Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
Months after the U.S. and European approvals of its CSL-partnered hemophilia A gene therapy Hemgenix, uniQure is selling some royalty rights for up to $400 million. In a deal with HealthCare Royalty (HCRx) and Sagard Healthcare, uniQure agreed to part ways with a portion of its Hemgenix royalty rights. The company previously licensed the drug to Australia’s CSL Behring, and it’s entitled to milestone and royalty payments as the launch progresses. Now, though, it’s trading some of those royalty rights for a quick payday. Under the new deal with HCRx and Sagard Healthcare, uniQure will get $375 million upfront and another $25 million if an undisclosed sales threshold is achieved. The cash lets uniQure “continue to invest” in its adeno-associated virus vector gene therapy pipeline, CEO Matt Kapusta said a statement. The pipeline includes a Huntington’s disease prospect, a refractory temporal lobe epilepsy candidate and an SOD-1 amyotrophic lateral sclerosis ...
As GSK’s July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit. The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users. A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK. But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement. Zantac is ranitidine’s brand name and much of the Zantac cases revolve around reports of N-nitrosodimethylamine (NDMA) contamination in the products. Health Canada started investigating the potential impurity in ...
Real-time patient experiences is the missing element to most electronic health records, artificial intelligence, and machine learning models today. Anish Patankar, SVP, GM, Oncology Informatics Software, Elekta Cancer treatment has come a long way in recent years and is now evolving more rapidly through the integration of artificial intelligence (AI) tools, such as machine learning (ML). Currently, health data exists in many forms, including electronic health records (EHR), diagnostic images, genomic and molecular data, pharmacological data, and patient-reported data. The creation of state-of-the-art cancer treatments can be enhanced by the ways clinicians leverage data to optimize care, and there’s no better way to achieve this than through the use of AI. Completing the picture There is a missing element to most EHR, AI, and ML models today – real-time patient-reported outcomes. This type of data refers to information regarding patients’ experiences with their medical conditions, treatments, and healthcare providers, ...
Daniel M. Keller, PhD Among patients with atrial fibrillation (AF), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows. Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications. Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen Hospital, Shenzhen, China, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AF. “The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said. The results were presented in a moderated poster session at the European Heart Rhythm Association (EHRA) 2023 in Barcelona and are available online. Widely Prescribed Anticoagulant ...
A new study investigates the risk of electromagnetic interference with pacemakers and defibrillators when using high power electric vehicle chargers. Amanda Pedersen | Apr 19, 2023 With the increasing popularity of electric vehicles, you might be wondering if it’s safe to drive or charge one of these bad boys if you have a pacemaker or defibrillator. According to a new study, presented this week at the European Heart Rhythm Association (EHRA) in Barcelona, Spain, the answer is yes – so long as you don’t place the charging cable directly over your cardiac device, or stay near the charging cable for extended lengths of time. The study was also published in EP Europace, a journal of the European Society of Cardiology, which hosts the EHRA scientific congress. “The new high power charging stations for electric cars have the potential to create strong electromagnetic fields and cause electromagnetic interference in pacemakers and defibrillators, leading them to malfunction,” said study author ...
Reviewed by Emily Henderson, B.Sc.Apr 17 2023 A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AEGEAN trial evaluated durvalumab given perioperatively, meaning therapy is given both before and after surgery. Participants on the trial received either pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab or neoadjuvant placebo and chemotherapy followed by adjuvant placebo. These represent the first data presented on the benefits of perioperative immunotherapy for resectable NSCLC and adds to the growing evidence supporting the benefits of both neoadjuvant and adjuvant immunotherapy for these patients. Our goal is to increase cures for lung cancer. ...
The copycat version of AbbVie’s blockbuster still has court clearance to launch on July 1, but only if regulators have approved it. For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday. The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product. An expected launch on July 1 could be delayed if the FDA doesn’t grant the main approval, which would clear the biosimilar for sale in the U.S. In a statement Thursday evening, Alvotech said it provided ...
Closely following a Mediterranean diet may cut a woman’s risk of heart disease and death by nearly 25%, according to a new analysis of 16 studies. “This study adds to what is already known about the cardiovascular benefits of a Mediterranean diet but further reiterates that it can be equally as beneficial in women as it is known to be in men,” said lead author Sarah Zaman, associate professor at the Westmead Applied Research Centre at the University of Sydney, in an email. Heart disease is the number one killer of women and men worldwide, according to the World Health Organization. Coronary artery disease kills more than twice as many women as breast cancer in the United Kingdom, while in 2020, one in five deaths among women in the United States was because of heart disease. Yet few studies on the heart have looked specifically at women, ...
The U.S. Food and Drug Administration (FDA) has recently approved a new treatment for a rare genetic disorder called hereditary angioedema (HAE). The treatment, called Berinert, is manufactured by CSL Behring and is the first and only therapy approved for the treatment of acute attacks of HAE in pediatric patients. HAE is a rare genetic disorder that affects about 1 in 10,000 to 1 in 50,000 people worldwide. It is characterized by recurrent episodes of swelling, or edema, in various parts of the body including the hands, feet, face, and airways. These attacks can be severe and potentially life-threatening, especially when the swelling occurs in the airways, which can lead to difficulty breathing and asphyxiation. Berinert is a human plasma-derived C1 esterase inhibitor (C1-INH) that works by replacing the deficient or malfunctioning C1-INH protein in patients with HAE. The treatment is administered through intravenous infusion and can ...
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