PharmaFocus Today – Page 127 – media

Beckman Coulter receives FDA warning letter

Dive Brief Beckman Coulter received a warning letter in March after inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests. The Food and Drug Administration, which published the letter Tuesday, said Beckman failed to adequately establish procedures for risk analysis and other activities at a facility in Minnesota. Beckman Coulter responded to the observations in January and February 2024, but the FDA said the responses to specific problems were either inadequate or impossible to assess at this time. Dive Insight The warning letter names the DxI 9000 Access Immunoassay analyzer instrument system and assays as the device that is “adulterated” because of the compliance failings. Rainer Blair, CEO of Beckman’s parent company Danaher, singled out Dxl 9000 as a new product that is “enabling faster, more accurate patient diagnosis” on an earnings call in January. Beckman was a growth driver in the fourth ...
- Source: drugdu
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- April 8, 2024
Simple Blood Test Combined With Personalized Risk Model Improves Sepsis Diagnosis

Sepsis, a critical condition that arises from organ dysfunction due to severe infection, can progress to severe sepsis and septic shock, leading to multi-organ failure and increased mortality rates. The complexity of diagnosing sepsis stems from the absence of a definitive test, with current detection methods depending on broad-ranged biomarkers such as CRP, PCT, and lactate levels. The disease’s variability and the general approach of administering broad-spectrum antibiotics, antivirals, and antifungals underscore the urgency for more specific diagnostic and treatment strategies. New research to be presented at ECCMID 2024 highlights the success achieved by researchers in identifying distinct molecular signatures associated with the clinical signs of sepsis that could enable more accurate diagnosis and prognosis of the condition, as well as help design targeted therapies for patients who stand to benefit the most. In this study, researchers from Lund University (Lund, Sweden) analyzed plasma samples collected over a period of ...
- Source: drugdu
- 139
- April 8, 2024
Legend Biotech’s “CARVYKTI®” was approved for second-line indications in the United States

Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
- Source: drugdu
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- April 8, 2024
World Health Organization launches AI-powered digital health assistant for public health

The World Health Organization (WHO) has announced the launch of a generative artificial intelligence (AI)-powered digital health promoter prototype ahead of World Health Day on 7 April. Celebrated annually, World Health Day draws attention to a specific health topic of concern to people globally. This year’s theme, ‘My Health, My Right’, champions the right of everyone, everywhere to have access to quality health services, education and information. The Smart AI Resource Assistant for Health (SARAH) will comprise new language models and cutting-edge technology to engage users across major health topics, including healthy habits and mental health. SARAH aims to provide an additional tool for people to learn their rights to health, by supporting them in developing a better understanding of risk factors for some of the leading causes of death worldwide, including cancer, heart disease, lung disease and diabetes. In addition, the AI assistant can help individuals access up-to-date information ...
- Source: drugdu
- 122
- April 8, 2024
myTomorrows and brainstrust partner to support patients living with brain cancer

myTomorrows has announced a new partnership with a UK-based charity, brainstrust, to support individuals living with brain cancer. The partnership will help equip patients with knowledge of relevant treatment options, participation in clinical trials and access to pre-approved drugs, while supporting clinicians when recruiting patients to relevant clinical trials. Brain tumours affect around 80,000 people in England, with only 12% of patients surviving beyond five years of their diagnosis. As part of the agreement, the charity will provide its patient network with timely, up-to-date and useful information surrounding credible and accessible clinical trials, along with myTomorrow’s expertise and support. In addition, myTomorrow’s trained patient navigators will play a key role as a single point of contact to help guide patients with brain tumours and their loved ones, as well as healthcare professionals, through medical care and help them make the best decisions during their treatment journey. Using a GDPR-compliant ISO ...
- Source: drugdu
- 108
- April 8, 2024
Key mechanism controlling bone marrow stem cells could lead to new therapies

Researchers from King’s College London’s (KCL) Comprehensive Cancer Centre have identified a key mechanism that governs how bone marrow stem cells work, which could potentially lead to new therapeutic pathways. The findings from the study will help researchers further understand the key principles involved in stem cell biology and could provide new avenues for the development of efficient stem cell therapeutics. Researchers identified two molecules, Hoxa9 and b-catenin, that control when bone marrow stem cells rest and recover, as well as when they act and replicate. Both molecules work together to control a rare population of self-renewing stem cells that are predominantly found in bone marrow, known as haematopoietic stem cells (HSCs). HSCs are protected from environmental stressors and prevent exhaustion by resting, while inactive HSCs must become active again, replicating themselves by turning into different blood cells, including red blood cells, white blood cells and platelets, to replenish the ...
- Source: drugdu
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- April 8, 2024
RemeGen’s Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren’s Syndrome

YANTAI, China, April 3, 2024 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren’s syndrome (pSS). The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs. Primary Sjögren’s syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator ...
- Source: drugdu
- 129
- April 8, 2024
Hengrui’s Innovative Drug Fluzoparib Alone or in Combination with Apatinib HER2 Negative Breast Cancer Indication Included in Breakthrough Therapy Variety

Recently, Hengrui Pharmaceuticals’ innovative drug fluazoparib (Errayi®) alone or in combination with apatinib (Etan®) for the treatment of HER2-negative breast cancer with mutations in the germline breast cancer susceptibility gene (gBRCA) has been included in the list of breakthrough therapeutic varieties by the Center for Drug Evaluation of the State Drug Administration (CDEA). According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is one of the most common malignant tumors in women. Currently, the incidence of breast cancer in domestic patients is growing rapidly and has been ranked first on the spectrum of female tumor incidence, and recurrence and metastasis occur in nearly 50% of patients after treatment. Human breast cancer susceptibility genes (BRCA) are important oncogenes in the human body, including BRCA1 and BRCA2. Compared with ...
- Source: drugdu
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- April 8, 2024
Profound Medical, Siemens Healthineers collab on ultrasound ablation

BY SEAN WHOOLEY The TULSA-PRO system from Profound Medical. [Image from Siemens Healthineers]Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). ...
- Source: drugdu
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- April 7, 2024
Bessel launches accelerator program for medtech startups

BY JIM HAMMERAND Bessel and an Alabama tech hub today said they are launching Hatch Powered by Bessel, an accelerator program for medtech startups. Applications are now open for the 10-week program, which starts in Fairhope, Alabama, this summer. The accelerator “combines the passion of startup founders, the guidance of seasoned medical device experts, and the burgeoning startup ecosystem and investment in Alabama,” Bessel said in a news release. “… The program aims to equip medtech startups to create sustainable and scalable innovations—breakthroughs that scale—and to give founders the entrepreneurial resource ecosystem they need for long-term success.” Startups selected for the program will receive a travel stipend, access to events and workshops, and guidance on strategy, fundraising and execution from lifescience industry entrepreneurs who will act as mentors and advisors. The startups may be offered funding for equity by Hatch Fairhope after the cohort concludes with finale events in Fairhope, ...
- Source: drugdu
- 134
- April 7, 2024

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