PharmaFocus Today – Page 51 – media

Pathalys secures $105m to advance SHPT drug through approval

Pathalys Pharma has secured $105m in a Series B financing round to support its clinical trials, file a new drug application (NDA) with the US Food and Drug Administration (FDA), and accelerate preapproval commercialisation preparations. The company’s lead candidate is upacicalcet, a drug used to treat secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). The calcimimetic drug mirrors the action of calcium on tissues, particularly the parathyroid glands. The medication is typically administered during dialysis sessions. Earlier this year, Pathalys launched two identical Phase III studies of upacicalcet, which will both enrol 375 patients. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30% or more in participants with SHPT and currently on haemodialysis. The funding round, led by TCGX, is set to support these clinical trials, and advance the ...
- Source: drugdu
- 70
- August 23, 2024
Theramex’s Eladynos recommended by NICE for post-menopausal bone disease

Osteoporosis currently affects 3.8 million people in the UK, particularly impacting older women after menopause Theramex’s Eladynos (abaloparatide) has been recommended by the National Institute for Health Care and Research (NICE) for treating bone disease after menopause. More than 14,000 people in the UK seek treatment for osteoporosis after menopause, and these patients will benefit from the drug (if there is a very high risk of fracture) once it becomes available in England on the NHS in three months’ time. Osteoporosis is a bone disease that affects 3.8 million people in the UK. It develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and ...
- Source: drugdu
- 83
- August 23, 2024
eXmoor pharma’s manufacturing facility receives licence from MHRA

The company’s Cell & Gene Therapy Centre can now offer a full range of GMP services Press release: eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, announced it has received a Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)) licence from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), authorising the manufacture of good manufacturing practice (GMP)-grade cell and gene therapy materials for use in clinical trials. This follows a successful inspection of eXmoor’s Cell & Gene Therapy Centre in Bristol, marking the end of a two-year project to design, build and bring online a 65,000 state-of-the-art advanced therapies manufacturing facility. The licence is a major milestone in eXmoor’s 20-year journey from a consultancy into a full-service, global CGT contract development and manufacturing organisation (CDMO). The Cell & Gene Therapy Centre has been designed in-house by eXmoor as a flexible and scalable manufacturing hub, with integrated ...
- Source: drugdu
- 64
- August 23, 2024
New Microfluidics Method to Speed Up Blood Analyses

Researchers have developed a new method to accelerate and potentially scale up the process of separating particles in fluids, a technique that could prove useful for analyzing cancer cells from blood. This speedier and more precise method of elasto-inertial microfluidics was developed by a team led by researchers at KTH Royal Institute of Technology (Stockholm, Sweden) and involves controlling the movement of tiny particles in fluids by leveraging both the fluid’s elastic properties and the inertial forces arising from fluid movement. The microfluidic device features specially engineered channels that accommodate larger volumes of fluid rapidly, making it ideal for applications requiring quick, continuous particle separation. These channels efficiently sort and line up particles, essential for distinguishing different particle types. This high precision is achieved through the use of specially formulated fluids with high polymer concentrations, giving the fluid viscoelastic properties similar to egg whites that can both flow and rebound. ...
- Source: drugdu
- 85
- August 23, 2024
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
- 73
- 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
- 82
- 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
- 78
- 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
- 71
- 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
- 86
- 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
- 73
- August 22, 2024

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