NPR Health - Shots
MARCH 4, 2023
Heumann was instrumental in pushing to expand the civil rights of Americans with disabilities and continued to advocate for disability rights around the globe. She died on Saturday at age 75.
Pharmaceutical Technology
MARCH 4, 2023
XNW-4107 is under clinical development by Evopoint Bioscience and currently in Phase III for Ventilator Associated Pneumonia (VAP). According to GlobalData, Phase III drugs for Ventilator Associated Pneumonia (VAP) have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how XNW-4107’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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NPR Health - Shots
MARCH 4, 2023
The 20 states where Walgreens won't sell mifepristone include some where abortion remains legal. It's not clear whether other retail pharmacies will follow suit. (Image credit: Michael M.
Pharmaceutical Technology
MARCH 4, 2023
Vebreltinib is under clinical development by Apollomics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Vebreltinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
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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
STAT News
MARCH 4, 2023
NEW ORLEANS – Esperion Therapeutics’ cholesterol-lowering drug saves people from heart attacks, according to a study released Saturday. But can that save Esperion? The oral medicine, Nexletol, is not potent enough at lowering cholesterol to be a first choice for preventing cardiovascular problems. But it is approved for people who won’t, because of real or perceived side effects, take one of the statin drugs, which are cardiologists’ first line of defense against chol
Pharmaceutical Technology
MARCH 4, 2023
TRGFT-201 is under clinical development by Orca Biosystems and currently in Phase III for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase III drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 4, 2023
VE-818 is under clinical development by Vedanta Biosciences and currently in Phase I for Graft Versus Host Disease (GVHD). According to GlobalData, Phase I drugs for Graft Versus Host Disease (GVHD) have an 89% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how VE-818’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MARCH 4, 2023
TRGFT-201 is under clinical development by Orca Biosystems and currently in Phase III for Myelodysplastic Syndrome. According to GlobalData, Phase III drugs for Myelodysplastic Syndrome have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how TRGFT-201’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for KALYDECO Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier.… The post New patent for Vertex Pharms drug KALYDECO appeared first on DrugPatentWatch - Make Better Decisions.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
MARCH 4, 2023
VE-800 is under clinical development by Vedanta Biosciences and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how VE-800’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for KALYDECO Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier.… The post New patent for Vertex Pharms drug KALYDECO appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MARCH 4, 2023
Treprostinil SR is under clinical development by Camurus and currently in Phase II for Raynauds Disease. According to GlobalData, Phase II drugs for Raynauds Disease have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Treprostinil SR’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for SYNJARDY+XR Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are six… The post New patent for Boehringer Ingelheim drug SYNJARDY XR appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
MARCH 4, 2023
Vebreltinib is under clinical development by Apollomics and currently in Phase II for Renal Cell Carcinoma. According to GlobalData, Phase II drugs for Renal Cell Carcinoma have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Vebreltinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for SYNJARDY Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are seven patents… The post New patent for Boehringer Ingelheim drug SYNJARDY appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MARCH 4, 2023
TRGFT-201 is under clinical development by Orca Biosystems and currently in Phase II for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia). According to GlobalData, Phase II drugs for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia) have a 23% phase transition success rate (PTSR) indication benchmark for progressing into Phase III.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for LILETTA Liletta is a drug marketed by Medicines360 and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Medicines360 drug LILETTA appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
MARCH 4, 2023
Vebreltinib is under clinical development by Apollomics and currently in Phase II for Non-Small Cell Lung Cancer. According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 39% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Vebreltinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for TRIJARDY+XR Trijardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fifteen… The post New patent for Boehringer Ingelheim drug TRIJARDY XR appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MARCH 4, 2023
TRGFT-201 is under clinical development by Orca Biosystems and currently in Phase III for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia). According to GlobalData, Phase III drugs for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia) have a 79% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for TRIKAFTA+%28COPACKAGED%29 Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Vertex Pharms drug TRIKAFTA (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
MARCH 4, 2023
Vebreltinib is under clinical development by Apollomics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Vebreltinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for EMERPHED Emerphed is a drug marketed by Nexus Pharms and is included in one NDA. It is available from one supplier. There are four patents… The post New patent for Nexus Pharms drug EMERPHED appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MARCH 4, 2023
TRGFT-201 is under clinical development by Orca Biosystems and currently in Phase III for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase III drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for OPZELURA Opzelura is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are eleven patents… The post New patent for Incyte Corp drug OPZELURA appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharmaceutical Technology
MARCH 4, 2023
VE-818 is under clinical development by Vedanta Biosciences and currently in Phase I for Graft Versus Host Disease (GVHD). According to GlobalData, Phase I drugs for Graft Versus Host Disease (GVHD) have an 89% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how VE-818’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
BioSpace
MARCH 4, 2023
Industry Seeks to Stimulate Innovation Through Grant Programs 5/3/2023
Pharmaceutical Technology
MARCH 4, 2023
TRGFT-201 is under clinical development by Orca Biosystems and currently in Phase III for Myelodysplastic Syndrome. According to GlobalData, Phase III drugs for Myelodysplastic Syndrome have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how TRGFT-201’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
BioSpace
MARCH 4, 2023
Pfizer Cuts Mid-Stage Candidates Amid Declining Revenues 5/3/2023
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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.
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