Pharmaceutical-Technology’s Post

Through Project Optimus, the FDA is taking aim at revising dose-ranging studies for oncology drug development. The future of oncology is here! While our team published this article in 2022 when the project was introduced, we've made recent revisions, offering new recommendations and insights. If you are developing an oncology drug, we recommend you collaborate with the FDA and to review the January 2023 guidance shared in this content – it is full of insights and a strong step in a positive direction for patients and industry. https://hubs.la/Q02lYyPQ0 Questions about your oncology development plan and your regulatory strategy? Connect with Halloran. We’re ready when you are. #Oncology #OncologyResearch #DrugDevelopment #ProjectOptimus #FDA #ClinicalTrials

📢 Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5- Year Retrospective Analysis 📍The study shows how the business pipeline meeting platform represents a valuable tool for the developers of medicinal products and provide insight on key challenges in the development of oncology medicines. #ema #medicinalproducts #oncology #businesspipelinemeetingplatform

The cancer drug shortage has been a critical issue, with significant impacts on patient care and clinical trials. Crystal Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network® (NCCN®), highlights the primary causes, including manufacturing issues, supply chain disruptions, and regulatory delays. Watch here! #CancerCare #DrugShortage #Oncology #ClinicalTrials #NCCN #Pharmaceuticals

Excited to share that my latest article on PROTACs in oncology has been featured in the The Economic Times! The global PROTACs market is projected to reach $3.7 billion by 2030. Read more about the future of oncology and the pharmaceutical industry's strides in this space. Out of 39 Phase I-III clinical trials evaluating PROTAC compounds worldwide, only two have reached Phase III clinical trial. #Arvinas is aiming to capture a higher market share by developing several PROTACs, targeting various cancers. Check out the full article here: GlobalData Healthcare https://lnkd.in/eQhWmVWw #Oncology #Pharmaceuticals #PROTACs #cancer #CancerResearch #Biotechnology #Innovation #DrugDevelopment #Healthcare #MedicalResearch #PharmaIndustry #LinkedIn #globaldata #drugdiscovery #TPD #protein

🧬 Celltrion has received approval from the US FDA for IND application for a phase 3 clinical trial of CT-P51, its biosimilar to Keytruda (pembrolizumab). 💉 With this IND approval, Celltrion plans to initiate a global phase 3 clinical trial involving 606 patients with metastatic non-small cell lung cancer (NSCLC). 🌍 The trial aims to demonstrate that CT-P51 is as effective as Keytruda, the original drug.

Merck & Co Inc (NYSE:MRK) announced Friday that its drug Keytruda has been backed by the European Medicines Agency’s Committee for Medicinal Products in Human Use (CHMP) for use in certain patients with biliary tract cancer. The CHMP’s recommendation to approve Keytruda in combination with gemcitabine and cisplatin for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma will now be reviewed by the European Commission for marketing authorization in the European Union, with a final decision expected by the year-end. “The CHMP’s positive opinion brings us one step closer to providing a new immunotherapy regimen, which has shown an overall survival benefit compared to chemotherapy alone, to these patients in the European Union,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research laboratories. More at #Proactive #ProactiveInvestors #NYSE #MRK #Merk http://ow.ly/HeTI1050Xew

Oncology Drug Development - Navigating The Timeframe Dynamics Oncology trials can be fast, just 5 months longer than others. Smart tactics like targeted therapies and FDA pathways can speed things up. Non-oncology trials are measured due to crowded markets and regulations. Here's a Strategy: explore rare diseases, innovate trial designs. Read more on the Pharma Leaders Blog. #OncologyTrials #TimeTravel #FluxCapacitor

In our recent blog, Dr Katherine Bowen, Senior Director of Regulatory Affairs, and Dr Julie Warner, Vice President of Regulatory Affairs, explore the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU. Read more: https://lnkd.in/eb2-NtXB #oncology #regulatoryaffairs #US #Europe #oncologydrugdevelopment

TAR-200 could provide a potential less-invasive option in BCG-unresponsive, high-risk non-muscle-invasive bladder cancer. Read more about The Janssen Pharmaceutical Companies of Johnson & Johnson's data below 👇 #clinicaltrials #drugdevelopment #EPRTalks

As we come to a close on #GlobalBiosimilarsWeek, check out our 3-part series exploring how oncology #biosmilars are being used in different global markets. Part 1 focuses on the clinical benefits, price changes, and uptake associated with #oncology biosimilars in China. Part 2 covers a cost-effectiveness analysis regarding oncology biosimilars in France, and part 3 analyzes whether clinical efficacy studies can predict EMA regulatory approvals. 🌍💉🥼 Check out Part 1 here: https://lnkd.in/e97J4xMX