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CBL-514 Phase 2b Study (CBL-0205) for Subcutaneous Fat Reduction

Caliway Biopharmaceuticals (Caliway) completed CBL-514 Phase 2b study for non-surgical fat reduction (CBL-0205, clinicaltrials.gov ID: NCT06005441) on October 22nd, 2024, with the topline results anticipated in Q1 2025. CBL-0205, the last of the two CBL-514 Phase 2b studies for fat reduction, was designed in accordance with the U.S. FDA recommendations for the upcoming Pivotal Phase 3 study. The possible success of two Phase 2b studies meeting endpoints will make CBL-514 the first fat reduction product for large area to enter the Phase 3 study. CBL-514 is a combination of multiple APIs, including CBL-A1 and CBL-A2. The CBL-0205 study is a multicenter, single-blinded, randomized, placebo-controlled Phase 2b trial designed to evaluate the efficacy, safety, and tolerability of CBL-514 versus its individual API, CBL-A1 and CBL-A2, as well as the placebo. A total of 173 participants were enrolled and randomly allocated to… 

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Rise Therapeutics secures funding

Rise Therapeutics announced today that it has received funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institute of Health (NIH) to enable infrastructure improvement that will scale GMP production and accelerate quality assurance (QA) and quality control (QC), significantly enhancing its biologics drug manufacturing capabilities. This Commercial Readiness Pilot (CRP) Program SBIR award will also support Phase 2 clinical GMP manufacturing to advance Rise Therapeutics‘ R-3750 program currently completing a Phase 1 proof-of-concept clinical trial in patients suffering from ulcerative colitis.

Chinese Anti-Tumor Tablets: Investigational New Drug (IND) Application Accepted

On October 17, 2024, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) submitted the company’s Investigational New Drug (IND) application for CS231295 tablets, a Class 1 innovative drug for the treatment of tumors. The application has been accepted by the Center for Drug Evaluation of National Medical Products Administration of China (Application Number: CXHL2401105, CXHL2401107, CXHL2401108). Malignant tumors are one of the main causes leading to human death. Although clinical treatments have been significantly improved, most tumors are still incurable. The drug resistance, tumor recurrence and metastasis still are the biggest threat to long-term survival of patients. Particularly, Malignant brain tumors and brain metastasis  not only brings direct life hazards but also has a natural barrier for drug efficacy due to the blood-brain barrier. Therefore, developing new anti-tumor drugs with good brain permeability has become a hot and… 

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Dehydration führt bei IRONMAN-Triathleten zu Muskelkrämpfen

PULLMAN, Washington – Während sich die Athleten darauf vorbereiten, am 26. Oktober zum ersten Teil der IRONMAN-Weltmeisterschaft in die hawaiianischen Gewässer einzutauchen, sollten sie dem Wasser in ihrem Körper vielleicht etwas mehr Aufmerksamkeit schenken. Im Gegensatz zu früheren Forschungsergebnissen stellte eine von der Washington State University geleitete Studie, die drei Jahrzehnte des IRONMAN-Spitzenwettbewerbs untersuchte, einen Zusammenhang zwischen Dehydrierung und trainingsbedingten Muskelkrämpfen fest. Die im Clinical Journal of Sport Medicine veröffentlichte Studie stützte sich auf medizinische Daten von mehr als 10.500 Triathleten und stellte einen starken Zusammenhang zwischen Dehydrierung und der Tatsache fest, dass Teilnehmer während des Wettkampfs wegen Muskelkrämpfen eine Behandlung suchten. Während viele gängige Theorien besagen, dass unausgeglichene Elektrolyte oder Kalium- und Salzwerte zu Krämpfen beitragen, konnte diese Studie keine Beweise dafür finden, was mit anderen aktuellen Forschungsergebnissen übereinstimmt. Muskelkrämpfe gehören zu den häufigsten Beschwerden im Triathlon. Laut einer… 

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Wearable cameras allow AI to detect medication errors

A team of researchers says it has developed the first wearable camera system that, with the help of artificial intelligence, detects potential errors in medication delivery. In a test whose results were published today, the video system recognized and identified, with high proficiency, which medications were being drawn in busy clinical settings. The AI achieved 99.6% sensitivity and 98.8% specificity at detecting vial-swap errors. The findings are reported Oct. 22 in npj Digital Medicine. The system could become a critical safeguard, especially in operating rooms, intensive-care units and emergency-medicine settings, said co-lead author Dr. Kelly Michaelsen, an assistant professor of anesthesiology and pain medicine at the University of Washington School of Medicine. “The thought of being able to help patients in real time or to prevent a medication error before it happens is very powerful,” she said. “One can hope… 

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Schnelle Genomanalyse eines Windhundes setzt neuen Maßstab für Artenschutz-Forschung

(Pugnalom.io) Der fortschreitende weltweite Verlust an Artenvielfalt macht es zunehmend erforderlich, genetische Informationen bedrohter Arten schnell zu erfassen und auszuwerten. Die Abteilung für Humangenetik des Bioscientia Instituts für Medizinische Diagnostik GmbH in Ingelheim am Rhein und das hessische LOEWE-Zentrum für Translationale Biodiversitätsgenomik (LOEWE-TBG) haben in einem Kooperationsprojekt in weniger als einer Woche das komplette Genom eines… Schnelle Genomanalyse eines Windhundes setzt neuen Maßstab für Artenschutz-Forschung

Asiens Unternehmen erwarten Anstieg der Insolvenzen

In Asien wächst die Sorge vor einem Anstieg der Insolvenzen in den kommenden Monaten. Das geht aus der aktuellen Ausgabe 2024 des Atradius Payment Practices Barometer Asia hervor. Beeinträchtigt wird dadurch insbesondere der B2B-Handel auf Kredit. Für die Hälfte der von Atradius in Asien befragten Unternehmen hat sich das steigende Insolvenzrisiko als eine der Hauptsorgen… Asiens Unternehmen erwarten Anstieg der Insolvenzen

Lilly’s Kisunla™ (donanemab-azbt) Receives Marketing Authorization in Great Britain

Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer’s disease in eligible adults in Great Britain. Eligible patients are limited to apolipoprotein E ?4 (ApoE ?4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Great Britain is the third major market to approve donanemab, marketed as Kisunla. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking… 

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VZBV kritisiert falsche Abrechnung von Kassenleistungen

Manche Patienten müssen beim Arztbesuch offenbar für Behandlungen bezahlen, die eigentlich von den Krankenkassen übernommen werden. Dies hat ein Verbraucheraufruf der Verbraucherzentrale Bundesverband (VZBV) ergeben, bei dem zwischen Februar und September rund 300 Meldungen eingegangen sind und über die die Zeitungen der Funke-Mediengruppe berichten. Die Auswertung zeigt, dass manche Behandlungen ungerechtfertigt als Individuelle Gesundheitsleistungen (IGeL) […] VZBV kritisiert falsche Abrechnung von Kassenleistungen

Cytokine Panels Informed Clinical Management in Nearly 30% of Pediatric Cases

Researchers from Children’s Hospital of Philadelphia (CHOP) demonstrated how rapid testing of cytokine levels can help distinguish different diseases with similar symptom profiles. Nearly 30% of clinicians changed how they managed disease in children after receiving cytokine level information, showing the potential for this testing to impact clinical practice. The findings were recently published in the Journal of Allergy and Clinical Immunology. During the COVID-19 pandemic, doctors began diagnosing patients with multisystem inflammatory syndrome in children (MIS-C), a condition that occurs weeks after infection and results from inflammation throughout the body. However, the initial symptoms – such as high fever and changes in blood pressure – are very similar to those of an acute, severe COVID-19 infection, so doctors needed to be able to distinguish between the two conditions, since each one requires a very different course of treatment. Distinguishing… 

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