Search Results for “EC” – Page 396 – media

EMA-endorsed statement targets Covid-19 vaccine misinformation

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 ...
- Source: drugdu
- 114
- July 8, 2023
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
- 101
- 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
- 108
- 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
- 94
- 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
- 89
- 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
- 96
- July 8, 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
- 112
- 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
- 108
- July 7, 2023
Lack of sleep found to lessen cognitive benefits of physical activity

Regular physical activity may protect against cognitive decline as we get older, but this protective effect may be diminished for people who are not getting enough sleep, according to a new study by UCL researchers. The study, published in The Lancet Healthy Longevity, looked at cognitive function over 10 years in 8,958 people aged 50 and over in England. The research team investigated how different combinations of sleep and physical activity habits might affect people’s cognitive function over time. They found that people who were more physically active but had short sleeps—less than six hours on average—had faster cognitive decline overall, meaning that after 10 years their cognitive function was equivalent to peers who did less physical activity. Lead author Dr. Mikaela Bloomberg (UCL Institute of Epidemiology & Health Care) said, “Our study suggests that getting sufficient sleep may be required for us to get the full cognitive benefits of ...
- Source: drugdu
- 106
- July 7, 2023
Fluctuating blood lipid levels linked with higher risk of Alzheimer’s disease, study finds

By Kristen Rogers, CNN Having a fluctuating cholesterol level has been linked with higher risk of Alzheimer’s disease, a new study has found. coldsnowstorm/iStockphoto/Getty Images Editor’s Note: Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life. CNN — The fact that having high cholesterol can cause health problems is well known. But a total cholesterol level that fluctuates a lot — either up or down within a five-year period — might also be problematic by raising the risk of later dementia, a new study found. “This study adds to a growing body of evidence showing that addressing certain modifiable risk factors and promoting healthy behaviors can reduce the risk of cognitive decline, possibly reduce the risk of dementia, and protect cognitive health,” said Christopher Weber, director of global science initiatives at the ...
- Source: drugdu
- 113
- July 7, 2023

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