PharmaFocus Today – Page 244 – media

Air pollution linked to increased breast cancer risk in women

Women living and working in places with higher levels of fine particle air pollution are more likely to get breast cancer than those living and working in less polluted areas. Results of the first study to take account of the effects of both residential and workplace exposure to air pollution on breast cancer risk are presented at the ESMO Congress 2023 in Madrid, Spain. Professor Béatrice Fervers, Head of Prevention Cancer Environment Department, Léon Bérard Comprehensive Cancer Centre, France, said, “Our data showed a statistically significant association between long term exposure to fine particle air pollution, at home and at work, and risk of breast cancer. This contrasts with previous research which looked only at fine particle exposure where women were living, and showed small or no effects on breast cancer risk.” In the study, home and workplace exposure to pollution in 2419 women with breast cancer was compared to ...
- Source: drugdu
- 203
- October 19, 2023
AbbVie announces positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared detailed results from a head-to-head study comparing its IL-23 inhibitor Skyrizi (risankizumab) to Johnson & Johnson’s Stelara (ustekinumab) in Crohn’s disease. The late-stage SEQUENCE study has been evaluating the drugs, both given as a subcutaneous injection every eight weeks after a lead-in period of intravenous infusions, in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery. The results from SEQUENCE, which were presented at the United European Gastroenterology Week, showed that Skyrizi was superior to J&J’s IL-12 and IL-23 inhibitor at achieving endoscopic remission after 48 weeks of treatment, with 32% and ...
- Source: drugdu
- 111
- October 19, 2023
Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
- Source: drugdu
- 172
- October 19, 2023
CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 110
- October 19, 2023
Q&A With Harpreet Gill, Head of Decentralized Clinical Trials at Icon

Mike Hollan Gill discusses her continuing work to transform clinical trials and improve the patient experience through DCTs. Harpreet Gill Head of decentralized clinical trials Icon Harpreet Gill, head of decentralized clinical trials (DCTs) at Icon, is working to make DCTs more easily implemented and more commonly used throughout the industry. She recently spoke with Pharmaceutical Executive about her work. Pharmaceutical Executive: Can you explain the importance of decentralized trials? Harpreet Gill: As the time has gone on over the last few years (and we know the pandemic accelerated this) there’s been a greater need to think about the different ways to engage patients in clinical trials. There’s an element of efficiency there in terms of how data is collected. One of the things that we are seeing is that there are more clinical trials, but there aren’t as many patients there are interested in being involved because it can ...
- Source: drugdu
- 201
- October 19, 2023
How Mass General Brigham Is Integrating Behavioral Care Into Its Primary Care Model

Mass General Brigham launched a program this month in collaboration with behavioral health medical group Concert Health. Under the program, more than 400 Mass General primary care providers can refer their patients to Concert. The health system’s goal is to increase patients’ access to diagnoses and treatment for mild to moderate behavioral health issues — particularly for Medicaid patients, who are the most underserved. By KATIE ADAMS Health systems are increasingly realizing the importance of integrating behavioral care into primary care. Physical and mental health are interconnected, and addressing one without the other can lead to incomplete or less effective treatment. Integrating behavioral care into primary care also aids the early detection of mental health concerns, which can prevent more severe issues from developing, as well as reduces the stigma associated with seeking mental health services by making them a routine part of overall healthcare. Mass General Brigham understands the ...
- Source: drugdu
- 110
- October 19, 2023
New contrastive learning method could improve voice pathology detection

Voice pathology refers to a problem arising from abnormal conditions, such as dysphonia, paralysis, cysts, and even cancer, that cause abnormal vibrations in the vocal cords (or vocal folds). In this context, voice pathology detection (VPD) has received much attention as a non-invasive way to automatically detect voice problems. It consists of two processing modules: a feature extraction module to characterize normal voices and a voice detection module to detect abnormal ones. Machine learning methods like support vector machines (SVM) and convolutional neural networks (CNN) have been successfully utilized as pathological voice detection modules to achieve good VPD performance. Also, a self-supervised, pretrained model can learn generic and rich speech feature representation, instead of explicit speech features, which further improves its VPD abilities. However, fine-tuning these models for VPD leads to an overfitting problem, due to a domain shift from conversation speech to the VPD task. As a result, the ...
- Source: drugdu
- 212
- October 18, 2023
Quality of ultrasound scans of the liver and kidneys found to be lower in obese patients

Ultrasound of the abdominal organs is a central diagnostic tool and is recommended as the first-line approach for many medical conditions. Compared with other imaging modalities such as computed tomography (CT) and magnetic resonance imaging (MRI), ultrasound is readily available, avoids unnecessary radiation exposure and can be used in almost every case. However, the accuracy of this method is usually limited in obese individuals because the imaging quality of anatomical structures is impaired. To date, the degree of obesity at which ultrasound diagnostics are no longer sufficiently precise has not been sufficiently researched. In a recent clinical study at the University of Leipzig Medical Center, researchers found that the quality of ultrasound scans of the liver and kidneys was significantly lower in obese patients. Professor Thomas Karlas, head of the study and corresponding author of the current publication, said, “The results showed that as the body mass index of the ...
- Source: drugdu
- 160
- October 18, 2023
FDA establishes new advisory committee to provide expertise on digital health

The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
- Source: drugdu
- 204
- October 18, 2023
Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
- Source: drugdu
- 116
- October 18, 2023

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