Amit Rakhit, MD, MBA

I am looking forward to moderating this cutting edge discussion with a panel of experts in the field of #AI in #medicalaffairs Luca Dezzani Herson Quiñones Sanjeev Welling Michael Vinegra #MASSEast #FierceMASS #MedicalAffairs #Technology #AI #GenerativeLangauge #FutureOfHealthcare #LifeSciences #Biotech #Pharma #FierceLifeSciences #WeAreFierce

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Sepsis patients ‘could get the right treatment faster, based on their genes’ Researchers hope the findings could help identify who would benefit from certain treatments and lead to the development of targeted therapies. The team, from the Wellcome Sanger Institute andthe University of Oxford, and collaborators, built on their previous work that identified different subgroups of patients with sepsis. They aimed to understand more about why sepsis response varies between patients and the different underlying immune response pathways. The new study, published today (18 June) in Cell Genomics, details the genetic basis of variability in sepsis response, and the different regulators and cell types involved in the different immune responses in each subgroup of patients. #sepsis Sepsis Alliance Aceso Subramaniam Krishnan #genes #sequencing #universityofoxford #sangerinstitute #innovation #infection #blood https://lnkd.in/ePdVT9iJ

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New research shows that the circRNA hsa_circ_0007590 plays a key role in glucose metabolism in pancreatic cancer (PDAC)...[facilitating] the proliferation, migration, and invasion of PDAC cells and promoted the Warburg effect. https://lnkd.in/gBJHnNX7 #bioviva #genetherapy #lizparrish #biohacking #biohacker #CRISPR #biohack #fitness #healthylifestyle #motivation #keto #nootropics #nutrition #biohackers #biohackingsecrets #longevity #meditation #brainhealth #mindfulness #healthy #functionalmedicine #antiaging #heartdisease #telomeres #klotho #healthnews #dementia #alzheimers #genetherapy

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Strategies to prevent and manage antibody-drug conjugate-associated nausea and vomiting https://lnkd.in/dyJfwuVt Sarah Cannon Research Institute Erika Hamilton, MD PeerVoice #Cancer #CancerResearch #Nausea #Vomiting #CancerTreatment #BreastCancer #Medicine #Health #Oncology #OncoDaily

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The ADDF is excited to announce the extension of the Treat FTD Fund in partnership with The Association for Frontotemporal Degeneration (AFTD)! Made possible with additional funding from the Lauder and Newhouse families, this new 10-year, $10 million commitment will provide critical funding for #FrontotemporalDementia (FTD) trials, which will advance new therapies and #repurposed drugs. Started in 2016, the Treat #FTD Fund has invested $7 million in early-stage clinical trials, testing #novel and repurposed #DiseaseModifying drugs, as well as therapeutics for FTD symptom management. The second phase of the initiative intends to carry on these efforts by validating the efficacy of drugs in Phase 2 trials with the aim of advancing these drugs to the next phase of clinical development. Learn more about the Treat FTD Fund here: https://bit.ly/4aiuDYA

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We look forward to disclosing first-in-patient clinical data at coming ASCO. CS5001 is antibody-drug conjugate (ADC) targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 is uniquely designed using LCB’s proprietary tumor-cleavable linker and pyrrolobenzodiazepine (PBD) prodrug. Only after enter the tumor cells, are the linker and prodrug cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. This double safety measure effectively reduces systemic toxicity associated with traditional PBD payloads, leading to a better safety profile and a larger therapeutic window.

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We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S  

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A great review for anyone struggling to decide between monoclonal antibodies and bispecific antibodies for use in ADCs. Bispecific antibodies have been showing great promise, particularly for targeted cancer therapies. As our understanding of them evolves, they'll likely play an even larger role in the treatment landscape - in part thanks to their ability to overcome several challenges associated with monoclonal antibodies. If you have further questions that this paper doesn't answer, reach out to our team at evitria! #Antibodies #BispecificAntibodies #Immunotherapy #ADCs

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Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference   • Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) • Results consistent with those shown in earlier human volunteer studies and Phase 2a studies • Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated  • Actinobacteria and Bacteroides preservation also confirmed using quantitative analysis   https://lnkd.in/eseFt8GZ   #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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Okay, this one is mostly for my life sciences/biopharma friends! I'm super proud of @ExoTherapeutics presenting a "late breaker" poster today at this year's American College of Rheumatology on our truly novel approach to targeting TBK1 to treat autoimmune diseases. The details: Aberrant activation of the cGAS/TBK1/STING pathway has been shown to be linked to autoimmune diseases like SLE, CLE, SSc and Sjögren’s. Historically, inhibiting this pathway has proven to be difficult for active-site inhibitors due to their inadequate selectivity, which can lead to off-target effects and narrow therapeutic indices. Exo’s approach seeks to overcome these challenges with its novel exosite inhibitors that disrupt STING-mediated TBK1 activation while avoiding the beneficial functions of the kinase on viral suppression and maintenance of autophagy. More details in the press release!

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Conclusions: * Innovation in small molecule drugs that are at risk under the IRA. * The "IRA" may reduce economic incentives to develop multiple indications. * Single-indication launches and investments in post-approval research for additional indications is severely diminished. * CMS Releases List of 10 Drugs Subject to Price Negotiation Under the IRA (diseases states from diabetes to heart failure to rheumatoid arthritis and cancer are impacted) Apixaban (Eliquis) Empagliflozin (Jardiance) Rivaroxaban (Xarelto) Sitagliptin (Januvia) Dapagliflozin (Farxiga) Sacubitril/valsartan (Entresto) Etanercept (Enbrel) Ibrutinib (Imbruvica) https://lnkd.in/eAZujzWE https://lnkd.in/eqTvBRA4 #drugdevelopment #clinicalresearch #FDA #goverment #IRA

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🔬 Remember the evidence-based medicine "ice berg"? Just talked with Evotec partners about how our patient-molecular database and the multi-omics approach in the human setting is critical for precise disease understanding. This reminded me of a 2022 paper by Vivek Subbiah, MD. It highlights the integration of wearable tech, data science, and machine learning in transforming evidence-based medicine - and, from my perspective, lays out a path of where drug discovery needs to go as well, based on longitudinal, "deep" molecular disease data sets. Read the paper here: https://lnkd.in/dKM8gBau.

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New Review by Park et al. @uoftmedicine provides comprehensive and in-depth mechanistic insight into the anti-atherosclerotic properties of GLP-1RAs demonstrated across large outcome trials https://ow.ly/5fwb50RuTwE #atherosclerosis #inflammation

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GTC published an abstract at ASCO titled Multiple Alternative Splicing of HER2 transcripts and Exon Skipping with Potential Consequences on Function and Antibody-Based Therapy. Check out this abstract: https://lnkd.in/eEdFuHeV #Exonskipping #Alternativesplicing #RNA #ASCO

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GTC published an abstract at ASCO titled Multiple Alternative Splicing of HER2 transcripts and Exon Skipping with Potential Consequences on Function and Antibody-Based Therapy. Check out this abstract: https://lnkd.in/eEdFuHeV #Exonskipping #Alternativesplicing #RNA #ASCO

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The closest rival of Illumina has raised $277 Million to Expand Innovative Sequencing and Multi-Omics Technologies. Element Biosciences has raised over $277 million in a Series D bringing total capital up to over $680 million. The new capital will support the expansion of Element Biosciences' global customer base and the advancement of its technological offerings. Central to these efforts is the AVITI™ benchtop DNA sequencer, which has been rapidly adopted since its release. Additionally, the company plans to launch AVITI24™, an instrument designed to integrate sequencing with cyto-profiling. This technology allows for the simultaneous examination of DNA, RNA, proteins, phosphoproteins, and cell structure within single cells, offering researchers comprehensive insights into biological systems. The market of NGS is heating up with a number of potential competitors to Illumina, which is currently dominates the market. Read about the companies to watch in the NGS space (link in the comments) Subscribe to Where Tech Meets Bio (Substack Newsletter) for weekly tech+bio roundup. #NGS #nextgenerationsequencing #omics #bigdata #biopharmatrend Image credit: iStock

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Biosimilars and the first MFP We will soon learn a lot about the effect on biosimilars from the transparent 2026 MFP re Stelara “Amgen will likely launch first on Jan. 1, 2025, while Samsung Bioepis, Sandoz, Fresenius Kabi (working with Formycon), and Biocon can launch their respective biosimilars in the US on Feb. 22. Reminder: Stelara had an estimated 25% absolute difference from net price for the MFP which is a larger gap than the first biosimilar (although we don't have much of a history for pharmacy brands). Source: Hernandez net price estimate Note J and J missed the MFP delay period for biosimilar entry (defined by time on market) by a whisker. #Stelara

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The much-anticipated Keytruda-beating data from Akeso and Summit Therapeutics, Inc.'s ivonescimab in first-line PD-L1-positive NSCLC are here. Impressive 49% benefit on PFS, ivonescimab's median PFS improvement was 5.32 months, reaching 11.14 months, according to results from the phase 3 HARMONi-2 trial presented at #WCLC24. Before we can call ivonescimab the new immuno-oncology king, some important considerations, including China-only data, overall survival analysis and whether Keytruda is the appropriate comparator, are discussed in details in the story. Still, I think now we can start thinking seriously about whether a new standard of care in lung cancer is on the horizon. P.S. The phase 3 was conducted solely by Akeso in China. Summit is a partner on ivonescimab in certain ex-China markets but is not involved in this trial. #Akeso #SummitTx #ivonescimab #Keytruda #Merck #PD1 #immunooncology #immunotherapy #NSCLC #lungcancer #HARMONi2 #VEGF #bispecific #cancerdrug

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The purpose of this review is to present our current understanding of cardiovascular risk factors for Alzheimer's disease (AD) and vascular dementia (VaD) by using clinical human data from observational, genetic studies and clinical trials, while elaborating on potential mechanisms https://lnkd.in/gGT2NeNa

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