JMSACL (Journal of Mass Spectrometry & Advances in the Clinical Lab)’s Post

Clinical Trials Updates: Takeda's Iclusig (ponatinib) has received accelerated approval from the FDA for treating newly diagnosed adults with a rare type of leukaemia. This approval marks the first time a targeted therapy has been approved in the US as the initial treatment for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph-positive ALL). This typeof leukaemiaa affects around 25% of adults with ALL and is identified by the presence of an abnormal gene called the Philadelphia chromosome. Iclusig, a kinase inhibitor, was previously approved in the US for various leukemia patients. This additional approval was supported by positive results from the PhALLCON study, showing Iclusig-treated patients achieved over two-fold improvement in minimal residual disease-negative complete remission. Congrats to Takeda once again for the successful approval! #medicalaffairs #clinicaldevelopment #clinicalcareers #FDAapproval #medicalcareers https://lnkd.in/efmHKAXQ

Great work illustrating the strong capabilities of the OSP suite with PK-Sim/MoBi for enzyme/pH-dependent DDIs and reliable dose adjustments. And all model files are made publicly available #opensource #openscience #DDI #personalizedosing

Design, synthesis, and biological evaluation of first-in-class indomethacin-based PROTACs degrading SARS-CoV-2 main protease and with broad-spectrum antiviral activity https://lnkd.in/gM7eQwSE To date, Proteolysis Targeting Chimera (PROTAC) technology has been successfully applied to mediate proteasomal-induced degradation of several pharmaceutical targets mainly related to oncology, immune disorders, and neurodegenerative diseases. On the other hand, its exploitation in the field of antiviral drug discovery is still in its infancy

CelluSPOT Synthese im Peptidsynthesizer MultiPep 2 Inhibition of the YAP-MMB interaction and targeting NEK2 as potential therapeutic strategies for YAP-driven cancers https://lnkd.in/eGFnuFwJ #Peptode #peptide #peptidsynthesizer #peptidesynthesis #CelluSPOT #Multipep #CEM #Intavis #medikamente

"Carvykti and Abecma have proved effective in earlier treatment of multiple myeloma, before patients cycle through other drugs currently used to hold their blood cancer in check. As with other CAR-T therapies for leukemia and lymphoma, their makers are using that evidence to try to broaden use." #DahliaConsulting #BiopharmaceuticalIndustry #CommercialLifeSciences #ManagementConsultant #LifeSciencesBusinessStrategy #GlobalPharma #GlobalBioTech #SupplychainOperations #CommercialOperations #CGTcommercialization #Manufacturing #QualityAssurance #OperationalExcellence #FinancialAnalysis #OpModelDesign #LifeScience #BioTechnology #Bioprocessing #Biosimilars #BioPharmaIndustry #MedicalResearch #CDMO #GMP #GMPbatch #GMPmanufacturing #GenomeEditing #GeneTherapy #CellTherapy #Car_T #mRNA #cGMP #ClinicalGradeManufacturing #ClinicalGradeProduction #BiologicsLicenseApplication #BLA #Pharmaceuticals #RegenerativeMedicine #BioPharnaDive #FDA #EMA #JohnsonAndJohnson #LegendBiotech #Carvykti #BristolMyersSquibb #Abecma #MultipleMyeloma

A study using Veterans Affairs data found that GLP-1 receptor agonists reduced the risk of cirrhosis and related complications in patients with diabetes and MASLD. In a cohort of over 30,000 patients, GLP-1 agonists were associated with a 14% lower risk of cirrhosis compared to DPP-4 inhibitors. Patients using GLP-1 agonists also had a 22% lower risk of cirrhosis complications and an 11% lower risk of all-cause mortality. However, there was little benefit for patients who already had cirrhosis at baseline. The protective effects were most evident 18 to 24 months after starting treatment. Semaglutide, a GLP-1 agonist, showed stronger protective associations than other drugs in this class. 1. **Reduced Risk of Cirrhosis**: GLP-1 receptor agonists were associated with a 14% lower risk of cirrhosis progression in patients with diabetes and MASLD, compared to DPP-4 inhibitors. 2. **Lower Risk of Complications and Mortality**: Patients using GLP-1 agonists experienced a 22% lower risk of cirrhosis complications and an 11% reduction in all-cause mortality. 3. **Delayed Onset of Benefits**: The chemopreventive effects of GLP-1 agonists became apparent 18 to 24 months after treatment initiation, with little benefit for those with pre-existing cirrhosis. 4. **Semaglutide's Effect**: Semaglutide demonstrated stronger protective outcomes than other GLP-1 agonists, suggesting that more potent GLP-1 drugs or dual/triple agonists could enhance the protective effects in the future. Primary Source: Kanwal F et al "GLP-1 receptor agonists and risk for cirrhosis and related complications in patients with metabolic dysfunction-associated steatotic liver disease" JAMA Intern Med 2024; https://lnkd.in/gpqF8_7d. American Association for the Study of Liver Diseases (AASLD) EASL | The Home of Hepatology Barcelona Institute for Global Health (ISGlobal) Global NASH Council Canadian Association for the Study of the Liver Global Liver Institute Jeff Minerd Written in collaboration with CHATGPT4o.

CelluSPOT Synthese im Peptidsynthesizer MultiPep 2 Inhibition of the YAP-MMB interaction and targeting NEK2 as potential therapeutic strategies for YAP-driven cancers https://lnkd.in/eGFnuFwJ #Peptode #peptide #peptidsynthesizer #peptidesynthesis #CelluSPOT #Multipep #CEM #Intavis

*** NEW PAPER ALERT *** 📢 Check out this recent publication describing a drug-drug-interaction (DDI) study for the tyrosine-kinase inhibitor, dasatinib, a treatment for chronic myeloid and acute lymphoblastic leukemia. The work aims to describe and predict enzyme-mediated and pH-dependent DDIs, and evaluate the impact of strong and moderate CYP3A4 inhibitors and inducers on dasatinib exposure. 👉 The work has significant utility for dose optimisation and personalisation of therapy and for clinical management of patient-related factors, such as elevated gastric pH. #OSPSuite #PKSim #DDI #MoBi #DoseOptimisation https://lnkd.in/e6q6hEAR

When real-life adds to clinical data :20,409 reports involving tirzepatide related to 1432 adverse events, the researchers analyzed 7460 reports referring to 286 selected adverse events. Tirzepatide displays an unprecedented glucose- and weight-lowering efficacy, it comes with a similar or even improved safety profile vs GLP-1 receptor agonists.Caveats: FAERS database is based on the spontaneous reporting of adverse events, meaning that "underreporting of some adverse events, especially those occurring several years following drug initiation (ie, thyroid cancer) could occur, [and] public awareness of the association between a drug and a given adverse event might affect reporting frequency," https://lnkd.in/eD6N4R4c