulatory submissions are planned in Canada and other regions included within Eisai's licensed territories.

Approximately 50,200 new lung cancer cases are diagnosed annually in the United Kingdom. Non-small cell lung cancer accounts for roughly 80% to 85% of these cases, with an estimated 2% of patients carrying the ROS1-positive mutation.

The regulatory filing is supported by findings from the pivotal Phase 2 TRUST-I and TRUST-II clinical trials, which evaluated taletrectinib in patients worldwide. Combined analyses from the TRUST program were first published in the Journal of Clinical Oncology in April 2025. Updated data, reflecting extended patient follow-up, were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026, further strengthening the treatment's observed efficacy and safety profile. Additional findings from the TRUST-I study were also published in the Journal of Clinical Oncology during the same month.

David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, welcomed the advancement of taletrectinib into the U.K. regulatory review process following recent progress in Europe. He noted that the therapy has already demonstrated meaningful benefits for patients in the United States, China, and Japan, and emphasized that the latest milestone represents another important step toward broadening global access to the treatment.

In June 2025, the U.S. Food and Drug Administration granted full approval to taletrectinib for patients with locally advanced or metastatic ROS1+ NSCLC across multiple lines of therapy, following a Priority Review process and the awarding of two Breakthrough Therapy designations. The treatment has also been approved in Japan, where it is marketed by Nippon Kayaku, and in China, where Innovent Biologics markets it under the brand name DOVBLERON.

Eisai's licensed territories for taletrectinib include Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam, and India.