Mon.Dec 25, 2023

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Opaganib by RedHill Biopharma for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval

Pharmaceutical Technology

Opaganib is under clinical development by RedHill Biopharma and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma).

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Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use

JAMA Internal Medicine

This randomized clinical trial examines whether an intensive food-as-medicine program can improve glycemic control and ,1rengagement with preventive health care compared with usual care among adults with diabetes and food insecurity.

Medicine 106
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Ribociclib succinate by Novartis for Oligodendroglioma: Likelihood of Approval

Pharmaceutical Technology

Ribociclib succinate is under clinical development by Novartis and currently in Phase II for Oligodendroglioma.

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Drug Patent Expirations for the Week of December 24, 2023

Drug Patent Watch

COREG CR (carvedilol phosphate) Woodward Patent: 7,268,156 Expiration: Dec 27, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com… The post Drug Patent Expirations for the Week of December 24, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Efineptakin alfa by NeoImmuneTech for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Efineptakin alfa is under clinical development by NeoImmuneTech and currently in Phase II for Solid Tumor.

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Top 3 Podcast Episodes of the Year

Pharmaceutical Commerce

This year’s PC Podcast episodes ranged in topic, from DSCSA compliance to pharmacovigilance.

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Which pharmaceutical companies have the most SPCs in Finland?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Finland. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Finland? appeared first on DrugPatentWatch - Make Better Decisions.

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HCW-9218 by HCW Biologics for Ovarian Cancer: Likelihood of Approval

Pharmaceutical Technology

HCW-9218 is under clinical development by HCW Biologics and currently in Phase I for Ovarian Cancer.

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Cabometyx by Exelixis for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

Cabometyx is under clinical development by Exelixis and currently in Phase II for Gastric Cancer.

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ZB-131 by ZielBio for Gallbladder Cancer: Likelihood of Approval

Pharmaceutical Technology

ZB-131 is under clinical development by ZielBio and currently in Phase II for Gallbladder Cancer.

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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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ION-537 by Ionis Pharmaceuticals for Metastatic Castration-Resistant Prostate Cancer (mCRPC): Likelihood of Approval

Pharmaceutical Technology

ION-537 is under clinical development by Ionis Pharmaceuticals and currently in Phase I for Metastatic Castration-Resistant Prostate Cancer (mCRPC).

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Cusatuzumab by OncoVerity for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

Cusatuzumab is under clinical development by OncoVerity and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia).

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Durvalumab by AstraZeneca for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

Durvalumab is under clinical development by AstraZeneca and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia).

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Magrolimab by Gilead Sciences for Metastatic Transitional (Urothelial) Tract Cancer: Likelihood of Approval

Pharmaceutical Technology

Magrolimab is under clinical development by Gilead Sciences and currently in Phase II for Metastatic Transitional (Urothelial) Tract Cancer.

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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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Sym-023 by Les Laboratoires Servier for Esophageal Squamous Cell Carcinoma (ESCC): Likelihood of Approval

Pharmaceutical Technology

Sym-023 is under clinical development by Les Laboratoires Servier and currently in Phase I for Esophageal Squamous Cell Carcinoma (ESCC).

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BDTX-4933 by Black Diamond Therapeutics for Central Nervous System (CNS) Tumor: Likelihood of Approval

Pharmaceutical Technology

BDTX-4933 is under clinical development by Black Diamond Therapeutics and currently in Phase I for Central Nervous System (CNS) Tumor.

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Y-101D by Wuhan YZY Biopharma for Metastatic Hepatocellular Carcinoma (HCC): Likelihood of Approval

Pharmaceutical Technology

Y-101D is under clinical development by Wuhan YZY Biopharma and currently in Phase II for Metastatic Hepatocellular Carcinoma (HCC).

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Dabrafenib mesylate by Novartis for Gastrointestinal Stromal Tumor (GIST): Likelihood of Approval

Pharmaceutical Technology

Dabrafenib mesylate is under clinical development by Novartis and currently in Phase II for Gastrointestinal Stromal Tumor (GIST).

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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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BDTX-4933 by Black Diamond Therapeutics for Metastatic Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

BDTX-4933 is under clinical development by Black Diamond Therapeutics and currently in Phase I for Metastatic Colorectal Cancer.

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Zanidatamab by Jazz Pharmaceuticals for Metastatic Biliary Tract Cancer: Likelihood of Approval

Pharmaceutical Technology

Zanidatamab is under clinical development by Jazz Pharmaceuticals and currently in Phase II for Metastatic Biliary Tract Cancer.

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Dupilumab by Regeneron Pharmaceuticals for Atopic Keratoconjunctivitis: Likelihood of Approval

Pharmaceutical Technology

Dupilumab is under clinical development by Regeneron Pharmaceuticals and currently in Phase II for Atopic Keratoconjunctivitis.

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BDTX-4933 by Black Diamond Therapeutics for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

BDTX-4933 is under clinical development by Black Diamond Therapeutics and currently in Phase I for Non-Small Cell Lung Cancer.

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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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Capivasertib by AstraZeneca for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval

Pharmaceutical Technology

Capivasertib is under clinical development by AstraZeneca and currently in Phase III for Triple-Negative Breast Cancer (TNBC).

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Taladegib by Endeavor BioMedicines for Idiopathic Pulmonary Fibrosis: Likelihood of Approval

Pharmaceutical Technology

Taladegib is under clinical development by Endeavor BioMedicines and currently in Phase II for Idiopathic Pulmonary Fibrosis.

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ADCT-901 by ADC Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval

Pharmaceutical Technology

ADCT-901 is under clinical development by ADC Therapeutics and currently in Phase I for Triple-Negative Breast Cancer (TNBC).

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NKTR-255 by Nektar Therapeutics for Diffuse Large B-Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

NKTR-255 is under clinical development by Nektar Therapeutics and currently in Phase III for Diffuse Large B-Cell Lymphoma.

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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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ABSK-021 by Abbisko Therapeutics for Tenosynovial Giant Cell Tumor: Likelihood of Approval

Pharmaceutical Technology

ABSK-021 is under clinical development by Abbisko Therapeutics and currently in Phase I for Tenosynovial Giant Cell Tumor.

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XB-002 by Exelixis for Esophageal Squamous Cell Carcinoma (ESCC): Likelihood of Approval

Pharmaceutical Technology

XB-002 is under clinical development by Exelixis and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC).

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Y-101D by Wuhan YZY Biopharma for Metastatic Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

Y-101D is under clinical development by Wuhan YZY Biopharma and currently in Phase II for Metastatic Colorectal Cancer.

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Nivolumab by Bristol-Myers Squibb for Myelodysplastic Syndrome: Likelihood of Approval

Pharmaceutical Technology

Nivolumab is under clinical development by Bristol-Myers Squibb and currently in Phase II for Myelodysplastic Syndrome.

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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.