Outset Medical gets FDA nod for dialysis accessory months after halting sales

Dive Brief Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines. Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance. BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog. Dive Insight San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020. The company also makes an accessory for the system, called TabloCart, which includes wheels, storage drawers, and water prefiltration to remove sediment and minerals from supply ...

• Source: drugdu
• 81
• May 9, 2024

Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections

Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are affected by sepsis annually, resulting in around 250,000 deaths. Similar statistics are reported in the European Union. Sepsis is characterized by life-threatening organ failure due to a dysfunctional systemic immune response. Rapid and accurate diagnostic methods are essential for timely and effective treatment, which is critical for patient survival. Now, a fully automated system for rapid antimicrobial susceptibility testing (AST) significantly reduces the time required to obtain clinically actionable results, thereby speeding up the administration of optimal treatments from days to just hours. The ASTar System from Q-linea AB (Uppsala, Sweden) revolutionizes the treatment of sepsis by enabling a rapid therapeutic response directly from a positive blood culture in about six hours. This system equips physicians with the necessary ...

• Source: drugdu
• 120
• May 9, 2024

FDA Approves Two of Scientia Vascular’s Neurovascular Catheters

Don Tracy, Associate Editor The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes. Scientia Vascular announced that the FDA has approved two of its neurovascular catheters. According to the company, the Plato 17 microcatheter offers physicians the ability to control and stabilize neurovascular applications and is also DMSO compatible. The Socrates 38, which is currently in a limited market release, is an aspiration catheter for treating ischemic strokes. Scientia stated that the approvals mark a significant advancement in its medical technology portfolio.1 “Our FDA clearance is a significant milestone for Scientia Vascular. By applying proven microfabrication technology to catheters and designing our access and treatment devices for efficiency when used together, we’re providing physicians the next generation of neurovascular access tools.” said John Lippert, CEO, Scientia Vascular, in a press release. “I am ...

• Source: drugdu
• 80
• May 9, 2024

AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis

Don Tracy, Associate Editor Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs. AstraZeneca announced that it has officially completed its equity investment and research collaboration agreement with Cellectis, a biotechnology company specializing in gene editing technologies. According to the company, the agreement is expected to result in a collaboration to develop up to 10 different cell and gene therapy (CGT) products in areas such as oncology, immunology, and rare diseases. Regarding terms of the deal, Cellectis earned an upfront payment of $105 million, which included $25 million in cash and $80 million in an equity investment. Cellectis will have the opportunity to profit further through an investigational new drug (IND) option fee, and additional payments based on development, regulatory, and sales milestones that could range from $70 million to $220 million.1 The collaboration, which was first announced ...

• Source: drugdu
• 104
• May 9, 2024

TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar launched for sale in the U.S.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that its partner, Bojian (NASDAQ: BIIB), has recently begun marketing and selling TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar in the United States. TOFIDENCE™, a biosimilar developed by BIO-THERA with reference to Amero® (tocilizumab), was approved by the U.S. FDA in September 2023 for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.TOFIDENCE™ is currently available in the U.S. as an intravenous infusion of 80 mg/4 ml, and is sold as an intravenous injection of 80 mg/4 ml. sales, 80 mg/4 mL, 200 ...

• Source: drugdu
• 71
• May 9, 2024

Lantern Pharma and Oregon partner to develop cancer treatment

Lantern Pharma has entered into a partnership with Oregon Therapeutics for optimising the development of the cancer drug candidate, XCE853, through an AI-driven approach. XCE853 is an inhibitor of protein disulfide isomerase (PDI). The partnership will utilise RADR AI platform of Lantern to identify biomarkers and efficacy-linked signatures of XCE853 for precision development across solid tumours. Furthermore, this alliance will identify biomarker signatures that can aid in stratifying tumours that are most responsive to the drug and facilitate in the clinical development and patient selection in the future. Oregon focuses on developing XCE853 for a range of cancer indications, including drug-resistant ovarian and pancreatic cancers, certain haematological cancers, and several paediatric cancers, such as central nervous system (CNS) cancers. The collaboration aims to harness computational tools, including machine learning and large-scale molecular analysis, to streamline the development process. The partnership will integrate and interrogate a vast array of molecular, genetic, ...

• Source: drugdu
• 69
• May 9, 2024

International phase 3 clinical trial for new melanoma treatment recruits first patients

A phase 3 international trial evaluating a new personalised immunotherapy treatment for melanoma has recruited its first patients at University College London Hospitals (UCLH) NHS Foundation Trust. Results from the phase 2 study evaluating Moderna and Merck & Co’s – known as MSD outside the US and Canada – mRNA-based technology treatment were published in the Lancet. Currently the fifth most common type of cancer, melanoma is a serious form of skin cancer that is responsible for over 8,000 new cases every year. The condition is characterised by the uncontrolled growth of pigment-producing cells. The new trial, INTerpath-001, is evaluating mRNA-4157 (V940) in combination with Merck’s PD-1 inhibitor, Keytruda (pembrolizumab), versus Keytruda on its own – the current standard of care – as a risk-reducing treatment option for patients with resected, high-risk, stage 2b to 4 melanomas following surgical removal of the cancer, with primary outcomes of recurrence-free survival and ...

• Source: drugdu
• 119
• May 9, 2024

Cambridge researchers develop robotic nerve devices for neurological conditions

Neurological disorders, such as epilepsy or chronic pain, affect over three billion people worldwide Researchers at the University of Cambridge have developed small, flexible devices, combining electronics and soft robotics, to help treat a range of neurological conditions, including epilepsy and chronic pain. Published in Nature Materials, the nerve cuff implant has the ability to change shape through electrical activation, opening up a variety of avenues for new, highly targeted treatment options. Affecting more than three billion people worldwide, neurological disorders are conditions that affect the brain as well as the nerves found throughout the human body and spinal cord. Currently, the tools for interfacing peripheral nerves are outdated, bulky and carry a high risk of nerve injury, according to the University of Cambridge. “Nerves are small and highly delicate, so anytime you put something large, like an electrode, in contact with them, it represents a danger to the nerves,” ...

• Source: drugdu
• 88
• May 9, 2024

New Blood Test Device Modeled on Leeches to Help Diagnose Malaria

Many individuals have a fear of needles, making the experience of having blood drawn from their arm particularly distressing. An alternative method involves taking blood from the fingertip or earlobe, but this often yields insufficient blood for many tests and can result in inaccurate laboratory values that vary between measurements. Now, researchers have developed an innovative device that uses microneedles and a suction cup instead of a large needle, which could be especially beneficial for those with needle phobia. This device can collect more blood than the traditional finger prick, enhancing the reliability of diagnostic measurements. Additionally, its low production cost makes it feasible for use in developing countries. The new device for taking blood samples developed by researchers at ETH Zurich (Zurich, Switzerland) operates on a principle similar to that of a leech and is less invasive than traditional arm blood draws. It is user-friendly and can be operated ...

• Source: drugdu
• 103
• May 8, 2024

The BCR::ABL1 fusion gene plays a key role in the pathogenesis of several blood cancers, particularly chronic myeloid leukemia (CML). This gene results from a chromosomal translocation that causes constitutive activation of the ABL1 tyrosine kinase domain, triggering unchecked cell growth. Testing for the BCR::ABL1 fusion gene is crucial in managing leukemia, as it helps identify patients with Philadelphia chromosome-positive leukemia who might benefit from targeted therapies such as tyrosine kinase inhibitors (TKIs). While Sanger sequencing has been the standard method for this analysis, it has its limitations in sensitivity. Next-generation sequencing (NGS) offers a more comprehensive approach to detecting, quantifying, and analyzing the genetic alterations associated with leukemia, including minor BCR::ABL1 transcripts and mutations. NGS thus provides detailed insights into disease progression, treatment response, and potential resistance mutations, enabling personalized treatment plans. BioVendor MDx (Brno, Czech Republic) has introduced the first commercial NGS assay specifically for the BCR::ABL1 fusion ...

• Source: drugdu
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• May 8, 2024