Sat.Mar 04, 2023

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STAT+: Esperion Therapeutics’ statin alternative reduces heart attack risk. Is that enough to save the company?

STAT

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

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XNW-4107 by Evopoint Bioscience for Ventilator Associated Pneumonia (VAP): Likelihood of Approval

Pharmaceutical Technology

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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Vebreltinib by Apollomics for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

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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TRGFT-201 by Orca Biosystems for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

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.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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VE-818 by Vedanta Biosciences for Graft Versus Host Disease (GVHD): Likelihood of Approval

Pharmaceutical Technology

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.

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TRGFT-201 by Orca Biosystems for Myelodysplastic Syndrome: Likelihood of Approval

Pharmaceutical Technology

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.

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Treprostinil SR by Camurus for Raynauds Disease: Likelihood of Approval

Pharmaceutical Technology

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.

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Vebreltinib by Apollomics for Renal Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

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.

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TRGFT-201 by Orca Biosystems for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia): Likelihood of Approval

Pharmaceutical Technology

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.

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Vebreltinib by Apollomics for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

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.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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TRGFT-201 by Orca Biosystems for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

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.

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Vebreltinib by Apollomics for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

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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TRGFT-201 by Orca Biosystems for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

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.

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VE-818 by Vedanta Biosciences for Graft Versus Host Disease (GVHD): Likelihood of Approval

Pharmaceutical Technology

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.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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TRGFT-201 by Orca Biosystems for Myelodysplastic Syndrome: Likelihood of Approval

Pharmaceutical Technology

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.

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VE-800 by Vedanta Biosciences for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

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.

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Treprostinil SR by Camurus for Raynauds Disease: Likelihood of Approval

Pharmaceutical Technology

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.