Search Results for “EC” – Page 369 – media

New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease

By Claire Jarvis Pictured: Close-up of an arm receiving a blood draw/iStock, montiannoowong Prior to the approval of effective therapies for Alzheimer’s disease, there was little need for biomarker tests. Now, with Eisai and Biogen’s anti-amyloid drug Leqembi on the market and approval of Eli Lilly’s donanemab expected to follow soon, the pipeline of Alzheimer’s drugs is expanding and the development of tests to detect the disease is accelerating. With Leqembi’s full approval, the Centers for Medicare and Medicaid Services (CMS) has instituted broader coverage of the drug—with stipulations. To ensure reimbursement, physicians must participate in a qualified registry and patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia with evidence of beta-amyloid deposits. To help facilitate this, CMS proposed in July 2023 to increase its coverage of PET scans to detect these amyloid plaques—however, cheaper and faster diagnostic methods are still being developed. The past ...
- Source: drugdu
- 186
- September 6, 2023
Amgen and Horizon Therapeutics settle FTC lawsuit

Amgen and Horizon Therapeutics have reached a consent order agreement with the Federal Trade Commission (FTC) to resolve an ongoing administrative lawsuit. This sets the stage for Amgen to proceed with the last steps in finalising the acquisition of Horizon. In December last year, Amgen reached an agreement to acquire the complete issued and to-be-issued ordinary share capital of Horizon Therapeutics for $116.50 (€107.82) per share in cash or nearly $27.8bn on a fully diluted basis. As a result of the agreement, Amgen and Horizon anticipate submitting joint proposals to dismiss the preliminary injunction motion and lift the temporary restraining order (TRO) in the US District Court for the Northern District of Illinois. In May this year, the FTC took legal action in federal court to prevent the transaction, arguing that it would allow Amgen to leverage rebates from its successful drugs to exert influence over insurance companies and pharmacy ...
- Source: drugdu
- 164
- September 6, 2023
Centogene finds diagnostic and predictive biomarker for Gaucher disease

Centogene has published data about the use of lyso-Gb1 (glucosylsphingosine) as a sensitive diagnostic and predictive biomarker for Gaucher disease. The study was published in the open-access MDPI journal, Diagnostics, and showed that lyso-Gb1 could be used to predict the clinical course of patients with Gaucher disease. Gaucher disease is a rare inherited metabolic disorder caused by mutations in the beta-glucocerebrosidase (GBA1) gene, responsible for producing a fat-breaking enzyme, glucocerebrosidase. Decreased activity of the enzyme causes fat accumulation in the cells causing symptoms such as liver enlargement, anaemia, bone pain, and spleen enlargement. Multiple biomarkers have been identified for the disease. However, these were present in other diseases and not exclusively in Gaucher disease. Lyso-Gb1 is a more specific biomarker for Gaucher’s, and it can be used to both diagnose the disease and monitor its progression. The confirmation of the biomarker serves as an important step forward in rare disease ...
- Source: drugdu
- 173
- September 6, 2023
Children participating in sports have better long term mental health

A study led by University of Queensland researchers has found children who regularly participate in sports from an early age will have better long term mental health. Associate Professor Asad Khan from UQ’s School of Health and Rehabilitation Sciences led the study, which analyzed the data of more than 4,200 Australian children over an eight-year period from the Longitudinal Study of Australian Children. Dr. Asad Khan (Associate Professor, UQ’s School of Health and Rehabilitation Sciences) said, “Consistent participation in sports from childhood is associated with better mental wellbeing amongst adolescents. Our research looked at the benefits of team sports such as football, cricket, or netball, and individual sports like karate, tennis, or gymnastics. We found there was a positive impact on mental health regardless of the type of sport, however children who played in a team experienced greater benefit. This could be due to the social aspects involved such as ...
- Source: drugdu
- 104
- September 5, 2023
Bavarian Nordic Drops COVID Booster After Poor Phase III Results

By Connor Lynch Pictured: Syringe drawing up drug from vial/iStock, Kuzmik_A Bavarian Nordic is dropping its experimental, Phase III COVID-19 booster after clinical data showed limited effectiveness against new and emerging variants of concern. The Danish company announced that despite its COVID booster ABNCov2 demonstrating non-inferior levels of neutralizing antibodies as compared to Pfizer’s Comirnaty against the SARS-CoV-2 variant, the original COVID virus, the company would nevertheless not be pursuing commercialization of the vaccine. “In a follow-up analysis, when looking at this more distant variant, the levels of neutralizing antibodies induced by ABNCoV2 were lower than those stimulated by the non-adapted Wuhan-based Comirnaty, and fewer people had detectable antibodies following ABNCoV2 (64%) versus Comirnaty (85%),” the company said. The booster’s commercial viability was called into question because the new variants, such as XBB.1.5, are now the primary variants of concern. Bavarian Nordic said that the data “support the current position ...
- Source: drugdu
- 100
- September 5, 2023
New screening model shown to predict ten year breast cancer mortality risk

The University of Oxford’s Nuffield Department of Primary Care Health Sciences has successfully developed a new model to predict the likelihood of a person developing and dying of breast cancer within ten years. The new risk-based screening model works to identify those at the highest risk of deadly cancers. Despite the ability of breast cancer screening to reduce deaths, it can sometimes lead to unnecessary treatments due to overdiagnosis when innocuous tumours are detected. In the UK, for every 10,000 women aged 50 years invited to breast screening for the next 20 years, 43 breast cancer deaths will be prevented, but 129 will be overdiagnosed. Researchers analysed anonymised data from 11.9 million women aged 20 to 90 years between 2000 and 2020 from the OResearch database. The team tested four different modelling techniques to predict breast cancer mortality risk: two traditional statistical-based models and two artificial intelligence (AI) models, all ...
- Source: drugdu
- 103
- September 5, 2023
Bayer bets big on Kerendia’s potential to treat heart failure

Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. In the second quarter, sales of Kerendia reached 67 million euros ($73 million). For Bayer to achieve its ambitious peak sales target of 3 billion euros ($3.3 billion), it will have to expand the label of the nonsteroidal mineralocorticoid receptor antagonist (MRA). To get there, Bayer is making a big play in heart failure. Thursday, the company said it’s planning three new phase 3 trials in the indication, in addition to one that’s already underway. The new studies will evaluate Bayer’s medicine in roughly 9,000 new heart failure patients with reduced, mildly reduced and preserved ejection fraction. The REDEFINE-HF trial will investigate finerenone as a monotherapy in approximately 5,200 patients with an ejection fraction of greater than 40%. The FINALITY-HF trial will ...
- Source: drugdu
- 101
- September 5, 2023
Amgen’s $28B Horizon buyout cleared for takeoff after FTC, states settle

After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address the “potential competitive harm” that could result from the merger deal. Alongside the FTC, attorneys general from six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are moving to dismiss their injunction requests. The FTC first filed its antitrust lawsuit against Amgen in May in an attempt to block the sale. In its suit, FTC argued that Amgen could leverage its lucrative product portfolio to “entrench the monopoly positions” of Horizon’s thyroid eye disease drug Tepezza and the company’s gout treatment Krystexxa. For its part, Amgen has promised not to use that tactic with Horizon’s drugs. In a press release Friday, the company said it “has consistently stated to the FTC, the courts and ...
- Source: drugdu
- 105
- September 5, 2023
【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
- Source: drugdu
- 307
- September 5, 2023
European Union medical device regulations
Low-dose aspirin linked to 15% lower risk of type 2 diabetes in older adults

New research to be presented at this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD) in Hamburg, Germany (2-6 October) shows that use of low dose (100mg daily) aspirin among older adults aged 65 years and older is associated with a 15% lower risk of developing type 2 diabetes. The authors, led by Professor Sophia Zoungas, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia, say the results show that anti-inflammatory agents such as aspirin warrant further study in the prevention of diabetes. The effect of aspirin on incident type 2 diabetes among older adults remains uncertain. This study investigated the randomised treatment effect of low dose aspirin on incident diabetes and fasting plasma glucose (FPG) levels among older adults. The authors did a follow-up study of the ASPREE trial – a double-blind, placebo-controlled trial of aspirin, the principal results of which were ...
- Source: drugdu
- 107
- September 4, 2023

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