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Diagnóstico Laboratorial: C2N Diagnostics e Unilabs cooperam

Unilabs („Unilabs“), ein führender internationaler Anbieter von Diagnosedienstleistungen, und C2N Diagnostics, LLC („C2N“), ein Pionier für fortschrittliche Diagnoselösungen im Bereich der Alzheimer-Krankheit (AD) und verwandter neurologischer Erkrankungen, gaben heute einen wichtigen Meilenstein in der Hirngesundheitsdiagnostik und Forschung in Europa und darüber hinaus bekannt. Unilabs und C2N haben einen mehrjährigen Partnerschaftsvertrag unterzeichnet, der den Zugang zu C2Ns Precivity Portfolio von Bluttests auf exklusiver Basis in Europa, einschliesslich Norwegen, der Schweiz und Grossbritannien, erweitern wird. Die Vereinbarung wird auch den Zugang in Peru, Saudi-Arabien und den Vereinigten Arabischen Emiraten exklusiv über die bestehenden C2N-Partnerschaften hinaus ermöglichen. C2N’s Precivity Portfolio von Bluttests hilft Gesundheitsdienstleistern und Forschern bei der Erkennung von Amyloid-Plaques und neurofibrillären „Tau“-Tangles im Gehirn, die pathologische Kennzeichen der Alzheimer-Krankheit sind. Diese Tests tragen auch dazu bei, Entscheidungen über das medizinische Management und die Behandlung auf der Grundlage der zugrunde liegenden Ursachen… 

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FDA aprova autoinjetor de cloridrato de nalmefeno para reverter overdose de opioides

Today, the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023. Drug overdose persists as a major public health issue in the U.S., with more than 107,000 reported fatal overdoses occurring in 2023, primarily driven by synthetic opioids like illicit fentanyl. Nalmefene and naloxone are two available options to reverse opioid overdose. The FDA has worked to increase availability and accessibility of both options to encourage harm reduction and reduce overdose death. Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation… 

more »FDA Approves Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose

Cartesian Therapeutics Anuncia Novas Concessões de Incentivo de Emprego

Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company developing mRNA cell therapies for the treatment of autoimmune diseases, today announced the granting of inducement awards to seven new employees. On August 1, 2024, the Company issued to these employees options to purchase an aggregate of 100,457 shares of the Company’s common stock with an exercise price of $15.47, the closing trading price of the Company’s common stock on the Nasdaq Global Market on the date of grant. The options were granted pursuant to the Company’s Amended and Restated 2018 Employment Inducement Incentive Award Plan and were approved by the Company’s board of directors. Each of the options vest as to 25% on August 1, 2025, and then in three equal annual installments thereafter such that the options will be fully vested on August 1, 2028. Each of the… 

more »Cartesian Therapeutics Announces New Employment Inducement Grants

CENTOGENE kicked out by Nasdaq

Centogene N.V., the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced that it received a notice from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist CENTOGENE’S common stock from Nasdaq. The notice indicates that CENTOGENE (the “Company”) remains noncompliant with Nasdaq Listing Rule 5450(b)(2)(C), which requires a minimum USD 15 million market value of publicly held shares. CENTOGENE Receives Delisting Notice From Nasdaq

Nipocalimab for the treatment of alloimmunized pregnant women

Johnson & Johnson (NYSE: JNJ) today announced the results from the Phase 2 open-label UNITY study of nipocalimab for the treatment of alloimmunized pregnant woman at risk of early onset severe (EOS) HDFN have been published in The New England Journal of Medicine (NEJM). The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT. Nipocalimab is currently the only therapy reported to be in clinical development for HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the developing fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.2 These results showed that nipocalimab delayed or prevented severe fetal anemia requiring treatment prenatally and reduced the need for IUTs in… 

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Avanço: Primeira Vacina Terapêutica contra Câncer por mRNA Relacionada ao Vírus EB do Mundo

WestGene to Advance Clinical Trials Following Dual IND Approvals for World’s First EB Virus-Related mRNA Therapeutic Cancer Vaccine. On 6 August, the Center for Drug Evaluation (CDE) of the NMPA approved the clinical trial application for WGc-043 injection, allowing the initiation of Phase I clinical trials. This dual approval further validates WestGene’s expertise in core mRNA technologies such as delivery vectors and sequence design, and accelerates the commercialisation of effective and low-toxicity anti-tumour mRNA vaccines worldwide. EBV, classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC), infects more than 90% of the world’s population and is associated with more than ten malignancies, including nasopharyngeal carcinoma, lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer and cervical cancer. WGc-043 is now approved in both countries for treating EBV-positive solid tumors and hematologic malignancies.… 

more »Breakthrough: World’s First EB Virus-Related mRNA Therapeutic Cancer Vaccine

Novartis erhält beschleunigte FDA-Zulassung für Fabhalta®

Novartis erhält beschleunigte FDA-Zulassung für Fabhalta® (iptacopan), den ersten und einzigen Komplementinhibitor zur Verringerung der Proteinurie bei primärer IgA-Nephropathie (IgAN). Fabhalta erzielte in der Phase-III-Zwischenanalyse von APPLAUSE-IgAN eine 44%ige Reduktion der Proteinurie gegenüber dem Ausgangswert, verglichen mit 9% im Placebo-Arm, was eine klinisch bedeutsame Reduktion von 38% gegenüber Placebo darstellt (p<0,0001)1Fabhalta ist ein Inhibitor des alternativen Komplementwegs, dessen Aktivierung vermutlich zur Pathogenese von IgAN beiträgt1-4Trotz der derzeitigen Standardbehandlung kommt es bei bis zu 50 % der IgAN-Patienten mit anhaltender Proteinurie innerhalb von 10 bis 20 Jahren nach der Diagnose zu Nierenversagen5-11Dies ist die erste Zulassung aus der Nieren-Pipeline von Novartis, die auch Atrasentan und Zigakibart umfasst

Biomarcador para glioblastoma

A detecção precoce de glioblastomas, uma das formas mais agressivas de tumores cerebrais, é crucial para melhorar o prognóstico e os resultados do tratamento. Nos últimos anos, os biomarcadores emergiram como ferramentas promissoras para a detecção e diagnóstico precoces desses tumores. Biomarcadores são moléculas biológicas que podem ser detectadas no sangue, em outros fluidos corporais ou tecidos e que indicam processos normais ou patológicos. Biomarcadores importantes para glioblastomas 1. Mutações IDH: Mutações na isocitrato desidrogenase (IDH) são comuns em gliomas de baixo grau e glioblastomas secundários, mas relativamente raras em glioblastomas primários. A presença de mutações IDH pode indicar um melhor prognóstico e é frequentemente usada para a classificação de gliomas. 2. Co-deleção 1p/19q: Essa anomalia genética é característica de tumores oligodendrogliais e também pode ser útil no diagnóstico e prognóstico de gliomas. Tumores com essa co-deleção frequentemente respondem melhor à quimioterapia. 3. Metilação do promotor MGMT: A metilação do promotor MGMT…

mais »Biomarcadores para Glioblastoma

Detecção precoce: Biomarcadores para câncer de bexiga

Atualmente, vários novos biomarcadores para a detecção precoce de câncer de bexiga estão sendo pesquisados: 1. Survivin e UBC® Rapid: Essa combinação de biomarcadores mostra resultados promissores na detecção de câncer de bexiga, especialmente tumores agressivos de alto grau, em amostras de urina[2]. 2. Nuclear Matrix Protein 22 (NMP22): Este biomarcador é liberado por células em desintegração e pode ser detectado em concentrações elevadas na urina de pacientes com câncer de bexiga[5]. 3. Teste de múltiplos genes baseado em RNA (Cxbladder®) e teste de perfil epigenético (AssureMDx TM): Esses testes utilizam alterações genéticas e epigenéticas para detectar câncer de bexiga[5]. Fontes:[1] Teste de urina detecta câncer de bexiga com até 12 anos de antecedência https://healthcare-in-europe.com/de/news/urintest-blasenkrebs-12-jahre-voraus.html[2] [PDF] Biomarcadores para detecção de câncer de bexiga | DGUV https://www.dguv.de/medien/ipa/publikationen/ipa-journale/ipa-journale2018/documents/ipa_journal_1803_blasenkrebs_biomarker.pdf[3] [PDF] Verificação de biomarcadores para detecção precoce de… – DGUV https://www.dguv.de/medien/ipa/publikationen/ipa-journale/ipa-journale2017/documents/ipa_journal_1703_harnblase_biomarker.pdf[4] Teste permite diagnóstico precoce de tumor de bexiga – Vorsorge online https://www.vorsorge-online.de/vorsorgefinder/ipf-faltblaetter/blasentumor-test-ermoeglicht-fruehzeitige-diagnose/[5] Biomarcadores para câncer de bexiga na urina – PI DE – Informações ao Paciente EAU https://patients.uroweb.org/de/biomarker-fur-blasenkrebs-im-urin/

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Tumor Biomarkers: A Patient’s Guide

Tumor biomarkers are substances found in blood, urine, or body tissues that can indicate the presence of cancer. They can help diagnose cancer, predict its course, and monitor response to treatment.Why are tumor biomarkers important?