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Clinical Development of Lutetium (177Lu) rhPSMA-10.1 Injection

Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced further positive developments for its novel investigational radioligand therapies. Enrolment of patients in the Phase 1 trial of Lutetium (177Lu) rhPSMA-10.1 Injection was completed in July. Early data from the trial suggests an encouraging safety profile. Radiation dosimetry performed for up to three cycles showed delivery of high tumour absorbed radiation doses relative to the dose delivered to the key normal organs, such as kidney and salivary glands. While final analysis is ongoing, the ratio between radiation dose to tumours vs. dose to the kidneys and salivary glands was compelling vs. published data1 for first generation radioligand therapies. This data opens the way for the Phase 2 portion of the Phase 1/2 trial to start later this year. The company has shared the intended Phase… 

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EuGH stärkt Datenschutz im Online-Arzneimittelhandel

Der Europäische Gerichtshof (EuGH) hat in der Rechtssache C-21/23 (Lindenapotheke) entschieden, dass Mitgliedstaaten Mitbewerbern eines Unternehmens die Möglichkeit einräumen können, Verstöße gegen die Datenschutz-Grundverordnung (DSGVO) als unlautere Geschäftspraktik gerichtlich anzugreifen. Das Urteil betrifft den Onlineverkauf apothekenpflichtiger Arzneimittel, bei dem eine ausdrückliche Einwilligung der Kunden in die Verarbeitung ihrer personenbezogenen Daten erforderlich ist – auch bei rezeptfreien Arzneimitteln. In seiner Entscheidung stellt der EuGH klar, dass die DSGVO Wettbewerbern erlaubt, gegen vermutete Datenschutzverstöße vorzugehen. Das stärke die Rechte der betroffenen Personen und sorge für mehr Datenschutz. Zudem könne dies helfen, weitere Verstöße gegen die DSGVO zu vermeiden.

Groundbreaking Study on Antimicrobial Stewardship in Wound Care

MolecuLight Inc., the global leader in fluorescence imaging technology for real-time detection of harmful bacteria in wound care, is excited to announce the publication of a new study that addresses a critical challenge in wound care: the need for standardized and evidence-based antibiotic and antimicrobial prescribing. Published in Diagnostics, this groundbreaking research underscores the urgent need for widespread adoption of antimicrobial stewardship programs (ASPs) and reveals the significant potential to improve prescribing practices with MolecuLight. The study, led by Dr. Thomas Serena and titled „Audit of Antimicrobial Prescribing Trends in 1447 Outpatient Wound Assessments: Baseline Rates and Impact of Bacterial Fluorescence Imaging“, examined antimicrobial prescribing practices in 2022 across eight U.S. outpatient wound clinics. By comparing trends between clinics with and without MolecuLight, the research provides valuable insights into current prescribing practices and the impact of MolecuLight on antimicrobial use.… 

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Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test

Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA’s De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes. Validation of Healgen’s at-home test data was supported through the Independent Test Assessment Program (ITAP), part of National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program. ITAP assessed Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test’s quality, accuracy and reliability, and found it demonstrated sensitivity and specificity of greater than 90% and 99%, respectively.

Judo Bio debütiert mit 100 Millionen US-Dollar

Das in Cambridge (Massachusetts) ansässige Biotech-Unternehmen verwendet sogenannte Ligand-siRNA-Konjugate, um Wirkstoffzielmoleküle in der Niere zu erreichen, die mit RNA-Therapien bisher nur schwer zu erreichen waren. Das berichtet Biopharma Dive:. „Ein neues Biotechnologieunternehmen namens „Judo Bio“ will Nierenerkrankungen bekämpfen. Ausgestattet mit 100 Millionen US-Dollar und einer RNA-Medikamentenplattform soll das Unternehmen Ziele erreichen, die für Forscher bislang nur schwer zu erreichen waren.Judo wurde vor drei Jahren gegründet und wird von einer Handvoll Investoren unterstützt, darunter Atlas Venture, das das Startup inkubierte und dessen Serie A mitleitete, sowie The Column Group und Droia Ventures.Mit seiner Technologie tritt Judo in die Fußstapfen von Alnylam Pharmaceuticals , das als erster Hersteller ein biologisches Verfahren namens RNA-Interferenz zur Herstellung einer neuen Medikamentenklasse einsetzte. Anders als die ersten Medikamente von Alnylam, die auf die Leber abzielen, behauptet Judo, dass es seine RNA-Medikamente zuverlässig in die Nieren schmuggeln… 

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Pet Health: Elanco Receives FDA Approval for Credelio Quattro™

Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug Administration (FDA) has approved Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), becoming the broadest approved canine oral parasiticide with its protection against six types of parasites—fleas, ticks, heartworms, and the three risky intestinal parasites—roundworms, hookwormsii and tapeworms. Credelio Quattro is a single, monthly chewable tablet for dogs eight weeks of age or older. „Zoonotic disease is more common than many might think. One of our own Elanco veterinarians recently found echinococcus tapeworm lurking in her back yard,“ said Dr. David Gosche, veterinarian and U.S. Pet Health Medical Director at Elanco. „Zoonotic disease affects millions of people and animals worldwide each year. Our pets can easily serve as the ‚bridge hosts,‘ bringing these parasites into our homes when they cuddle with us on couches or in… 

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MediLink Announces Global Clinical Trial Collaboration

MediLink Therapeutics (Suzhou) Co., Ltd. („MediLink“), a clinical-stage biotech company, today announced a global clinical trial collaboration and supply agreement with Amgen Inc. Amgen will lead a global clinical study to evaluate the therapeutic potential of the combination of MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 and Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE®) IMDELLTRA™ in extensive-stage small cell lung cancer (ES-SCLC) under the clinical trial collaboration and supply agreement. MediLink will provide the investigational drug YL201 for the combination study. This open-label, global, multi-center Phase Ib clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of this combination regimen in ES-SCLC patients. Both YL201 and IMDELLTRA™ have shown potential in ES-SCLC. In May of this year, IMDELLTRA™ received accelerated approval from the FDA and is currently marketed in the US for the treatment of adult patients… 

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Medizin-Nobelpreis für Genforscher

Der Nobelpreis für Physiologie oder Medizin geht in diesem Jahr an Victor Ambros und Gary Ruvkun. Das teilte das Karolinska-Institut am Montag in Stockholm mit. Die beiden Wissenschaftler wurden für ihre Entdeckung der microRNA und ihrer Rolle bei der posttranskriptionalen Genregulation ausgezeichnet. Der Preis ist mit elf Millionen schwedischen Kronen, umgerechnet etwa 970.000 Euro, dotiert. […] Medizin-Nobelpreis für Genforscher

BMG: „Pflegeversicherung ist nicht pleite“

Das Bundesgesundheitsministerium hat der Darstellung widersprochen, dass der Pflegeversicherung unmittelbar die Zahlungsunfähigkeit drohe. „Die Pflegeversicherung ist nicht pleite“, sagte eine Sprecherin des Ministeriums am Montag in Berlin. Dafür werde entsprechend gesorgt. Bundesgesundheitsminister Karl Lauterbach (SPD) will demnach in Kürze ein „Finanzkonzept“ vorlegen, mit dem die Pflegeversicherung gestützt werden soll. Dies werde „sowohl kurzfristig als auch […] Gesundheitsministerium: „Pflegeversicherung ist nicht pleite“

Promising Results from MRX-5 Study for Treating Mycobacterium abscessus Infections

MicuRx Pharmaceuticals announced the publication of groundbreaking research on MRX-5, a novel oral oxaborole prodrug, demonstrating significant potential in the treatment of pulmonary infections caused by Mycobacterium abscessus (Mab), a severe nontuberculous mycobacterium (NTM) infection. The research was led by Dr. Gyanu Lamichhane, Associate Professor at Johns Hopkins University School of Medicine. Mab infections are notoriously difficult to treat, often requiring prolonged, complex, and poorly tolerated courses of multiple antibiotics. With no FDA-approved treatment for Mab, the results of this study are a promising step towards addressing the growing unmet clinical need for effective and convenient treatment options. Importantly, MRX-5 offers an oral alternative to current treatment regimens that are primarily intravenous and highly toxic, with failure rates exceeding 50%. MRX-5 could vastly improve patient compliance and quality of life compared to the current standard intravenous therapies