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European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion (RVO)

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved Vabysmo® (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch RVO or central RVO). RVO is the third indication for Vabysmo in the European Union, in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).1 Together, the three retinal conditions affect close to 80 million people worldwide and are among the leading causes of vision loss.2-5 “Vabysmo is a new treatment option for people with retinal vein occlusion in Europe that can help preserve and improve vision, with the added benefit of retinal drying,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The efficacy and safety of Vabysmo has been well established in global clinical… 

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Guardant erhält FDA-Zulassung für Bluttest auf Dickdarmkrebs

Die amerikanische Gesundheitsbehörde Food and Drug Administration hat den Bluttest Shield von Guardant Health als primäre Screening-Option für Dickdarmkrebs bei Erwachsenen mit durchschnittlichem Risiko ab 45 Jahren zugelassen, teilte das Unternehmen am Montag mit. Guardant positioniert den Test, der im Rahmen eines Routinebesuchs beim Arzt durchgeführt werden kann, als angenehmere und bequemere Alternative zur Darmspiegelung oder zu Stuhluntersuchungen und möchte so mehr Menschen dazu ermutigen, sich einer Darmkrebsvorsorge zu unterziehen. Der Guardant Shield-Test erkennt Veränderungen, die mit Dickdarmkrebs in Zusammenhang stehen, indem er die zellfreie DNA aus der Blutprobe eines Patienten sequenziert.

Diamyd Medical Announces Positive Interim Analysis Results for Phase 3 Trial in Type 1 Diabetes

Diamyd Medical today announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications. The interim analysis evaluated six-month data from 74 patients enrolled in the trial, assessing the likelihood of the trial achieving one of its co-primary endpoints, specifically the preservation of endogenous insulin-producing capacity measured as stimulated C-peptide. The DSMB’s recommendation is based on the data observed to date, indicating that the trial is on track and has the potential to meet its objectives.

ARUP Laboratories‘ Grant Will Fund Innovative Research to Advance Laboratory Medicine

The ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™ (R&I Institute) today announced the creation of the Sherrie Perkins Research and Innovation Collaboration Grant. The new grant will fund cutting-edge research in laboratory medicine that has the potential to significantly impact patient care. The grant is designed to foster partnerships within the medical community and may award up to a maximum of $150,000. The grant will be available to industry and academic partners in collaboration with ARUP medical directors and scientists. „With this grant program, ARUP will fund innovation efforts that focus on improving laboratory medicine while also establishing partnerships with academic or industry collaborators,“ said Tracy George, MD. George, ARUP’s chief scientific officer and president of the Innovation Business Unit, has been a key proponent of innovation at ARUP. The grant is named in honor of… 

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GLP-1-Agonist könnte vor Demenz schützen

Ein Glucagon-ähnliches Peptid-1 (GLP-1)-Medikament scheint den kognitiven Verfall zu verlangsamen, indem es das Gehirn schützt. Dies geht aus klinischen Phase-2b-Studiendaten hervor, die heute auf der Alzheimer’s Association International Conference® (AAIC®) 2024 in Philadelphia und online veröffentlicht wurden. GLP-1-Rezeptor-Agonisten, die das natürliche Hormon Glucagon-like Peptide nachahmen, das vom Magen nach dem Essen freigesetzt wird, können Menschen dabei helfen, Diabetes in den Griff zu bekommen, Gewicht zu verlieren und ihr Risiko für Herzerkrankungen, Schlaganfälle und Nierenerkrankungen zu senken. Forschungen an Tiermodellen der Alzheimer-Krankheit deuten darauf hin, dass diese Medikamente neuroprotektive Wirkungen haben, frühe Formen von Amyloid reduzieren, die Verarbeitung von Glukose im Gehirn normalisieren und das Gedächtnis und die Lernfähigkeit verbessern können. Liraglutide (Novo Nordisk) wirkt wahrscheinlich über mehrere Mechanismen im Gehirn. Diese neuen Forschungsergebnisse, über die auf der AAIC 2024 berichtet wurde, deuten darauf hin, dass Liraglutid die Gehirne von Menschen… 

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Long-term lecanemab data show increased patient benefit with maintained safety profile

BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today presented the latest findings for lecanemab (generic name, brand name: Leqembi®). Three-year data show that lecanemab continues to give increased patient benefit for patients with early Alzheimer’s disease with maintained safety profile. In addition, data from the earliest patient cohort showed that 51% of these patients improved their cognition and function score after three years of treatment. The data was presented at the Alzheimer’s Association International Conference (AAIC) 2024, held in Philadelphia, USA, and virtually July 28 – August 1, 2024. The presentations from AAIC will be available on the Eisai Co. Ltd. investor page by 01:00 a.m. on July 31st CET. Highlights of the presentations included: Clear and meaningful long-term treatment effect – Three years of continuous lecanemab treatment reduced clinical decline by -0.95 as measured by the cognitive… 

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Wiley Surface-to-Spectral Analysis

The new Wiley Surface-to-Spectral Analysis provides a comprehensive, powerful software solution to process, combine, and analyze images and data from various spectroscopic techniques. Designed to make your lab more efficient, you can do it all in a single interface: Spectral processing and analysis Spectral map and image processing Correlative analysis3D visualization of 2D compositional data Users can even take their analysis a step further by sending spectra to Wiley’s KnowItAll software* to search against spectral libraries for further investigation. Wiley Surface-to-Spectral Analysis

Inimmune publishes positive proof of mechanism for TLR4 Agonist INI-2004 in Allergic Rhinitis

Inimmune, a leading biotech company focused on the development of novel immunotherapies and vaccine adjuvants announced the publication of pre-clinical efficacy and safety data for INI-2004. „Intranasal administration of a synthetic TLR4 agonist INI-2004 significantly reduces allergy symptoms following therapeutic administration in a murine model of allergic sensitization“ was published in Frontiers in Immunology on July 23, 2024 (https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1421758/full). This research highlights the significant disease modifying impacts of INI-2004 in allergic disease following intranasal administration and describes the remarkable safety profile of this innovative treatment.

VGXI, accepted as a Member of the US Government’s Rapid Response Partnership Vehicle (RRPV)

VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is proud to announce its selection as a member of Rapid Response Partnership Vehicle (RRPV) which supports the Biomedical Advanced Research and Development Authority (BARDA) in its objective to accelerate Medical Countermeasure (MCM) product and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats. With more than two decades of experience in plasmid DNA manufacturing, VGXI has the largest plasmid manufacturing capacity (4000L) in the world from its two state-of-the-art facilities covering 160,000 sq. Ft.

Nervonik receives regulatory approval to start First-in-Human study with Novel Peripheral Nerve Stimulation Technology for Chronic Pain

Nervonik, a medical device startup focusing on neurotechnology approaches to peripheral nerve stimulation, has received approval to conduct a first-in-human feasibility study utilizing its proprietary technology. The focus will be on chronic pain of peripheral nerve origin, although the novel technology will eventually be utilized for a variety of medical indications. Enrollment in the study is anticipated to begin later in the 3rd quarter of 2024 with presentation of results following.