Latest news with #clinicaltrials
Medscape
an hour ago
- Business
- Medscape
FDA Approves Dupilumab for Bullous Pemphigoid
Dupilumab has been approved by the FDA for the treatment bullous pemphigoid in adults, the manufacturer Regeneron announced. Dupilumab (Dupixent), a human monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is now approved in the United States for eight diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. Dupilumab, administered by subcutaneous injection, is the first targeted treatment to be approved in the United States for bullous pemphigoid, according to the company's press release. The approval follows a supplemental New Drug Application filed with the FDA in February 2025 and is based on data from ADEPT, a pivotal phase 2/3 study in more than 100 adults with moderate-to-severe bullous pemphigoid known as, according to Regeneron. The study's design was published in Advances in Therapy. In the study, 106 patients were randomized to 300 mg of subcutaneous dupilumab or a placebo injection every 2 weeks, added to standard-of-care oral corticosteroids. At 36 weeks, 18.3% of patients in the dupilumab group achieved the primary endpoint of sustained disease remission compared with 6.1% of those in the placebo group. The study defined sustained remission as a combination of complete clinical remission and no relapse after an oral corticosteroid taper by 16 weeks, with no use of rescue therapy during the study period. More patients treated with dupilumab achieved a clinically meaningful reduction in itching (38.3% vs 10.5%), and the median cumulative oral corticosteroid dose in the dupilumab-treated group was 2.8 g vs 4.1 g in the placebo group, according to the company release. The most common adverse events among patients receiving dupilumab (affecting 2% or more) compared with those receiving placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One patient receiving dupilumab also developed acute generalized exanthematous pustulosis; no cases were reported among those receiving placebo. The dupilumab study was funded by Sanofi and Regeneron, the companies co-developing dupilumab.
Forbes
an hour ago
- Health
- Forbes
Technology Has A Role To Play As Research Adapts To New Constraints
Jiang Li, Ph.D., is the Founder and CEO of Vivalink, Inc. Hybrid and decentralized clinical trials (DCTs) have been gaining momentum in recent years. Following the pandemic, sponsors and regulators increasingly adopted remote-friendly designs, regulatory agencies encouraged their adoption and digital health companies developed tools to facilitate these trials. In 2023, the FDA issued draft guidance on DCTs that promoted the use of decentralized elements, such as remote data collection, telehealth visits and wearable sensors, to enhance trial flexibility, efficiency and inclusivity. This guidance was finalized in September 2024, solidifying the FDA's support for incorporating decentralized elements in clinical trials. Policy shifts threaten progress. That momentum is now under pressure. The National Institutes of Health (NIH) funds the bulk of medical research in the U.S. But a new federal policy would cap overhead reimbursement at 15%, reducing indirect cost support for many research centers and potentially reshaping how academic science is funded. Plus, the Department of Health and Human Services has begun cutting nearly 10,000 employees and plans to eliminate a total of 20,000 positions. The layoffs, part of a sweeping restructuring effort, have already impacted core health agencies like the NIH and FDA. As a result, trials have been paused, grants delayed and many research institutions, including major universities and academic medical centers, have reduced staff or scaled back operations. These shifts have posed major challenges for the implementation of DCTs in academic and early-stage research, where adoption was just beginning to gain traction. With fewer staff and less funding, institutions face greater barriers to adopting and managing the technologies essential to decentralized trial models. Yet regulatory support for DCTs, and the need for efficient and accessible trials, haven't gone away. Technology alone can't offset these setbacks, but it can help support ongoing research by reducing operational burden, enabling remote participation and helping sponsors manage studies with fewer resources. Prioritize interoperability. The increased application of DCTs has introduced a growing array of tools into how research is conducted, including wearables, remote monitoring devices, telehealth platforms, mobile apps and dashboards. But as academic institutions and research centers face staffing cuts and constrained budgets, managing a patchwork of disconnected systems is increasingly unsustainable. This environment heightens the need to prioritize interoperability. Even before these changes, sponsors were leaning toward solutions that integrate easily into their existing workflows. Now, they're looking for platforms that reduce the operational burden on already stretched teams. Interoperability should be a core design consideration. Solutions that connect with EHRs, lab systems, participant-reported outcomes and sponsor dashboards can reduce friction, cut down on manual processes and allow research teams to focus on science instead of system management. Equally important are ready-to-use mobile apps and connected devices that require minimal setup or IT support. Planning for integration early, both across systems and devices, can help trials run more efficiently as organizations adapt to doing more with less. Deliver measurable impact. With tighter budgets and increased scrutiny, sponsors need to justify every dollar. That means technology must deliver clear and measurable results, whether by accelerating recruitment, improving retention, reducing site visits or producing more complete datasets. Flexibility is just as important. As trials evolve, sponsors need platforms that can adapt, such as being able to adjust mid-study, support multiple arms or accommodate late-stage protocol changes. Tools that can be configured on the fly or deployed across different trial designs help teams stay responsive when timelines shift or priorities change. Real-time monitoring and continuous data collection are shifting how sponsors track progress during a trial. These technologies often surface early insights and preliminary findings faster than traditional timelines would. As a result, teams now have an opportunity to adjust mid-study, including changes to the study design, resource allocation or cohort size. A recent study highlighted this need for adaptability, pointing to modular digital platforms as a way for sponsors to retain control when trial activities shift. But it also made clear that technology alone isn't enough. As these platforms evolve, clinical and technical teams will need to work together to build solutions that meet the needs of everyone involved, from investigators and sponsors to participants. Technology providers that offer both measurable impact and flexibility, without locking sponsors into rigid ecosystems, are better positioned to support research teams under pressure. Support what remains. Recent funding cuts are disrupting the infrastructure supporting early-stage and academic research, from lab space and shared equipment to staff and resources. While technology can't reverse these cuts, it can support the trials that continue and help sponsors maintain critical metrics like participant adherence. Studies have shown that technology solutions like remote monitoring and digital platforms can increase patient adherence. For example, a recent study using electronic diaries resulted in compliance rates of up to 94%, compared to just 11% with paper diaries. Another study found that remote patient monitoring has been proven to improve adherence to medications and lifestyle changes. Platforms that can track adherence in real time, send automated reminders and flag protocol deviations give research teams the visibility they need to act quickly. These systems can alert teams when a participant's device isn't sending data as expected, track whether devices are being used correctly and help staff identify participants who may need follow-up. With fewer team members and more limited oversight, access to this information is important. As research institutions shift from growth to preservation, technology is playing a more functional role. Technology can't replace the research that's been paused or the teams that have been downsized, but it can help keep ongoing trials on track. That includes maintaining data quality, flagging issues early and helping teams follow up when participants miss visits or fall behind. Forbes Technology Council is an invitation-only community for world-class CIOs, CTOs and technology executives. Do I qualify?
Health Line
2 hours ago
- Health
- Health Line
GLP-1 Weight Loss Results Not as Effective in Everyday Life, Study Finds
Researchers report that people taking GLP-1 drugs in daily life don't lose as much weight as those in clinical trials who take the same medications. The researchers add that people using weight loss drugs don't regain weight as quickly as those in clinical trials. One possible reason for the weight loss differential is that people in the 'real world' tend to stop taking these medications sooner than people in clinical trials. People who use commonly prescribed weight loss medications don't lose as much weight as participants in clinical trials, but they also don't regain weight as quickly. That's the conclusion of a new study published on June 10 in the journal Obesity. The study authors reported that the weight loss differential was mainly due to the fact that people tend to stop using GLP-1 drugs sooner than clinical trial participants. They also tend to use lower doses of these medications. The researchers also reported that A1C blood level reductions were similar for both groups of people. The researchers noted that they will initiate further research into what other measures, such as lifestyle changes or bariatric surgery, people may have adopted after discontinuing weight loss medications such as Wegovy and Zepbound. The researchers also want to look into why people stopped using weight loss drugs before their program regimen ended. 'Our findings indicate that treatment discontinuation and use of lower maintenance dosages might reduce the likelihood of achieving clinically meaningful weight reduction in patients who initiate obesity pharmacotherapy with semaglutide or tirzepatide,' the study authors wrote. 'Our findings could inform the decisions of healthcare providers and their patients on the role of treatment discontinuation and maintenance dosage in achieving clinically meaningful weight loss,' they added. 'Real world' use of weight loss medications For their study, researchers looked at the health records of 7,881 adults with obesity or weight management issues who did not have type 2 diabetes. Those people were seen between 2021 and 2023 at the Cleveland Clinic's facilities in Ohio and Florida. Their average age was about 51 years. Nearly 80% of the subjects were white. Of those participants, 6,109 were prescribed a weight loss medication such as Wegovy with the active ingredient semaglutide. The other 1,772 were prescribed a weight loss drug, such as Zepbound, with the active ingredient tirzepatide. About 80% of those subjects were given low doses of their weekly injectable weight loss medications. Researchers reported significant differences between people using weight loss medications in phase 3 clinical trials and those taking the drugs in the 'real world.' For starters, about half of those taking either medication in daily life stopped within the first 12 months. About 51% of those using a tirzepatide drug discontinued its use in that same time period. That compares with only 17% of semaglutide users and between 14% and 16% of tirzepatide users in clinical trials who quit during the first year. In addition, the average weight reduction for semaglutide participants in daily life was nearly 8% after one year while it was 12% for people taking tirzepatide. By comparison, the average weight loss in clinical trials was nearly 15% for semaglutide subjects as well as 15% for people on low dose tirzepatide and 20% for those on a higher dose of that medication. In general, weight loss was greater in people who took weight loss medications for a longer period of time. In addition, about 54% of people who had prediabetes at the start of their treatment plan improved to healthier A1C levels after one year. Around 3% of those studied progressed to type 2 diabetes after 12 months. Weight loss is a long-term commitment Mir Ali, MD, a surgeon and bariatric surgeon as well as the medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in California, said the main takeaway from this study is that weight loss is a long-term commitment. Ali wasn't involved in the new study. 'The long-term use of medications is more effective than short-term use,' Ali told Healthline. 'The study confirms that obesity is a chronic condition like diabetes or hypertension.' Sarah Kim, MD, a professor of medicine at the University of California San Francisco, noted that discontinuing medication is common for people being treated for obesity and other conditions. Kim was likewise not involved in the new study. Kim added that adherence to medication schedules as well as diet and exercise programs isn't as easy in real life because people don't have the supervision and support a person gets during a clinical trial. 'Real life is different and results aren't always as spectacular as in clinical trials,' Kim told Healthline. Kim and Ali agreed that another reason people stop taking medications is that these drugs can be expensive, even if insurance is picking up part of the cost. There is also the fact that the side effects from these medications can be severe for some people. Plus, people in real life sometimes just get tired of the obligation of taking a pill or injecting themselves on a regular basis. Ali and Kim also noted that people need to realize that medications are only a tool to help them eat less. To lose weight and keep it off, a person needs to adopt lifestyle habits such as a healthy diet and regular exercise. 'The medications are not a short-term kickstart. They don't burn fat,' said Kim. 'The medications just help with the suppression of hunger.' 'The ultimate goal of the medications is to give people a tool to get them to a healthy weight,' Ali added. What to know about GLP-1 drug for weight loss Glucagon-like peptide-1 receptor agonists (GLP-1s) work by mimicking a hormone in the body that helps regulate blood sugar levels and reduces hunger pangs. One class of the newer GLP-1 medications uses the active ingredient semaglutide. They are sold under different brand names. Ozempic and Rybelsus have been approved to treat type 2 diabetes. Wegovy is approved for use in weight management. Semaglutide drugs are available as both oral tablets and injections. The other newer group uses the active ingredient tirzepatide. Mounjaro is approved to treat type 2 diabetes. Zepbound is approved for use in weight management. These medications are available only as injections. Previous studies have highlighted the effectiveness of these drugs on helping people lose weight. Past research has also indicated that these weight loss drugs can help lower a person's risk of cancer as well as provide benefits to heart health and brain health. Experts say the medications have proven to be effective and their use is likely to increase. 'This is a massive market and it's not going to go away,' Ali said. 'These medications are going to continue to be a big part of weight loss programs.'
Zawya
4 hours ago
- Health
- Zawya
Nigeria, Africa bear 25% of global disease burden — Expert
An Executive Consultant with over 25 years of clinical research and data management experience in the United States of America, Dr Bisi Adekoya, has disclosed that Nigeria—and Africa generally—shares 25 percent of the global disease burden. Adekoya, who is the Founder of a clinical research company called NxtCRO, made this disclosure at a symposium titled Clinical Trials in Underserved Populations: Barriers and Strategies for Inclusion, held on Thursday at the University of Lagos. She explained that disease burden comprises deaths (mortality), disability (years lived with illness), economic cost, and overall reduction in quality of life. Similarly, the expert lamented that more than half of pharmaceutical ingredients in Nigeria, and 100 percent of vaccines, are imported. She pointed out that Nigeria is a country at risk if it cannot produce and consume pharmaceutically. 'It has been gathered that Africa shares 25 percent of the global disease burden. 'Disease burden comprises deaths (mortality), disability (years lived with illness), economic cost, and overall reduction in quality of life. 'In the same vein, it is shocking that Nigeria imports 85–100 percent of pharmaceutical ingredients and 100 percent of vaccines (biopharmaceuticals), and 85 percent of marketed medications. 'Nigeria is a country currently at risk if we cannot produce and consume pharmaceutically,' she said. Meanwhile, Adekoya called on the Federal Government to look inwards towards the local production of pharmaceutical products. She also advocated for the conduct of clinical trials within the country and the collection of local data for the survival and advancement of the country's health sector. Copyright © 2022 Nigerian Tribune Provided by SyndiGate Media Inc. (
WIRED
5 hours ago
- Health
- WIRED
The FDA Just Approved a Long-Lasting Injection to Prevent HIV
Jun 20, 2025 7:30 AM Clinical trials have shown that six-monthly injections of lenacapavir are almost 100 percent protective against becoming infected with HIV. But big questions remain over the drug's affordability. Photograph: Konstantin Voronov/GETTY IMAGES The US Food and Drug Administration has just approved lenacapavir, an injectable form of HIV prevention that is almost 100 percent effective and requires only two doses per year. Science magazine described the medicine the most important scientific advance of 2024. In clinical trials, lenacapavir proved to be 99.9 percent effective in preventing HIV infection through sexual transmission in people weighing more than 35 kilograms. The drug, an antiretroviral, works not by stimulating an immune response, but by blocking HIV from reproducing during its early stages—specifically, by disrupting the function of the virus's capsid protein. This happens so long as the body receives injections every six months. Lenacapavir has already been approved in some countries as a treatment for HIV in people with forms of the virus that are resistant to other treatments. However, prior to this week, its prophylactic use had not been approved anywhere, making the FDA's decision a significant new development in the fight against the HIV/AIDS epidemic. The drug is not the first medicine that can be taken preemptively to protect against an HIV infection: pre-exposure prophylaxis (PrEP) pills were already available in many countries, including the United States. But these must be taken every day, and ensuring ongoing access to these medicines, and that people actually remember to take them, is a known challenge. It's hoped the long-lasting effects of lenacapavir will make it easier for people to stay protected against the virus. According to its creator, Gilead Sciences, lenacapavir will be marketed under the trade name Yeztugo. The company has committed to manufacturing 10 million doses by 2026. 'This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,' Daniel O'Day, president and CEO of Gilead, said in a statement on Wednesday. However, lenacapavir's price may be a barrier to access. Yeztugo will have an annual list price of $28,218 per person in the US. Winnie Byanyima, executive director of of the Joint United Nations Program on HIV/AIDS (UNAIDS), has also flagged in the past that the drug is unaffordable for many people in Africa, where the medicine has the potential to have the biggest impact. Roughly two-thirds of the people living with HIV worldwide live in sub-Saharan Africa. Gilead said in a statement last year that it had been 'developing a strategy to enable broad, sustainable access globally' to lenacapavir, although the company has not yet provided detailed information on how it will do this. One option could be 'voluntary licensing,' where other companies are granted permission to produce and sell generic versions of a patented product exclusively to people in certain (often low-income) countries. Researchers at the University of Liverpool in the UK have calculated that a year's worth of lenacapavir could be made available for as little as $25. This story originally appeared on WIRED en Español and has been translated from Spanish.
