Join our webinar this week as we unravel the intricacies of leveraging FDA interactions to drive your projects forward. ?? ??Key Insights: ? Understand the distinct features of INTERACT, pre-IND, and Type D meetings and their unique requirements. ? Discover when and how to prepare comprehensively for successful interactions with the FDA. ? Acquire knowledge on engaging with the FDA to optimize decision-making processes in early drug development. ?? Register now to secure your spot: https://lnkd.in/dR5wMDCy Don't miss out on this opportunity to elevate your understanding of FDA interactions! #TrialWithoutBorders #HiRO #FDA #PreIND #RegulatoryWebinar
贺维斯特医药科技 HiRO的动态
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Find out more about this and the key trends and standout deals shaping the pharmaceutical industry.
Licensing deal volume was down, yet value was up in H1 2024. Discover how this trend is reshaping the competitive landscape in drug development. Download the #PharmaDeals H1 Review of 2024 to find out more https://bit.ly/4gNZQrl #PharmaLicensing #PharmaceuticalStrategy
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The IQVIA Pharma Deals Half Year Review of 2024 reveals important trends in the pharmaceutical sector's mergers, acquisitions (M&A), and licensing activities. Although the number of M&A deals dropped by 20% compared to the first half of 2023, the total value of these deals increased significantly. This shows that big pharmaceutical companies, like Johnson & Johnson, Merck & Co., and Gilead Sciences, are focusing on larger, more strategic acquisitions, especially in the areas of oncology and immunology. Licensing deals also saw a change. While the number of deals fell by 24%, the overall value went up by 22%. This suggests that companies are more interested in securing high-value, later-stage products rather than a large number of early-stage assets. Oncology remained the top focus for deals, driven by advances in immuno-oncology and new treatments like radiopharmaceuticals. Looking ahead, the report predicts that deal-making will continue, particularly as many major drug patents are set to expire. This will push companies to look for new, innovative therapies through acquisitions and partnerships. Although regulatory issues may limit some large deals, targeted acquisitions and licensing agreements will likely remain a key strategy for future growth. For more detailed insights, IQVIA provides a comprehensive analysis on this topic. #pharma #pharmadevelopment #pharmadeals #strategy #pharmastrategy #pharmalicensing #pharmaceuticalstrategy
Licensing deal volume was down, yet value was up in H1 2024. Discover how this trend is reshaping the competitive landscape in drug development. Download the #PharmaDeals H1 Review of 2024 to find out more https://bit.ly/4gNZQrl #PharmaLicensing #PharmaceuticalStrategy
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Licensing deal volume was down, yet value was up in H1 2024. Discover how this trend is reshaping the competitive landscape in drug development. Download the #PharmaDeals H1 Review of 2024 to find out more https://bit.ly/4gNZQrl #PharmaLicensing #PharmaceuticalStrategy
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TODAY! Join us for the free Expert Insights webinar: Type II Drug Master Files for Early-Stage, Small Molecule, Drug Development. ?? Have questions on managing administrative components, regulatory documentation, and holder obligations of Type II DMFs? ?? Face challenges determining what CMC information is sufficient for each phase of the investigation? ?? Lack clarity on how to navigate the industry requirements for organizing the DMF content to ensure technical compliance with FDA’s Submissions Standards Catalog? Answering these questions is an esteemed panel of regulatory minds, including Margaret Studzinska, Christine A. Clarke, PhD and Sandra Atkins. Don't miss out - This is your last chance to register: https://hubs.li/Q02qHXw80 #DMF #DrugMasterFile #DrugDevelopment #eCTD #RegulatorySubmission #Pharma
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We just released our July Pipeline Report! ??? This comprehensive report offers insights into recent drug approvals, products on our radar, and more! ????Get your hands on the full report: https://bit.ly/4frsUEg #pipelinereport #newmedications #fdaapproved #specialtypharmacy
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We just released our July Pipeline Report! ??? This comprehensive report offers insights into recent drug approvals, products on our radar, and more! ????Get your hands on the full report: https://bit.ly/3A2wTXA #pipelinereport #newmedications #fdaapproved #specialtypharmacy
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In this webinar, by International Society of Pharmacometrics , our Martin Bergstrand, Ph.D. presents how MIDD can support new drug applications, from informing trial design, to providing evidence of the drug’s safety and effectiveness for regulatory decision-making. Register via ISOP’s homepage, see link below. #pharmaceutical #sciencecommunication #lifesciences #drugdevelopment
Join us for the next webinar in the MIDD Webinar Series on June 19th! ?? June's Session: "MIDD to Support New Drug Applications" ?? Wednesday, June 19th, 12 noon ET ???? Presenter: Martin Bergstrand Learn more about the speaker and register now: https://buff.ly/3wWc6E3 The MIDD Webinar Series is a series of webinars focused on shaping the future of drug development and regulatory decision-making.
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4 Drug Development Strategies To Accelerate Commercialization https://buff.ly/4a9nqL1 #drugdevelopment #clinicaldevelopment #clinicaltrials
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Are you navigating the complexities of regulatory submissions? At MMS, we’re here to help! Our expert team specializes in providing tailored support to streamline your submission process and ensure compliance. With our in-depth knowledge and experience, we’ll guide you every step of the way. Don’t go it alone - reach out to me today and let’s work together to achieve your regulatory goals! #RegulatoryAffairs #Compliance #MMS #Pharma #Biotech
Do you need global submissions support that spans the entire spectrum of regulatory requirements, from the Investigational New Drug (IND) application stage through to the New Drug Application (NDA) stage? MMS has the experts for you. From the initial IND phase, where we guide you through the complexities of early-stage clinical trials, to the NDA/BLA/MAA phase, where we compile and submit robust evidence for product safety and efficacy, MMS offers unparalleled support. Connect with a submissions expert here: https://hubs.li/Q02Sw75J0 #NewDrugApproval #NDA #BLA #MAA #Pharma #Biotech #MedicalDevice
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? How can we revolutionize drug approvals and speed up innovation? After analyzing 20 years of FDA drug approvals, we've uncovered the hurdles in drug development: ?? How can we generate trustworthy efficacy data faster to keep up with accelerated approvals? ?? How can drug developers prioritize their portfolios more effectively? ?? How can we better collaborate with regulators to provide them with the right tools for decision-making? The EMA’s qualification of #SV95C as a primary #digitalendpoint for #clinicaltrials paves the way for better answers to these less attention-grabbing questions and for a silent (r)evolution in drug development. At Sysnav Healthcare, our mission is to provide meaningful real world data to accelerate medical progress.
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QA and Research Manager
6 天前Hi Shawn, is this recorded?