Beide in der Studie getesteten Medikamente unterstützen Immunreaktionen gegen Tumorzellen. CS1002 erhöht die Aktivierung und Vermehrung von T-Immunzellen durch Bindung an einen T-Zell-Rezeptor namens CTLA-4. CS1003, auch Nofazinlimab genannt, blockiert das programmierte Zelltodprotein 1, das auf verschiedenen Arten von Immunzellen exprimiert wird und eine Rolle bei der Unterdrückung des Immunsystems spielt.
PCM Trials, the largest independent mobile research nurse visit provider for decentralized clinical trials (DCTs), today announced the acquisition of EmVenio Research based in Durham, North Carolina. EmVenio is the largest provider of community-based clinical trial sites served with mobile research units. The acquisition, which is effective immediately, strengthens PCM Trials‘ and EmVenio’s abilities to recruit and retain diverse populations for clinical research studies, as required for regulatory approval. Site networks are key to delivering critical study data for sponsors; by combining capabilities with EmVenio, PCM Trials now has access to a site network that is focused on serving underrepresented patient populations in previously hard-to-reach communities and can work flexibly with sponsors to achieve their study goals.
CAMBRIDGE, Mass., Feb. 23, 2024 — Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND). Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP
CHICAGO, IL, Feb. 22, 2024 — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that enrollment is now complete in its Phase 2 THIO-101 go-to-market clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC). MAIA Biotechnology Completes Enrollment in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer
Diese Erkenntnisse sind ein Durchbruch in der Immunmedizin. Es ist bereits schon jetzt möglich, die CAR-T-Zelltherapie im Rahmen der sogenannten CASTLE-Studie, die am Uniklinikum Erlangen durchgeführt wird, bei weiteren Patientinnen und Patienten mit schweren Formen des systemischen Lupus erythematodes, der systemischen Sklerose und der Myositis anzuwenden.
The National Institutes of Health (NIH) has launched a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network (CSRN) will support the Biden-Harris administration’s Cancer Moonshot? by investigating how to identify cancers earlier, when they may be easier to treat. Eight groups have received funding from the National Cancer Institute (NCI), part of NIH, to carry out the initial activities of the network. In 2024, the network will launch a pilot study, known as the Vanguard Study on Multi-Cancer Detection, to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. MCDs are blood tests that can screen for several types of cancers. The study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits…
Sanbexin® sublingual tablets has substantially enhanced neurological functions and independence in daily living activities among AIS patients following the treatment.
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity
Forscher in Kalifornien haben gezeigt, dass Brustkrebspatientinnen mit einer RNA-Expressionsrate von ENPP1 (Ektonukleotid-Pyrophosphatase/Phosphodiesterase 1) im unteren 50. Perzentil mit Keytruda (Pembrolizumab) und einer Operation behandelt werden können.
AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy The post Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma appeared first on Bio Tech Winners. Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma
