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  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Review, Journal, PD(L)-1 Biomarker, IO biomarker, Surgery:  Clinical updates in neoadjuvant immunotherapy for melanoma before surgery. (Pubmed Central) -  Aug 14, 2023   
    Localized intralesional therapies such as Talimogene laherparepvec (T-VEC) and Tavokinogene Telseplasmid (TAVO) electro-gene-transfer combined with anti-PD1 have demonstrated favorable pathologic responses and increased immune activation...Current evidence supports neoadjuvant therapy as a standard of care for locoregionally advanced melanoma. Ongoing research will define the optimal regimens and the biomarkers of therapeutic predictive and prognostic value.
  • ||||||||||  Entresto (sacubitril/valsartan) / Novartis, ROVI Pharmaceuticals Laboratories
    Review, Journal:  Therapies for patients with coexisting heart failure with reduced ejection fraction and non-alcoholic fatty liver disease. (Pubmed Central) -  Aug 14, 2023   
    This study highlights the importance of considering HFrEF and NAFLD when developing treatment plans for patients with these comorbidities. Further research is needed in patients with coexisting HFrEF and NAFLD, with an emphasis on novel therapies and the importance of a multidisciplinary approach for managing these complex comorbidities.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Trial completion date, Trial suspension, Trial primary completion date, Metastases:  Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib (clinicaltrials.gov) -  Aug 14, 2023   
    P2,  N=25, Suspended, 
    Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023 Trial completion date: Dec 2023 --> Mar 2024 | Recruiting --> Suspended | Trial primary completion date: Jul 2023 --> Nov 2023
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen, NN1213 / Novo Nordisk, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    Trial completion date:  Anti-inflammatory Therapy to Improve Outcomes After TPIAT (clinicaltrials.gov) -  Aug 14, 2023   
    P4,  N=44, Active, not recruiting, 
    Trial completion date: Jan 2029 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jan 2025 Trial completion date: Jul 2026 --> May 2025
  • ||||||||||  Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
    Enrollment change, Trial withdrawal, Metastases:  Ladarixin With Sotorasib in Advanced NSCLC - Phase II (clinicaltrials.gov) -  Aug 14, 2023   
    P2,  N=0, Withdrawn, 
    Trial completion date: Jul 2026 --> May 2025 N=28 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  erfonrilimab (KN046) / Alphamab, Stivarga (regorafenib) / Bayer
    New P2 trial, Combination therapy, IO biomarker, Metastases:  KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer (clinicaltrials.gov) -  Aug 14, 2023   
    P2,  N=98, Not yet recruiting, 
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion:  Erenumab for Idiosyncratic Facial Pain (clinicaltrials.gov) -  Aug 14, 2023   
    P4,  N=29, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  Parsabiv (etelcalcetide) / Amgen
    Journal:  Changes in Bone Quality after Treatment with Etelcalcetide. (Pubmed Central) -  Aug 14, 2023   
    Active, not recruiting --> Completed Treatment with etelcalcetide for 36-weeks was associated with improvements in central skeleton areal bone mineral density and trabecular quality and lowered bone turnover without affecting bone material properties.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Lynparza (olaparib) / Merck (MSD), AstraZeneca
    Journal, BRCA Biomarker, PARP Biomarker:  Discovery of dual PARP and CDK6 inhibitors for triple-negative breast cancer with wild-type BRCA. (Pubmed Central) -  Aug 14, 2023   
    Compared with Olaparib, the inhibition capacity of the three BRCA wild-type (MDA-MB-231, MDA-MB-468 and BT-549) cells was about 10-20 times higher, and even better than the combination of Olaparib and Palbociclib. As a novel PARP multifunctional molecule, it is a potential compound for the treatment of BRCA wild-type TNBC.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
    Journal:  CDK4/6 Inhibitors: Existing and Emerging Differences. (Pubmed Central) -  Aug 14, 2023   
    We focus particularly on how emerging findings may help us to understand similarities and differences between the available CDK4/6 inhibitors. Even at late-stage clinical development, there remains much to learn about how agents in this class exert their varying effects.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
    P2 data, Clinical Trial,Phase II, Journal:  Phase 2 trial of palbociclib and ganitumab in patients with relapsed Ewing sarcoma. (Pubmed Central) -  Aug 14, 2023   
    For patients who received first-line doublet chemotherapy for KRAS wild-type mCRC, adding anti-EGFR mAb was associated with significantly longer OS and TTF, especially for left-sided primary tumors. This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease.
  • ||||||||||  Journal:  Expenditure of biological drugs for rheumatoid arthritis treatment in the Brazilian public health system. (Pubmed Central) -  Aug 13, 2023   
    This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease. The results obtained allow us to draw a more recent profile of expenditure on RA treatment and indicate trends in the use of biological drugs for this condition, generating data that can support management decisions in public health policies.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Journal, HEOR, Real-world evidence, Real-world:  Impact of anti-CGRP monoclonal antibodies on migraine attack accompanying symptoms: A real-world evidence study. (Pubmed Central) -  Aug 13, 2023   
    Higher photophobia ratios were associated with higher response rates between three and six months. It could indicate an involvement of peripheral CGRP in photophobia as well as a central modulation of migraine through these treatments which mainly act on the periphery.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Long-Term Efficacy of Evolocumab in Patients With and Without Multivessel Coronary Artery Disease (Zone 3, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_4345;    
    Evolocumab reduced the rate of MACE in patients with and without MVD, with earlier and larger benefit seen in patients with MVD. The magnitude of benefit grew over time, supporting early initiation of intensive LDL-C lowering both in patients with and without MVD.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Response to PCSK9 Inhibition in Homozygous Familial Hypercholesterolemia Patients is Variable in Different Regions of the World and According to Age (Zone 3, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_4340;    
    Reductions in LDL-C achieved with PCSK9-inhibition in HoFH subjects are highly variable and differ according to region and age. However, given the clinically significant reductions in LDL-C in 1/3 of patients including patients from India and Turkey with null/null or novel variants, PCSK9 inhibition should remain part of standard of care for HoFH patients who remain with elevated LDL-C levels despite treatment with statin and ezetimibe.
  • ||||||||||  Miostat (carbachol) / Novartis
    Contractile Effects of Glucagon in Atrial Preparations From Transgenic Mice and Men (Zone 2, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_4005;    
    However, given the clinically significant reductions in LDL-C in 1/3 of patients including patients from India and Turkey with null/null or novel variants, PCSK9 inhibition should remain part of standard of care for HoFH patients who remain with elevated LDL-C levels despite treatment with statin and ezetimibe. These effects were antagonized by the glucagon receptor antagonist SC203973 (1
  • ||||||||||  ivabradine / Generic mfg.
    Management of Inappropriate Sinus Tachycardia: A Promising Breakthrough (Zone 2, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_3934;    
    SNSHA offers a reasonable treatment option for patients with drug resistant IST. This procedure provided symptom alleviation and improvement in HR without increasing the risk of complications in comparison to sinus node modification ablation, which has previously been shown to be associated with higher incidence of pacemaker implantation.
  • ||||||||||  prednisone / Generic mfg., midodrine hydrochloride / Generic mfg., ivabradine / Generic mfg.
    Postural Orthostatic Tachycardia Syndrome After COVID-19 Vaccination (Zone 2, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_3933;    
    This procedure provided symptom alleviation and improvement in HR without increasing the risk of complications in comparison to sinus node modification ablation, which has previously been shown to be associated with higher incidence of pacemaker implantation. After 417.2
  • ||||||||||  ivabradine / Generic mfg.
    Heart Rate Reduction Alone Produces Reverse Remodeling in Heart Failure Patients Refractory to Beta-Blockers: The PROBE-IT Trial (Zone 3, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_3875;    
    In a 2-center trial (Pulse Reduction on Beta-Blocker and Ivabradine Therapy (PROBE-IT)) we tested the hypothesis that failure to adequately reduce heart rate (HR) contributes to non-response to beta-blockers... In NDC patients meeting the PROBE-IT entry criteria, HR lowering produces a substantial increase in LVEF accompanied by gene expression changes that differ from those associated with beta-blocker therapy.
  • ||||||||||  ivabradine / Generic mfg.
    Generation of Rate-Tuned Pacemaker Organoids From Human Pluripotent Stem Cells (Zone 1, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_3853;    
    In NDC patients meeting the PROBE-IT entry criteria, HR lowering produces a substantial increase in LVEF accompanied by gene expression changes that differ from those associated with beta-blocker therapy. Optical mapping of spontaneous action potentials showed that blockade of I(f) current with ivabradine substantially reduced the automaticity of AOs (116.2
  • ||||||||||  Evkeeza (evinacumab-dgnb) / Regeneron, Ultragenyx, Sanofi, Repatha (evolocumab) / Amgen, Astellas
    A PCSK9 and APOB Double Heterozygote Presenting Phenotypically Similar to Homozygous Familial Hypercholesterolemia (Zone 1, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_3825;    
    Chaudhry et al established genetic diagnosis of HoFH in 0.9% of patients initially diagnosed as HeFH, of which 3 were true homozygotes and 3 were compound heterozygotes. These findings support the idea that various heterozygous combinations of mutations in the genes for LDLR, APOB and PCSK9, may present clinically similar to HoFH.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Long-Term Neurocognitive Safety of LDL-C Lowering With Evolocumab: Open-Label Extension Data From FOURIER (204C) -  Aug 12, 2023 - Abstract #AHA2023AHA_3368;    
    These findings support the idea that various heterozygous combinations of mutations in the genes for LDLR, APOB and PCSK9, may present clinically similar to HoFH. In 152 patients originally randomized to evolocumab, there was no significant change in SWMI from randomization through long-term follow-up over a median of 6.7 and a maximum of 7.2 years (mean change 0.1
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    CAD Polygenic Risk Score and Incident Complex Coronary Revascularization in Adults With Atherosclerosis (Zone 2, Science and Technology Hall, Level 2) -  Aug 12, 2023 - Abstract #AHA2023AHA_3143;    
    Among patients with established ASCVD, a CAD PRS predicted incident complex coronary revascularization procedures. Genetic prediction of advanced coronary disease requiring specific complex interventions has not previously been shown, and these findings may have the potential to yield novel approaches for reducing the need for these high-risk and costly procedures.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Preclinical, Journal:  ? Humanized RANKL Transgenic Mouse Model of Progestin-Induced Mammary Carcinogenesis for Evaluation of Novel Therapeutics. (Pubmed Central) -  Aug 12, 2023   
    The prophylactic treatment of humTgRANKL mice with Denosumab significantly prevented the rate of appearance of mammary tumors from 86.7% to 15.4% and the early stages of carcinogenesis, whereas therapeutic treatment did not lead to any significant attenuation of tumor incidence or tumor burden compared to control mice, suggesting the importance of RANKL primarily in the initial stages of tumorigenesis. Overall, we provide unique genetic tools for investigating the involvement of RANKL in breast carcinogenesis, and allow the preclinical evaluation of novel therapeutics that target hormone-related breast cancers.