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Alzheimer’s drug development pipeline

Alzheimer’s treatment studies offer hope as UNLV expert predicts new potential drugs, biomarkers will yield critical insight for future development. There are 164 trials assessing 127 drugs across the 2024 AD pipeline. There were 48 trials in Phase 3 testing 32 drugs, 90 trials in Phase 2 assessing 81 drugs, and 26 trials in Phase 1 testing 25 agents. Of the 164 trials, 34% (N = 56) assess disease-modifying biological agents, 41% (N = 68) test disease-modifying small molecule drugs, 10% (N = 17) evaluate cognitive enhancing agents, and 14% (N = 23) test drugs for the treatment of neuropsychiatric symptoms. The world of Alzheimer’s treatments is at an inflection point as more potential drugs make their way out of clinical trials. And on the heels of newly FDA-approved drugs Aduhelm® (aducanumab) in 2021 and Leqembi® (lecanemab) in 2023, a… 

Dresden startet drei Supercomputer

Das Zentrum für Informationsdienste und Hochleistungsrechnen (ZIH) der Technischen Universität Dresden (TUD) hat am 23. April 2024 das hochspezialisierte neue Supercomputing-System „Barnard“ sowie erste Komponenten der Rechnerarchitektur „SpiNNaker2“ mit einem Festakt eingeweiht. Zugleich wurde mit „Capella“ auch die Beschaffung eines weiteren Computing-Clusters vorgestellt. Als Gesamtsystem adressiert das Trio die Anforderungen an hohe Rechenleistung in enger Verbindung mit großen Datenmengen ebenso wie spezielle Lösungen für die Bereiche Künstliche Intelligenz und maschinelles Lernen und bedient damit den aktuellen Bedarf der Forschung. Als Schlüsseltechnologie für innovative Entwicklungen in einer Vielzahl von Wissenschaftsgebieten bieten die Systeme im Rahmen des NHR-Verbundes (Nationales Hochleistungs­rechnen) exzellente Voraussetzungen, um kompetitiv neue Wege zu gehen und schnelle Lösungen für die Künstliche Intelligenz umzusetzen. Während mit Barnard ein CPU-basierter Hochleistungsrechner (CPU: Central Processing Unit) insbesondere für datenintensive Anforderungen bereitsteht, ergänzt die aktuelle Beschaffung Capella einen strategisch wichtigen Aufwuchs an Rechenkapazität… 

Enzalutamide: EU Approval for Use in Additional Recurrent Early Prostate Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, „Astellas“) today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy. The extended approval for XTANDI is based on results from the Phase 3 EMBARK trial in 1,068 men with high-risk BCR nmHSPC, in whom levels of prostate-specific antigen (PSA), the biomarker which can be indicative of prostate cancer activity, doubled in nine months or less. The study showed patients treated with XTANDI in combination with leuprolide had a 57.6% lower chance of their cancer spreading or dying compared to those treated with leuprolide alone. Participants who were treated with XTANDI alone had a 36.9%… 

Apothekenreform  vermutlich verfassungswidrig

Ein verfassungsrechtliches und ein gesundheitsökonomisches Gutachten entkräften die vom Bundesgesundheitsministerium (BMG) vorgestellten Eckpunkte für eine Apothekenreform. Obwohl der Referentenentwurf für eine von Bundesgesundheitsminister Karl Lauterbach seit Monaten angekündigte Apothekenreform noch nicht vorliegt, hatte die ABDA – Bundesvereinigung Deutscher Apothekerverbände zwei Studien beauftragt. Einerseits sollte juristisch geklärt werden, ob die von Minister Lauterbach verfolgte „Apotheke ohne Apothekerin oder Apotheker“ zulässig ist. Andererseits wurde wirtschaftlich geprüft, wie sich die vom Ministerium angekündigte Umverteilung des Apothekenhonorars auf die chronisch unterfinanzierten Apotheken auswirken würde. ABDA-Präsidentin Gabriele Regina Overwiening sagt dazu: „Das Gutachten von Professor Di Fabio beweist unwiderruflich, dass eine Versorgung über Apotheken ohne Apothekerinnen und Apotheker einen Grundrechtseingriff darstellen würde. Ohnehin warnen wir seit Monaten vor solchen Vorschlägen, weil sich für unsere Patientinnen und Patienten dadurch Qualitätseinbußen und Leistungskürzungen ergeben würden.“

Smart Lab: Synthese ohne Mensch. Prompts: Corax Consultants LLC

KI-basierte Software für klinische Studien

Risklick, ein Spin-off der Universität Bern, hat heute sein neustes Produkt Protocol AI vorgestellt. Protocol AI ist die erste Software ihrer Art und markiert einen Wendepunkt in der Pharmaindustrie. Sie setzt künstliche Intelligenz ein, um die Entwicklung klinischer Studien zu beschleunigen, Kosten zu senken und Sicherheitsstandards zu erhöhen. Die innovative Technologie hat das Potenzial, den Bereich der klinischen Studien zu revolutionieren und Millionen von Patienten weltweit einen schnelleren Zugang zu lebensrettenden Therapien zu ermöglichen. „Wir haben eine wegweisende Lösung geschaffen, die die Entwicklungszeit und die Kosten klinischer Studien um bis zu 35 % reduziert und so Patienten den Zugang zu Therapien erleichtert. Unsere innovative Technologie hat das Potenzial, das Leben von Millionen von Patienten weltweit zu verbessern“, sagt Poorya Amini, Co-Gründer und CEO von Risklick. Protocol AI ist die erste Software ihrer Art, die künstliche Intelligenz nutzt, um vorhandene klinische… 

First medicine for children with gastroenteropancreatic neuroendocrine tumors

Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. NETs are a type of cancer that originates in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies1. The diagnosis of NETs is often delayed due to the inactive nature of the disease, and approximately 10% to 20% of pediatric patients are diagnosed with metastatic disease2,3. Even though NETs are an orphan disease, their incidence has increased over the past several decades. The approval was based on the NETTER-P trial, which evaluated Lutathera in patients aged 12 to <18… 

Researchers create artificial cells

In a new study published in Nature Chemistry, UNC-Chapel Hill researcher Ronit Freeman and her colleagues describe the steps they took to manipulate DNA and proteins — essential building blocks of life — to create cells that look and act like cells from the body. This accomplishment, a first in the field, has implications for efforts in regenerative medicine, drug delivery systems, and diagnostic tools. “With this discovery, we can think of engineering fabrics or tissues that can be sensitive to changes in their environment and behave in dynamic ways,” says Freeman, whose lab is in the Applied Physical Sciences Department of the UNC College of Arts and Sciences. Cells and tissues are made of proteins that come together to perform tasks and make structures. Proteins are essential for forming the framework of a cell, called the cytoskeleton. Without it,… 

FDA approves immunotherapy drug combo for non-muscle invasive bladder cancer

The U.S. Food and Drug Administration (FDA) has approved the immunotherapy-boosting drug N-803, which is marketed under the brand name Anktiva, to be used in combination with the immunotherapy Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer. The decision was based on results of the QUILT 3.032 clinical trial, which was led by Dr. Karim Chamie, associate professor urology at the David Geffen School of Medicine at UCLA and a researcher at the UCLA Health Jonsson Comprehensive Cancer Center. Findings from the phase 2/3 trial were presented at the 2022 American Society of Clinical Oncology annual meeting and published in NEJM Evidence. Chamie, who was the principal investigator for the trial, reported that this combination treatment resulted in longer overall survival and was more effective and safer than other treatments available for BCG-unresponsive non–muscle-invasive bladder… 

Microscopy demystifies metabolism of Alzheimer’s

Researchers at UC San Diego have deployed state-of-the art imaging techniques to discover the metabolism driving Alzheimer’s disease; results suggest new treatment strategies. Using their own state-of-the art imaging technologies, scientists at the University of California San Diego have now revealed how the metabolism of lipids, a class of molecule that includes fats, oils and many hormones, is changed in Alzheimer’s disease. They also revealed a new strategy to target this metabolic system with new and existing drugs. The findings are published in Cell Metabolism. The researchers discovered that in brains with tauopathy, neurons accumulate excess lipids as a result of stress or damage. This influx forces neurons to offload the excess to immune cells in the brain, called microglia. These microglia then mount an inflammatory response that causes further stress to neurons, triggering a repeating and worsening cycle. https://www.sciencedirect.com/science/article/abs/pii/S1550413124001189?via%3Dihub

World’s chocolate supply threatened by devastating virus

A rapidly spreading virus threatens the health of the cacao tree and the dried seeds from which chocolate is made, jeopardizing the global supply of the world’s most popular treat. About 50% of the world’s chocolate originates from cacao trees in the West Africa countries of Ivory Coast and Ghana. The damaging virus is attacking cacao trees in Ghana, resulting in harvest losses of between 15 and 50%. Spread by small insects called mealybugs that eat the leaves, buds and flowers of trees, the cacao swollen shoot virus disease (CSSVD) is among the most damaging threats to the root ingredient of chocolate. “This virus is a real threat to the global supply of chocolate,” said Benito Chen-Charpentier, professor of mathematics at The University of Texas at Arlington and an author of “Cacao sustainability: The case of cacao swollen-shoot virus co-infection”…