Providers must abandon paternalism and treat patients like partners in the decision-making process when drawing up care plans, according to Chris Waugh, Sutter Health’s chief design and innovation officer. Instead of prescribing a major lifestyle overhaul without considering a patient’s unique life circumstances, providers should “recognize that it’s about the tiny things and the accumulation of marginal gains,” he said. By KATIE ADAMS Historically, healthcare providers have had a reputation of paternalism — as one might guess, this type of approach doesn’t support patient engagement or care plan adherence. Like many other innovators in the industry, Chris Waugh — Sutter Health’s chief design and innovation officer, believes providers need to abandon paternalism and pivot toward collaboration. They must start treating patients like partners in the decision-making process when drawing up care plans, he said during an interview last week at the Reuters Total Health conference in Chicago. “We’re often asking ...
The widely available blood thinner apixaban substantially reduced stroke in at-risk patients with a type of atrial fibrillation only detectable by a pacemaker or other implanted cardiac electronic device, a global study has found. The oral anticoagulant medication, which helps to prevent dangerous blood clots by thinning the blood, reduced the risk of stroke and blood clotting by 37% and reduced fatal or disabling stroke by 49% in individuals with device-detected atrial fibrillation, also known as sub-clinical atrial fibrillation (SCAF). This condition is not easily detectable through standard tests like electrocardiograms, unlike clinical atrial fibrillation. The study was published on Nov. 12 in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association Scientific Sessions by lead researcher Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI), a joint research institute of McMaster University and Hamilton Health Sciences. Healey and a global ...
By Tyler Patchen Legend Biotech has secured an exclusive global license deal with Novartis giving the Swiss pharma access to Legend’s CAR-T cell therapies. The deal announced on Monday will give Novartis access to CAR-Ts that target the delta-like ligand protein (DLL3) candidate LB2102, which Legend has been investigating to treat adults with certain small cell lung cancers. Novartis will pay Legend $100 million upfront, and the New Jersey–based biotech “will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties,” according to the company’s announcement. The deal has Legend taking the lead on the Phase I trials for LB2102 in the U.S., while Novartis will handle all other development. No hard date has been given as to when the deal will close. For its part, Novartis will receive exclusive worldwide rights to develop, produce and eventually commercialize the therapies. The company ...
By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
Don Tracy, Associate Editor The growing issue of medical debt has caused stakeholders to reevaluate tactics as the cost of pharmaceutical healthcare continues to rise. In modern times, hospitals have continuously employed aggressive tactics to collect debts from patients, especially those in low-income situations. A recent study published by The New England Journal of Medicine (NEJM) notes that these tactics include wage garnishments, selling debts to third party buyers, reporting of delinquent debts to credit bureaus, lawsuits, seizures of bank accounts, property liens, foreclosures, refusals of care, and even arrests. Politicians on both sides of the spectrum have criticized these tactics, citing the lack of charity care. Since the 1980s, hospitals have shifted away from this in favor of incessant debt collection tactics, according to the investigators. In a recent episode of the An Arm and a Leg podcast, Luke Messac, MD, PhD, discussed his experience in this area. In ...
BY SEAN WHOOLEY Conforming devices can be identified by their serial number. The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT)+ McGrath Mac video laryngoscopes is Class I, the most serious kind. Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products. The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation. Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment. More details on the Medtronic recall The recall affects 5,709 devices in the U.S., distributed between July 5, 2019, and July 14, 2022. Medtronic’s ...
Merck & Co – known as MSD outside the US and Canada – has announced that the European Medicines Agency’s human medicines committee has recommended its Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC). The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the anti-PD-1 therapy be used alongside gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic BTC. BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 211,000 people are diagnosed with the disease each year globally and about 70% of BTC patients are diagnosed at an advanced stage, at which point the prognosis is poor. The CHMP’s positive opinion was supported by results from the late-stage KEYNOTE-966 trial, in which the Keytruda/chemotherapy combination demonstrated a significant overall survival benefit in these patients versus chemotherapy alone. ...
GSK’s momelotinib has been recommended for approval by the European Medicines Agency’s human medicines committee as the first treatment option specifically indicated for myelofibrosis patients with moderate-to-severe anaemia. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Eligible patients will also have either not been treated with JAK inhibitors before or have been treated with Novartis’ Jakavi (ruxolitinib), GSK said. Myelofibrosis is a rare blood cancer that can lead to severely low blood counts, with about 40% of patients having moderate-to-severe anaemia at the time of diagnosis and nearly all patients developing anaemia at some point in the course of their disease. Transfusions are often required by myelofibrosis patients with anaemia and more than 30% will discontinue treatment ...
Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients. Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss. The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%. Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by ...
Dive Brief The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway. Acon Laboratories secured the 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. The firm received emergency use authorization (EUA) in 2021 and, by following in the footsteps of Cue Health’s de novo molecular test, converted that approval into a conventional clearance. The clearance gives Americans another fully authorized test ahead of an infectious respiratory disease season in which testing volumes are forecast to be down compared to prior years. Dive Insight The EUA program enabled the FDA to quickly make COVID-19 tests available in the U.S. during the public health emergency. Today, the administration maintains EUAs on 65 antigen tests and 276 molecular diagnostic tests for COVID-19. While the EUAs remain in effect, the FDA is encouraging manufacturers to transition to its normal pathways now that the acute ...
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