World Courier’s Post

The FDA recently released a 40-page draft guidance offering insights into best practices for common questions received by the Office of Therapeutic Products (OTP). Louis Cicchini, Ph.D., Director of Scientific Affairs and Cell & Gene Therapy, and Cori Gorman, Ph.D., Senior Director of Biopharmaceutical CMC and Regulatory Affairs summarized key points from the draft in a recent Drug Discovery & Development article. Read it here: https://ow.ly/8f6V50UnO69

Pipeline Dynamics, a powerful comparative analysis tool from PharmaCircle, now charts the pharmaceutical industry’s pipeline and market dynamics over the past 10 years. Every year, since 2015, PharmaCircle has taken a snapshot of the pharmaceutical industry to provide our clients with historical comparisons of the ever-changing development pipeline. Now, they can more easily identify new market trends and better visualize the direction that the market is heading for any therapy or disease area.   When did cell therapies first appear in the pipeline? When did gene therapies transition from preclinic to clinic? What is the shift in disease areas, molecule types, and routes over the last decade? How have the market dynamics within a specific indication progressed? These are just a few of the questions that can be answered using Pipeline Dynamics. To see for yourself, schedule your demo at www.pharmacircle.com or email info@pharmacircle.com.  

How does the Pharma and Biopharma CDMO landscape look like in Europe? This infographic gives an overview of the main CDMO players in Small Molecules, Biologics and Cell & Gene therapies. With state-of-the-art facilities and 30+ years expertise in contract development and manufacturing, Merck is a major player in all these fields, supporting programs across multiple modalities and at all stages, from pre-clinical to commercial. You can download the infographic by PharmaSource here: https://lnkd.in/eZszdPfn If you are looking for a CDMO partner for your small molecule program, you can contact our experts here: https://bit.ly/3zIoyrM We can accelerate your drug development and support any of the following programs: HPAPIs, APIs, ADCs, Next-Generation Conjugates, Linker-Payloads, PEGs, or Targeted Protein Degradation.

Genenta Science amended its Development and Master Services Agreement with AGC Biologics for an exclusive GMP suite at AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing of Genenta’s cell therapy product to help ensure cGMP compliance. https://hubs.li/Q031Vqbq0

Thoughts on this? >> Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Portion of Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy in Combination with Tecentriq® in Extensive Stage Small Cell Lung Cancer - PR Newswire >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #competitivemarketing #pharmaceutical #healthcare #biotech

BioPharmSpec, a global CRO, has announced three new European facilities 🏢🏢🏢 ➡️ The new facilities will focus on discovery and R&D services, offering structural and physicochemical characterisation services for a wide variety of biopharmaceutical products. 💬 "The Freiburg, Bergamo and Vilnius sites join our existing UK and US-based facilities to create the BioPharmaSpec Group of companies, serving the global biopharmaceutical industry," said Prof. Howard R. Morris FRS, Founder of the BioPharmaSpec Group of companies. 🗓️ The new laboratories are set to open in January 2025 and will focus on products including monoclonal antibodies, antibody-drug conjugates, cell and gene therapy products, bioactive peptides, oligonucleotides and carbohydrates. #CRO #ContractResearchOrganization #Biopharma

Globally, over 4,000 #CGT therapies are currently in development, with 31 #gene therapies and 68 #non-genetically modified cell therapies already clinically approved. These advancements offer immense hope for patients but also present complex challenges for sponsors. Navigating these challenges effectively is crucial for achieving regulatory approval and clinical success. Achieving success in #cell and #gene therapy development requires not only innovation but also a comprehensive strategy that addresses clinical, operational, and regulatory challenges. At Tigermed, we are committed to supporting our clients through this complex landscape to bring life-changing therapies to patients worldwide. Read on to learn the latest on #CGT drug development, future trends, and how to stand out from the competition: https://lnkd.in/gCxrr2DW

What the Pharma and Biopharma #CDMO landscape look like in North America? This infographic gives an overview of the main CDMO players in Small Molecules, Biologics and Cell & Gene therapies. With state-of-the-art facilities and 30+ years expertise in contract development and manufacturing, MilliporeSigma is a major CDMO player in all these fields, supporting programs across multiple modalities and at all stages, from pre-clinical to commercial. You can download the infographic by PharmaSource here: https://lnkd.in/eZszdPfn If you are looking for a CDMO partner for your small molecule program, you can contact our experts here: https://bit.ly/3zIoyrM We can accelerate your drug development and support any of the following programs: #HPAPIs, #APIs, #ADCs, Next-Generation Conjugates, Linker-Payloads, PEGs, or Targeted Protein Degradation.

The High Cost of Drug Pricing: Unveiling the Profits behind Research Discover the shocking truth behind drug pricing and how it no longer represents the actual cost of research. Dive into the financial influence of big pharmaceutical companies seeking disproportional profits, as new gene therapies for cancer and rare diseases continue to skyrocket in price. #DrugPricingRevealed #PharmaceuticalProfits #GeneTherapy #CancerTreatment #RareDisease #MedicalResearch #PharmaceuticalIndustry #HealthcareCosts #PatientAdvocacy #AffordableMedicine

Thoughts on this? >> Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Portion of Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy in Combination with Tecentriq® in Extensive Stage Small Cell Lung Cancer - PR Newswire >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #healthcare #pharmaceutical #biotech #pharma