Dive Brief The Federal Trade Commission has intervened in a legal case to correct what it called “erroneous assertions and mistaken legal points” made by Medtronic. In an amicus brief filed Monday, the FTC rebuts aspects of Medtronic’s defense against accusations made by Applied Medical Resources in an antitrust case. The FTC has taken no position on the accuracy of the allegations but filed the brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement” in its filing to dismiss Applied’s claims. Dive Insight Applied Medical filed a lawsuit against Medtronic earlier this year. The manufacturer of bipolar energy devices accused Medtronic of conspiring to bundle devices for cutting tissue and sealing vessels “in a way that is unhealthy for competition, hospitals, and patients in need of medical treatment.” Medtronic called the claims “baseless” and moved to dismiss the case. The argument for dismissing the case ...
A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25 per cent. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood – instead of the usual practice of using normal saline (sodium chloride and water). David Johnson, UQ Professor, said, “Of those study participants who received intravenous Plasma-Lyte 148, 30 per cent needed dialysis after their transplants, compared to 40 per cent for those given normal saline. This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal ...
In an age where Covid-19 vaccine misinformation is rife, the International Coalition of Medicines Regulatory Authorities (ICMRA) issued a statement tackling the exaggerations of side effect severity and frequency. The 5 July statement, which was swiftly endorsed by the European Medicines Agency (EMA), points to overwhelming evidence demonstrating a good safety profile across all age groups. There have so far been more than 13 billion vaccine doses given worldwide. ICMRA says the vast majority of side effects due to Covid-19 vaccines are mild and temporary. Any serious side effects identified by safety monitoring systems, such as myocarditis and blood clots, are very rare – meaning they occur in less than one in 10,000 people. The statement pointed towards false and misleading information being spread, especially on social media, that exaggerates the frequency and severity of side effects. The statement read: “As for all medicines, reports of medical events after Covid-19 ...
The US Food and Drug Administration (FDA) has granted an orphan drug designation to ImPact Bio’s padeliporfin vascular targeted photodynamic therapy (VTP) for patients with locally advanced pancreatic cancer. Israel-headquartered ImPact Bio expects to submit an investigational new drug application (IND) later in 2023, with a Phase I trial of the treatment in patients with locally advanced pancreatic ductal adenocarcinoma also scheduled for this year, per a 5 July press release. Orphan drug designations come with certain benefits such as granting tax credits for US-based clinical trials and recommendations from the FDA on the required clinical and preclinical studies. Padeliporfin VTP is based on the combined use of the drug padeliporfin and non-thermal laser light. The drug is administered intravenously to a patient after which it is activated by a non-thermal laser light in the specific area of the tumour, per the company’s website. The light results in the drug’s ...
It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fledged, traditional approval. Now, the drug—also known as Leqembi—is set to unshackle itself from a strict coverage determination by the Centers for Medicare & Medicaid services (CMS). With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s under the traditional approval pathway, Eisai Executive Vice President Alex Scott, who oversees government affairs, said in an interview. Those benefits stand across a “broad patient group that’s generalizable to the whole Medicare population,” he added. Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that’s believed to be ...
Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will “be exclusively for the Chinese people” and won’t “be exported,” a Moderna spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China that could be worth around $1 billion, citing unnamed sources. The outlet also reported that Moderna CEO Stéphane Bancel was visiting Shanghai. The Moderna spokesperson did not confirm the report or comment on the size of the deal. “These agreements are focused on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions available to patients in China,” the spokesperson said. ...
Reviewed by Danielle Ellis University of Queensland research has found verbal and physical abuse of medical receptionists by patients is rife, and causing lasting harm. Dr Fiona Willer from UQ’s Centre for Community Health and Wellbeing led a review of 20 studies across five countries, analysing aggression faced by receptionists in medical clinics and doctor’s surgeries. Our findings show receptionists are frequently subjected to verbal abuse from patients such as shouting, swearing, accusatory language and racist and sexist insults. They also face armed and unarmed physical violence. Patient aggression towards medical receptionists is so frequent it’s become accepted as a normal workplace hazard, which is extremely concerning.” Dr Fiona Willer from UQ’s Centre for Community Health and Wellbeing The research found the behavior severely affected the receptionists’ health and wellbeing. “They reported workplace stress, absenteeism, burnout, lasting psychological trauma and even physical harm,” Dr Willer said. “Only a small proportion ...
Reviewed by Danielle Ellis AI (artificial intelligence) may sound like a cold robotic system, but Osaka Metropolitan University scientists have shown that it can deliver heartwarming-;or, more to the point, “heart-warning”-;support. They unveiled an innovative use of AI that classifies cardiac functions and pinpoints valvular heart disease with unprecedented accuracy, demonstrating continued progress in merging the fields of medicine and technology to advance patient care. The results will be published in The Lancet Digital Health. Valvular heart disease, one cause of heart failure, is often diagnosed using echocardiography. This technique, however, requires specialized skills, so there is a corresponding shortage of qualified technicians. Meanwhile, chest radiography is one of the most common tests to identify diseases, primarily of the lungs. Even though the heart is also visible in chest radiographs, little was known heretofore about the ability of chest radiographs to detect cardiac function or disease. Chest radiographs, or chest ...
Poor air quality affects mental health in many ways, according to a new review of evidence published in the British Journal of Psychiatry. Led by Professor Kam Bhui at the University of Oxford’s Department of Psychiatry, researchers in the BioAirNet program, analyzed existing studies looking at the effects of both indoor and outdoor air pollution across the life course, from birth and pregnancy, to adolescence and adulthood. They found evidence that exposure to air pollutants may lead to depression, anxiety, psychoses, and perhaps even neurocognitive disorders, such as dementia. There were also indications that children and adolescents might be exposed to air pollution at critical stages in their mental development making them at risk of the most severe impact and significant future mental health problems. Additional risk factors included poor housing, over-crowding, poverty, a lack of green spaces as well as individual social and psychological vulnerabilities, such as lack of ...
A study conducted by researchers from the Department of Neurology at MedUni Vienna and University Hospital Vienna has demonstrated for the first time that the diagnosis of multiple sclerosis (MS) can be significantly improved by additionally measuring the thickness of retinal layers in the eye. Use of the procedure, which is already available at the Departments of MedUni Vienna and University Hospital Vienna, helps to detect the condition at an earlier stage and predict its progression more accurately. This can lead to a decisive increase in the chance of improved patient outcomes. The findings have been published in the journal Neurology. As part of their investigation, the research team headed by Gabriel Bsteh and Thomas Berger of the Department of Neurology at MedUni Vienna and University Hospital Vienna collaborated with colleagues from MedUni Vienna and University Hospital Vienna’s Department of Ophthalmology and Optometrics to examine 267 MS patients over a ...
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.