Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo. MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine ...
Patients are now enrolling in an early stage clinical trial to test a universal flu vaccine based on messenger RNA technology, the National Institutes of Health announced Monday. Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year. Messenger RNA, or mRNA, is the technology behind Moderna ’s and Pfizer ’s widely used Covid vaccines. NIH played a crucial role in developing the mRNA platform used by Moderna. “A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic,” Dr. Hugh Auchincloss, acting director of National Institute of Allergy and Infectious Diseases, said in a statement Monday. The universal flu vaccine trial will enroll up to 50 healthy people ages 18 through 49 to test whether the experimental shot is safe and produces ...
Advanced or metastatic estrogen receptor-positive (ER+) breast cancer is commonly treated with drugs that block the estrogen receptor. However, estrogens that stimulate the receptor can also be effective. Building on their previous studies, researchers at Dartmouth Cancer Center recently concluded a Phase II clinical trial aimed to test the efficacy of alternating between estrogen stimulation and estrogen deprivation in patients with metastatic ER+ breast cancer, and to identify tumor characteristics that predict who might benefit from this strategy. The results, newly published ahead of print in Clinical Cancer Research, support cyclical estrogen/anti-estrogen therapy as a promising strategy to treat advanced/metastatic ER+ breast cancer. The POLLY trial stands for “Phase II study of Pre-emptive oscillation of ER activity levels through alternation of estradiol/anti-estrogen therapies prior to disease progression in ER+/HER2- metastatic or advanced breast cancer.” Among 19 patients enrolled in the trial, 3 (16%) experienced tumor shrinkage during cyclical treatment and ...
WebMD Health News Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. The self-sampling kits, which detect human papilloma virus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online Thursday in the journal Lancet Public Health. Experts writing in a commentary published with the study said it “provides the required evidence that … self-collected samples can be an effective strategy for hard-to-reach populations.” The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More ...
By Brenda Goodman, CNN CNN — The US Food and Drug Administration on Friday approved a new type of drug to treat hot flashes and night sweats during menopause. Veozah, or fezolinetant, made by Astellas Pharma, is the first approved neurokinin 3 (NK3) agonist. It blocks receptors in the brain that play a role in the regulation of body temperature. It’s an alternative to traditional hormone replacement therapies to manage hot flashes, which are a common symptom of menopause that can be disruptive if they become severe. Women at higher risk of stroke, heart attacks or some kinds of cancer are sometimes advised against using hormone replacement therapies because they increase the risk of blood clots and cancers. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, director of the FDA’s Office of ...
Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients. The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is a recombinant human α‑Galactosidase‑A enzyme expressed in plant-cell culture that is designed for providing a long half-life. The therapy was found to have an initial half-life of 78.9 ± 10.3 hours, in clinical trials. Chiesi Global Rare Diseases head Giacomo Chiesi said: “While much progress has been made in the treatment of Fabry disease, there is still a need for new treatment options. “We established Chiesi Global Rare Diseases to deliver innovative therapies and solutions for people affected by rare diseases. “With the FDA approval of PRX-102, we can now offer people ...
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, ...
GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 170,000 hospitalisations and approximately 14,000 deaths each year in the US. The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed ...
Lisette Hilton | Healthcare practices are already using chatbots to help with administrative tasks like scheduling appointments or requests for prescription refills. And while users say the current generative artificial intelligence (AI) technology falls short for safely treating patients, a recent survey of healthcare practices suggests 77% of users predict chatbots will be able to treat patients within the next decade. According to Software Advice’s 2023 Medical Chatbot Survey of 65 healthcare providers or practice owners who use live chatbots on their websites, which was conducted in March 2023, more than three quarters of those surveyed are extremely or somewhat confident in chatbots’ ability to assess patients’ symptoms. Chris R. Alabiad, MD, professor of clinical ophthalmology and ophthalmology residency program director at Bascom Palmer Eye Institute, Miami, FL, has tested the use of ChatGPT (Open AI) in the academic and clinical settings. He piloted the use of ChatGPT at Bascom ...
McMaster University researchers Dena Zeraatkar and Tyler Pitre have found that the drug solriamfetol is the most effective treatment for excessive daytime sleepiness (EDS) for people with obstructive sleep apnea (OSA). The standard treatment for OSA is a positive airway pressure (PAP) mask that uses compressed air to support lung airways during sleep. However, some people with OSA still experience EDS and may benefit from anti-fatigue medication. Zeraatkar and Pitre published their results in the Annals of Internal Medicine. “The most important thing that people with OSA should do is use their PAP machine, but if they are still sleepy there are options in the form of medications that can reduce their tiredness.” Tyler Pitre, first author, resident physician in internal medicine at McMaster University and incoming respirology fellow at the University of Toronto “Fifteen to 30 per cent of people in North America have a diagnosis ...
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