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  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, Vectibix (panitumumab) / Amgen
    Enrollment closed, Trial completion date, Trial primary completion date:  STRATEGIC-1: Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (clinicaltrials.gov) -  Mar 12, 2024   
    P3,  N=464, Active, not recruiting, 
    No adverse drug-related reactions were observed during the follow-up. Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2024 | Trial primary completion date: Jun 2021 --> Jul 2023
  • ||||||||||  ivabradine / Generic mfg.
    New P2 trial:  RECOVER-AUTONOMIC Platform Protocol (clinicaltrials.gov) -  Mar 12, 2024   
    P2,  N=380, Not yet recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen
    New P1/2 trial:  NAPO - Novel Approach for Oligospermia (clinicaltrials.gov) -  Mar 12, 2024   
    P1/2,  N=42, Not yet recruiting, 
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Trial completion, Metastases:  Study of Regorafenib in Patients With Advanced Myeloid Malignancies (clinicaltrials.gov) -  Mar 12, 2024   
    P1,  N=16, Completed, 
    Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2024 | Trial primary completion date: Jun 2021 --> Jul 2023 Active, not recruiting --> Completed
  • ||||||||||  Stivarga (regorafenib) / Bayer, Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Exelixis, Ipsen
    Discovery of a new class of aryl-thiazoline sulfonamides as CDK4/6 inhibitors targeting hepatocellular carcinoma (Virtual; Virtual Session (Virtual Only)) -  Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_11462;    
    Current chemotherapeutic options available for systemic treatment include sorafenid, lenvatinib, regorafenib, and cabozantinib, which are tyrosine kinase inhibitors...These results provide a framework for further optimization of the chemical structure and elaborate biochemical studies to understand the mechanism of cell death better. We also plan to synthesize a series of PROTACs using these newly discovered CDK4/6 targeting molecules and investigate their biological activity.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Development of a commercial manufacturing process for sotorasib, a first-in-class KRASG12C inhibitor (Hybrid; Room 346 (Ernest N. Morial Convention Center)) -  Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_10762;    
    Optimization of the downstream processing steps reduced impurity formation and improved manufacturing cycle times, which resulted in improved API quality and manufacturing efficiency. These efforts resulted in the rapid development of a manufacturing process that enabled commercialization of sotorasib at an industry-leading speed while improving environmental sustainability.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
    Breaking the rules in tagless purification with iCapTagTM | Poster Board #1109 (In-person; Poster Board #1109; Hall C (Ernest N. Morial Convention Center)) -  Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_9232;    
    Moreover, different types of buffers, additives, and protease inhibitors can be used without affecting the performance of this technology or its recyclability. Cases of purifications will be here presented (e.g., fragments of monoclonal antibodies, filgrastim, and EPO).
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Enrollment change, Trial withdrawal, Minimal residual disease:  DLI-TARGET: Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab (clinicaltrials.gov) -  Mar 11, 2024   
    P2,  N=0, Withdrawn, 
    Although the development of LUMAKRAS N=12 --> 0 | Unknown status --> Withdrawn
  • ||||||||||  ivabradine / Generic mfg.
    Journal:  Acute Effect of Ivabradine in Mitochondrial Cardiomyopathy. (Pubmed Central) -  Mar 11, 2024   
    The present study findings hold significance for standard treatment guidelines under India's government-funded health insurance program. No abstract available
  • ||||||||||  Herceptin (trastuzumab) / Roche, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche, Perjeta (pertuzumab) / Roche
    Journal:  Timing of Administration of Pegfilgrastim and Prophylaxis for Febrile Neutropenia for Patients with Early Breast Cancer Receiving Chemotherapy (Pubmed Central) -  Mar 11, 2024   
    Regarding neoadjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer, taxanes and trastuzumab with the addition of pertuzumab have shown higher pathological complete response rates and elevated incidences of FN...The RDI of all regimens was 99.7%. Although there were some differences in chemotherapy regimens, an earlier timing of PEG prophylaxis(especially 24-48 hours from chemotherapy completion)has been shown to reduce the incidence of FN and increase the RDI.
  • ||||||||||  Procysbi (cysteamine bitartrate delayed release) / Chiesi, Amgen
    Journal:  Fibrosing colonopathy associated with cysteamine bitartrate delayed-release capsules in cystinosis patients. (Pubmed Central) -  Mar 11, 2024   
    As outlined in changes to the U.S. prescribing information for cysteamine DR, healthcare professionals should be aware of the potential risk of fibrosing colonopathy with cysteamine DR, especially as symptoms can be non-specific leading to misdiagnosis or delayed diagnosis. If the diagnosis of fibrosing colonopathy is confirmed, consideration should be given to permanently discontinuing cysteamine DR and switching to cysteamine immediate-release treatment.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Journal:  Long noncoding RNA LINC00675 drives malignancy in acute myeloid leukemia via the miR-6809 -CDK6 axis. (Pubmed Central) -  Mar 11, 2024   
    A high level of LINC00675 expression may make patients more susceptible to palbociclib treatments. In conclusion, our study demonstrated that LINC00675 is an oncogenic lncRNA that enhances the malignancy of AML by upregulating CDK6 expression through miR-6809 sponging, providing a new perspective and feasible target for the diagnosis and treatment of AML.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
    Review, Journal, Metastases:  The role of anti-EGFR rechallenge in metastatic colorectal cancer, from available data to future developments: A systematic review. (Pubmed Central) -  Mar 11, 2024   
    In our systematic review, we revised available data from clinical trials assessing anti-EGFR rechallenge activity in chemo-refractory mCRC patients, discussing as well potential future scenarios and development to implement this therapeutic approach. Particularly, we discussed the role of ctDNA as a safe, timely and comprehensive tool to refine patient's selection and the therapeutic index of anti-EGFR rechallenge.
  • ||||||||||  omecamtiv mecarbil (AMG 423) / Amgen, Servier
    Clinical data, Journal:  Tricuspid Regurgitation and Clinical (Pubmed Central) -  Mar 8, 2024   
    In symptomatic patients with HFrEF, baseline moderate/severe TR was independently associated with cardiovascular death or HF events driven predominantly by HF events. The beneficial treatment effect of omecamtiv mecarbil on the primary outcome was not modified by TR.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal, IO biomarker:  Long-Term Results of the Dasatinib-Blinatumomab Protocol for Adult Philadelphia-Positive ALL. (Pubmed Central) -  Mar 8, 2024   
    ABL1 mutations were found in seven cases. The final analysis of the D-ALBA study shows that a chemotherapy-free induction/consolidation regimen on the basis of a targeted strategy (dasatinib) and immunotherapy (blinatumomab) is effective in inducing durable long-term hematologic and molecular responses in adult Ph+ ALL, paving the way for a new era in the management of these patients.
  • ||||||||||  Krystexxa (pegloticase) / Amgen
    PEGLOTICASE FOR TUMOR LYSIS SYNDROME (SUN-345; Exhibition Hall and Main Foyer) -  Mar 8, 2024 - Abstract #ISNWCN2024ISN_WCN_1891;    
    Pegloticase is extremely effective and safe in cancer patients with severe tumor lysis syndrome. None of the patients who received Pegloticase ended up needing dialysis, ICU transfer or prolonged hospitalization.
  • ||||||||||  erythropoietin long acting (LP-001) / Longbio Pharma, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    LP-001, A NOVEL LONG-ACTING EPO OF MOST COSTEFFECTIVE IN CKD ANEMIA (SUN-216; Exhibition Hall and Main Foyer) -  Mar 8, 2024 - Abstract #ISNWCN2024ISN_WCN_1345;    
    The pre-clinical and phase I study of LP-001 suggests that this novel long-acting EPO has a comparable glycosylation form and half-life to Aranesp. Moreover, it can improve the EPO level more smoothly therefore renders a potential safer and cost-effective ESA that might be alternative for CKD treatment.
  • ||||||||||  Tavneos (avacopan) / Amgen
    AVACOPAN IN MPO-ANCA VASCULITIS: WHEN CORTICOSTEROIDS CAN NOT BE THE LONG TERM ANSWER (TUE-084; Main Foyer) -  Mar 8, 2024 - Abstract #ISNWCN2024ISN_WCN_960;    
    Avacopan, as a C5aR antagonist that blocks the effects of C5a, may reduce AAV-induced lesions, and is a new strategy to reduce drug side effects including CCT toxicity. Due to its incidence in older patients, these tend to have more comorbidities that may be aggravated with the current therapies, namely CCT.Avacopan has been used as an alternative in maintaining MPO-ANCA vasculitis remission, particularly in patients with an increased risk of CCT toxicity as was the case of our patient with several cardiovascular risk factors, besides the vasculitis itself, which was successfully treated with this approach.
  • ||||||||||  Entresto (sacubitril/valsartan) / Novartis, ROVI Pharmaceuticals Laboratories
    Examinating the Safety of Recently Approved Drugs for Cardiovascular Disease Using A Large Database () -  Mar 8, 2024 - Abstract #ISPOR2024ISPOR_2477;    
    Due to its incidence in older patients, these tend to have more comorbidities that may be aggravated with the current therapies, namely CCT.Avacopan has been used as an alternative in maintaining MPO-ANCA vasculitis remission, particularly in patients with an increased risk of CCT toxicity as was the case of our patient with several cardiovascular risk factors, besides the vasculitis itself, which was successfully treated with this approach. In comparison to valsartan, sacubitril/valsartan exhibited significantly higher reports of hypotension (ROR=2.22, 95% CI: 1.28
  • ||||||||||  Tepezza (teprotumumab-trbw) / Roche, Amgen, Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
    Evidence Gap Analysis of the Burden of Illness and Treatment of Thyroid Eye Disease () -  Mar 8, 2024 - Abstract #ISPOR2024ISPOR_2255;    
    TED negatively affects patient vision, health-related quality of life, and ability to work. Despite current treatment options, there is an unmet need for a new, effective treatment with a beneficial safety profile to control the symptoms of this potentially sight-threatening condition.
  • ||||||||||  U.S. Real-World Biosimilar Adoption By Specialty Therapeutic Area () -  Mar 8, 2024 - Abstract #ISPOR2024ISPOR_2182;    
    We analyzed data from Trisus Medication Compare (The Craneware Group, Edinburgh, UK) between 1/1/2019-12/25/2023 to identify encounters in eleven specialties (dermatology, endocrinology, gastroenterology, hematology, infectious diseases, nephrology, neurology, oncology, ophthalmology, rheumatology, and solid organ transplant) with a reference or biosimilar product dispensation for filgrastim, pegfilgrastim, infliximab, rituximab, bevacizumab, trastuzumab, insulin glargine, epoetin alfa, and ranibizumab . National data show increasing biosimilar adoption across specialty therapeutic areas, except ophthalmology, over a five-year period.