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EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment

By Brenda Goodman, CNN Updated 2:49 PM EDT, Tue April 11, 2023 The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices. The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk. Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas. In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process. The EPA issued the report on the new risks without issuing a news release, as ...
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- April 13, 2023
FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

Dive Brief: The Food and Drug Administration told Merck KGaA not to give an experimental drug for multiple sclerosis to new patients and to pause treatment for study participants who have been on it for less than 70 days amid concerns about possible liver damage. Regulators acted after laboratory tests suggested the livers of two patients might have been adversely affected by the drug, known as evobrutinib. However, neither patient exhibited symptoms and their liver enzyme levels returned to normal after they stopped taking the medicine, Merck KGaA said Wednesday. The German drugmaker had already fully enrolled a Phase 3 study known as Evolution, and that program will continue as planned because all the patients have already had received the medication for at least 70 days. Results are still expected in the fourth quarter. Dive Insight: Evobrutinib is part of a class of drugs known as BTK ...
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ImmuneBridge raises funds to advance new cell-based immunotherapies

Biotechnology company ImmuneBridge has raised $12m seed financing to advance new natural killer (NK) cell-based immunotherapies. Co-led by global investors Insight Partners and M Ventures, the financing round has also seen participation from Gaingels and One Way Ventures. ImmuneBridge is developing allogeneic NK cell-based immunotherapies to treat solid tumours and hematologic malignancies. According to the company, NK cells represent a platform for allogeneic immunotherapy as they are potent cancer killers, with less risk profile. The company’s orthogonal approach leverages an expansion technology and a diverse clinic-ready source for accelerating the discovery and translation of potent cell therapies. Its expansion technology expands hematopoietic stem cells (HSCs), which are natural NK cells precursors. ImmuneBridge CEO and co-founder Peretz Partensky said: “Cell therapy is a new pillar of medicine and is inextricably human. Cell therapy developers fear donor-to-donor variability, yet we humans are unapologetically diverse in our innate ...
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Mediterranean diet may lower heart disease risk in women by nearly 25%, study finds

Closely following a Mediterranean diet may cut a woman’s risk of heart disease and death by nearly 25%, according to a new analysis of 16 studies. “This study adds to what is already known about the cardiovascular benefits of a Mediterranean diet but further reiterates that it can be equally as beneficial in women as it is known to be in men,” said lead author Sarah Zaman, associate professor at the Westmead Applied Research Centre at the University of Sydney, in an email. Heart disease is the number one killer of women and men worldwide, according to the World Health Organization. Coronary artery disease kills more than twice as many women as breast cancer in the United Kingdom, while in 2020, one in five deaths among women in the United States was because of heart disease. Yet few studies on the heart have looked specifically at women, ...
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The virological characteristics of XBB.1.16

In a recent study posted to the bioRxiv* preprint server, researchers perform extensive multiscale investigations to explore virological characteristics of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron XBB subvariant, XBB.1.16. Background The SARS-CoV-2 XBB.1.16 variant is associated with a 1.27- and 1.17-fold higher effective reproductive number (Re) as compared to the XBB.1 and XBB.1.5 subvariants, respectively, thus indicating the ability of this novel Omicron variant to disseminate quickly. As a result of this increased transmissibility, the World Health Organization (WHO) began monitoring XBB.1.16 on March 30, 2023, following its detection in several countries, including India. Earlier, the SARS-CoV-2 Omicron XBB subvariants with the F486P substitution in their spike (S) protein, which include XBB.1.5 and XBB.1.9, were widely circulating worldwide. Study findings The current analyses showed that as compared to its predecessor mutant strains, XBB.1.16 had two S substitutions, including E180V and T478R in the N-terminal domain (NTD) ...
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Dietary supplement helps combat resistance in breast cancer, finds study

Many cancer therapies do not produce the hoped-for results. A common reason for this is that the tumors develop resistance to the medications. This is the case, for example, with alpelisib, a drug that has been approved for use in Switzerland for the past few years as a treatment for advanced breast cancer. A research group at the Department of Biomedicine of the University of Basel has now discovered that the loss of the neurofibromin 1 (NF1) gene leads to a reduced response to alpelisib. The researchers also found that the dietary supplement N-acetylcysteine restores the sensitivity of cancer cells to this treatment. The findings have been published in the journal Cell Reports Medicine on April 11. Loss of gene triggers resistance At the moment, patients with advanced and metastatic breast cancer lack effective treatment options. The PI3K signaling pathway is often overactive in breast cancer due to mutations promoting tumor ...
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- April 12, 2023
STDs are on the rise. This morning-after-style pill may help

US health officials released data Tuesday showing how chlamydia, gonorrhea and syphilis cases have been accelerating, but doctors are hoping an old drug will help fight the sexually transmitted infections. Experts believe STDs have been rising because of declining condom use, inadequate sex education and reduced testing during the COVID-19 pandemic. Millions of Americans are infected each year. Rates are highest in men who have sex with men, and among Black and Hispanic Americans and Native Americans. “Sexually transmitted infections are an enormous, low-priority public health problem. And they’ve been a low-priority problem for decades, in spite of the fact that they are the most commonly reported kind of infectious disease,” said Dr. John M. Douglas Jr., a retired health official who lectures at the Colorado School of Public Health. To try to turn the tide, many doctors see promise in doxycycline, a cheap antibiotic that has been sold for more than ...
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A Future Without Screening Colonoscopies?

Kerry Dooley Young April 05, 2023 US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening. Most recently, Guardant Health, Inc, announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test. Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC. If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years. “They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, ...
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‘This Is a First’

Marcia Frellick April 07, 2023 Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Researchers have found for the first time that COVID infection has crossed the placenta and caused brain damage in two newborns, according to a study published online today in Pediatrics. One of the infants died at 13 months and the other remained in hospice care at time of manuscript submission. Lead author Merline Benny, MD, with the division of neonatology, department of pediatrics at University of Miami, and colleagues briefed reporters today ahead of the release. “This is a first,” said senior author Shahnaz Duara, MD, medical director of the Neonatal Intensive Care Unit at Holtz Children’s Hospital, Miami, explaining it is the first study to confirm cross-placental SARS-CoV-2 transmission leading to brain injury in a newborn. Both infants negative for the virus at birth ...
- Source: drugdu
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GSK outlines deal to send cell therapies back to Adaptimmune

The pharma is handing back two experimental cancer medicines amid a retreat from cell therapy research. GSK has outlined a deal to send two cancer immunotherapies back to biotechnology company Adaptimmune Therapeutics, a move that follows the larger drugmaker’s recent decision to stop investing in cell and gene therapy research. Adaptimmune announced last October that it would regain rights to the two programs, each of which are in development for solid tumors. On Tuesday, the biotech revealed terms of the agreement. It will get about $37 million in cash from GSK, and receive all materials, data and trial sponsorship responsibilities related to the drugs later this year. The agreement will formally end a partnership between GSK and Adaptimmune that dates back to 2014. That year, the two began working on a program called lete-cel, which works by genetically modifying cells to detect NY-ESO, a protein expressed on several ...
- Source: drugdu
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- April 12, 2023

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