PharmaFocus Today – Page 47 – media

Genetic Analysis of Lyme Disease Bacteria to Enable More Accurate Diagnostic Tests

Lyme disease is the most prevalent tick-borne illness in North America and Europe, affecting hundreds of thousands of individuals annually. The disease is caused by bacteria from the Borrelia burgdorferi sensu lato group, which are transmitted to humans through the bites of infected ticks. Symptoms typically include fever, headache, fatigue, and a distinctive skin rash. If not treated promptly, the infection can spread to the joints, heart, and nervous system, leading to more severe complications. Now, researchers have conducted a genetic analysis of the bacteria responsible for Lyme disease, potentially leading to advancements in the diagnosis, treatment, and prevention of this tick-borne illness. A research team led by biologists at CUNY Graduate Center (New York, NY, USA) has mapped the complete genetic sequences of 47 strains of Lyme disease-related bacteria from across the globe, creating a valuable resource for identifying the specific bacterial strains that infect patients. This genetic data ...
- Source: drugdu
- 72
- August 23, 2024
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma

August 21, 2024 By Don Tracy, Associate Editor Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma. Image Credit: Adobe Stock Images/magicmine The FDA has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for an immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC). According to BMS, acceptance of the sBLA was based on promising results from the Phase III CheckMate-9DW trial, which demonstrated that the combination significantly improved overall survival (OS) compared to Lenvima (lenvatinib) or Nexavar (sorafenib).1 “HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option. With the number of individuals diagnosed with HCC in the United States increasing over ...
- Source: drugdu
- 78
- August 23, 2024
FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option. By Frank Vinluan on August 21, 2024 Regeneron Pharmaceuticals already lags companies that have launched new multiple myeloma drugs, and it will have to wait a little bit longer to join them. The FDA turned down Regeneron’s application for its drug candidate, but not for any issues with the therapy itself. The regulator cited problems with the treatment’s third party manufacturer. The FDA rejection for the drug, linvoseltamab, is not a surprise. Regeneron foreshadowed that decision earlier this month during its conference call to discuss second quarter 2024 financial results, disclosing that that the FDA flagged unresolved findings with the contract manufacturer. Those problems centered on another company’s ...
- Source: drugdu
- 75
- August 23, 2024
POC Saliva Testing Device Predicts Heart Failure in 15 Minutes

Heart failure is a serious condition where the heart muscle is unable to pump sufficient oxygen-rich blood throughout the body. It ranks as a major cause of death globally and is particularly fatal for individuals without access to medical facilities. Traditionally, heart failure is monitored biannually through a blood test that measures B-type natriuretic peptide (BNP) levels, indicating excessive heart strain. Recently, advancements in point-of-care technology aim to revolutionize this approach by introducing simple, at-home saliva tests, allowing frequent monitoring of heart health more regularly than the current every six-month blood test. Until now, the widespread application of portable saliva tests has been hampered by complex production processes and the limited scope of data they can provide, usually restricted to a single biomarker. Now, a team of researchers at Colorado State University (Fort Collins, CO, USA) aims to bring heart failure screening from clinical settings to the home. The team ...
- Source: drugdu
- 69
- August 22, 2024
Rapid Diagnostic System to Deliver Same-Shift Antibiotic Susceptibility Test Results

The World Health Organization estimates that sepsis impacts around 49 million people worldwide each year, resulting in roughly 11 million deaths, with about 1.32 million of these deaths directly linked to bacterial antimicrobial resistance. Given the urgency, there’s a growing need for rapid antimicrobial susceptibility testing (AST) that can guide the use of targeted antimicrobial therapies. Such testing is crucial for enhancing patient outcomes, reducing hospital costs, and curbing the rise of antimicrobial resistance. Now, a rapid AST system aims to deliver same-shift results, significantly aiding antimicrobial stewardship teams and clinicians in promptly customizing treatments for patients with severe infections. The WAVE system from Accelerate Diagnostics (Tucson, AZ, US) is designed to deliver rapid AST results from positive blood culture (PBC) bottles and isolated bacterial colonies (isolates), delivering precise results in approximately 4.5 hours. Utilizing cutting-edge holographic imaging technology, the WAVE system tracks bacterial growth and morphology changes in real-time, ...
- Source: drugdu
- 82
- August 22, 2024
Johnson & Johnson Set to Acquire V-Wave Ltd

By Don Tracy, Associate Editor The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.Johnson & Johnson (J&J) has reached a definitive agreement to acquire V-Wave Ltd., a private company specializing in cardiovascular implants for heart failure patients. The acquisition is expected to integrate V-Wave into Johnson & Johnson MedTech. V-Wave was recently granted FDA Breakthrough Device Designation and CE mark approval for the Ventura Interatrial Shunt technology, which treats heart failure with reduced ejection fraction (HFrEF). The deal is expected to close by the end of this year.1 “We are excited to welcome V-Wave to Johnson & Johnson MedTech and to take another meaningful step toward transforming the standard of care for cardiovascular disease. We recognize the importance of identifying more diverse and effective treatments for heart failure, and our recent ...
- Source: drugdu
- 70
- August 22, 2024
Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy

In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure. By Frank Vinluan The longest clinical trial to date for a blockbuster Eli Lilly metabolic disorder drug now has data showing the treatment delayed progression to type 2 diabetes in patients who are obese or overweight, results that continue to build the case of broader health benefits for the therapy. The preliminary results announced Tuesday come from a clinical trial designed to test once-weekly injections of tirzepatide in prediabetes participants. In addition to being overweight or obese, participants also had at least one weight-related complication, excluding diabetes. The main goal of the placebo-controlled study is assessing tirzepatide’s effect on weight. At the highest of three ...
- Source: drugdu
- 74
- August 22, 2024
J&Js Rybrevant plus Lazcluze combination gets FDA approval in NSCLC

Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC). The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso. The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These ...
- Source: drugdu
- 83
- August 22, 2024
Adcendo and Multitude ink ADC deal potentially worth $1bn

The antibody drug conjugate (ADC) dealmaking trend has seen yet another example as Adcendo has signed a licencing agreement potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate. The Danish company will acquire the global rights for the development and commercialisation rights for ADCE-T02, except in the Greater China region, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan. The companies were light on financial details noting that upfront and milestone payments will “total over $1bn”. The deal also has the option for “single digit to low double digit” tiered royalties. “We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024,” said Adcendo CEO, Michael Pehl. “The highly ...
- Source: drugdu
- 76
- August 22, 2024
Nature publishes new research on genetic causes of colorectal cancer

Colorectal cancer (CRC) is the third most commonly diagnosed cancer globally, with more than 44,000 new cases of the disease diagnosed in the UK every year. Now a study led by the Institute of Cancer Research (ICR), the University of Oxford and the University of Manchester has revealed previously unknown genetic causes of (CRC). The new research, published in Nature, offers a novel view of the genetic landscape of CRC and treatment responses. Led by Genomics England and NHS England, researchers analysed 2,023 bowel cancers from the 100,000 Genomes Project to identify new gene faults that lead to CRC. The research uncovered new CRC cancer sub-groups with specific genetic characteristics that affect how cancer behaves and responds to treatment. Commenting on the findings, co-lead researcher and ICR’s professor of cancer genomics, Richard Houlston, said: “This research is a great insight into the biology of CRC, uncovering the clues as to ...
- Source: drugdu
- 52
- August 22, 2024

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