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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
GSK has announced results from a survey revealing that parents are less knowledgeable about meningitis compared to other childhood infectious diseases. The multi-country GSK-commissioned and funded survey conducted by Ipsos revealed that 72% of over 4,000 parents said they were somewhat knowledgeable or knew a lot about meningitis. However, this result was significantly lower compared to other infectious diseases, including COVID-19 (95%), influenza (94%), measles (86%), pneumonia (82%) and whooping cough (74%). Additionally, 93% of parents across the US, Brazil, Germany, France, Spain, the UK and Italy surveyed said they could not identify the three most common symptoms of the condition: fever, headache and stiff neck. Annually, 2.5 million people are diagnosed with meningitis globally, of which 1.2 million cases are invasive meningococcal disease (IMD). Despite 88% of parents considering meningitis to be a serious childhood illness, only 38% said they believed that their child was at risk of catching ...
Pfizer has announced that a new personalised treatment option, Braftovi (encorafenib) plus Mektovi (binimetinib), has been approved by the US Food and Drug Administration (FDA) for certain lung cancer patients. The regulator’s decision specifically applies to adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Lung cancer is the second most common type of cancer and NSCLC accounts for up to 85% of all lung cancers cases. Certain lung cancers are linked to acquired genetic abnormalities such as a BRAF V600E mutation, which occurs in approximately 2% of NSCLC cases. “BRAF V600E mutations identify a unique subtype of metastatic NSCLC that presents an actionable biomarker that precision medicines like Braftovi plus Mektovi combination therapy can help address,” explained Gregory Riely, an investigator in the ongoing mid-stage PHAROS trial that supported the FDA’s approval. The study, which is evaluating the combination ...
Although people with opioid use disorder (OUD) are significantly more likely to overdose or have a complication after major surgery than those without the disorder, using medications for the treatment of OUD before surgery may eliminate that extra risk, suggests a large, first-of-its-kind study presented at the ANESTHESIOLOGY® 2023 annual meeting. Patients with OUD who didn’t use an OUD medication (such as buprenorphine or methadone) were over four times more likely to overdose after having surgery, yet those who used evidence-based OUD medication before surgery were essentially at no greater risk than those who didn’t have OUD, according to the study. Taken orally, OUD medications reduce withdrawal and cravings and prevent opioids from producing the feeling of euphoria that drives addiction. Anjali Dixit, M.D., MPH, pediatric anesthesiologist at Stanford University, California, said, “We know that OUD treatments are very effective in helping to prevent relapse, overdose and death in nonsurgical ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.