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 ...
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 ...
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 ...
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, ...
CellVoyant – an AI biotechnology spin-out from the University of Bristol – has announced a £7.6 million funding round. Led by Octopus Ventures – with additional participation from Horizons Ventures, Air Street Capital and Verve Ventures – the funding represents the first stage in commercialising CellVoyant’s first of its kind AI and imaging platforms. Meanwhile, the company now aims to enable the rapid development of novel cell therapies. Stem cells unlock a wide range of treatment possibilities that have not historically been available to patients. Indeed, current treatments tend to act on the body’s existing cells, while stem cells have the potential to develop into different cell types in the body – replacing dysfunctional cells or regenerating damaged tissues and organs. CellVoyant’s platform combines advanced AI with live cell imaging to address pain points. The technology can extract spatial and temporal information in real-time from hundreds of millions of cells. ...
Aston University is on course to create the Aston Institute for Membrane Excellence (AIME) – a cross-disciplinary facility to develop novel biomimetic membranes – having received £10m from Research England. The institute will be led by Professor Roslyn Bill, from the School of Biosciences, along with Professor Paul Topham from the department of Chemical Engineering and Applied Chemistry. Both biological and synthetic membranes are significant across several many sectors. Indeed, the world’s top ten selling human medicines all target proteins in biological membranes, while synthetic polymer membranes are commonly used in the water purification industry. The AIME believes that the full potential of membranes will only be realised by an interdisciplinary group which spans biology, physics and chemistry and that can investigate membranes holistically. Professor Bill, a European Research Council (ERC) Advanced grantee leads Aston Membrane Proteins and Lipids (AMPL) research centre of excellence that studies the structure and function ...
Dive Brief Baxter has received 510(k) clearance for its large volume infusion pump (LVP) Novum IQ, the company said Monday. The clearance follows three years of talks with the Food and Drug Administration, in which time a delay to the authorization drove Baxter to wipe $100 million in sales off its forecast in 2022. A Baxter spokesperson said in an email that the company will update 2024 guidance on its upcoming first-quarter earnings call and expects Novum IQ to be a meaningful contributor to future growth. Evercore ISI analysts said the success of Baxter’s Spectrum pumps and the return of BD’s Alaris to the market means the $100 million annual sales assumption no longer applies. Even so, Evercore and Stifel analysts called the clearance positive for Baxter in notes to investors. Dive Insight The FDA identified an issue with Baxter’s filing for clearance of the LVP version of Novum IQ ...
Alebund Pharmaceuticals has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its investigational drug AP303. This designation is intended for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes the growth of numerous cysts in the kidneys. AP303 is an internally developed drug candidate that has shown promise in improving renal survival in an ADPKD mice model. The drug has successfully completed a first-in-human study in healthy subjects in Australia and is poised to enter Phase II trials. ADPKD has a prevalence of between one in 400 and one in 1,000 live births and is a significant cause of end-stage kidney disease (ESKD), which often necessitates renal replacement therapy. Alebund co-founder, chairman, and CEO Dr Gavin Xia said: “We are very excited that AP303 has been granted orphan drug designation by the FDA. “It is an important milestone for Alebund ...
SHANGHAI, March 27, 2024 /PRNewswire/ — YolTech Therapeutics, a trailblazing biopharmaceutical company specializing in gene editing, is delighted to announce its participation in 2024 Cell & Gene Meeting on the Mediterranean. The event will take place from April 9th to 11th, 2024, at the esteemed Rome Cavalieri, A Waldorf Astoria Hotel, situated at Via Alberto Cadlolo, 101, 00136 Roma RM, Italy. The Cell & Gene Meeting on the Mediterranean stands as the premier conference uniting the ATMP (Advanced Therapy Medicinal Products) community from Europe and beyond. Covering an extensive array of commercialization topics spanning market access, regulatory issues, manufacturing, and financing within the sector, this program boasts expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and over 60 dedicated presentations by leading publicly traded and privately held companies in the space. YolTech is poised to make a significant impact at this event, showcasing its pioneering advancements in in vivo ...
In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ‘Observed Inspection Program‘ involves interaction between the USFDA India office and State Drug Control Authorities, with the former inviting the latter as observers during inspections. As the letter indicates, ‘FDA has shared best practices and inspectional protocols in regulatory forums with several states.’ It is logical that the US FDA would now turn to replicate these efforts in other states, especially those with many FDA-registered facilities, like Maharashtra, for instance, and explore the possibility of adding to this ...
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