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FDA grants orphan drug designation to ImPact’s focal cancer therapy

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 ...
- Source: drugdu
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- July 8, 2023
With full Alzheimer’s approval in hand, Eisai and Biogen kick off Leqembi’s launch in earnest

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 ...
- Source: drugdu
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- July 8, 2023
Moderna strikes deal to develop mRNA drugs in China

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. ...
- Source: drugdu
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- July 8, 2023
Patient aggression causes lasting harm to medical receptionists

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 ...
- Source: drugdu
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- July 8, 2023
New AI system could revolutionize the diagnosis of valvular heart disease

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 ...
- Source: drugdu
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- July 8, 2023
Poor air quality found to affect mental health in many ways

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 ...
- Source: drugdu
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- July 8, 2023
New biomarker confirmed for early diagnosis of multiple sclerosis

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 ...
- Source: drugdu
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- July 8, 2023
Medtronic identifies cybersecurity vulnerability in cardiac data system

Dive Brief Medtronic has found a cybersecurity vulnerability in an optional messaging feature in its Paceart Optima cardiac device data workflow system and reported the problem to the U.S. Cybersecurity & Infrastructure Security Agency. Medtronic has not observed any unauthorized access or patient harm related to the issue, the device maker said in an emailed statement. The company said it has notified healthcare delivery organizations about the vulnerability and has provided them with instructions to eliminate it. Dive Insight The number of data breaches in healthcare continues to climb as the industry has become a prime target for cyber criminals who seek to access its troves of patient information. As more connected medical devices make their way into patient homes, ransomware, phishing and software vulnerabilities are among the biggest challenges facing the sector. Medtronic’s Paceart Optima software application, which runs on a hospital’s Windows server, collects cardiac device data from ...
- Source: drugdu
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- July 7, 2023
New protein found to help melanoma evade the immune system

New research from Sanford Burnham Prebys has helped explain how melanoma evades the immune system and may guide the discovery of future therapies for the disease. The study found that a protein known to be active in immune cells is also active inside melanoma cells, helping promote tumor growth. The findings, published in the journal Science Advances, suggest that targeting this protein with new drugs may deliver a powerful double hit to melanoma tumors. “The immune system’s control of a tumor is influenced by both internal factors within tumor cells, as well as factors from the tumor’s surroundings,” says first author Hyungsoo Kim, Ph.D., a research assistant professor at Sanford Burnham Prebys in the lab of senior author Ze’ev Ronai, Ph.D. “We found that the protein we’re studying is involved in both, which makes it an ideal target for new cancer therapies.” One of the most significant breakthroughs in cancer ...
- Source: drugdu
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- July 7, 2023
Taking good care of your teeth may be good for your brain, study suggests

Taking good care of your teeth may be linked to better brain health, according to a study published in the July 5, 2023, online issue of Neurology. The study found that gum disease and tooth loss were linked to brain shrinkage in the hippocampus, which plays a role in memory and Alzheimer’s disease. The study does not prove that gum disease or tooth loss causes Alzheimer’s disease; it only shows an association. “Tooth loss and gum disease, which is inflammation of the tissue around the teeth that can cause shrinkage of the gums and loosening of the teeth, are very common, so evaluating a potential link with dementia is incredibly important,” said study author Satoshi Yamaguchi, Ph.D., DDS, of Tohoku University in Sendai, Japan. “Our study found that these conditions may play a role in the health of the brain area that controls thinking and memory, giving people another reason ...
- Source: drugdu
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- July 7, 2023

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