US Pharmacopeia’s Post

Despite an abundance of guidance documents and papers, #manufacturers still face many #nonclinical challenges when developing complex #biological #products. This article from David Jones in the #January issue of #RegulatoryRapporteur provides guidance on the #nonclinical #safetyevaluation of #biologicalproducts as well as key considerations and challenges. Read it online now 👉 https://lnkd.in/eRX5EMv5 #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. The January edition focuses on #biologics and how #regulators are navigating the complexities involved in manufacturing these #innovative products.

𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐬𝐭𝐬 𝐨𝐧 𝐭𝐡𝐞 𝐕𝐞𝐫𝐠𝐞 𝐨𝐟 𝐑𝐞𝐯𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐚𝐫𝐲 𝐃𝐞𝐧𝐭𝐚𝐥 𝐑𝐞𝐠𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐨𝐧 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧 The first human tooth regrowth pharmaceutical is poised to commence clinical trials involving human subjects within the upcoming months, potentially as early as September of this year. Should these trials prove successful, it is anticipated that the drug will be made commercially available to the general public prior to the year 2030. The drug, developed by a team of Japanese researchers, will undergo its initial clinical phase, spanning 11 months, involving a cohort of children aged 2 to 7 years with congenital agenesis of four permanent teeth. Subsequently, the trial will progress to a phase involving individuals who have lost 1 to 5 teeth due to environmental factors. This groundbreaking pharmaceutical innovation operates by effectively neutralizing the activity of a specific protein gene known as USAG-1. This protein engages in interactions with other proteins, thereby impeding the natural process of tooth development. Through the targeted inhibition of USAG-1, a pathway is effectively established, facilitating the remarkable regrowth of teeth. #tooth_regrowth #gene_inhibition #dental_regenerastion

🚀 Breaking News: Biogen's QALSODY® Nears Approval for Revolutionary ALS Treatment in EU 🌟 Biogen Inc. announced the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND). Biogen licensed QALSODY from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement. QALSODY was discovered by Ionis. QALSODY® (tofersen) is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production. The U.S. Food and Drug Administration granted accelerated approval for QALSODY to treat amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. Leveraging our #Patent Analytics module, we have identified Biogen as the top patent owner treating Amyotrophic lateral sclerosis. However, Ionis Pharma company is making significant strides, currently sitting at the fifth position. 💡 With GlobalData's #Patent module, we offer specialized expertise in the #pharmaceutical industry. Our unique blend of #data, #insights, and #analytics ensures a tailored approach, delivering comprehensive answers to specific patent-related inquiries. 🧠💼 Empower your understanding with our precise and insightful deliverables – because innovation deserves nothing less! 💪 #HealthcareRevolution #amyotrophicleteralsclerosis #ALS   #LouGehrigdisease  #PatentExcellence  #EMA To learn more about our Patent capabilities or to have a chat, just drop us an 📧 email at patents@globaldata.com or ☎ contact us here>>> https://lnkd.in/deGad__f and we will get in touch! #patent #biogen #als #pharma

🌐🧬 Excited to share that I presented my E-poster on "IMPACT OF CYP2C19 GENETIC POLYMORPHISM ON POPULATION PHARMACOKINETICS OF SERTRALINE IN SOUTH INDIAN PATIENTS" at the three-day international conference on Global Collaboration in Pharmaceuticals. 🎓 This insightful study explores precision medicine in pharmacokinetics, shedding light on tailored treatments for diverse patient populations. 🌍 Honored to contribute to the dialogue on bridging borders and breaking barriers in pharmaceutical research. #PrecisionMedicine #Pharmacogenomics #GlobalCollaboration 📊🔬

"BIOTECHMED" Forum Kicks Off in Sochi: Spotlight on Cutting-Edge Solutions in the Pharma Industry Today, the city of Sochi transforms into a hub of pivotal discussions and innovations in the pharmaceutical sphere, welcoming participants to the "BIOTECHMED" forum. The event zeroes in on contemporary trends and challenges of drug production, medical devices, and integrating the latest technologies into the industry. IPharma, part of the "ChemRar" Group and a proactive leader in clinical research, is taking an active role in this annual forum. Experts from the “ChemRar” Group will share their professional insights and experience during panel discussions, fostering knowledge exchange and skill-sharing with industry peers, and establishing new strategic partnerships. Key focus areas of the forum include:  • Sustaining technological sovereignty in the pharmaceutical field;  • Ensuring biological safety and developing threat control methods;  • Crafting and developing drugs with the latest innovations in cellular and gene therapy;  • Shaping a digital healthcare system to meet the needs of doctors and patients;  • The "Pharma-2030" program and its impact on the industry’s future #BIOTECHMED #PharmaceuticalIndustry #Innovation #MedicalTechnology #BiologicalSafety #DigitalHealthcare #Pharma2030 #ClinicalResearch #IPharma #ChemRar #Sochi #HealthcareSolutions

CBER chief says pilot program will justify increasing reviewer headcount - Regulatory Focus >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #competitivemarketing #pharma #biotech

🔬 Raw Material Considerations for Advanced Therapies In the realm of advanced cell and gene therapies, raw materials are vital for ensuring product safety, efficacy, and quality. Here are some key points to consider: - US FDA Regulatory Guidance emphasizes the importance of reagents and ancillary materials in manufacturing processes, such as cell growth and differentiation. These materials, including fetal bovine serum and monoclonal antibodies, can impact safety, potency, and purity, highlighting the need for rigorous qualification and testing. https://lnkd.in/drQX_MKE - EU Directive 2001/83/EC defines materials used during active substance manufacturing, like culture media and growth factors, as raw materials. Ensuring their quality is crucial for product integrity. https://lnkd.in/dMx_86ab - ISO Standard ISO/TS 20399-1 Biotechnology categorizes materials that contact cell or tissue products during processing as critical for product quality assessment. https://lnkd.in/dNb623UA -Implementing a robust quality risk management approach for raw material qualification is essential. Guidelines from the European Pharmacopoeia and the US Pharmacopoeia offer valuable insights in this regard. https://lnkd.in/dwbtZ_v7 Remember, meticulous attention to raw material selection and testing is key to the success of advanced therapies! 🌟 #Biotech #Pharma #QualityAssurance #CDMO #Gene #DNA #science #medical #genetics #healthcareinnovation #medicalresearch #healthcare #genetherapy #celltherapy #celltherapies #genetherapies #scienceresearch #medical #healthcareinnovation #medicalresearch #healthcare #biotech #scienceandtechnology #medtech #healthtech #technologyinnovation

Prime Medicine showcases its first in vivo editing data in monkeys and mice >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #biotech #healthcare #productmarketing

𝗩𝗶𝗿𝗮𝗹 𝗩𝗲𝗰𝘁𝗼𝗿 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 𝗠𝗮𝗿𝗸𝗲𝘁 𝟮𝟬𝟮𝟰-𝟮𝟬𝟯𝟭. 𝗚𝗹𝗼𝗯𝗮𝗹 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗥𝗲𝗽𝗼𝗿𝘁 The report provides a comprehensive overview of the Viral Vector Development Service industry chain, offering insights into the market status of key players such as Pharmaceutical Manufacturers (Retroviral Vectors, Lentiviral Vectors) and Biotechnology Companies (Retroviral Vectors, Lentiviral Vectors). It delves into the development of this sector, examining cutting-edge technologies, patents, applications, and market trends. Regionally, North America and Europe are experiencing stable growth, driven by governmental initiatives and increased consumer awareness. Meanwhile, Asia-Pacific, notably China, emerges as the global leader in the Viral Vector Development Service market, propelled by robust domestic demand, supportive policies, and a resilient manufacturing base. x𝗧𝗼 𝗞𝗻𝗼𝘄 𝗙𝘂𝘁𝘂𝗿𝗲 𝗦𝗶𝘇𝗲 𝗮𝗻𝗱 𝗗𝗲𝗺𝗮𝗻𝗱 𝗼𝗳 𝗩𝗶𝗿𝗮𝗹 𝗩𝗲𝗰𝘁𝗼𝗿 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 𝗠𝗮𝗿𝗸𝗲𝘁. 𝗥𝗲𝗾𝘂𝗲𝘀𝘁 𝗳𝗼𝗿 𝗥𝗲𝗽𝗼𝗿𝘁 𝗦𝗮𝗺𝗽𝗹𝗲 𝗣𝗗𝗙: https://lnkd.in/dx28WmGT *𝗕𝘆 𝗧𝘆𝗽𝗲: Retroviral Vectors, Lentiviral Vectors, Adenoviral Vectors, Adeno-associated Viral Vectors, Others Viral Vectors *𝗕𝘆 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Pharmaceutical Manufacturers, Biotechnology Companies, Research Institutes *𝗕𝘆 𝗥𝗲𝗴𝗶𝗼𝗻: North America, Europe, Asia-Pacific, South America, Middle East & Africa *𝗕𝘆 𝗞𝗲𝘆 𝗣𝗹𝗮𝘆𝗲𝗿𝘀: FUJIFILM Diosynth Biotechnologies, Sanofi, Spark Therapeutics, Inc., uniQure, MassBiologics, FinVector Oy, Thermo Fisher Scientific, Brammer Bio, Cell and Gene Therapy Catapult, COBRA BIOLOGICS LIMITED #ViralVectorDevelopment #GeneTherapy #Biotechnology #Pharmaceuticals #LentiviralVectors #RetroviralVectors #InnovationInHealthcare #MedicalTechnology #MarketAnalysis #BiotechTrends #AsiaPacificHealthcare #NorthAmericaHealthcare #EuropeHealthcare #HealthcareIndustry #AdvancedTherapeutics #MedicalResearch #LifeSciences #InfectiousDisease #HealthcareInnovation #DrugDeliveryTechnology

𝐈𝐧𝐭𝐞𝐫𝐩𝐫𝐞𝐭𝐢𝐧𝐠 𝐒𝐚𝐦𝐞𝐧𝐞𝐬𝐬 𝐨𝐟 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐔𝐧𝐝𝐞𝐫 𝐭𝐡𝐞 𝐎𝐫𝐩𝐡𝐚𝐧 𝐃𝐫𝐮𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 Read article here: https://lnkd.in/eEqEgS_S 📞Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #genetherapy  #consulting #fda  #quality #compliance #qualityassurance #regulatoryaffairs