FDA Committee Recommends High Dose EPA for CV Event Reduction

The high-dose EPA product icosapent ethyl (Vascepa, Amarin) was today unanimously recommended by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for approval to reduce cardiovascular events as an adjunct to statin therapy in patients with elevated triglyceride levels. However, the exact population for whom the drug should be prescribed was not decided at today’s meeting. All 16 committee members voted …

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Severe allergic reactions rise in children in England over past five years

Image copyright Family handout/PA Wire Image caption Natasha Ednan-Laperouse died in 2016 after eating a baguette containing hidden sesame The number of children being admitted to hospital in England with a severe allergic reaction has risen every year for the past five years. NHS figures show 1,746 children were treated for anaphylactic shock in 2018-19, up from 1,015 in 2013-14. …

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Will It Really Improve Mental Health?

The recent move by social media giant Instagram to make “like” counts private for some US users is getting a cautious thumbs-up from mental health experts who say it’s a good first step in alleviating some of the psychological distress linked to social media use. Many believe it may eliminate some of the tension and “toxicity” around the perception, particularly …

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FDA Clears New Option for Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has granted an accelerated approval to zanubrutinib (Brukinsa, BeiGene USA Inc) capsules for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This is …

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China’s BeiGene gets FDA approval for drug to treat rare form of lymphoma

(Reuters) – The U.S. Food and Drug Administration on Thursday approved BeiGene Ltd’s lymphoma treatment, validating the China-based drugmaker’s strategy of largely using data from trials held outside the United States to file for approval. The company tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21% Caucasian, and between …

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Diabetes tied to increased risk of hidden spinal fractures

(Reuters Health) – People with type 2 diabetes are more likely than others to develop spinal fractures that sometimes have no obvious symptoms but are tied to increased risk of future broken bones, a research review suggests. The analysis focused on so-called vertebral fractures, also known as compression fractures, that happen when bones in the spine weaken and crumple, often …

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Mortality Rate for Chronic Liver Disease Underestimated

An updated definition of chronic liver disease that captures cirrhosis-related deaths would help correct the current underestimation of mortality rates reported by the Centers for Disease Control and Prevention (CDC), report researchers. “The CDC definition of chronic liver disease is very narrow,” said Connor Griffin, MD, from the Baylor University Medical Center in Dallas. Currently, it only encompasses three International …

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FDA panel unanimously backs expanding use of Amarin’s heart drug Vascepa

(Reuters) – A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc’s fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease. The panel on Thursday voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for the …

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BeiGene drug wins U.S. FDA approval for rare form of lymphoma

(Reuters) – The U.S. Food and Drug Administration on Thursday approved BeiGene Ltd’s lymphoma treatment, validating the China-based drugmaker’s strategy of largely using data from trials held outside the United States to file for approval. The company tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21% Caucasian, and just …

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Skin Tests Can Overestimate Penicillin Allergy

Women are more likely to react to a skin prick test for penicillin allergy than men, investigators report. “We don’t really have any idea why,” said Dayne Voelker, MD, from the Mayo Clinic in Rochester, Minnesota. Initially, the researchers thought the data reflected the fact that women are more likely than men to engage with the healthcare system. But after …

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Cancer doctors hesitate to discuss fertility issues with young women

(Reuters Health) – Although cancer doctors know it’s important to talk about fertility concerns with young women patients, they may feel uncomfortable and unprepared to discuss the issue, a study in Canada suggests. The American Society of Clinical Oncology guidelines recommend discussing potential infertility resulting from cancer treatments, but many doctors and patients are still not having these talks, the …

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Best surgery for long-term weight loss not yet clear

(Reuters Health) – People with obesity may initially shed more excess pounds with an older operation known as Roux-en-Y gastric bypass than with a newer sleeve gastrectomy procedure, but a research review suggests that longer-term, which one is better for weight loss remains unknown. Researchers examined data from previous studies on a total of 2,475 obese patients in 13 countries …

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Prognostic Biomarker Test Identifies High-Risk Sepsis in Kids

The prediction of septic shock outcomes and the selection of early optimal treatment may become more precise, thanks to a new biomarker-based tool. The investigative Pediatric Sepsis Biomarker Risk Model (PERSEVERE) assay is a rapid blood test that measures five biomarkers involved in sepsis and accurately stratifies patients as being at low, medium, or high risk for septic death. The …

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Improved rabies vaccine could be better and cheaper

By Ruby Prosser Scully This image taken with an electron microscope show the rabies virus in bright green   Tweaking the rabies vaccine to spur the body into mounting a stronger immune response could lead to more effective and cheaper treatments. This could help save some of the 60,000 lives thought to be lost to the disease each year. Around …

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Hearing loss, even when mild, linked to mental decline in seniors

(Reuters Health) – Slight declines in hearing, smaller than the usual cutoff for diagnosing hearing loss, are associated with measurable mental decline in seniors, a new study suggests. When researchers used a stricter threshold to include mild hearing loss, they found evidence that the well-established link between age-related hearing loss and cognitive decline might begin sooner than is recognized, according …

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U.S. vaping-related deaths rise to 42, cases of illness to 2,172

FILE PHOTO: A man uses a vaping product in the Manhattan borough of New York, New York, U.S., September 17, 2019. REUTERS/Carlo Allegri (Reuters) – U.S. health officials on Thursday reported 2,172 confirmed and probable cases and 3 more deaths from a mysterious respiratory illness tied to vaping, taking the death toll to 42, so far this year. Last week, …

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CDK4/6 Combo Better Than Chemo in Advanced Breast Cancer

A new study shows that the combination of a CDK4/6 blocker plus endocrine therapy is better than chemotherapy in young women with advanced breast cancer.   Specifically, these were premenopausal women with metastatic hormone receptor-positive (HR+) and human epidermal receptor 2-negative (HER2–) breast cancer.  The CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) plus endocrine therapy significantly improved progression-free survival compared with single-agent …

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Fertility Preservation in Cancer Often Not Discussed: Why?

“The failure of oncologists to engage with fertility is truly a failure, because it is not a lack of available information or knowledge, it’s more the physician’s lack of interest, lack of accessing available information, lack of acting on it, and a lack of patience to actually take the initiative.” The sentiments expressed above came from a Canadian oncologist, one …

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Curiosity, Skepticism Over New Algae-Derived Alzheimer’s Drug

US experts are curious and skeptical about a new Alzheimer’s disease (AD) drug (GV-971; oligomannate; Shanghai Green Valley Pharmaceuticals, China) that was conditionally approved earlier this month by China’s National Medical Products Administration for mild-to-moderate AD. Oligomannate is a drug manufactured from an oligosaccharide extracted from marine algae and is the first novel drug approved for AD globally since 2003, …

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National Living Kidney Donor Registry to Be Launched in US

The first national living donor registry for kidneys is soon to be launched in the United States by Donate Life America who, in partnership with the Fresenius Medical Care Foundation, plan to have it up and running in 2020. “On average, about 17 people in the US die every day waiting for a life-saving kidney transplant,” David Fleming, president and …

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