Search Results for “FDA” – Page 158 – media

Researchers discover critical protein for common bone growth disorder

A team led by UT Southwestern Medical Center researchers has discovered a protein that appears to be pivotal for traumatic heterotopic ossification (HO), a condition in which bone forms in muscles, tendons, and other soft tissues after traumatic injury or surgery. The findings, published in Science Advances, could yield new ways to prevent this common complication, the researchers say. “Right now, we have no ways to prevent HO from occurring, which can cause significant impairments in quality of life. For example, it can alter patients’ range of motion, producing chronic pain, and affect the ability of amputees to fit into prostheses,” said Benjamin Levi, M.D., Associate Professor of Surgery and Plastic Surgery, and Chief of the Division of Burn, Trauma, Acute, and Critical Care Surgery at UT Southwestern. “Hopefully, these new findings will lead to treatments that can stop this process from unfolding so patients never develop it.” HO occurs when cells ...
- Source: drugdu
- 145
- April 19, 2023
EPA proposes new ethylene oxide rules for medical device sterilization

April 12, 2023 By Jim Hammerand Leave a Comment FacebookTwitterLinkedIn New ethylene oxide rules from the EPA would reduce EtO emissions from commercial sterilizers by 80%, the agency said. The EPA this week proposed new regulations for companies that sterilize medical devices with EtO, following up on last week’s proposal for new EtO rules on chemical plants that make or store the sterilant. EtO is the most common method of medical device sterilization, used for around half of the 40 billion devices sterilized each year in the U.S. For some devices, there’s no alternative to EtO because gamma ray and electron beam sterilization can only be used on certain materials. FAQ: What is electron beam sterilization? But health risks for sterilization plant workers and neighbors have the EPA, FDA, Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) working together to reduce those risks without reducing sterilization capacity. “OSHA’s mission is to ...
- Source: drugdu
- 235
- April 19, 2023
Pre- and post-surgical immunotherapy-based treatment significantly improved lung cancer outcomes

Reviewed by Emily Henderson, B.Sc.Apr 17 2023 A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AEGEAN trial evaluated durvalumab given perioperatively, meaning therapy is given both before and after surgery. Participants on the trial received either pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab or neoadjuvant placebo and chemotherapy followed by adjuvant placebo. These represent the first data presented on the benefits of perioperative immunotherapy for resectable NSCLC and adds to the growing evidence supporting the benefits of both neoadjuvant and adjuvant immunotherapy for these patients. Our goal is to increase cures for lung cancer. ...
- Source: drugdu
- 124
- April 18, 2023
Higher Paxlovid uptake in winter 2022 could have prevented nearly 5,000 deaths

In a recent study published in the JAMA Health Forum, researchers in the United States estimated the reduction in coronavirus disease 2019 (COVID-19) mortality rates after the Paxlovid rollout. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections were the third largest cause of mortality in the United States in 2022, and after the Food and Drug Administration (FDA) approved Paxlovid (nirmatrelvir and ritonavir), the test-to-treat strategy became a pillar of the US pandemic response. Treatment with Paxlovid necessitates testing and medication initiation within five days after COVID-19 symptoms start. However, the population-level effect of the Paxlovid rollout has not been evaluated. About the study In the present study, researchers estimated the simulated influence of the Paxlovid rollout on COVID-19-related hospitalizations and deaths. The team modeled COVID-19-related hospitalization and death rate reductions after Paxlovid introduction as the product of (1) the number of symptomatic patients diagnosed within five ...
- Source: drugdu
- 105
- April 17, 2023
To protect kids from tobacco, pediatricians say, focus should be on quitting – or never starting

Although smoking rates for adults in the US are at their lowest recorded levels, more must be done to stop children from using tobacco, according to a new set of policy statements from the American Academy of Pediatrics. The statements, published Monday, are the association’s first tobacco policy update since 2015. They’re based on newer science and better reflect how many children now use e-cigarettes as more kid-friendly products have flooded the market. AAP policy statements are created by expert pediatricians to help leaders craft more effective public health policy and to guide physicians on how to keep kids safe – in this case, from tobacco. High rates of tobacco use Researchers have been telling Americans for generations that tobacco products are bad for them, yet nearly 200 US children take up smoking every day, according to the US Centers for Disease Control and Prevention. Tobacco ...
- Source: drugdu
- 127
- April 17, 2023
Spherix

U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake. That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year. Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water. The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was ...
- Source: drugdu
- 134
- April 14, 2023
Appeals court rules abortion drug can stay on market — but limits access

A three-judge panel decided mifepristone’s FDA approval shouldn’t be revoked, but its decision could still make the drug much harder to obtain. An appellate court has blocked a ruling that would have suspended the approval of a decades-old abortion pill, but decided the medicine should only stay on the market with strict limitations. The 2-1 decision from the U.S. Court of Appeals for the 5th Circuit upholds the Food and Drug Administration’s 2000 approval of mifepristone, a medicine used in more than half of all U.S. abortions and to treat miscarriages. But the panel also unwound long-running efforts by the regulator to expand access to mifepristone in recent years. Since 2016, the FDA has enabled the drug to be used through ten weeks of gestation, instead of seven. The agency has also allowed the medication to be delivered by mail and prescribed through a teleheath visit, rather than ...
- Source: drugdu
- 193
- April 14, 2023
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, ...
- Source: drugdu
- 121
- April 12, 2023
US health officials aim to ‘transform’ Alzheimer’s disease research with $300 million data platform

The US National Institute on Aging is moving forward with efforts to build a real-world Alzheimer’s disease database as part of its aim to improve, support and conduct more dementia research. Last month, the agency, part of the National Institutes of Health, posted a notice of the grant for the six-year database project, setting its earliest start date as April 2024. The NIH confirmed Tuesday that plans are underway to fund the Alzheimer’s disease and Alzheimer’s disease-related dementias’ real-world data platform. The National Institute on Aging intends to commit $50 million per year, starting in fiscal year 2024, to fund one award. The nonprofit Alzheimer’s Association is among those planning to apply for the grant. “The newly-announced NIA funding for a large-scale Alzheimer’s disease research database is truly exciting and a very important step forward for our field, and the Alzheimer’s Association will apply for ...
- Source: drugdu
- 144
- April 12, 2023
GSK will have to pay additional royalties to AstraZeneca on cancer drug Zejula

[GSK already has concerns with cancer drug Zejula, which is under scrutiny as a member of the PARP inhibitor class. Not the company has taken a loss in court as it will have to surrender added royalties to AstraZeneca for the drug which rolled up sales of 463 pound sterling ($571 million) last year. (GSK)] When Emma Walmsley took over as CEO at GSK in 2017, one of her first moves was to beef up the company’s oncology portfolio with a $5.1 billion acquisition of cancer specialist Tesaro and its newly approved drug Zejula. The ovarian cancer treatment generated 463 pound sterling ($571 million) in 2022, representing a 17% increase from the previous year. So far, so good, right? Well, not exactly. After losing a patent case in court on Wednesday, GSK will have to surrender a portion of its sales of Zejula to Tesaro’s partner on ...
- Source: drugdu
- 159
- April 6, 2023

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