Halloran Consulting Group, Inc.’s Post

EU access to oncology medicines lags behind in the Netherlands In the study, funded by the European Fair Pricing Network (EFPN), time-to-patient access was assessed at the hospital level, including those products that entered markets initially under early access programmes. - https://lnkd.in/dSbVUtrQ #pharma #oncology #medicineaccess #marketaccess

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

New oncology drugs: benefits or not ? Could we be measuring such benefits in the wrong way ? Could the PASKWIL criteria (referring to palliative, adjuvant, specific side effects, quality of life, impact of treatment, and level of evidence) prove a much better option in assessing how these novel agents can prove advances ? The case of CDK4/6 agents shows that initiating such as second line treatment for HR+/HER2- advanced breast cancer led to substantial cost savings of approximately €25m over the trial’s duration without compromising clinical outcomes.These findings challenge conventional guidelines recommending upfront use of CDK4/6 inhibitors as first line Illustrated by rational use studies like exploration of efficient drug administration and dosing strategies hold significant potential in reducing healthcare costs while retaining, or even enhancing, patient benefits. https://lnkd.in/eWXZVDsb https://lnkd.in/e2ySuKqb

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

🧬 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.

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

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

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

Did you know that the FDA approved 13 novel anti-cancer therapies in 2023? Read this new blog post to learn about the trends and setbacks in #oncology drug approvals over the last year and what’s on the horizon for the rest of 2024. 🔬 #DrugDevelopment

Today the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). #FDA, #drugdevelopment #Regulatoryscience #cancer