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Important update! The FDA just released an alert update to the guidance on biosimilars, detailing additional tools to be taken in consideration when demonstrating their interchangeability with the reference product!" Press the following link for the full guidelines https://lnkd.in/gQbmU6AZ Are you struggling with keeping pace? We are here to help you align with the latest guidelines. 𝐂𝐨𝐧𝐭𝐚𝐜𝐭 𝐮𝐬 𝐡𝐞𝐫𝐞: https://lnkd.in/d_8jYVxw #pharma #Biotech #Biopharma #regulatoryaffairs #regulatorycomplience

The Certara U.S. Market Access team's research on the Inflation Reduction Act (IRA) and its impact on Biosimilar uptake is currently featured as an Editor's Choice in Fierce Pharma. If you're developing biosimilar products, we can help with strategic guidance on access and reimbursement. In addition, our drug development experts can help you design clinical trials that meet regulatory standards for showing biosimilarity to the reference product. Looking for more information on biosimilar drug development best practices? Check out our blog, 'What are biosimilars & how are they developed?' https://lnkd.in/egf-Pgk9

Thoughts on this? >> Takeda signs option deal for TKI inhibitor; Enveda's $55M raise >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharmaceutical #healthcare #pharma #productmarketing

Join Dr. Chia-Hua Maggie Ho, D.Phil., in conjunction with the Taiwan Bio Industry Organization and the Maryland Department of Commerce for a virtual talk on entering the U.S. medical products market. For more information visit https://lnkd.in/enMNYmDv. Learn more about Dr. Maggie Ho, Amarex Taiwan Vice President and COO, at https://lnkd.in/ej9xdSnW. #cro #clinicalresearch #clinicaltrials #fda #fdaapproval #maryland #Taiwan #marylandbusiness #productdevelopment #regulatoryaffairs #biotech #biotechnology #pharma #pharmaceutical #medicaldevice #reseachanddevelopment #drugdevelopment

Speed is crucial in drug development, but it must go hand-in-hand with quality. Rushed methods can derail your timeline. Quick thinking and adaptability are key to staying on course. Partner with those who prioritize speed, quality, and flexibility. Explore the benefits of speed in our industry https://hubs.la/Q02NwNCM0 #Biotech #Pharma #DrugDevelopment #CRO #Turnaround

Thoughts on this? >> #ASCO24: With a promising new Keytruda contender, Summit prepares to spar with Merck >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #productmarketing #biotech #pharmaceutical #healthcare

It's almost here!!! Looking forward to seeing you at this educational event! The first episode of Crystal Pharmatech Formulation Forum - "Overcoming Poor Solubility and Dissolution of Insoluble Molecules" is going to be streamed on April 17 at 2 PM EDT. For Registration: https://lnkd.in/eZTXvYzA #drugdevelopment #formulationdevelopment #drugproduct #researchanddevelopment

Thoughts on this? >> Takeda signs option deal for TKI inhibitor; Enveda's $55M raise >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #biotech #pharma #healthcare #pharmaceutical

Delve into the world of small molecules, biologics, and the latest addition of ATMPs (Advanced Therapy Medicinal Products) at the 8th CCP Summit. By combining real-world case studies and practical business insights, this forum aims to provide a definitive answer to the question of why continuous processing is essential. The ultimate goal is to expedite the production of high-quality drug products and improve speed-to-market through the implementation of end-to-end continuous manufacturing processes. 📍 March 26-28, 2024 | Boston, MA, USA 🌟 Register by Friday January 19, to save up to USD 850! Our experts in continuous manufacturing will be on hand to discuss Dec's latest innovations and present on day one, March 27 at 3:30 pm :   Reducing API development time with Continuous Rapid API Development Systems & Modular Type Packages (MTP)   by Simon Coleman - Isolation and Drying Product Manager ALCONBURY WESTON LIMITED (AWL) Dec Group ✅ Information & Registration: https://lnkd.in/e_644pt #decgroup #continuousmanufacturing

Do you want to learn how to navigate the nuances of #PreclinicalDevelopment and associated #CMC work for #ATMPs? 🚀 ...we have the answer to you❗❗ You can find myself representing our Pharmaron Lab and Manufacturing Services at #AdvancedTherapiesEUROPE in Portugal from the 10th to the 12th of September (from tomorrow on). We wait for you on the #InnovationZone...just look for the #Pharmaron logo and will be happy to have a chat about your ongoing programs and how we can help you succeed 😊 #CRO #CDMO #biotech #pharma #ATMPs #AdvancedTherapies