Pharmacodia Global India - Pharmaceutical Intelligence Database’s Post

Level up your patent reports with Pharmacodia Global! Tired of generic patent data hindering your IP strategy? Stop settling for average. Supercharge your patent reports with Pharmacodia Global! #globaldata #pharmaceuticalintelligence #scientificinnovation #competitiveedge #clinicaldata #patents #drugdiscovery #drugapprovals #realtimeinformation #dataanalytics #researchanddevelopment #pharmaceuticalindustry #healthcareindustry #biotech #lifesciences #medtech #digitalhealth #drugdevelopment #healthtech #clinicalresearch #drugdiscoveryresearch #pharmacodiaglobal

Did you know? Successful FDA approval processes often hinge on early, effective collaboration. Better coordination and communication can streamline interactions between regulatory bodies and industry professionals. It's more than just teamwork—it's a formula for success! Learn more about how Stat One can help below. #FDA #healthcarecollaboration #approval #biotech #medtech #FDAapproval #FDAapproved https://lnkd.in/eWCFQc6z

Enabling Quality and On-Time Tech Transfer of a Drug Product Read the article here - https://lnkd.in/dVjxkuHi #DrugDevelopment #CDMOPartnerships #TechTransfer #RegulatoryCompliance

Stop struggling with portfolio diligence! Pharmacodia Global Database provides the detailed portfolio information you need to conduct thorough due diligence. Don't settle for incomplete information. Empower your portfolio with Pharmacodia Global! #globaldata #pharmaceuticalintelligence #scientificinnovation #competitiveedge #clinicaldata #patents #drugdiscovery #drugapprovals #realtimeinformation #dataanalytics #researchanddevelopment #pharmaceuticalindustry #healthcareindustry #biotech #lifesciences #medtech #digitalhealth #drugdevelopment #healthtech #clinicalresearch #drugdiscoveryresearch #pharmacodiaglobal

Nice information for everybody. The article "Impurities management in drug products: A simulated case study" is now available on Regulatory Focus. This is the fourth and last article of the series dedicated to the regulatory management of impurities in both DSs and DPs. Thanks to #Parexel and #RAPS for the opportunity. https://lnkd.in/dtg6mvY4

The CMA is for the first time investigating suspected anti-competitive disparagement, in a case concerning iron deficiency treatments, and the European Commission has a parallel investigation where it has recently started consulting on commitments. What is anti-competitive disparagement, when can this infringe competition law, and what options for redress are available for victims of unlawful disparagement? Jamie Cooke and Richard Whish KC discuss these issues, as well as the reasons why this type of conduct may particularly occur in the pharmaceutical sector although disparagement cases can also arise in other sectors. Watch the full video: https://ow.ly/gjYL50Rvxu1

We are currently evaluating content for a new course on mRNA as a technology platform. Just as a reminder of how relevant this is to the future of medicines and advanced manufacturing, the FDA has now released its draft of "Platform Technology Designation Program for Drug Development, Guidance for Industry" (draft copy for comment only). Page 11 uses "LNP platforms for mRNA vaccine or gene therapy products" as the first example of potential platform technologies: "V. GENERAL CONSIDERATIONS FOR ELIGIBILITY Platform technologies that are appropriate for the designation program are those that meet the definition of a platform technology and the eligibility factors for designation as described in section II.A of this guidance document. Included below are examples of potential platform technologies, with examples of key elements of each technology: Lipid nanoparticle (LNP) platforms for mRNA vaccine or gene therapy products: • Composition, including type, amount, and manufacture of the lipids • Manufacturing process unit operations (e.g., transcribing RNA, synthesizing lipid 386 moieties, and formation of the lipid nanoparticles) that are not sensitive to inputs (e.g., template sequences), and yield consistent outputs across multiple products, and where sequence differences of the mRNA have no effect on product quality­ • Manufacturing process parameters, in-process controls, and equipment critical to manufacture of the mRNA LNP vaccine or gene therapy­ • Process-related impurity clearance across a defined downstream purification process..." Guidance document is currently open for comment and we encourage Australian input. #mRNA #mRNAtechnologyPlatform #advancedmanufacturing

🚀 Exciting FDA Updates on Advanced Manufacturing Tech! 🚀 The FDA’s Advanced Manufacturing Technologies Designation Program just got a boost with the latest draft guidance. If you’re working on innovative manufacturing methods that can improve drug production, this program is something to keep an eye on. Here are the key takeaways: 1. Eligibility: The FDA is looking for novel manufacturing technologies or innovative uses of existing methods that improve product quality and supply chain reliability. 2. Early Engagement: You can now engage with the FDA’s Emerging Technology Team (ETT) early in the process to smooth your path to approval. 3. Streamlined Path: With FDA feedback and prioritization, this program is especially valuable for those addressing critical drug shortages or looking to speed up development. 🗓️ Mark your calendars—final guidance is expected by December 2024! #FDA #AdvancedManufacturing #PharmaInnovation #Biotech #DrugDevelopment References: 1. https://lnkd.in/gTi642vQ 2. https://lnkd.in/gnrCANiU 3. https://lnkd.in/geKvy56G

How to draft broad claims for biological sequences to enhance the scope of protection? 📝 Narrow biological sequence claims can be particularly vulnerable to invalidation if they fail to meet specific patentability criteria such as: 1. Written description, 2. Non-obviousness, and 3. Subject matter eligibility. 🏛 Courts and patent boards have frequently scrutinized the sufficiency of the written description, and non-obviousness of such claims as is evident in: Amgen Inc. vs Sanofi (2017) - the court invalidated Amgen's patents for lack of written description. The claimed sequences were specific to antibodies that lower LDL cholesterol by inhibiting PCSK9. Allowing more variations in a biological sequence patent claim can make the claim broader and more robust, increasing the likelihood of surviving legal challenges and providing more comprehensive protection. ✅ WSLI(https://lnkd.in/gJPGYD2g) outlines 4 different ways to help you draft broader patent claims for biological sequences. ❇ #patentdrafting #patents #patent #patentingbiologicalsequences #biotechnologicalpatents #pharmaceuticalpatents #pharmapatents #patentsearch #patentanalysis #patentcourse #patentanalyst

Are multiple guidelines creating walls of understanding during analysis, synthesis, degradation studies, and eventually setting the limits of impurities? At Pharma Impurity Conclave you will have a chance to dive deeper into the latest regulatory updates, common compliance challenges, and innovative strategies for managing impurities. Don't Miss Out & Register Now: https://lnkd.in/gMdQsYvw #eminencebusinessmedia #ebmpic2024 #eminencegroupventures