Search Results for “Johnson ” – Page 23 – media

Clinical Trial Set to Change Kidney Transplant Practice

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25%. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. The research was published in The Lancet. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood—instead of the usual practice of using normal saline (sodium chloride and water). “Of those study participants who received intravenous Plasma-Lyte 148, 30% needed dialysis after their transplants, compared to 40% for those given normal saline,” Professor Johnson said. “This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal Adelaide Hospital Nephrologist ...
- Source: drugdu
- 115
- July 14, 2023
J&J Megadyne Unit’s Electrode Pad Recall Labeled Class I over Burn Risk

Dive Brief Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries, the agency said in a Tuesday notice. Megadyne contacted customers last month after receiving reports of burns linked to its reusable electrode pads. The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths. The Class I recall covers 21,200 MEGA 2000 and MEGA Soft reusable electrodes sold in the U.S. In an emailed statement, a spokesperson for J&J wrote that the notification was not a product removal, and Mega Soft pads may continue to be used. Dive Insight Megadyne is a subsidiary of Johnson & Johnson’s Ethicon segment that makes tools used in electrosurgery, procedures that involve the use of electric current to heat or cut tissue or to stop bleeding. The ...
- Source: drugdu
- 132
- July 14, 2023
Anti-inflammatory Drugs Do Not Lead to a Swifter Hospital Exit

Anti-inflammatory drugs may reduce deaths due to Covid-19, but they do not help speed up the recovery for those in hospital, according to a recent study. Results from s study, published in The Journal of the American Medical Association, demonstrated that giving abatacept, cenicriviroc, or Johnson and Johnson’s Remicade (infliximab) in addition to standard of care did not decrease time to recovery for patients hospitalised with Covid-19 pneumonia. The standard of care included in this study involved Gilead Sciences’ Veklury (remdesivir) and the corticosteroid dexamethasone. Patients who took either one of the three drugs recovered after a similar number of days compared to those who were on placebo. The investigators also measured mortality across the sub-studies by day 28 – which did show slight differences, though not statistically significant. Abatacept and Remicade led to a narrow decrease in patient deaths – a 4.1% and 4.4% difference respectively, whilst ...
- Source: drugdu
- 135
- July 13, 2023
Kidney transplant recipients may benefit from new fluid therapy

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25 per cent. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood – instead of the usual practice of using normal saline (sodium chloride and water). David Johnson, UQ Professor, said, “Of those study participants who received intravenous Plasma-Lyte 148, 30 per cent needed dialysis after their transplants, compared to 40 per cent for those given normal saline. This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal ...
- Source: drugdu
- 140
- July 8, 2023
FDA rejects Alvotech’s Humira biosimilar for the third time

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
- Source: drugdu
- 110
- July 1, 2023
Former J&J sales rep indicted on charges of defrauding Boston hospital

Dive Brief A former DePuy Synthes sales representative and team lead was arrested this week for allegedly defrauding a Boston area hospital and lying to federal authorities investigating whether he interfered with the hospital’s sterilization processes. Matthew Capobianco, 45, of Winchester, Massachusetts, was indicted on eight counts of wire fraud and one count of making material false statements, according to the U.S. Attorney’s Office in Boston. Johnson & Johnson unit DePuy Synthes, in an emailed statement, said all government claims against the company in the matter have been resolved. Dive Insight According to the Department of Justice indictment, Capobianco defrauded the hospital out of hundreds of thousands of dollars’ worth of spine products that he falsely represented as used in surgeries from January 2016 through June 2017. The Boston area hospital was not named in the DOJ’s statement. To boost his sales numbers and his compensation, Capobianco falsely represented on ...
- Source: drugdu
- 138
- June 30, 2023
analysts

Dive Brief Intuitive Surgical’s minimally invasive bronchoscopy platform Ion may provide “some of the most exciting advancements in robotic technology” in the coming years, according to analysts at BTIG. While Ion contributed an estimated $115 million of the company’s $6.2 billion in revenue last year, the analysts see scope for Intuitive to grow sales by capturing more of the lung biopsy market and expanding into the ablation of tumors. Intuitive competes for the bronchoscopy market with Johnson & Johnson’s Monarch platform. The analysts estimate there are about twice as many Ion systems as Monarch devices in use. Dive Insight Intuitive’s success rests on its da Vinci robotic platform and discussions of the future of the company focus on whether J&J and Medtronic can challenge the dominance of that device, the BTIG analysts said. “Intuitive’s push into robotic bronchoscopy is purposeful, not just simply for the bronchoscopy opportunity, but for its ...
- Source: drugdu
- 107
- June 26, 2023
Empress Therapeutics emerges with $50m to fund small molecule development

Life sciences venture capital firm Flagship Pioneering has unveiled Empress Therapeutics, a small molecule drug development startup. The Moderna-backed venture fund has launched Empress with a $50m investment. This will support development of its proprietary Chemilogics platform and drug discovery pipeline. So far, Empress claims to have generated 15 drug leads across multiple indications. These span multiple structural classes and target several classes of proteins, including cytokines, enzymes, G protein-coupled receptors (GPCRs), and ion channels. With this pipeline, Empress hopes to address unmet clinical needs in immune and inflammatory conditions, and metabolic, neurologic, oncologic, and pain disorders. The company expects to file multiple IND applications in these areas over the next couple of years. Empress benefits from a wealth of clinical data, and recent advances in genomics, artificial intelligence (AI) and synthetic biology. This allows the company’s platform to read genetic code and use biosynthetic instructions to find, make and ...
- Source: drugdu
- 122
- June 23, 2023
Merck’s efinopegdutide shows promise in nonalcoholic fatty liver disease

Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD). NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD. There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition. The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound’s efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients. The candidate was ...
- Source: drugdu
- 129
- June 16, 2023
analysts

Dive Brief Pulsed field ablation (PFA) devices from Boston Scientific, Johnson & Johnson and Medtronic are a threat to Abbott’s $1.9 billion electrophysiology business, according to analysts at Stifel. Abbott is taking a “wait-and-see” approach to PFA, advancing a later generation device in the belief that the first wave of products will have shortcomings that limit adoption, the report said. The analysts see “some logic” to Abbott’s position but expect the company to suffer share losses in the coming years. The pressure could ramp up quickly, with the analysts warning products that make up around 90% of Abbott’s electrophysiology sales could be affected by the switch to PFA by 2025. Dive Insight Abbott has a PFA device in development but it is years behind the front-runners, with first in-human use planned for this year. Based on that, the analysts estimate the device, named Volt, could win approval in the U.S. ...
- Source: drugdu
- 112
- June 15, 2023

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