Greg Coulter

Discover how computational sequence analysis and 3D structural modeling can speed up your therapeutic discovery process, uncovering potent antibody leads while minimizing liabilities. Learn more about Orion’s Antibody Discovery Suite.

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FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development The U.S. Food and Drug Administration (FDA) released a new draft guidance on September 16th titled "Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs”.1 Recognizing that most drug development is global, the guidance explains how drug developers should address requirements for ensuring that oncology MRCTs include populations that enable interpretability and relevance of the results to U.S. patients. The guidance also clarifies the FDA’s position on the use of foreign data to support marketing applications for cancer therapies in the U.S. The FDA will no longer accept data from clinical trials conducted in only one country or single geographical region as sufficient to support a marketing application, since these data will not enable understanding of any differences in treatment effect for the diverse U.S. population. While FDA regulations allow for the use of foreign data to support a marketing application2,3, the regulations, along with the guidances4,5,6 focused on ensuring diversity in clinical trials, state that foreign data are acceptable only if the patient population is representative in terms of criteria such as demographics and disease characteristics. Consequently, companies developing therapies for oncology indications who have already conducted their clinical trials in a single country or geographical region may have to conduct additional trials to ensure their clinical program is representative of the target U.S. patient population. The guidance also means that companies must begin their Diversity Action Plan as early as Phase 1 and well before their Phase 3 pivotal studies. In many instances, companies rely upon their Phase 2 oncology study(ies) to support their marketing application, with the Phase 3 trial(s) serving as confirmatory and completed post-approval. The guidance's overall goal is to ensure that data from oncology MRCTs are applicable to the U.S. population and medical practice while maintaining the efficiencies of global trials. https://lnkd.in/ea86t7YQ

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Mark your calendars. Our brilliant scientist, Leo Liu, is all set to share SEC-MALS insights on July 18th webinar, "Episode 6: USP Chapter 129 Updates and SEC-MALS" in collaboration with Waters Corporation and US Pharmacopeia. Make sure you’re there for this exchange of wisdom!

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Save the date! On July 18th join scientist Leo Liu for the "Episode 6: USP Chapter 129 Updates and SEC-MALS" webinar. This event, in collaboration with Waters Corporation and US Pharmacopeia, promises valuable insights into SEC-MALS. Don't miss it! #Webinar #SECMALS #PharmaceuticalScience #USPharmacopeia #WatersCorporation

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DC Chemicals developed a novel ionizable lipid C14-A1 for LNP research. https://lnkd.in/g7HASB6j Lipid C14-A1 is an ionizable lipid. C14-A1-LPN is a potent and safe LNP platform to deliver Foxp3 mRNA to CD4+ T cells to engineer immunosuppressive FP3T cells. ---[1]Thatte AS, Hamilton AG, Nachod BE, Mukalel AJ, Billingsley MM, Palanki R, Swingle KL, Mitchell MJ. mRNA Lipid Nanoparticles for Ex Vivo Engineering of Immunosuppressive T Cells for Autoimmunity Therapies. Nano Lett. 2023 Oct 31

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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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FDA Approves Crovalimab for the Treatment of PNH Full story in comments below

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Novartis has joined forces with Versant Ventures to establish Borealis Biosciences, Inc., an independent biotechnology company based in Vancouver, Canada. This collaboration aims to pioneer next-generation xRNA-based medicines specifically tailored for kidney diseases. With xRNA as a core technology platform, Novartis can precisely target the body's natural mRNA to regulate the production of disease-causing proteins. As part of this partnership, Novartis retains the option to acquire two future development-ready programs, enhancing its renal portfolio – a strategic focus area for the company. Borealis leverages the scientific expertise inherited from Novartis' acquisition of Chinook Therapeutics, a Novartis Company Therapeutics, which bolsters the potential and pace of successful early drug discovery endeavors. #creativefinancing #kidneydisease #advancedtherapies #xRNA #renaldisease #funding #financing #biotech #biotechnology #lifescience #lifesciences #technologyplatform #partnership #bigpharma #renalportfolio3Drugdiscovery

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Check out my podcast interview discussing Vivacelle Bio's innovative approach to addressing Septic Shock.

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The globally approved CAR-T cell products and their respective manufacturers include: 1. Kymriah (tisagenlecleucel) – Novartis 2. Yescarta (axicabtagene ciloleucel) – Gilead Sciences (acquired Kite Pharma) 3. Tecartus (brexucabtagene autoleucel) – Gilead Sciences (acquired Kite Pharma) 4. Breyanzi (lisocabtagene maraleucel) – Bristol Myers Squibb 5. Abecma (idecabtagene vicleucel) – Bristol Myers Squibb 6. Carvykti (ciltacabtagene autoleucel) – Janssen Biotech, Inc., a Johnson & Johnson company, in partnership with Legend Biotech and Novartis In addition, CAR-T therapies approved outside the U.S. include: Relma-cel (relmacabtagene autoleucel) – JW Therapeutics (China) Yuanruida (inaticabtagene autoleucel) – Innovative Cellular Therapeutics (China) NexCAR19 (actalycabtagene autoleucel) – Immuneel Therapeutics (India) Recently released, the "Global CAR-T Cell Therapy Market – Market Size, Forecasts, Trials & Trends, 2024" describes the current state of CAR-T cell therapies and explores their future potential. It identifies the CAR-T products approved to date and the number of patients treated annually with each. It identifies products under development in late-stage trials. It reveals market size figures for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with future forecasts through 2032. It quantifies CAR-T funding events, including licensing deals, collaboration deals, IPOs, M&A activity, and venture investments. It tracks rates of scientific publications, patents, grants and clinical trials, as well as reveals company data for the industry's leading competitors. Learn more at: https://lnkd.in/eCkW5rn

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Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) to Discuss Second Quarter 2024 Financial Results on August 9, 2024 Conference Call and Provide Business Update   Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP), a clinical stage #biopharmaceutical company focused on developing new #antibiotics for difficult-to-treat #bacterial infections, has announced a conference call to discuss its second quarter 2024 financial results. The call is scheduled for August 9, 2024, at 8:00 am ET, before the U.S. financial markets open.   The company's President and CEO, David Luci, along with CFO Robert Shawah, will host the call to present the #financial results and provide a business update. #Investors and interested parties can join the call using the provided toll-free number for U.S. participants or international access numbers.   https://lnkd.in/esMuCywW #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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A nice and short article by the FDA on biosimilars that was just updated on 20/JUN/2024. Biosimilars can be advantageous in clinical trials for various reasons including shelf life and pricing. If you are looking to source or considering biosimilars for your study, let's connect and discuss how Inceptua is helping sponsors with these products.

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The Rise of the Global Exosome-Based Cosmeceuticals Market in 2024 - https://lnkd.in/g5rQKaP4 A cosmeceutical is defined as a product that is marketed as a cosmetic but has the capacity to exert pharmaceutical effects. In recent years, exosomes have been utilized within the global cosmetics industry to manufacture and market skincare products that use the power of these small extracellular vesicles to enhance a broad range of traits, including but not limited to skin health and rejuvenation, scar improvement, hair regrowth, anti-aging effects, and beyond. Exosome-based hair regeneration products have also arrived in the global market. On August 1, 2023, EXOCEL BIO launched its Evovex hair growth serum, Refine. Refine contains exosomes derived from placental MSCs. These exosomes stimulate hair follicles and promote hair growth and prevent additional hair loss. Currently, more than 500 dermatologists across the U.S. are offering this treatment in their clinics. Another major player in exosome-based hair treatment is Rion Aesthetics. The company’s clinically proven HAIR serum significantly improves the appearance of scalp coverage. The product contains platelet-derived exosomes, along with a blend of biotin, sea moss, turmeric, hyaluronic acid, and an antioxidant mix. Read more at: https://lnkd.in/g5rQKaP4 #exosomes #cosmetic #stemcell

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Ready to launch your IND application? Success starts with preparation 🔥 Key elements for a smooth IND submission: 𝟏. 𝐒𝐭𝐫𝐨𝐧𝐠 𝐩𝐫𝐞𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐝𝐚𝐭𝐚 𝐩𝐚𝐜𝐤𝐚𝐠𝐞 - Complete safety studies - Robust pharmacology results - Well-documented manufacturing process 𝟐. 𝐂𝐥𝐞𝐚𝐫 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐩𝐫𝐨𝐭𝐨𝐜𝐨𝐥 - Detailed study design - Patient safety measures - Specific endpoints 𝟑. 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 - FDA guidelines alignment - Quality control systems - Documentation standards 𝟒. 𝐄𝐱𝐩𝐞𝐫𝐭 𝐭𝐞𝐚𝐦 𝐚𝐬𝐬𝐞𝐦𝐛𝐥𝐲 - Regulatory specialists - Clinical researchers - Manufacturing experts ⚡ Learn these elements, and your IND application will stand out. The path to approval becomes clearer when you focus on quality and thoroughness 💪 Your innovative treatment is one submission away from helping patients. ------------------------------------ ♻️Repost to help your Network 🔔Follow Olivier Freytag for more

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Arcturus lipid 2(Lipid 2,2 (8,8) 4C CH3,ATX0114 ) DC Chemicals developed a novel ionizable lipid ATX0114 for RNA delivery. https://lnkd.in/g9nNffXA Arcturus lipid 2(Lipid 2,2 (8,8) 4C CH3,ATX0114 ) is a novel ionizable lipid for mRNA delivery.

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