England’s National Institute for Health and Care Excellence (Nice) has recommended Almirall’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer, Eli Lilly, and AbbVie, respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of ...
By Don Tracy, Associate Editor Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies. Results from the second interim analysis of the Phase III CARTITUDE-4 study, which evaluated Johnson & Johnson’s (J&J) Carvykti (ciltacabtagene autoleucel; cilta-cel) for patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy showed that the treatment achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard therapies such as omalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 “Carvykti, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, in a press release. “As we continue to ...
As Eli Lilly’s Kisunla (donanemab) enters the Alzheimer’s treatment space, its leading competitor Biogen is undergoing therapy diversification after completing its $1.15bn acquisition of Human Immunology Biosciences (HI-Bio). The deal, which was agreed upon in May this year and includes $650m in milestone payments, sees Biogen bolster its pipeline with US-based HI-Bio’s anti-CD38 monoclonal antibody candidate felzartamab. Biogen’s head of development Priya Singhal said the company is “very excited” about the addition of felzartamab to its rosters in a 2 July press release, adding that Biogen will advance the candidate to Phase III now the transaction is complete. Felzartamab has already demonstrated positive Phase II data in a range of immune-mediated diseases, including IgA nephropathy (IgAN), antibody-mediated rejection (AMR), and primary membranous nephropathy (PMN). The Phase III development plans are for all three diseases, according to Biogen. Felzartamab was originally developed by MorphoSys as a possible competitor to Johnson & ...
By Mike Hollan The platform utilizes standards set forth in a recently published document from the CDC. After years of collaborating with hospitals, Magnolia Medical has launched a new digital platform designed to prevent sepsis misdiagnosis.1 The platform, Magnolia Analytics, was designed with the CDC’s recently published Blood Culture Contamination guidelines in mind. The main addition to the guidelines is a new step utilizing initial specimen diversion devices, which Magnolia specializes in. CDC notes that reducing sepsis misdiagnosis is important as it can play a key role in reducing the amount of needlessly prescribed antibiotics, which can then further play a role in reducing instances of antibiotic resistance. In a press release, Magnolia Medical co-founder and CEO Greg Bullington said, “In response to our customer’s clear unmet needs, we developed Magnolia Analytics as a custom, exclusive solution to support our hospitals in achieving and sustaining their blood culture contamination rates ...
Parkinson’s UK has awarded nearly £100,000 to researchers at Imperial College London (ICL) to develop a new drug for Parkinson’s disease (PD) through the charity’s drug accelerator award grant scheme. Researchers will use a computer-based programme to simulate good targets for new drugs to slow the progression of the neurological disease and improve the success of clinical trials. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. In the process of drug development, the more information that researchers have when planning a clinical trial, including simulating how a drug might work, the more likely it is to be successful when being trialled in people and compared to other available treatments. Using simulation, researchers aim to test the best way to target GPNMB, a protein that has been linked to PD. Previous ...
Researchers from the University of Bristol have revealed a new disease-driving mechanism that could help treat the development of atherosclerosis. The new therapeutic, IMSET, is being developed by researchers at the Bristol Medical School: Translational Health Sciences (THS) and is being supported by funding through beLAB1407, one of Evotec’s global portfolio of BRIDGE partnerships. Affecting 42% of adults without heart disease, atherosclerosis is characterised by the build up of atherosclerotic plaques (fatty deposits) in the arteries, which can lead to heart attacks, strokes and peripheral arterial disease. When investigating how immune cells in the blood contribute to the creation of atherosclerotic plaques within the arteries, researchers found that these cells could exist in different forms, with particular types driving the development of the plaques. The discovery allowed researchers to identify a certain genetic target, known as IMSET, “which is a central regulator of their behaviour… [which] will allow us to ...
Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. By Frank VinluanA blockbuster Argenx therapy now has an additional FDA approval as a treatment for a rare autoimmune disorder affecting nerves, marking the first new treatment for this condition in decades and a new blockbuster opportunity for this pipeline-in-a-product drug. The disease, chronic inflammatory demyelinating polyneuropathy, or CIDP, develops as the immune system attacks myelin, the protective covering of nerve fibers. CIDP leads to weakness and impairment of motor function, numbness and tingling, and difficulty walking. In many cases, the loss of muscle function requires patients to rely on a wheelchair for mobility. The FDA’s late Friday approval of the Argenx product, Vyvgart Hytrulo, covers the treatment of ...
Osteal Therapeutics has raised $50m in Series D financing, as the orthopaedic infection treatment specialist turns its eyes to a regulatory submission for its lead candidate VT-X7. Medtech giant Zimmer Biomet led the round with participation from existing investors, including Johnson & Johnson Innovation, among others. The funds, which follow $23m raised in Series C financing in late 2023, will be used for a new drug application (NDA) to the US Food and Drug Administration (FDA) for VT-X7. Proceeds will also go towards advancing the US-based company’s musculoskeletal portfolio, according to a 5 June press release. Osteal has designed VT-X7 for the treatment of periprosthetic joint infection. The condition is a complication of joint replacement surgery in which bacteria infiltrate the joint implant. This causes biofilms, a layer of microorganisms that are hard to treat. VT-X7 is a drug/device combination product, consisting of antibiotic drugs vancomycin hydrochloride and tobramycin sulfate ...
GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.A GSK multiple myeloma drug that was withdrawn from the market is accumulating new clinical data that could support its return — perhaps as an earlier line of therapy. With the latest results, clinicians and GSK executives say they may have figured out how to address a lingering question about how to safely dose the drug, Blenrep. The new data were presented Sunday during the annual meeting of the American Society of Clinical Oncology in Chicago. Blenrep is an antibody drug conjugate (ADC) that targets the BCMA protein on multiple myeloma cells, delivering to them a payload of toxic chemotherapy. There are many multiple myeloma drugs available, but frequent relapse in this ...
Johnson & Johnson is acquiring a bispecific antibody that Numab Therapeutics engineered to address two pathways associated with the inflammation and itching of atopic dermatitis. It’s J&J’s second immunology acquisition this month. By Frank Vinluan Johnson & Johnson is building up its immunology pipeline, striking a $1.25 billion deal for a bispecific antibody in development for atopic dermatitis — its second acquisition agreement in the indication in the past two weeks. The deal announced Tuesday will bring J&J a Numab Therapeutics drug codenamed NM26. The pharmaceutical giant is acquiring global rights to the experimental treatment, which is ready to enter Phase 2 testing. Atopic dermatitis, also known as eczema, is the most common inflammatory skin disease. While the disorder typically presents as red and itchy skin, it stems from multiple pathways that vary from one group of patients to another. NM26 is a bispecific antibody designed to address two of ...
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