PharmaFocus Today – Page 51 – media

Breas Medical flags risk of formaldehyde exposure in ventilators

Dive Brief Breas Medical started a correction of more than 8,000 ventilators after identifying a risk of formaldehyde exposure, the company said Friday. The notice, which was shared by the Food and Drug Administration, states internal testing of Vivo 45 LS ventilator devices showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions. Breas, which had not received any related injury reports, has reduced the maximum room air temperature of the ventilators and updated its instructions for new devices to mitigate the risk. Dive Insight The potential for ventilators to expose patients to formaldehyde, a chemical that can harm the lungs and nervous system, has prompted actions by the FDA and companies including GE Healthcare over the past two years. Breas began a nationwide U.S. correction of 8,186 Vivo 45 LS ventilator devices on Aug. 5. Internal testing of the Vivo 45 LS, a small, portable ...
- Source: drugdu
- 84
- August 16, 2024
UroGen Pharma Submits FDA New Drug Application for UGN-102, a Potential Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

By Don Tracy, Associate Editor UGN-102 has the potential to be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, UroGen says. UroGen has completed its New Drug Application (NDA) submission for UGN-102 (mitomycin) for intravesical solution, suggesting that it has the potential to become the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA submission is supported by results from the Phase III ENVISION trial, which demonstrated that patients treated with UGN-102 had a 79.6% complete response (CR) rate at three months following the first instillation.1 “The completion of the NDA submission for UGN-102 marks a crucial milestone for UroGen and underscores our dedication to advancing this groundbreaking treatment for patients with LG-IR-NMIBC,” said Liz Barrett, president, CEO, UroGen, in a press release. “By providing a viable alternative to repeated surgeries, if approved UGN-102 may offer patients quality of life benefits and clinically ...
- Source: drugdu
- 75
- August 16, 2024
FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
- Source: drugdu
- 72
- August 16, 2024
Replimune kickstarts Phase III melanoma trial studying RP1 immunotherapy

Replimune has announced the first patient in the Phase III melanoma trial with its lead immunotherapy RP1 or vusolimogene oderparepvec has been dosed and randomised. The IGNYTE-3 study (NCT06264180) will investigate the use of RP1 plus Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are ineligible for anti-CTLA-4 therapy. Massachusetts-based biotech Replimune’s CMO Kostas Xynos stated that the trial will serve to, “advance of our planned BLA submission of RP1 in advanced melanoma later this year”. In spite of slowing research, the wider oncolytic virus-based market has been projected to grow from $114mn in 2023 to $2.4bn in 2029 according to GlobalData analyst Kevin Marcaida. Marcaida expects that within this period, Replimune’s RP1 could claim a 74% market share. The IGNYTE-3 trial comes as Replimune continues a downward financial trend. Despite announcing $100m in private placement ...
- Source: drugdu
- 62
- August 16, 2024
Kezar stalls solid tumour trial to focus on autoimmune disease candidate

Clinical stage biopharma Kezar Life Sciences will drop its Phase I solid tumour drug to streamline focus on its lead autoimmune disease drug zetomipzomib. The San Francisco-based biotech shared this update in its 2Q financial results. The candidate, dubbed KZR-261, was being investigated in a Phase I trial (NCT05047536) in patients with solid tumours. Of the 61 enrolled patients, five experienced stable disease for four months or longer, with two of these patients experiencing stable disease for a year or longer. No objective responses have been reported. Enrolment in the trial has been halted, but the 61 patients will continue to have access to KZR-261. All eyes will now be on zetomipzomib, a selective immunoproteasome inhibitor. The candidate is being evaluated in a Phase IIb PALIZADE clinical trial (NCT05781750) for lupus nephritis and a Phase IIa PORTOLA clinical trial (NCT05569759) for autoimmune hepatitis. Everest Medicines secured the Greater China, South ...
- Source: drugdu
- 70
- August 16, 2024
International researchers use shear waves to map blood vessel structures

Researchers from King’s College London’s (KCL) School of Biomedical Engineering and Imaging sciences, along with partners at the University of Michigan, the Institut national de la santé et de la recherche médicale in Paris, Norway and Germany, are using shear waves to map blood vessel structures to improve treatments for tumours and other medical conditions. Findings published in Science Advances could improve cancer treatment and potentially improve drug delivery while helping researchers better understand tumours. Michigan and KCL experts developed a new theory using MRI-based elastography imaging to study how shear waves travel through tissue. By analysing them, researchers are able to measure the architecture of blood vessels non-invasively using readily available clinical imaging devices. Shear waves store information about the materials they pass through, including tissue stiffness, which can help diagnose diseases. The method allows researchers to see tiny blood vessels that are usually too small to detect and ...
- Source: drugdu
- 56
- August 16, 2024
Study finds AI reduces underdiagnosis of Black patients with common heart failure

A study led by King’s College London (KCL) has revealed that Black patients are less likely to be underdiagnosed with a common type of heart failure when using artificial intelligence (AI), compared to in routine practice. The research, funded by the British Heart Foundation, could help researchers understand the extent of heart failure with preserved ejection fraction (HFpEF) underdiagnosis across ethnicities, as well as reduce bias and improve diagnoses. Heart failure is estimated to affect more than one million people in the UK, 50% of whom have HFpEF, which occurs when the heart pumps out blood normally but cannot fill up as well, leading to signs and symptoms of failure such as breathlessness, fatigue and dizziness. Using an AI algorithm called Natural Language Processing (NLP), which reads and understands medical text and analyses electronic medical records, researchers identified nearly 1,973 patients who met the current European Society of Cardiology guidelines ...
- Source: drugdu
- 74
- August 16, 2024
Cell adhesion and starvation found to be key drivers of pattern formation in keratinocytes

Cell-cell adhesion-induced patterning in keratinocytes can be explained by just starvation and strong adhesion, Hokkaido University researchers find. Fingerprints are one of the best-recognised examples of pattern formation by epithelial cells. The primary cells in the epithelium are the keratinocytes, and they are known to form patterns at the microscopic and macroscopic levels. While factors affecting this pattern formation have been reported, the exact mechanisms underlying the process are still not fully understood. A team of researchers, led by Associate Professor Ken Natsuga at the Faculty of Medicine, Hokkaido University, have revealed that cell-cell adhesion governs pattern formation in keratinocytes. Their findings were published in the journal Life Science Alliance. Ken Natsuga, Associate Professor, Faculty of Medicine, Hokkaido University, said, “In this study, we used an immortalized keratinocyte cell line, called HaCaT, which retains all the properties of normal keratinocytes. In order to ensure that our findings were accurate, we ...
- Source: drugdu
- 68
- August 15, 2024
Humor could be an effective parenting tool, study suggests

They say that laughter is the best medicine, but it could be a good parenting tool too, according to a new study led by researchers from Penn State. In a pilot study, the research team found that most people viewed humor as an effective parenting tool and that a parent or caregiver’s use of humor affected the quality of their relationship with their children. Among those whose parents used humor, the majority viewed their relationship with their parents and the way they were parented in a positive light. The researchers published their findings in the journal PLOS One. Benjamin Levi, professor of pediatrics and humanities at Penn State College of Medicine and senior author of the study, said, “Humor can teach people cognitive flexibility, relieve stress, and promote creative problem solving and resilience. My father used humor and it was very effective. I use humor in my clinical practice and ...
- Source: drugdu
- 102
- August 15, 2024
CMT Research Foundation invests in research project to develop treatments for CMTs

The CMT Research Foundation (CMTRF) has invested in a research project based at Nationwide Children’s Hospital, US, to develop new vehicles for delivering gene therapies to treat several types of Charcot-Marie-Tooth disease (CMT). The new project aims to improve the treatment efficacy and safety of gene therapies for forms of CMTs, including CMT1A, the most prevalent form, which accounts for 50% of all patients with nerve-damaging disorder. Recognised as a rare peripheral neuropathy disease that affects nearly three million people globally, CMT is a group of inherited conditions that damage the peripheral nerves, which are found outside the main central nervous system. The development of safe and effective gene therapies for CMT requires the delivery of a therapeutic genetic payload into the peripheral nervous system, which specifically targets Schwann cells, a type of glial cells that help form the myelin sheath around the nerve fibres, for types of CMT including ...
- Source: drugdu
- 84
- August 15, 2024

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