Sat.Nov 18, 2023

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MRNA-1083 by Moderna for Influenzavirus B Infections: Likelihood of Approval

Pharmaceutical Technology

MRNA-1083 is under clinical development by Moderna and currently in Phase III for Influenzavirus B Infections.

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SLAS 2024 International Conference and Exhibition

Drug Discovery World

SLAS 2024 International Conference and Exhibition will take place in Boston, MA, US from 3-7 February 2024.

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LuAG-09222 by H. Lundbeck for Migraine: Likelihood of Approval

Pharmaceutical Technology

LuAG-09222 is under clinical development by H. Lundbeck and currently in Phase II for Migraine.

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Which pharmaceutical companies have the most drug patents in Russian Federation?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Russian Federation. Patents must be filed in each country (or, in some cases regional patent office) where patent protection… The post Which pharmaceutical companies have the most drug patents in Russian Federation? appeared first on DrugPatentWatch - Make Better Decisions.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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BB-1701 by Bliss Biopharmaceutical (Hangzhou) for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer): Likelihood of Approval

Pharmaceutical Technology

BB-1701 is under clinical development by Bliss Biopharmaceutical (Hangzhou) and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer).

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BB-1701 by Bliss Biopharmaceutical (Hangzhou) for Metastatic Transitional (Urothelial) Tract Cancer: Likelihood of Approval

Pharmaceutical Technology

BB-1701 is under clinical development by Bliss Biopharmaceutical (Hangzhou) and currently in Phase II for Metastatic Transitional (Urothelial) Tract Cancer.

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Risk adjusted net present value: What is the current valuation of TScan Therapeutics’s TSC-200-A0201?

Pharmaceutical Technology

TSC-200-A0201 is a gene-modified cell therapy commercialized by TScan Therapeutics, with a leading Phase I program in Metastatic Ovarian Cancer.

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Risk adjusted net present value: What is the current valuation of TScan Therapeutics’s TSC-200-A0201?

Pharmaceutical Technology

TSC-200-A0201 is a gene-modified cell therapy commercialized by TScan Therapeutics, with a leading Phase I program in Metastatic Ovarian Cancer.

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Risk adjusted net present value: What is the current valuation of Rocket Pharmaceuticals’s RPA-501?

Pharmaceutical Technology

RPA-501 is a gene therapy commercialized by Rocket Pharmaceuticals, with a leading Phase II program in Glycogen Storage Disorders (GSD).

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Rilzabrutinib by Principia Biopharma for Acquired (Autoimmune) Hemolytic Anemia: Likelihood of Approval

Pharmaceutical Technology

Rilzabrutinib is under clinical development by Principia Biopharma and currently in Phase II for Acquired (Autoimmune) Hemolytic Anemia.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Mirikizumab by Eli Lilly and Co for Crohn’s Disease (Regional Enteritis): Likelihood of Approval

Pharmaceutical Technology

Mirikizumab is under clinical development by Eli Lilly and Co and currently in Phase III for Crohn's Disease (Regional Enteritis).

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Risk adjusted net present value: What is the current valuation of Celltrion’s Aflibercept Biosimilar.?

Pharmaceutical Technology

Aflibercept Biosimilar. is a fusion protein commercialized by Celltrion, with a leading Phase III program in Diabetic Macular Edema.

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Risk adjusted net present value: What is the current valuation of Celltrion’s Aflibercept Biosimilar.?

Pharmaceutical Technology

Aflibercept Biosimilar. is a fusion protein commercialized by Celltrion, with a leading Phase III program in Diabetic Macular Edema.

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Tusamitamab ravtansine by Sanofi for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval

Pharmaceutical Technology

Tusamitamab ravtansine is under clinical development by Sanofi and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma).

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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APHD-012 by Aphaia Pharma for Pre-Diabetes/Impaired Glucose Tolerance: Likelihood of Approval

Pharmaceutical Technology

APHD-012 is under clinical development by Aphaia Pharma and currently in Phase II for Pre-Diabetes/Impaired Glucose Tolerance.

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MRNA-1083 by Moderna for Influenza A Virus, H1N1 Subtype Infections: Likelihood of Approval

Pharmaceutical Technology

MRNA-1083 is under clinical development by Moderna and currently in Phase III for Influenza A Virus, H1N1 Subtype Infections.

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MRNA-1083 by Moderna for Influenza A Virus, H3N2 Subtype Infections: Likelihood of Approval

Pharmaceutical Technology

MRNA-1083 is under clinical development by Moderna and currently in Phase III for Influenza A Virus, H3N2 Subtype Infections.

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Risk adjusted net present value: What is the current valuation of F. Hoffmann-La Roche’s Basmisanil?

Pharmaceutical Technology

Basmisanil is a small molecule commercialized by F. Hoffmann-La Roche, with a leading Phase II program in Dup15q Syndrome.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Risk adjusted net present value: What is the current valuation of F. Hoffmann-La Roche’s Basmisanil?

Pharmaceutical Technology

Basmisanil is a small molecule commercialized by F. Hoffmann-La Roche, with a leading Phase II program in Dup15q Syndrome.

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Risk adjusted net present value: What is the current valuation of Kymera Therapeutics’s KT-413?

Pharmaceutical Technology

KT-413 is a small molecule commercialized by Kymera Therapeutics, with a leading Phase I program in Primary CNS Lymphoma.

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Risk adjusted net present value: What is the current valuation of Bavarian Nordic’s PXVX-0317?

Pharmaceutical Technology

PXVX-0317 is a subunit vaccine commercialized by Bavarian Nordic, with a leading Phase III program in Chikungunya Fever.

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BB-1701 by Bliss Biopharmaceutical (Hangzhou) for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

BB-1701 is under clinical development by Bliss Biopharmaceutical (Hangzhou) and currently in Phase II for Solid Tumor.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Risk adjusted net present value: What is the current valuation of Biomea Fusion’s Icovamenib?

Pharmaceutical Technology

Icovamenib is a small molecule commercialized by Biomea Fusion, with a leading Phase II program in Type 2 Diabetes.

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Risk adjusted net present value: What is the current valuation of Biomea Fusion’s Icovamenib?

Pharmaceutical Technology

Icovamenib is a small molecule commercialized by Biomea Fusion, with a leading Phase II program in Type 2 Diabetes.

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Risk adjusted net present value: What is the current valuation of Moderna’s MRNA-3705?

Pharmaceutical Technology

MRNA-3705 is a gene therapy commercialized by Moderna, with a leading Phase II program in Methylmalonic Acidemia.

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Risk adjusted net present value: What is the current valuation of Moderna’s MRNA-3705?

Pharmaceutical Technology

MRNA-3705 is a gene therapy commercialized by Moderna, with a leading Phase II program in Methylmalonic Acidemia.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Amphotericin B by Cystetic Medicines for Cystic Fibrosis: Likelihood of Approval

Pharmaceutical Technology

Amphotericin B is under clinical development by Cystetic Medicines and currently in Phase I for Cystic Fibrosis.

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Tusamitamab ravtansine by Sanofi for Endometrial Cancer: Likelihood of Approval

Pharmaceutical Technology

Tusamitamab ravtansine is under clinical development by Sanofi and currently in Phase II for Endometrial Cancer.

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PF-07257876 by Pfizer for Non-Small Cell Lung Carcinoma: Likelihood of Approval

Pharmaceutical Technology

PF-07257876 is under clinical development by Pfizer and currently in Phase I for Non-Small Cell Lung Carcinoma.

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Tusamitamab ravtansine by Sanofi for Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

Tusamitamab ravtansine is under clinical development by Sanofi and currently in Phase II for Colorectal Cancer.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.